Search This Blog

Monday, 8 May 2017

A Quick note on the ASCOT-LLA "Nocebo" statin side-effects study

Here's a comment I put on Malcolm Kendrick's post about the "statin side effects minimal" Lancet paper.
For what it's worth, there's evidence that lipid lowering is effective in secondary prevention of CVD, but only in people with lipid markers associated with hyperinsulinaemia.
This is an easy syndrome to correct without drugs. In people without hyperinsulinaemia (shown by high HDL level and low TG/HDL ratio) placebo is just as effective as any lipid lowering meds for secondary prevention of CVD.


The comment:

I tried to understand the ASCOT-LLA Nocebo study. It had an inherently high potential to be unethical and irresponsible, either because its agenda was to discourage side-effect reporting, or if not because its effect will be just that.

So it needed to be clear – it wasn’t clear at all.It needed to be open-access, something its millionaire backers could easily have afforded - it was instead behind a paywall, with only the media reports of its authors statements being free.

(Here it is)
It needed to be representative. To do that, it needed to collect baseline data about people who might have been in the study but weren’t – the people who didn’t respond to the invites, the people who were excluded, and the people who dropped out.
It may be there, but I can’t find it.
What I can find is that a high % of people in all arms of the study had already been on lipid lowering medicines. Other lipid lowering meds actually cause similar side effects to statins, and this probably included prior statin treatment too, so that would have screened out a lot of people who wouldn’t want to repeat the experience.
But also, the % of people who formerly took lipid lowering meds is highest in the arms with most reported side effects. So there can also be an exposure effect, the longer people are exposed to lipid lowering (those with immediate SFX having been screened out) the more likely it is that they will develop SFX. There’s no evidence that this possibility was controlled for, even though it seems perfectly obvious from the study design that the unblinded arm were on statins for longer than the blinded arm. (One of the few things that is obvious).
This is p-hacking a study of a low-dose intervention, for atorvastatin only, over 10 years after the fact to try to discredit people reporting side effects from the entire range of statins and dosage today.
As I said, it’s unethical to propose such a thing unless you’re proposing the perfect trial of it, which this is not.
You'd need a representative sample of drug-naive individuals prescribed a variety of drugs and doses, as in real life, to even begin. And that is the population reporting a high incidence of debilitating (and very specific) side effects; see the comments on the Malcolm Kendrick blog above.
Is it any wonder that people doubt the safety of basic things like vaccines and flouridation today, when this sort of bogus attempt at reassurance, which no-one trusts as far as they can throw it, is being encouraged in the mainstream medical journals?

1 comment:

Jessical Alba said...

ALL THANKS TO DR WILLIAMS
I was diagnosed of hepatitis B in 2011, I have tried all possible means to get cure but all my effort proved abortive, until a friend of mine introduced me to a herbal doctor , who prepare herbal medicine to cure different kind of diseases including hepatitis b virus (HBV), when i contacted this herbal doctor via his email, he sent me hepatitis b herbal medicine via courier service, when i received the herbal medicine he gave me step by step instructions on how to apply it, when i applied it as instructed i was totally cured from this disease within 1 months of usage. any body with similar problem can Contact this great herbal doctor via his email drwilliams098675@gmail.com for advice and for his product,and thanks to you admin for such an informative blog.