I am at the European Academy of Neurology (EAN) congress in Oslo. It is quite clear that in the message of brain health and the holistic management of MS has moved center stage. Everyone is talking about #BrainHealth.
The emphasis is now on early diagnosis, early effective treatments and maximising brain health as a treatment goal. To do this we need a full toolbox of treatments, new therapies and to manage MS holistically with a focus on the individual with MS.
In terms of getting these messages across Genzyme-Sanofi have commissioned an art installation on their EAN stand; a large brain ice sculpture that is gradually melting over course of the Congress. Embedded in the ice sculpture are items that are meaningful to MSers, for example, a wedding ring to symbolise relationships, a cocktail glass for social activities, a passport for travel, a teddy bear for children and family and various other work and other activity related items. As the ice sculpture melts these items will emerge to remind us why protecting the brain for the individual with MS is so important. On the plinth of the ice sculpture, it states ‘there is no MRI for quality of life’ to remind us that behind every MRI scan is a living person with hopes and aspirations. It is also suggesting that we need a person-focused, and not an MRI-focused, view of MS.
On the stand, there is a photographer who is taking pictures of Congress attendees alongside the ice brain sculpture holding various pledges in connection with brain health in MS. I took a pledge.
My concern is that the regulators, in particular, the EMA and the FDA, don’t see it this way. The EMA is currently reviewing alemtuzumab’s risks and benefits, under an article 20 procedure, to see if it needs to change alemtuzumab’s license. At the moment it has put temporary handcuffs on alemtuzumab recommending that it is only used third-line, i.e. after MSers have failed at least two prior DMTs. The problem I have with this is that the average MSers spends about fours years on each tier of DMT, in addition to the many years lost in the asymptomatic and diagnostic phases of the disease. In other words, most MSers would have had MS for more than 10 years before they can access alemtuzumab 3rd-line. In 10 years many MSers would lose more than 10% of their brain volumes, become cognitively impaired, developed bladder dysfunction and have walking problems; not to mention the impact that undertreated MS has on their social and occupational functioning. Limiting alemtuzumab, our most effective DMT when it comes to ‘normalising’ brain volume loss in MS, to these sorts of patients is wrong and makes no sense.
So a plea to the EMA to think very carefully before taking away the option of using alemtuzumab early in the course of MS.
My interpretation is that we have found ourselves in this article 20 position because the American neurologists are having to use alemtuzumab 3rd-line and later in the course of MS; i.e. in older patients with more comorbidities. This almost certainly explains some of the vascular complications of alemtuzumab. Alemtuzumab was never tested in this population and therefore we don’t really know its risks and benefits in an older more disabled population of MSers.
I predict that if the EMA makes alemtuzumab a 3rd-line agent then we will start to see the same problems the Americans have seen with alemtuzumab. Forcing us to keep our most efficacious DMT for last flies in the face of conventional wisdom and current thinking about how to manage MS.
Another issue I have is that the EMA and FDA think they need to protect MSers from risky therapies and irresponsible neurologists and HCPs. In other words, the regulators don’t trust MSers to be able to make their own decisions about the treatment they receive. In short, the EMA is saying to you that you can’t assess what risks you are prepared to accept and as a result, you can’t choose the most effective DMT 1st-line. I would argue that this is patronising and not in keeping with the wish to empower MSers.
I am sure that if we are forced to stop offering alemtuzumab first-line more of my patients, who can afford it, will seek HSCT and other risky treatments abroad. Is this what we want? I have learnt that all decisions have unintended consequences and the EMA may in fact put more patients at risk of off-label treatments as a result of the unintended consequences of their decision(s) and they will entrench inequalities, i.e. the rich will simply travel abroad to get treated and the poor will be left to fester.
The EMA needs to understand what it is really like to be someone with MS, staring down a barrel playing Russian roulette on low efficacy DMTs, whilst their brains are being irreversibly shredded by MS. The brain is the most precious organ we have and we need to do everything we can protect it so we can have some resilience in old age.
I, therefore, call upon you the MS community to prevent the EMA from handcuffing alemtuzumab and denying neurologists and their patients the option of using alemtuzumab, our most effective DMT, early on in the course of MS. We will all be worse off for not having the option of using alemtuzumab the way we use it now.
CoI: multiple
That’s a great post showing that you try to manage MS holistically and taking into account *everything* that can be foreseen.
Thank you for the post!
Thank you so much for this straight to the point post. As someone who was lucky enough to receive alemtuzumab as a first line treatment, I find it extremely frustrating and unfair that this isn’t the case for everyone. We as an MS community will do everything we can to influence guidelines, but how much of an impact can we really have? I feel that our future is in the hands of the regulators and neurologists, like Gavin who push for better care and treatment options for us. Please tell us what we can do to help ensure we get the most effective treatments and early as possible following diagnosis, as I currently feel we have no say or power to alter decision making.
This impassioned call to arms sounds like the EMA is about to change the label indication to third line. What don’t we know Prof G?
The EMA will make their first response in early July
The EMA sneezes and the TGA catches a cold. Let’s hope the indication remains unchanged for the sake of all MS patients globally.
Prof Gavin, I have MS since 08/2000 and I see my personal case in the words you’ve writen (Rebif, Tysabri and Alemtuzumab (02/2019) maybe too late)
In Portugal I’m trying, with the ms associations and some doctors, to make a change in the approach to treat MS.
We, associations, are open, and willing, to a different, more agressive, approach.
You and your colleagues worldwide could start a “task force” to get this problem solved, I promise you that the ms community will back up all neurologists, at the EAN could be the starting point of this project!!
I want NEDA !!
Thank you for the efforts you make in behalf of the ms community.
P.S. sorry for eventual errors on spelling…
I completely agree with you, and I thank you for trying, but I don’t know what someone like me can do? I’m just an autistic person severely disabled by MS, who is working class, Northern, lacks a formal education and is on benefits. The NHS wouldn’t even let me see a neurologist and get a diagnosis of MS. No one cares what I have to say. I very much want Lemtrada or HSCT, but making it happen is a fight I may well lose.
Very apt post – as I have just been turned down by my neurologist after I requested to be bumped up to a stronger drug (not alemtuzumab) – as my MS symptoms are getting worse. My neuro pointed to my MRI showing no new disease activity in the past year – and no relapses – as the reason to turn me down. And this is not at some regional hospital tucked away in the UK, but at a top London one recognised around the world (not Barts I hasten to add!)
Will continue to push, of course, but it shows you what we – people with MS – are up against.
Rachel
I am also under a major London hospital also not st. Bart’s and I did get alemtuzumab two courses before the new NHS guidelines were introduced ,Blueteq,
I did not have the required active MRI scan although had had one or two relapses but I know now that because of blueteq their hands are tied so that if they cannot tick the boxes and if you don’t fit the exact nice criteria you are excluded.
Lemtrada has been a god send to me. 13 years since first infusion (of two) and no relapses, stable EDSS and no new lesions (last MRI six months ago). Walked the dog for 45 mins this morning. I got Graves Disease (sorted) and vitiligo. A small price to pay for not loosing my mobility (I had highly active MS with disabling relapses) and being a near normal dad to my children. Many at the clinic I attend have had similar experiences. The consultant classifies my MS as inactive (I suppose the equivalent of ‘in remission’ in relation to cancer). As my children have a higher risk of getting MS, I want them to have (hopefully they won’t need it) the same choice as I had – the choice of a near-normal life. The regulators need to look at the positive outcomes, not just the rare more serious side effects. Potential patients should know the pros and cons, and once they have considered the risks, should have Lemtrada as a first line option.
Thanks for your comments. I got the opinion of ProfC to where he thinks the EMA will go. Not long to wait for first response. Some neuros will not touch it with a bargepole.
We need ocrelizumab cladribine HSCT data post diagnosis to see how they fair
Yeah, I’ve just read the first round review available on the EMA website. Given the safety events in question and a perceived inability to adequately mitigate via monitoring, Lemtrada is set to go third line. I can’t see it going any other way. The problem is the Australian TGA takes its lead from the EMA. So, this change will have a global impact. Time for pwMS to start lobbying the regulators.
I I have had MS since 1972 and advanced MS since 2000. I have only had one severe relapse which just came and went and I’m now definitely living with advanced MS. I can see at first hand what the disease has done to my life. Somehow I managed to keep going for many many years and it is only in the last 10 that it has had a profound effect upon my life. I was diagnosed before Alemtuzamab was even on the scene in the 1990s. If I could have been treated with it I would probably still be working.
ProfG, I agree with your thoughts entirely. The NICE guidelines need to reflect current thoughts on ways to stop this disease in its tracks. I missed the boat. It is an option that would never have been made available to me but I have seen the benefits to other people.
You’ve just got to keep on trying to kick down the door but I’m sure you know this already
The contrast between this post and MD’s post yesterday is marked! Yet both have had me well-up due to the hurt and frustration on the one hand and the positivity and poignancy on the other – so clearly represented by the ice brain.
My son returned from Canterbury today and recounted to me the meeting he’d had with a woman fundraising for the MS Society. He explained I am a PwMS and as a result of chatting to her learned she is a lawyer, which has tickled him because he is a trainee solicitor.
She also told him she is 50 years old, was diagnosed 15 years ago, regularly runs 5km in support of the MS Society and significantly that her most recent mri shows signs of disease activity The shock-horror for me was when he told her I’d received Lemtrada and her reply was that she’s never heard of it!!
Is there anyone who doesn’t access this site who truly stands any chance of being able to act as an informed patient?
With MD’s teethnashing on one side and the focus of the EAN on the other, does the Bart’s team see a time in the near future where you won’t be a lone voice in the wilderness? I’m genuinely encouraged by the EAN focus, but hope those attending don’t solely represent preaching to the converted!
Fully supported
I agree with you! I feel proud of you, an important neurologist in the MS world who doesn’t take afraid to say his truth, that is the truth of users early induction treatment for our patients. We could seen the real improvement, not all the MRI. I hope that EMA and FDA listen de real world experience.