When will you risk drug induced death

Fox RJ, Salter A, Alster JM, Dawson NV, Kattan MW, Miller D, Ramesh S, Tyry T, Wells BW, Cutter G. Risk tolerance to MS therapies: Survey results from the NARCOMS registry. Mult Scler Relat Disord. 2015 May;4(3):241-9.

BACKGROUND:There is little information about risk acceptance of multiple sclerosis (MS) patients to various MS therapies.
OBJECTIVE:To determine MS patients׳ tolerance to risky therapies and identify associated characteristics.
METHODS: MS patients from the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry׳s online cohort were invited to complete questionnaires on decision making and risk tolerance (RT) to two therapeutic scenarios: a theoretical cure for MS [CureMS], with permanent reversal of all MS symptoms but a risk of immediate painless death; and natalizumab [NAT], a real-life scenario with benefits and risks as defined by Phase III trial results.
RESULTS: The median RT for both scenarios was 1:10,000; 15-23% of respondents were not willing to take any risk for their MS therapy. Participants with greater disability or not taking any MS therapy showed a greater RT, while females and those caring for dependants had a lower RT. Females and older age were predictors of lower RT, while increasing disability and greater blunting attitude with respect to information seeking behaviour were predictors of higher RT.
CONCLUSION: MS patients displayed a wide range of RT for MS therapies. Our study identified gender, age, disability and information seeking behaviour to be associated with RT.

So you can read the study which says  if the risk of death you would accepted this in 1 in 10,000 chance of risk of death for a hypothetical cure. Gilenya is associated with relatively immediate adverse effects as is alemtuzumab.  Is this latter a cure? We don’t know and certainly not for some as people need retreating. However, are you queuing-up to be treated I don’t think so. 

But what about Tysabri. So the risk of death from PML is about 1 in 5 of people affected by PML and the risk of PML is about 1 in 100 for some groups of MSers so about 1 in 500  which is somewhat lower than 1 in 10,000. 

I suspect you will say get the cure and then we can assess risk

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  • Interesting. What exactly is meant by 'greater risk blunting'? I'm JC positive (albeit a very low titre) and on Tysabri, and it took a while to "reconcile" to the risks, including lots of risk to benefit calculations and research. But I don't feel entirely comfortable with this, sometimes downright terrified.

  • Oh, MD… 🙂 PML in those who survive leaves them with the quality of life that is worse than death. I would say the risk of Tysabri is 1:100 for potential "death" of your normal self in some populations.
    I was offered Tysabri right at the start 10 years ago, but opted out. But I would certainly consider HSCT with the potential risk of dying for the benefit of getting rid of the MonSter for good. ( never given the option)

  • Considering that I was on the cusp of EDSS 7.0 before starting Ampyra a few days ago, I have one basic rule: I would rather die on my feet than live in a bed.

    • I think the only weak person here is you. Anyone that has to post nasty comments like this, has huge problems;) I could go on but that will only legitimise you. Quite a few nasty comments recently, I wonder if they are related.

    • No offense taken. I was talking in regards to my risk tolerance to treatments. I'm on Tysabri and JC+. My rationale on PML is that Tysabri is the remote control trying to hit pause on the MS, and PML is just fate hitting the fast forward button instead. Even if the pause button gets a little stuck, it's still However times larger than the fast forward button.

  • I find the last sentence confusing. "and the risk of PML is about 1 in 100 for some groups of MSers so about 1 in 500 which is somewhat lower than 1 in 10,000. ".

    How do you define "some groups of MSers" ?
    How did you get to "1 in 500" ?

    • if you look at the top bar there is something that says PML in that there is a graph if you are JC virus positive have used immunosuppuressives and have been on tysabri for 24 months your risk of getting PML is 1 in 89 which is about 1 in 100. If you get PML there is a 20-25% chance of dying so for every 4-5 people who get PML so for 1 person to die about 400-500 people (who are JC+ have been on tysabri for2 years and have had immunosuppression

  • Surely it's a not a surprise that there are various factors that influence people's appetite for risk and what those might be. As someone with small children, obviously that's going to play into my risk profile. As an 'information seeker' (which I'm taking to be most people who read this blog) I was keen to get on a DMT asap.

    MD – you have keep pointing out that Alemtuzumab hasn't been taken up in significant numbers. I haven't gone for it straight away, primarily as it wasn't recommended as a first line treatment for me. The more interesting question for me would be to assess the approach of different neurologists to similar patient profiles. How many would recommend Alemtuzumab as a first-line for newly diagnosed patients with a set of moderate clinical indicators? For much as I'm in favour of finding out information to ask the right questions or understand the issues, I'm still heavily influenced by what is recommended by my neurologist. I'd take a punt on it being the primary reason why it's not been taken up by more people.

    That and others might be like me and hoping that one of the drugs in the pipeline comes out with a better risk profile and are happy to take a moderately effective DMT in the meantime.

  • We are from Australia.

    My partner has consulted a number of neurologists. Each seems to have its own set of guidelines on how to make MS related decisions. Many but not all of them seem to not want to share the basis for making those decisions for their patients.

    My partner has been offered Tysabri and Lemtrada as first therapy for what is a suspected progressive MS on the basis that she had inflammation on an MRI. She is now coming off Tysabri and one neurologist has told her to take Gilenya one month after her last Tysabri infusion for at least two month to manage the transition off Tysabri (she is JCV neg). Another neurologist told her not to take Gilenya, she can try intravenous steroids instead, as drugs like Gilenya take a while to work so have questionable effect on preventing rebound effect. The non-Gilenya neurologist is upset at second guessed when questions are raised about this.

    We have a friend who has been having 4-6 monthly relapses for 2.5 years and is getting progressively worse while on Copaxone. She is JCV positive with very high titres. Her neurologist and another neurologist she consulted with want her to go on Tysabri for ‘a while’ and will not prescribe Lemtrada for her because of the side effects.

    Honestly, it seems like a Wild Wild West out there in the neurological world but few are prepared to allow their patients to choose the risks.

    Really grateful for blogs like these as a result of my experiences, though I appreciate much less the personal attacks that come from both sides!




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