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.