It may be the building block for your sex hormones, your vitamin D and more but, dammit your unruly liver keeps making so much that it might give you a heart attack!
Thank goodness for those benevolent souls at big pharma are here to provide highly expensive drugs to correct your own endogenous cholesterol issues that seem to defy any logic.
If we didn’t have enough issues with statins, ruining your energy, muscle, hormones, K2 and vitamin D levels.
Check out old newsletter here:
We now have a new drug on the block to really make sure your cholesterol levels are pinned to the floor.
Meet Evolocumab a PCSK9 inhibitor (no idea).
This was licensed in 2017 after a study showed a statistical reduction in an end point composite of: CV death (important), MI, stroke, hospitalisation, for unstable angina, or coronary re-vascularisation – which ever occurred first, which is frankly odd.
If the point of the drug is to reduce the risk of death, let’s use death of all causes (excluding trauma) as one of our primary end points (this covers us for side effects that could cause death).
And the total number MI’s/strokes.
The trial was scheduled to run 56 months, but they stopped it at 26 months (on average) because……it was just so bloody good for you they wanted to tell everyone ASAP!
Check the results:
A 1.5% drop in that slightly odd composite point of first past the post for CV death, MI, stroke, hospitalisation, for unstable angina, or coronary re-vascularisation.
Now you might not be impressed by 1.5 % absolute risk reduction, but it is statistically significant and that is all that matters.
Plus, the relative risk reduction is 13.2 % (1.5 of 11.5 is a relative 13% drop) so stick that in your pipe you conspiracy-loving theorists.
Anyhoo, back to boring old death from cardiovascular disease of all kinds and things are looking less shiny.
It could be my eyes, but to me it looks like more people died in the drug group?
And in the death from any cause (includes side effects, remember) they were also higher in the drug group.
Now, that did not stop it being approved, and I am sure the fact the MHRA in the UK get 86% of their funding from the drug industry has nothing to do with it at all.
Though it is worth noting it is licensed for reducing cholesterol……but not for reducing the risk of death or heart CV disease, a tiny technicality I am sure.
No doubt the prescribing physicians will be 100% up front for the sake of informed consent (a central tenant of evidenced-based medicine) and explain the subtle difference in treatment outcomes to the patient.
But the interesting news is a few researchers felt maybe stopping the study short was a little suspicious (Merck did that with Vioxx remember).
They run group called RIAT – Restoring Invisible and Abandoned Trials initiative.
They downloaded 25,000 pages of evidence from the “clinical study report’ (CSR) that was sent to the CDC for approval of the drug, based on the published study.
Turns out the published study and the CSR seem to have different outcomes to each other, how odd?
It looks like the published study had changed the causes of deaths which had been previously reported locally.
In fact, when they added it all up, 41.4% of the time, the cause of death adjudicated by the trial committee was different to the local investigator.
Let us be clear, the local MD says myoacardial infarction (MI) while the study committee decide this is incorrect and label it as non-cardiovascular death.
They also note in 1/3 of all deaths they could not give a specific a cause of death as no autopsies were done.
Overall, it looks pretty bad for the drug group to placebo when they added back all the misclassified cases.
It is so blatantly obvious, they only need to tweak a few cases and turn that into a “significant” reduction of a mickey mouse end point, while ignoring the overall death rate.
To me, this is organised corruption.
The industry and the reglaution are both rotten to the core.