Thursday, 21 February 2013

Research Day Question Time-Question #3


The Third Question of Question Time filmed for the MS Blog at the Research Day February 2013. 


Question 3.

Why bother with drug approvals? Can’t you simply prescribe drugs (Simvastatin) to people with progressive MS (Q.posted 14th December 2012) (once small scale trials suggest an effect?).



Panel: 
David Baker
Jeremy Chataway
Ruth Dobson
Ila Gangotra
Gavin Giovannoni
Gareth Pryce-Chair
Vasilis Vasilopoulos


For Introductions see Beginning of Question 1

11 comments:

  1. My heart sinks at the idea of drug companies being allowed to re-license old drugs. Instead, I wish somebody would think of a way to get them past Phase 3 trial and make them available at an affordable rate.

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  2. I think Dr Jeremy got an unfair bashing in the last video. I don't understand how you can attack the idea of simvastatin being tested / prescribed off-license to MSers while testing HIV drugs in the Charcot Project or thinking it okay to give children Tysabri.

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  3. I don't think Dr J got a bashing. I think the panel had to put the questions to him about the safety of high dose simvastatin and about phase 3 trials. You only get a problem with prescribing off label if something goes wrong, and neurologists are wary of getting sued or taken before the BMC. However, I can see a lot of progressive MSers going to their GPs and asking to be put on simvastatin anyway, and I agree with off label prescribing if the MSeer is fully aware of the dangers. I don't know what the side effects of the retroviral to be used in the Charcot project are

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  4. Dr Jeremy has done a good thing by testing simvastatin, I dont agree with Prof G here.
    Now the MS societies and other patient groups should join in finding a way to hold ph 3 trials. This issue really deserves a social media tsunami. Patient pressure led to CCSVI trials with no pharma involvement, why can't the same thing happen for simvastatin?

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    Replies
    1. PR tsunami is needed indeed. However, first the docs show unity. If one prof disagrees even with the idea of phase 2 trials then you're are not going to win but if they all agree and market simvastatin as the ONLY drug in the making for progressive MS then you have a winner. The newspapers will pick it up, the social media etc. Dr J is erudite & has the necessary academic credentials so he should go on a world tour with his finding.

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    2. Patient pressure can do a lot even when doctors disagree, as seen with CCSVI

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  5. Agreed. Dr J is certainly a brilliant communicator. He's good enough to be a broadcaster on television/ radio. The BBC should ask him to be on the panel for the real Question Time. I bet he's got well thought out ideas on a range of things other than just medicine. Very impressed by Dr J.

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  6. I think this issue regading balancing risk and benefits is interesting. Its just briefly touched upon.

    Take for instance vit-d which has not been proven to effect MS outcome. However, there is indeed plenty of evidence to suggest so.
    Neurologist would take it if they found themself with an MS diagnosis - but wouldnt prescribe it to patients.
    http://www.ncbi.nlm.nih.gov/pubmed/23388851

    The same goes for the cholesterol drugs. It may have an effect, it may not. As a patient with a pragmatical approach we simply need to take the risks where the balance between benefit and risk is reasonable. Regardless of phase3 studies or not.

    The same goes for diet, exercise e.g. which have not been proven but where there certainly is plenty of indication that it has a favourable outcome on MS.

    Thats why my main interest is really not in the advice from neurologist whos advice is purely based on RCT. However, I do listen carefully to neurologists/doctors who are with a diagnosis him-/herself.

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  7. Here is the link to the full article above
    http://msj.sagepub.com/content/19/2/143.full

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    Replies
    1. The title of article is
      "If I had CIS with MRI diagnostic of MS, I would take vitamin D 10,000 IU daily"

      Well if you do have CIS there is a trial in the Netherlands looking at the influence of vitamin D supplementation. Will they recruit enough people and I donot know how much vitamin D they are giving. Which would you rather get a nutriceutical or a pharameceutical

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  8. Would all statins of a similar type ie 80mg simvastatin equates to 40mg atorvastatin or 20mg rosuvastatin have a similar effect? I think simvastatin and atorvastatin are relatively cheap- maybe they're out of licence, but I don't think rosuvastatin is. Could this be a way to get big Pharma on board?

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