My second course of “Lemtrada” is about to start in 4 days time.
To bring you up to date, I was diagnosed with a degenerative neurological condition called Multiple Sclerosis [“MS”] 18 months ago. Because of its aggressive progression, I opted for an aggressive treatment – and had my first bout of chemotherapy treatment in October 2015. The drug of choice was Campath/Lemtrada – and the recommended treatment was for a second dose 12 months later i.e. now.
Trying to understand, yet alone relaying, exactly how the drug works gets me into cognitive deep waters – so probably best just to summarise its processes as a “re-booting” of the immune system. I can liken this to a return to ground-zero – like switching off a frozen laptop – when it turns back on again, the theory is that the bugs will have disappeared. The magic of the human body, or I guess of the laptop in my example above – is that the user doesn’t need to understand how this “fix” happens… it just happens, out of sight, hidden deep within the inner machinations of a body’s atoms, molecules and DNA.
Because I, the patient, cannot truly get my head around the exact details of immunity-replenishment (I soon get lost when told that Lemtrada will be attacking my lymphocytes, monocytes, some dendritic cell populations and, to a lesser degree, natural killer (NK) cells and other leukocytes), I have had to rely on the guidance of my (trusted) neurological consultant, coupled with a bit of high level, largely web-based, research. The problem is that the guidance is not black and white. The treatment has the risk of some potentially very serious side-effects – the decision to commit has to be balancing act between risk and reward; cost versus benefit. It becomes an “elective” medical procedure (e.g. one made by choice) rather than an “acute” one.
For me, despite all the vast wealth of opinions, reports, studies, blogs and pamphlets available, my decision last year to go-ahead with Lemtrada was largely based on the act of the drama that was my 30 minute meeting with my consultant. He was very keen that the decision be ‘mine’ – so I questioned and questioned him about the risks, and the benefits, and then signed-up for Round 1…. soberly so, but confident enough that I had tried to make a decision as dispassionately as possible, about a subject that is just about as emotive, or passionate, as they come.
Last week I signed-up for Round 2.
Having already completed Round 1, you might have thought that this second decision was a foregone conclusion – but the stakes are high, so, in my anxiety, I did feel compelled to re-visit.
At the highest level, nothing has changed:
The “pros” are still based upon the analysis of large data-pools which show that (statistically) MS patients are likely to suffer fewer relapses post-Lemtrada, and have decelerated disability scores – both, very roughly, by a factor of 50% [MS Society].
The “cons”, again, are probability-based. The “chances” of thyroid dysfunction are still ~40% [MS Society]; the risk of something more serious – you can’t get more serious than death – are small, but not zero. More minor side-effects are much more likely, but I still take the view that, if these are short-lived, I can tolerate them if they’re offset by long-term benefits.
But, drill down into the detail, and I’m another 12 months older. With new concerns to fret about.
This last year has followed the same pattern as the preceding 6. During the summer months I was largely in good health. Residual MS symptoms chiselled away, but they were rarely amplified beyond an ongoing background noise.
I rode my bike across the Alps.
But, scroll back to last February and March, I was laid low by the mix of a Lemtrada hang-over, MS fuzziness and winter colds. The most debilitating symptom was a new one: disabling vertigo that brought me to the floor; a spinning head dragging me down to my left. I started to feel badly disorientated in crowds, or in noisy environments, like busy cafes or echoing rooms.
And this October, I have, again, spent more days ill than at work. I’ve been suffering a symptom I struggle to articulate, but perhaps best described as a mental-fogginess or confusion (see my last blog). I’ve been finding it very difficult to work because looking at a computer screen has left me feeling dizzy and dislocated; and my cognitive function has been scrambled to the extent that I’ve been moving my cursor across the screen before realising that I can’t remember why, or where its heading. The fatigue has been bad – and I can’t give my body enough sleep. Right now, I’m absolutely sick of being sick.
Before my MS diagnosis, I struggled to articulate something that I knew was “wrong”. Now I have been diagnosed, the above are symptoms that I want to (need to) tackle with as much energy and fight as I can muster.
All this combines for an ongoing “tick” for Lemtrada Round 2.
However…. the biggest thing nagging away at me is this term, “elective procedure”: I’m choosing to have this done.
I’m choosing an illness and a hang-over that, last year, lasted ~5 months.
I’m choosing cold-sores, body-rash, vertigo and nausea.
But, most of all, I’m choosing risk.
Despite the malaises of the mid-seasons, this summer, I was fit, healthy and happy and life was pretty much as good as it gets. MS may have been murmuring, but I was in charge.
It makes me think how gutted, how absolutely gutted, I would be if I chose this treatment and it ended up jeopardising that.
My pre-treatment appointment last week reinforced this. Since NHS certification in 2014, 20 patients have been treated at Southmeads Hospital. This year, tragically, there was the first fatality. A patient died having contracted Listeria in the aftermath of their treatment. To have been diagnosed with MS and to have then gone through the same difficult risk:reward decision-making process as me, only then to have been unlucky enough to be the one ‘outlier’ – the one that statistically “can’t be you” – makes my stomach knot in empathy, tragedy and an undirected sympathy to a family I’ve never met.
This fatality does not (of course) translate to there being a 1-in-20 chance of dying at Southmeads Hospital, but the news did push me into some more internet-research.
The web is a dangerous place to try and research ‘science’. I quickly happened across a blog written by a patient just starting their first course of Lemtrada: “I’m nervous because there’s 1 in a 1000 chance of me dying because of this treatment” [my first reaction was that this must be an ill-informed statistic]; and others which discussed the risks in more heart-felt ways: “I want to be around to see my children grow up and have children of their own. If I have to attend weddings and the births of grandchildren from a wheelchair, that is my fate. But I can’t quite accept the thought of dying from my MS treatment and missing all of those things.”
In summary, the most striking points from my internet trawling were:
Firstly, how unlikely you are to actually die, either directly or indirectly from Lemtrada.
The results of clinical trials showed that more patients died having been hit by cars, or by a train, or from motorbike accidents, than by any side-effects [Alz. Advisory Committee Briefing Document BA103948] – (in fact, these, and other such results, did make me ponder quite how many causes of death seem to be lurking around us at every turn!) That said, there were 2 (indirect) deaths during trials (from secondary ITP and sepsis). In fact, ~3% of patients [again, MS Society] suffered from ITP (immune thrombocytopenia) which, to put it bluntly, kills you if you don’t treat it quickly. To put this in perspective, very roughly patients in the clinical trials suffered a similar mortality rate as mothers giving birth in India or Cambodia (to give two random examples) in 2015.
Secondly, although I knew that Lemtrada was a “new” drug, I was surprised at how small these pools of statistical test-data actually were – and how recent.
The major drug trials incorporated hundreds of patients worldwide (not thousands) – and many ‘secondary’ trials only involved tens of patients. Of course, any information regards long-term effects are not going to be reliable for many years – and several critical trials examining secondary risk factors are still only at their early stages.
Suddenly that “1-in-1000” throw-away statistic I quoted above (and initially dismissed out of hand) doesn’t seem so far-fetched: 2 deaths were reported during the clinic trials of a couple of thousand. However, “one” is now being countered by monthly blood-tests for all Lemtrada patients (which should pick up ITP issues). Recent cases this year have meant that monthly blood-tests are now being advised for 10 years post-treatment, rather than just the 5. The second, sepsis, is still an unmitigated (and unmitigat-able) risk. As is the Listeria that killed a patient in Bristol. The only defence offered is extremely careful guidance on post-treatment foods (no white cheese; nothing ‘mouldy’) and hygiene.
In amongst all these statistics (lies, damn lies and random web-based blogs), I must remember that the main pillars of my confidence: the drug has been sanctioned for use in the UK by “NICE” – so it’s now approved by the NHS; the FDA has approved it in the United States of America; and the EMA within Europe.
To finish with, I must remember that the option of Lemtrada is a blessing, not a curse.
It is a “good” drug, here to help me.
I often think how lucky I am to have been diagnosed now – rather than 10 years ago when I would have been advised to follow a healthy diet – yet, how unlucky I am not to have been diagnosed in 10 years time, by when the current leaps and bounds in stem-cell technologies may have found a risk-free cure.
The NHS, and the tax-payer, is putting its faith in Lemtrada, and in me: a daily dose of the drug costs £7,045. The full (double) treatment costs £57,000.
I hope I can look forward to many years of great health so I can start repaying some of that debt.