AN INDEPENDENT SUPPLEMENT FROM MEDIAPLANET ABOUT MULTIPLE SCLEROSIS

MULTIPLESCLEROSIS

26 MARCH 2008

Unpredictable and incurable – the facts about this devastating condition

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Introduction

MS research: hope and theopportunity Multiple sclerosis (MS) is a devastating andincurable neurological condition that affectsaround 85,000 people in the UK. Usuallydiagnosed in the 20s and 30s age group, it is achronic condition that affects three times asmany women as men. It is unique in its range ofsymptoms and unpredictability.

MS can cause grinding fatigue, nervepain, loss of sight and mobility, de-pression, loss of memory, moodswings, incontinence, sexual dys-function and spasticity. The quality oflife of people with MS can be verypoor. People with more severe formsof MS often rate their lives as effec-tively worse than death.

MS damages the central nervoussystem and because of this its symp-toms can fluctuate dramatically.Someone can feel fighting fit one day,only to wake unable to see or get out

of bed the next. This causes majorproblems in working life, as a parent,husband, wife, or friend.

You may have two friends with MS,one who runs marathons from time totime and the other confined to theirbed, unable to eat, wash or move with-out assistance. This is the nature of MS.

We know that people with MS aremore likely to get divorced, lose theirjob, to end up in poverty, take their ownlives, and to die on average five to tenyears earlier than the general popula-tion. Living with a chronic long-term

condition like MS without care or sup-port is a recipe for becoming isolated,dependent on state benefits and – in theworst cases – written off by life.

Working to beat MSAt the same time, many people withMS battle day in and day out to takeit on and fight MS, to try to beat it bystaying in work, to try to beat it bystaying in the family home, andthrough the support of their family,friends and others like them.

There is no good time to get diag-nosed with MS, but, thanks to advancesin our understanding of MS and to de-velopments brought about by medicalresearch, there is a range of therapeuticoptions now avail-able.

And for themany hundreds ofthousands of peo-ple across the UKliving with MS, re-search offers thegreatest hope forthe future.

As the UK’slargest single fun-der of MS researchin the UK, the MS Society is wellplaced to try to turn this hope into re-ality. In the past three years we havetrebled our annual commitment toMS research. More than £5millionwill be invested this year, mostlymoney raised through the support ofthousands of volunteers and donors.

The money we contribute adds to agrowing pool of MS investmentworldwide. The UK government, thepharmaceutical industry and otherMS charities from the UK and over-seas are putting unprecedentedamounts of expertise and effort intobeating MS. We all need to work to-gether to ensure that we make thebest use of our shared knowledge.

CONTENTS

What is multiple sclerosis? 4

Living with MS 5

Current MS diseasemodifying drugs explained 6

MS risk-sharingscheme 7

Causes of MS 8

Childhood MS 9

Future MS therapies 10 -11

MULTIPLE SCLEROSIS A TITLE FROM MEDIAPLANET

Project manager: Kerren TriffonEditor: MS Society Production Manager: Katherine WoodleyDesign: Sherine Barnes/James WhitePrepress: Jez MacBeanPrint: News International

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MULTIPLE SCLEROSIS

Shedding light on the scienceThis supplement aims to shed morelight on where MS research standsand what lies ahead. Research intoMS offers scientists at all levels amassive and complex challenge.While there will never be the moneyfor MS that attracts to cancer andother common conditions, there arepassionate, committed researchersworking across the world to try tocrack MS.

The main drive is always ultimatelytoward finding a cure and we willcontinue to devote significant moneyto this, but there is a need for a meas-ure of realism. The complexity of thecondition – it affects the single most

complex area ofthe human body,the central nerv-ous system –means a cure re-mains a distantprospect.

There is realhope of develop-ing much moreeffective treat-ments for peoplediagnosed with

MS. Many MS experts believe thatwithin our lifetimes MS will be a con-dition that remains long-term but islargely treatable. As an example,many people with diabetes who wouldhave faced losing limbs and even theirlives a few decades ago now live rel-atively normal lives through betterdrug treatments and management.

With MS it seems likely that early di-agnosis and intervention with a combi-nation of drug therapies, physiotherapyand exercise, good diet, counselling andquality social care will be the answer. Toput this package together we need tounderstand the many faces of this enig-matic, devastating disease and the keyto this is research.

“With MS,early diagnosis

will be theanswer”

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What is MS?MULTIPLE SCLEROSIS

How MS causes damage to the nerv-ous systemTo understand what happens in MSyou need to understand the basics ofthe body’s central nervous system (thebrain and spinal cord). The brain con-trols bodily activities, such as move-ment and thought, and the spinalcord is the main pathway for thesemessages between the body and thebrain.

Surrounding and protecting thenerve fibres of the central nervous sys-tem is an insulating substance calledmyelin, which helps messages travelquickly and smoothly from the brainto the rest of the body.

MS is an autoimmune condition.This means that the immune system,which normally helps to fight off in-fections, mistakes its own tissue for aforeign body and attacks it. In MS theimmune system attacks the myelinsurrounding the nerve fibres. It alsoattacks myelin-making cells, knownas oligodendrocytes. The process ofstripping myelin from nerve fibresleaves scars, known as lesions,plaques, or sclerosis. Magnetic reso-nance imaging (MRI) scanning canshow some of the damage MS causes.

Without this layer of insulation, thenerve fibres do not work properly. Atfirst they may simply not be able totransmit signals as fast as they should.This can make movement slow orclumsy or can reduce a person’s abil-ity to think clearly. Initially the body isable to replace the damaged myelin, aprocess known as remyelination, butover time this repair process fails. Intime the nerve fibres themselves

become damaged and nerves begin tofail to conduct impulses.

Throughout the course of MS nervefibres start to degenerate and, as timegoes on, myelin damage becomesmore extensive. This loss becomesmore noticeable in the symptoms aperson experiences. It is this damageand ultimate loss of nerve fibres, sim-ilar in effect to an electrical wire grad-ually wearing away with time, whichmeans the messages no longer get

through. This process is thought to beresponsible for the slow progressiveincrease in disability experienced bypeople with progressive forms of MS.

To clear up a few common miscon-ceptions, it’s worth pointing out that– although incurable – MS is not aterminal illness. Like diabetes, it’sknown as a ‘chronic condition’ so itneeds to be managed for life. Mostpeople with MS live a normal lifespan, with perhaps a five to ten yearreduction in life expectancy. This dif-ference is being eroded with advancesin medical management.

MS is also not a muscle wasting dis-ease. While its effects on the centralnervous system can cause muscledamage through lack of use, the sameeffect can be seen if your leg is in plas-ter for six weeks after a break. Physio-therapy and other types of care canhelp with this.

Different types of MS and futureprognosisHealth care professionals will oftentalk about different types of MS,which give a broad picture of howsomeone’s MS is likely to behave.These may give only a general out-look, but can be helpful to understandwhen trying to explain MS to others.

Relapsing remitting MS Most people with MS (around 60 percent) are first diagnosed with relaps-ing remitting MS. This means theyexperience a relapse or flare up ofsymptoms (also known as an attackor exacerbation) followed by remis-sion (a period of recovery). A relapseis usually defined as the appearanceof new symptoms, or the return of oldsymptoms, for a period of 24 hours ormore, at least 30 days since the startof any previous relapse.

Relapses can take a few days to de-velop and can last for days, weeks ormonths. Symptoms can be mild or se-vere. In relapsing remitting MS,symptoms can disappear completelyduring remissions.

All the current licensed MS treat-ments in the UK are for relapsing re-mitting MS. You can read more aboutthese later in the supplement.

Secondary progressive MS Many people who start out with re-lapsing remitting MS later develop aform that is known as secondary pro-gressive MS and around 40 per centof people with MS live with this formof the condition. In secondary pro-gressive MS, symptoms do not goaway completely after a relapse andthere is an underlying increase in dis-ability over time.

The current disease modifying drugsfor MS may be used in people withsecondary progressive MS who con-tinue to experience relapses, but spe-cific treatments for this type of MShave not yet been developed.

People with secondary progressiveMS are encouraged to look at othertypes of therapy – including physio-therapy, counselling, better diet andmore – to manage their symptoms.The lack of a drug option does notmean people with secondary progres-sive MS should assume there is noth-ing out there for them.

Primary progressive MSPrimary progressive MS is a relativelyunusual form of MS which tends to bediagnosed in older people and affectsmen and women equally. From the out-set those with primary progressive MSexperience steadily worsening symp-toms and an increase in disability.Symptoms may level off for a time, ormay continue to worsen. Approximately10 to 15 per cent of people with MShave the primary progressive form andthere are no licensed treatments. Thera-pies to relieve symptoms as well as carefrom a multi-disciplinary team of health

profesionals are very important for thelong-term care of people with this typeof MS.

‘Benign’ MSPeople with relapsing remitting MSwho only have a small number of re-lapses, followed by a complete recov-ery, may be described as havingbenign MS. It is only possible to makea diagnosis of benign MS once a per-son has experienced little or no dis-ability for a period of 10 to 15 yearsand around 10 per cent of people withMS have a benign form. However, adiagnosis of benign MS does notmean they will be free of problems; arelapse may occasionally occur aftermany years in which the MS has beeninactive.

SYMPTOMS OF MSMS can affect people verydifferently depending on whereand how damage takes place andone of the most frustrating aspectsof the condition is itsunpredictability – not knowingwhat symptoms may arrive, when,or how long they will last. A lot ofinformation about MS can onlygive an idea of averages, looking athow it affects large numbers ofpeople in general.

Common symptoms include:

• fatigue – an overwhelming sense of tiredness making physical or mental activity difficult and, for some, impossible

• balance problems and vertigo - walking difficulties, problems with coordination

• visual problems – blurred or double vision, temporary loss of sight in one eye or both

• numbness or tingling – commonly in the hands or feet

• pain – sometimes mild, sometimes severe

• loss of muscle strength and dexterity

• stiffness and spasms – tightening or rigidity in particular muscle groups

• sexual dysfunction• anxiety, depression or mood

swings• cognitive problems – difficulty

with memory and concentration

• speech problems – slurring, slowing of speech, or changes in pitch or tone

• incontinence – a lack of control over bladder or bowel functions

“There is anunderlyingincrease in

disability withtime ”

What is multiple sclerosis?

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Living with MS MULTIPLE SCLEROSIS

Living with MS Taking part in clinical trials or using new MStreatments can make a huge difference topeople’s lives. There are a range of treatments onoffer, but here two people with MS speak abouttheir experiences over the past two years.

Karen Ayres was diagnosed withmultiple sclerosis in 2002, aged 24.Shortly after her diagnosis Karenagreed to take part in a pioneeringdrugs trial which turned her lifearound.

“My symptoms started when I fellover in a nightclub, I laughed aboutit at the time but the following day Iexperienced a loss of sensation onone side of my body which graduallydeveloped into a heavy, sluggishfeeling.

“A few weeks later I could barelywalk and I was admitted to hospitalwhere tests proved inconclusive. Iwas discharged but three days latercollapsed unconscious; when I wokeup in hospital I was completely paral-ysed from the neck down.

“I was quickly transferred to theWalton Centre, a neurological hospital

in Liverpool, where I was diagnosedwith multiple sclerosis. That’s when Imet neurologist Dr Boggild who askedme to take part in a pioneering newdrugs trial. I agreed immediately andstarted the treatment.

“I received the chemotherapy drugMitoxantrone by drip for six monthsand then a daily injection of the drugCopaxone. While taking the treat-ment, I completely regained the use ofmy body.

“Six years later, the drugs trial hasturned my life around. I now inject adaily dose of Copaxone, it’s some-thing I have come to accept and does-n’t interfere with my lifestyle.Probably the most remarkable thingis that I haven’t had a single relapse.

“I am so thankful I was introducedto these drugs and that I am under thecare of Dr Boggild. Copaxone isn’t

suitable for everyone with multiplesclerosis, but taking part in the trialhas proved to be the best thing I haveever done.”

Caroline Haynes, 44, can trace thefirst symptoms of MS back to 1993when she suffered problems with hereyesight. Then a bladder collapse in2000 and feelings of depressiongreatly affected her confidence andher performance at work as a HotelManager.

It was after an optician’s appoint-ment when Caroline was referred to aneurologist that lesions on her brainand spine led to a diagnosis of MS inNovember 2001.

“I’d had three vicious relapses be-fore I was offered the chance to takepart in a two and a half year Tysabriclinical trial at Kings College hospitalunder Dr Eli Silber. I started takingthe drug and soon realised I actuallyfelt good – a lot of the symptoms hadstopped like the tingling, the numb-ness, the pins and needles, the awfulburning sensation, the aches andpains that you get in your legs, inyour arms. They all disappeared.

“In fact for two and a half years, Iwas completely in remission. All theMRI scans I had during the trialshowed that nothing had changed butwhen the trial stopped, I had a relapse.

I realised I couldn’t live without thedrug and I wanted it back.

“Other treatments for MS can in-volve daily injections but I hate nee-dles. Having the drugs by infusionsuits my lifestyle, if I had the choicebetween going into hospital for an in-fusion or injecting the drugs at home– I would always opt for the hospital;you know it’s being done properly.

“There are risks associated withTysabri but they’ve been very well doc-umented and explained to us. I think youjust have to make an informed decision;I fortunately have had a great experiencewith Tysabri and will not look back.”NICE has now agreed to make Tysabriavailable to those people with MS whoneed it as a result of the clinical trialsprocess in which Caroline was involved.

The prescription is only the start

PHARMACEUTICALS LTD

� Karen Ayres

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Modifying drugsMULTIPLE SCLEROSIS

Current MS disease modifying drugs explainedThe current range of disease modifying drugsdecrease the rate and severity of MS relapses andthere are also drugs to provide relief fromsymptoms. A range of more powerful drugs arein development, bringing a greater need tobalance the benefits and risks of treatments withpotential side effects.

MS research is opening up new fieldsof therapies and we will look at someof those in more depth later, but formany people with MS there is now agenuine range of treatment options atthe point of diagnosis and beyond.

Disease modifying drugsThe core MS therapies in use today arethe disease modifying drugs (DMDs). Al-though not a cure, they act to reduce thenumber of MS relapses by around athird. They may also reduce the severityof relapses. Whether DMDs are able toslow the rate of disability progression inthe long term is still open to question.

The four main DMDs are the beta-in-terferons (Avonex, Rebif and Betaferon)and glatiramer acetate (Copaxone).They are all given by injection, at home,either under the skin or into the muscle.Injections are daily, every other day,three times a week, or weekly, depend-ing on which drug is used.

Interferons are substances producedby the body to regulate the immunesystem. The beta-interferon drugswork by diminishing the activity of thespecific white blood cells thereby re-ducing the potential for autoimmuneattack of the myelin sheath. Glatiramerworks to modify the immune processthat causes MS.

Some research suggests that theearlier these drugs are used, the betterthe potential long-term benefits. Thisreinforces the importance of early di-agnosis of multiple sclerosis, and theneed for someone with multiple scle-rosis to be referred to a neurologist orMS nurse at the earliest appropriateopportunity.

These four drugs are available toadults on the NHS for those who meetcertain criteria set down by the Asso-ciation of British Neurologists (ABN).The NHS has agreed to pay for thedrugs for anyone who meets these cri-

teria, under a scheme known as the‘Risk-sharing Scheme’.

Another disease modifying drug,natalizumab (Tysabri) is not part ofthe Risk-sharing Scheme, but is ap-proved for use on the NHS for peoplewith ‘severe, highly-active relapsingremitting MS’. This is the only MSdrug to have been judged cost effec-tive by the National Institute ofHealth and Clinical Excellence (NICE).

In two-year clinical trials Tysabri re-duced the relapse rate in people with MSby around two-thirds. It also showedpromise against long-term disabilityprogression. It works in a different wayto the other DMDs, preventing inflam-matory immune cells from entering thecentral nervous system.

Tysabri, which is given by a once-monthly infusion, has demonstratedbetter treatment results but is not suit-able for everyone with relapsing remit-ting MS. While Tysabri is very effective

there are also some rare but very seri-ous side effects associated with thisdrug. People living with MS and healthprofessionals have a challenging timeahead in working out how to assessrisks and decide on the best treatment.

Steroids and mitoxantroneAmong a range of other non-licensedtreatments used in MS are steroidsand a powerful immune suppressantcalled mitoxantrone.

Steroids are commonly used to treatan attack of neurological symptoms –either the first episode, or later re-lapses. Although they do not alter thecourse of the condition, steroids reduceinflammation in the central nervoussystem and speed up recovery. Theycan have some unpleasant side effectsbut are a relatively safe option. It’s im-portant to note that these steroids(known as ‘corticosteroids’) are some-times used by athletes to build muscle.

Mitoxantrone is not licensed forMS but is available for use. It is mostoften used for people with aggressiverelapsing remitting or secondary pro-gressive MS. Mitoxantrone is a pow-erful immune system suppressantused to treat some forms of cancer. Itappears to be most effective where re-lapses are a key feature of a person’sMS. It is often used for people whocontinue to have severe relapses de-spite treatment with beta interferon orCopaxone.

Clinical trials suggest mitoxantronecan reduce the frequency of relapsesin relapsing types of MS by up to 80per cent, although it is not beneficialfor everybody. Treatment with mitox-antrone is usually limited to two tothree years in order to prevent poten-tial toxic effects on the heart. Severalstudies are looking at mitoxantrone incombination with other treatments,such as Copaxone.

SATIVEXSativex is a cannabis based medi-cine that is currently taken as anoral spray by around 1,200 peoplewith MS in the UK. This drug canhelp to relieve pain, spasticity, blad-der problems and problems withsleeping. It is approved as a pre-scription medicine in Canada and iscurrently undergoing late stage clin-ical development in Europe and theUnited States.

Doctors in the UK can prescribeSativex for individual patients if theybelieve it will be of benefit to peoplewho have not gained adequate relieffrom existing treatments, but the de-cision as to whether or not to fund thedrug is at the discretion of the Pri-mary Care Trust.

More than 85,000 people in the UK havemultiple sclerosis. For those affected thediagnosis has a major impact on their lives;they have to learn how to live with an unpre-dictable disease, the cause of which is notfully known.

In the fight against multiple sclerosisBayer Schering Pharma brought to marketone of the first therapies approved for thecondition. We also continue to investigatenew therapies in the area.www.bayerscheringpharma.co.uk

Providing HopeFighting Multiple Sclerosis

Science For A Better Life

NICE stepped in and ruled that al-though they worked, they were not acost-effective use of NHS resources.

The MS Society and other MS char-ities contested thedecision and, as aresult, the Depart-ment of Healthlaunched the Risk-sharing Scheme in2002. This was astatutory directionto ensure that any-one with MS whomet the Associationof British Neurolo-gists’ criteria shouldget the drugs. It stillstands.

Although thescheme is not aclinical trial, acore part of it isthe monitoring ofa cohort of 5,000people with MS toevaluate the cost-effectiveness of thedrugs over 10 years. The MS Trust isresponsible for administering thescheme, which is a partnership be-tween government, the pharmaceuti-cal industry and MS charities.

The first results from this cohort,based on two full years of data, aredue to be published in a peer-re-viewed scientific journal in mid-2008.

The theory behindrisk-sharing is that ifthe drugs do notperform accordingto expectations, theprice of the drugswill alter to reflectthis. In effect theNHS and relevantp h a r m a c e u t i c a lcompanies are shar-ing the financial riskover the provision ofthe drugs.

The Risk-sharingScheme has alsoseen the establish-ment of nearly 100MS prescribing cen-tres across the UKand the introductionof around 200 MS

nurses to the NHS. These expertnurses are part funded by the NHSand part by the pharmaceutical com-panies. Around 100 of the nurses de-pend on charitable funding from theMS Society.

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Risk-sharing scheme MULTIPLE SCLEROSIS

The drugs beta interferon and glatiramer acetate were first made available in the UKin the 1990s but they rapidly becamesynonymous with the ‘postcode lottery’ inthe health service. People with MS whoneeded them were being turned away ongrounds of cost.

“The Risk-sharing

Scheme hasseen the

establishmentof about 100

MSprescribingcentres”

The MS Risk-sharing Scheme

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CausesMULTIPLE SCLEROSIS

What causes MS? The causes of MS remain a mystery. While a number of pieces of thejigsaw have fallen into place in recent years, there is still a long way to gobefore we can say with any certainty why some people get MS and othersdon’t and many questions remain.

Genes – does MS run in the family?Genes play only a small part in deter-mining who gets MS. For example, ifone twin of an identical pair has MSthere is only a 30 per cent chance thatthe other twin will also develop it. Ifgenes were wholly responsible thiswould be 100 per cent. This meanscertain genes can make you more sus-ceptible, but they are far from the fullstory.

Around one in every 800 people inthe UK develops MS. Where one par-ent has MS the chances of a child de-veloping MS are higher, but still verysmall: about one in 50. Furthermore,the severity of MS progression withinfamilies can vary, suggesting otherfactors also play a part.

Rates in women on the increaseIn the past few decades there has beena significant increase in the rate of re-lapsing remitting MS among womenwhile the rate among men has stayedthe same. A recent study found thatthe female to male ratio has increasedfrom around one to one (reported inScotland in the 1950s) to more thanthree women for every man. This has

happened in too short a time for it tobe explained by genetic changes butit is not clear what is actually respon-sible.

Is MS triggered by a virus?MS can occur in geographical clusters,

which suggests there may be an infec-tious agent (e.g. a virus) involved. Oneclassic case was in the Faroe Islands,where MS was rare before the SecondWorld War. During the war troops fromareas with higher rates of MS were sta-tioned on the Faroes and rates rose

steeply, before falling again over time.More than 20 viruses have been impli-cated as having some role to play in MS,including the Epstein-Barr virus whichcauses glandular fever, but none deci-sively. It is important to note, however,that these viruses are common in thegeneral population and do not cause MSin themselves.

The higher the latitude, the higher theriskGeography has a strong influence onrates of MS. In Scotland and North-ern Ireland, rates appear to be twiceas high as in England, and the further

you are from the equator, the morelikely you are to be affected. The UK,Scandinavia, Southern Australia andCanada have much higher rates of MSthan places like Ecuador and Malaysiawhere it is almost unheard of.

When people migrate from coun-tries with a low risk of MS to some-where with high risk as adults, theyretain a low risk of developing MS.But if they migrate as children or

adolescents, their risk increases. So,for example, people from Pakistanand India who moved to England be-fore the age of 15 have a greater riskof acquiring multiple sclerosis thanthose who moved after that age. First-generation African-Caribbean immi-grants to the UK have a much lowerincidence of MS than second-genera-tion immigrants (i.e. their children).This suggests that where you live as achild and the environment you areexposed to play an important role.

Diet and MSThere are claims that diet is a factor insusceptibility to MS and a number ofstudies have looked at a possible con-nection between what people eat andMS. One early study found that therewere higher numbers of people withMS living in rural regions than on thecoast. Investigations showed coastaldwellers ate more fish and consumedless saturated fat, but a number ofstudies since then have thrown up arange of contradictory results andthere is no clear answer.

Sunlight and vitamin DAnother theory is that vitamin D de-ficiency can cause MS. Vitamin D isobtained from the diet and made inthe body after exposure to sunlight.This is consistent with the higherprevalence of MS in northern coun-tries, where the winter sun is notstrong enough to produce adequateamounts of vitamin D and so there issome evidence to suggest that vitaminD may play a protective role againstdeveloping MS.

Coming soon – the MS Society UK MS Register The MS Society has estimated that there are atleast 85,000 with MS in the UK, but the simplefact is that no-one is sure.

As a result, 2008 will see the launchof the MS Society UK MS Register.This will initially be a pilot project ina number of regions but will lead tothe first attempt to establish the ex-tent of MS nationwide.

This isn’t just a question of wantingto know for the sake of it. Instead, thereis a huge appetite to know for a num-ber of practical reasons relating to re-search, to clinical trials, and to healthand social care service provision.

In the first place MS is an expensivecondition. From the drugs available,through to the impact on the economyfrom people losing the ability to work,the need to claim benefits and more,MS has a range of social and economicimpacts. Only by knowing how manypeople it is affecting and where, can

local and national government allo-cate resources effectively.

MS researchers are always keen toknow more about the prevalence andincidence of MS. The more they knowabout its patterns, its progression andlong-term prognosis, the better theycan direct avenues of investigation.Understanding MS is the key to beat-ing it.

The MS Society UK MS Register willseek to answer these questions when itis formally launched later in 2008.

Work is underway to ensure that theRegister delivers effective data andthat the personal details of everyonetaking part are fully protected. Withthe right safeguards and methodologyin place the benefits for people withMS could be significant.

“A number ofstudies havethrown up

contradictoryresults ”

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Childhood MS MULTIPLE SCLEROSIS

Childhood MS – diagnosis and treatmentMS has traditionally been thought of as an adultcondition, but it is now becoming apparent thatchildren and teenagers can also be susceptible.Of the estimated 85,000 people with MS in theUK, perhaps as many as five per cent willdevelop MS before the age of 16 – that’s up to4,250 young people.

So, although MS is not common inchildren, it has been known to affectchildren as young as two years oldand there are hundreds, possiblythousands, of children living with alargely unrecognised condition.

Children can be affected with manyof the same symptoms as adults suchas fatigue, problems with balance orvision, stiffness and spasms, anxiety,depression or mood swings, speechproblems and incontinence. Cogni-tive problems – having difficulty withmemory and concentration – may bemore common in children with MSthan in adults, an issue which can af-fect school or university studies if theright support and adjustments are notmade available.

MS is a condition that affects thewhole family. It can affect communi-cation, relationships and daily inter-actions. Children may also exhibit arange of emotions and behaviourssuch as aggression, denial, depression

and anxiety as a reaction to the diag-nosis and brothers, sisters and parentscan find it just as difficult to adapt tolife with a long-term condition.

Like in adults, MS in children is dif-ficult to diagnose, with no single de-finitive test – and the difficulties canbe amplified with children. Symptomsthat are mild and quickly pass mightbe missed or not reported by childrenthemselves; even more obvious orprolonged symptoms may be put

down to other conditions more com-mon in children.

A diagnosis of MS normally requires

two or more attacks of symptoms, atleast a month apart, but second at-tacks, if they ever happen, can be

months or years away, so diagnosingMS from the first symptoms is usuallynot possible. Meanwhile, the uncertainwait, for child and family, continues.MS-like symptoms can turn in tomany other things or nothing at all,and although with hindsight manyadults can trace the origins of the con-dition back to their childhood, manyother people may indeed have just asingle attack of neurological symp-toms, which never return.

MS is difficult to predict and variesfrom person to person, so saying ex-actly how it will affect each child isnot possible. Almost all children de-velop relapsing remitting MS, withperiods of good, if unpredictable, re-covery. Some children can be moreseverely affected, but progressiveforms of the condition are rare inchildren.

Many drug treatments used for MSare not licensed specifically for thecondition and are even less likely tobe licensed specifically for children.So drugs are commonly prescribed ona ‘named-patient’ basis, where indi-vidual prescriber and patient agree tothe possible risks of using a drug notlicensed for MS. But though doctorscan tailor appropriate doses for chil-dren and theoretically prescribe in thesame way as for adults, access to the‘disease modifying drugs’ (beta inter-ferons and Copaxone) can be delayedby arguments over funding.

Talking senseabout science

When the subject of these reports are‘cures’ or ‘miracle treatments’ forchronic diseases like multiple sclero-sis – for which there is currently nocure – affected people and those con-cerned about them need to know the‘facts’ behind the headlines and whatit means for them.

Sense About Science is a registeredcharity that responds to the misrepre-sentation of science and scientific ev-idence on issues that matter to society.

We have been working with the MSSociety to help equip people withneurological diseases with thetools, scientific insights andreasoning they need to makesense of claims that are publicisedin the media and in advertisementsonline.

Is it evidence-based?Evidence-based medicines are thosethat are rigorously assessed to make

sure that they are bothsafe and effective.Assessing medi-cines and treat-

ments in thisway safe-guards pa-tients from

fraudulent andpotentially very

damaging “treatments”on offer. From our dis-cussions with the MS

Society, other patientgroups, and with doctors andscientists, we identified some

key problems that lead people touse therapies that are not

based on rigorous and ob-jective evidence from re-search. Among these isthe problem that somepeople will buy into

therapies because noproven alternative exists; whilst

others are misled into believing thatmarketed therapies are evidence-based.

But rather than offering “patientchoice”, therapies that sell hope without

scientific evidence to back up theirclaims can cause real harm, mislead andmisinform. So how can people judgewhich claims should be taken seriously?Which treatments are scientificallyvalid, and which have not been checkedby other scientists?

In the first place, it is useful toknow that there is a system calledpeer review,used by scien-tists to decidewhich researchresults appearvalid. Here, sci-entific researchis subjected toscrutiny byother inde-pendent ex-perts (peers)before they arepublished. Overone million pa-pers about sci-entific research are published inscientific journals worldwide annu-ally. It is important to know whetherone set of results is reproducible andwill stand up to further testing. How-

ever, many of the claims that are inthe newspapers, magazines and onthe internet have not been publishedin a peer-reviewed journal, whichmeans that other scientists can’tcheck them. Unpublished researchmay be just an opinion and is morelikely to be flawed, so decisions aboutsafety or health benefits cannot be

based upon it.The status of re-

search results is asimportant as thefindings themselves.Peer review is an es-sential arbiter of sci-entific quality andbegins the process ofother scientists con-sidering the size andapproach of thestudy and where itsits in a wider bodyof evidence. With somany “miracle-cure”

stories flying about in the press, nomatter how compelling or excitingnew scientific or medical research is,always ask whether it has been peer-reviewed – and if not, why not?

“Like in adults,MS in children is

difficult todiagnose with no

single test”

Could goat’s blood cure multiple sclerosis? Canheavy snoring cause Alzheimer’s? Does redwine protect you against lung cancer…orincrease your risk of bowel cancer? And aresuper-foods still super? Developments inscience and medicine frequently make thenews headlines and enter public discussion.

“Many of theclaims havenever beenpublished in

scientificjournals ”

Prof Giovannoni says he believesCladribine has potential to revolu-tionise current therapy methods avail-able to people with MS.

“The main advantage of oralCladribine is that it is administeredorally for only 10 or 20 days per year.If oral Cladribine is shown to be effec-tive and safe, intermittent oral dosingwill provide a more convenient alter-native to the current injectable thera-pies and will improve adherence totherapy.” The results of the trial are ex-pected in 2009.

Other oral treatments for relapsingremitting MS which effect the im-mune system include Fingolimod,which has shown more than a 50 percent reduction in relapse rates com-pared to a placebo, and Laquinimodwhich has shown a 40 per cent dropin the number of MS lesions, com-pared to a placebo as measured byMRI. Phase III trials are currently un-derway for both these therapies.

A number of pharmaceutical com-panies are also carrying out phase IIand III trials into oral versions of therecently licensed drug Tysabri, whichis currently only available as an intra-venous infusion given once every fourweeks.

In terms of preventing progressivedisability there are several promising

agents in late stage clinical trials. Thenovel cancer and rheumatoid arthritisdrug Rituximab has also shown bene-fits when administered to people withMS and a large-scale clinical trial ofRituximab is ongoing in people withprimary progressive MS

Campath is licensed in the UK forthe treatment of a type of leukaemia. Itis currently being tested in clinical tri-als for the treatment of relapsing re-mitting MS. It is given as anintravenous infusion and works bysuppressing certain immune cells.

In relapsing remitting MS, first yearresults from a phase II clinical trial inpeople who had been newly diagnosedshowed at least a 74 per cent reductionin the risk of relapse, when comparedto people treated with beta interferon.However, study results to date alsoshow it is able to reduce disability ac-cumulation by more than 70 per centover three years inpeople with relaps-ing remitting, MScompared to betainterferon thera-pies. UnfortunatelyCampath has notbeen shown to beeffective at reduc-ing disability pro-gression for peoplewho have alreadydeveloped second-ary progressive MS.

Two large phaseIII clinical trials ofCampath are now underway.

There are benefits and risks associ-ated with all therapies and these needto be carefully considered before anytreatments are begun. MS is an ex-tremely unpredictable condition and itis difficult to say how and when anyindividual will be affected. It cantherefore be difficult to judge howbeneficial a treatment will be for anindividual.

It is important to consider that thetherapies being trialed for MS haveonly been researched and studied fora relatively short period of time. The

Some potential therapies which arecurrently being trialled are discussedbelow, however there is in-depth infor-mation about many more potentialtreatments and trial results on the MSSociety’s website www.mssociety.org.uk.

Oral therapies are particularly desir-able as they are potentially easier forpeople with MS to use as a long termtherapy, avoiding injections and asso-ciated side effects such as injection sitereactions.

is an oral therapy which is effectiveagainst certain immune cells in thebody which are thought to be mis-di-rected in MS to attack myelin. It alsohas a well established safety record inits treatment of other conditions.

Three studies to date in people withboth relapsing remitting and progres-sive forms of MS have indicated thatCladribine may be able to reduce thenumber and size of MS lesions (areasof damage in the central nervous sys-tem of people with MS), as well as re-duce relapse rate and slow disabilityprogression.

Two two-year clinical trials of oralCladribine are now underway, lookingat it as a sole therapy and in conjunc-tion with beta interferon. One of thetrials is headed by chief investigatorProfessor Gavin Giovannoni fromQueen Mary University London.

There is now a strong focus on devel-opment of oral therapies as currentlyall the treatments for relapsing remit-ting MS rely on injections. Therapieswhich reduce long-term disabilityprogression are much needed and areconsequently receiving increasing re-search attention. There is also a con-siderable unmet need for treatmentsand therapies to relieve the numerousand often distressing symptomswhich people with MS experience.

Basic laboratory research increasesour understanding of how the bodyworks and how it changes in condi-tions like MS. When this work identi-fies useful targets for treatment andonce substantial tests from a labora-tory indicate a drug or therapy is safe,it is allowed to enter clinical trialswhere it is tested on people. Clinicaltrials are the only way to show if anew therapy is safe, effective and bet-ter than what is currently available. Asa rough guide, a treatment in phase IItrials is still probably five or moreyears away from being available, if allresults continue to remain positive. Adrug or therapy in phase III trials maybe only three or four years away,pending regulatory approval. But allthis can change and there is no easyway to predict time from trials toavailability.

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A range of potential therapies for multiple sclerosis (MS) are workingtheir way through the clinical trial pipeline at the moment.Pharmaceutical companies are now exploring treatments focusing ondifferent stages of the condition.

What lies ahead – future MS therapies

� Basic laboratory research increases ourunderstanding of how the body works andhow it changes in conditions like MS.

field of MS research is relativelyyoung and treatments only becameavailable around ten years ago. Peo-ple with a long term condition likeMS are potentially likely to be takingthese drugs over many years and it isimportant that they are given asmuch information as possible aboutthe effects of these drugs so that theycan make informed decisions abouttheir benefits and risks.

While world class research intotreatments for MS continues, one ofthe most important issues that affectsthe quality of everyday life for peoplewith MS is living with their unpre-dictable and often distressing symp-toms.

The MS Society has begun a newinitiative to fund research into symp-tom relief and has committed £2.5mil-lion over the next three years to fundprojects in this vital area.

MS cancause a widevariety ofsymptoms and,to date, symp-tom relief is anarea of researchwhich has beenu n d e r - e x -plored. Re-search projectsfocusing onpain, fatigue,depression andmany othersymptoms are

currently underway and it is hopedthat ultimately therapies and treat-ments might be designed which allowpeople affected by MS to have morecontrol over their symptoms and a bet-ter quality of life. More informationabout symptom relief research projectscan be found at www.mssociety.org.uk.

The future of MS therapies lookspromising. There are currently morethan 50 ongoing trials for MS treat-ments involving more than 30 differ-ent agents and there is promise thatmore effective, more convenient ther-apies will soon be available.

“It can bedifficult to judgehow beneficial a

treatment willbe for an

individual ”

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The prescription is only the start

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als investigating drug treatmentswhich might be able to protect nervefibres, more than £3 million has beeninvested in new research centres inCambridge and Edinburgh, which areinvestigating the use of adult stemcells along with other techniques toprotect nerve fibres and promotemyelin growth.

The mission for the MS SocietyCambridge Centre for Myelin Repair isto develop new therapies for promot-ing myelin repair and preventingnerve fibre loss in people with MS. Thecentre unites existing expertise in stemcells, brain repair and MS in a focused

programme of work. Professor RobinFranklin, who heads up the centre, be-lieves the research at the heart of the£1.2 million project could one daychange the lives of thousands of peo-ple with MS.

“As with all new and challenging re-search projects, the time scales in-volved are long term,” he admitted.“But these treatments involve workingwith fundamental components of thecentral nervous system and we cannotcut corners. In the long run, this re-search shows great promise and I amconfident the wait will prove to beworthwhile.”

The MS Society Edinburgh Centrefor Translational Research based at Ed-inburgh Royal Infirmary, is an excit-ing and innovative development in theworld of MS research. The structure ofthe Translational Research Centre, di-rected by Professor Charles ffrench-Constant, means that basic scienceresearch can take place alongside clin-ical work, with the added benefit of

links with local MS outpatient services.It is a more streamlined approach toresearch involving active collaborationwith the Cambridge Centre for MyelinRepair to share knowledge and speedthe journey from bench to bedside. It isalso hoped that the Centre will en-courage new methodologies and prac-tices which will spark real progress intreating MS.

In an effort to discover further treat-ments which might benefit people withprogressive forms of MS, the MS Soci-ety has been in discussion with a num-ber of leading neurologists, clinicians,

basic scientists and statisticians in theMS field who are interested in devel-oping therapies to protect nerves andhas formed an MS Clinical Trials Net-work (CTN). The CTN is currently inthe planning stages of a project to as-sess the benefits of certain interven-tions for the treatment of progressiveMS.

While we are several years awayfrom treatments for progressive formsof MS, this, along with other leadingMS research, offers real hope for fu-ture therapies and for people livingwith MS.

Protecting nerves – a newapproach to fighting MS One of the most distressing aspects of MS is theprogressive disability that the majority of peoplewith the condition experience over time. Thishas been shown to be due to damage and loss ofnerve fibres from the earliest stages of thecondition.

Current licensed disease modifyingdrugs do not have any proven bene-fit for people with progressive formsof MS and there are a limited numberof research projects and clinical trialsto develop therapies for treating thisform of the disease.

The MS Society has therefore priori-tised the funding of research investi-gating nerve damage, repair andprotection and steps have been takento address the lack of clinical trials in-vestigating the damage and loss ofnerve fibres (neurodegeneration) andprogressive forms of MS. As well asproviding funding for two clinical tri-