I am sure the FDA is going to use a study of 46 people from Iran in which none of the baseline data is cited in a usable manner and they don't even clarify what medicines the 46 people were taking. At face value, the paper indicates they took nothing other than Omega3 or placebo. You cannot assume they were statin treated, especially since there are no meaningful baseline data presented.
I also read several of the other papers you cited last week - they were retrospective studies done in Korea on exceptionally small amounts of patients. From those papers there is no way to tell the magnitude of effect of MACE increase / reduction from a change of LDL-C in the 75-84 mg/dL range (which is where the REDUCE-IT population were.) Oh, and the vast majority of the cases cited in these papers were elective revascularizations. One of the papers had 20 events total - seriously a retrospective study where thousands of people were culled down to a population that produced a grand total of 16/4 events is not useable for showing the effects of statin doses in a very finite range of LDL-C control.
I think perhaps the biggest red herring being purported by some all-knowing individuals is how and what time of day the 8200 REDUCE-IT enrollees took their pills. If by instruction, the Vascepa or mineral oil should have been taken in two doses with meals and the overwhelming amount of statins, should have been taken before bed (some exceptions such as time-released statins). So, if patients in the placebo arm were following instructions, the 2 grams of mineral oil from the evening dose should have slid a long way down the small intestine before the statin ever got to the stomach. To assume that one knows for certain that most people in the trial just took all the pills at once is just BS. Such an assumption cannot be made. Worst case, a minority percentage of the placebo arm was taking their statin with 2 grams of mineral oil (the evening dose).
