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    Senior Member nukecad's Avatar
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    Invited to take part in Clinical Trial.

    Has anybody else received a letter from the NHS inviting them to take part in a phase-4 clinical trial of a new cholesterol reducing injection?
    It's called the Orion-4 trial.
    It's a six-monthly injection which is hoped could replace taking statins daily.
    More info for those interested:
    https://www.hra.nhs.uk/planning-and-...aries/orion-4/
    https://www.ctsu.ox.ac.uk/research/orion-4

    It's a 'double blind random trial' in which half the participants get the treatment and half get a placebo. (saline solution).
    Neither the patient or the staff know who is getting which.
    The drug is not yet approved for use in the UK, which is usual with trial treatments and is why they have trials to gain approval.
    All that is fair enough.

    (I'm already in one 10-year trial, UK-Cosmos, but that one is just monitoring neurological health long term not taking new drugs).

    I received the invitation letter this weekend, but it's slightly concerning on a number of fronts.

    To start with the invitation letter already includes a 'provisional' appointment to attend at a local hospital.
    Although it does clearly say that you don't have to attend or take part this would seem to be pressure to take part?
    People getting a 'hospital appointment' letter may not read further and simply assume that they have to attend.

    The included explanatory leaflet give more details of the trial, including the information that you will be given an injection (it doesn't say what of) at this first visit.
    Again undue pressure?
    You've turned up simply to find out what it's about, and find yourself pressured to be injected and so on the trial?

    The leaflet also includes why you have been chosen, what will happen in the trial, who is running and funding the trial, data protection, etc. etc.

    One thing it noticably neglects to tell you is the the drug being trialed, Inclisiran, is a "gene silencer". - It acts by modifying how your RNA works.
    (Note that this is not 'gene therapy' which permenantly alters DNA).
    There is nothing too alarming with gene silencing in itself, the technique has been know for a while and is now making it to the market.
    https://www.bbc.co.uk/news/health-47907971
    But it's something I feel should be clearly pointed out in the information leaflet.

    The new drug is claimed (by the manufacturers) to "reduce cholesterol by 50%".
    Err, no. The same was/is claimed for statins. Statistics can be easily manipulated.
    Reading the medical litrature Inclisiran is thought to be 50% more effective at reducing cholesterol than statins, which is where the manufacturers get that headline claim.
    Statins are thought to reduce the risk of heart attack or stroke in 4% of people who take them.
    So it may reduce the risk of heart attacks or stroke in 6% of all people who take the new drug. (Or it might not).

    And, although it's become widely accepted, there is still debate about whether cutting LDL (bad cholesterol) is actually of any use at all in preventing heart attacks and stroke.

    So I'm still undecided whether to take part in this trial, in particular I'm not impressed by the way this invitation has been done.

    I'd be interested in your thoughts, especially if you have also received the invitation.
    Last edited by nukecad; 29-09-19 at 14:03.
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