Carl Heneghan
👤 PersonAppearances Over Time
Podcast Appearances
In fact, what happened is I got contacted by the media, people from Sky about this, basically asking me when it was coming out, pre the releases, can I get your thoughts on this announcement?
Is it significant?
So the first thought is to say, if you're a person who's going to get involved in the media and work with the media, these are the sorts of things which if you give responses to, they'll come back to you.
So I think the first thing is to say, if you're going to be involved with the media, you're either in or you're out.
And I tend to think my job, part of my job is to try and help think about that.
So first is I put, you know, the framing is if you theoretically can reduce LDL while improving adherence, because this is a injection that you take every six months, it could benefit patients with heart disease.
But what I couldn't see is, and I think what you're alluding to, and he nearly did get ranty there, is where is the clinical path benefit and the pathway to developing a robust evidence base that establishes it's superior to current cholesterol-lowering therapy, particularly for the important clinical outcomes?
Because I'm aware there's been a study that's shown it's lowered LDL, and that's what the claim is.
And that's what it's going to go to the FDA for approval on,
for its approval which is a thorough get outcome so immediately then that I did what you thought but I thought I'll go and look so what I did is look on clinicaltrials.gov and put the name in and said what's going on and there I found a 15,000 patient cardiovascular outcome trial that is run out of Oxford competing interest from the University of Oxford but it's set to complete in 2024 so I'm like hmm
That's interesting.
And the outcomes of that trial are the important clinical outcomes, coronary heart disease death or myocardial infarction and number of overall participants who die.
So we won't know until 2024.
I can't understand that myself.
And it was stated 2021.
And NICE will probably fast track approve it in 2021.
But we won't know the vital outcomes to 24.
The news outlets that ran with this story completely missed it.
And I couldn't understand.
Now, one of the trialists said this is about the trial and other people said this is about making it widely available.