The FDA does not allow or disallow particular things to be used as a placebo. They use their common sense.
My common sense says "Mineral oil is inert, because (a) it is mineral rather than animal or vegetable, and (b) we use Paraffin as a laxative, because it is inert."
Unfortunately my common sense is wrong.
That's life.
To their credit, the REDUCE-IT people and the EVAPORATE people did not *assume* it was inert. They tested that hypothesis.
REDUCE-IT result of that careful test:
Ouch!!!
And the CRP?
Ooooofffff!
That gotta hurt. 8-(
Then EVAPORATE did the rate of coronary atheroma accumulation.
Yowsers!
The rate of deterioration in the placebo is far, far worse than in other studies.
If the Y axis is in terms of plaque volume, that is about 10 times faster than other studies.
And if the Y axis actually is logarithmic (there is still some doubt over what it means; hopefully they will clarify the paper in an update at some stage) then it is absolutely insane rate of accumulation.
We knew before AHA, from the data above, that mineral oil makes your bloods *look* worse (from REDUCE-IT), and that "looking" worse really is *being* worse (from EVAPORATE).
The only question was:
"How much of the between arm difference is due to the aggravation in the placebo arm rather than amelioration in the active arm?"
i.e. "What is the VEXABO RATIO?"
And AHA's results show that the answer is "About 100%". i.e. almost all the between-arm difference in REDUCE-IT and EVAPORATE is due to the Mineral Oil induce harassment of the bloods and coronaries.
Good question to ask, if you were relying on memory of the EVAPORATE results:
But now look at the actual EVAPORATE results.
Still want to ask that question?
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Elisabeth Bik is a VERY hard woman. I thought she was outing these for "A" and "C" not being differently treated rats, different _slides_, but actually the same slide flipped upside down.
Personally I have led a charmed life and never been bullied at work.
But as a TPD this is something I am determined to uncover and eradicate.
When I was a junior doctor, we always assumed that if anyone complained about anything "the old bastards will shaft you forever".
But now we once-registrars have become consultants, we realise we are the same people and
(a) Old gits don't actually shaft anyone - they can't be bothered and indeed have no levers for it: nobody cares what some old git says about someone, when making appointments.