Helen MacDonald

They also come up with a nice or showcase a nice series of questions that you might ask as you're designing your study, which include, is blinding needed for a scientifically sound result, i.e.

will there be a placebo effect of your intervention and do you think it's important to separate it out?

How likely is it that patients and or clinicians will behave differently if they know what the intervention is and how might that bias the result?

How harmful might blinding be to patients and is that harm excessive?

And finally, this point, which I thought was quite interesting, I had never thought of this before, was does the financial cost of actually achieving blinding compromise spending on other methodological aspects of the trial's integrity?

What do you think of those, Carl?

So I think what we're saying is that when you're writing up your trial, or what I guess I would like to see as an editor thinking about this issue more, is you just want to see a thoughtful discussion of the kind of biases that might have come in and for the decisions that you've made about who has been blinded or who hasn't, to make clear why you made those choices.

Yes, I'm less annoyed about Inclisiran, but this incredibly celebratory press release, which crossed my inbox this week.

It came from the Department of Health and it was a press release about their plans, I think, which were quite confused in the press release.

to test a currently unlicensed drug called Inclisaban, which is part of a promising group of new cholesterol-lowering drugs, PCSK9s, in a group of people with heart failure, presumably to prevent the outcome of death.

And that's kind of so far so good.

And also so far so good was the idea that the NHS was embedding a trial of this new drug in its care to make a prompt decision about whether things are worth it.

But I think where it starts to unravel for me, or the way that this was conveyed, was it just did not seem to entertain the possibility that this drug either might not work, it might not work as well as they thought, or that it might have some harms linked to it.

And I think the point of doing a trial is that you start with uncertainty or equipoise of some kind.

And that just did not seem to come across here.

And

Parts of it just sort of made my jaw drop.

And there's quotes from their health secretary, from the chair of NHS England, from the CEO of Novartis, from professors at Oxford University, Carl.

And also included this quite incredible fact.

They said over the past decade, the pharmaceutical industry has largely stopped finding solutions for large public health issues such as diabetes, cardiovascular disease and obesity due to the large costs of developing new treatments.