Peter Attia· MD
so did I care when they did the secondary analysis that but wait a minute myocardial infarctions were down
The headline is broadly defensible, but the qualifications matter. Effect sizes vary by population, the strongest claims rest on shorter trials, and credible voices push back on how it's typically framed.
so did I care when they did the secondary analysis that but wait a minute myocardial infarctions were down
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and then they had a niacin immediate-release niacin arm and now you know in a clinical trial world if you go down to the FDA and you just put a drug through a clinical trial you better be empowered or better not have been much toxicity and you better come in and have hit your primary endpoint because what will the FDA never ever allow you to discuss a secondary endpoint if you fail the primary endpoint you have failed drug all you've done by improving some secondary endpoint is generated in new hypothesis let's go back and do a trial on those people so what was the primary endpoint in the coronary drug project the favorite endpoint that people today love mortality and guess what nice and get the mortality it worsened it not statistically but it you could say it was no but it was certainly going in the wrong direction so did I care when they did the secondary analysis that but wait a minute myocardial infarctions were down there's like me telling you in that aortic stenosis trial but hey zhenya reduce by Carl infarctions but it didn't reduce the order that's but in fairness was the trial powered for mortality or was it powered from look this doesn't know who's powered mortality was the end the only endpoint and all the arms that are straddles that's what they were looking back at then all cause mortality or coronary more now it's not cause mortality I don't know it's kind of amazing because I mean that's very I'm talking about a trial in the 1960s you know the early trophy you know what how they picked endpoints and stuff but nice so don't come and preach to me that it hit secondary endpoint wait a second wait a second why is it that niacin failed this trial in the 60s and it was only three or four years ago that the basically the payer said we're no longer paying for it I'll be because we've had a lot of other trial data that's come down since then where other types of niacin and probably better designed trials also failed to reduce any endpoints so the evidence became overwhelming show me a damn trial where it works and then maybe we'll give you will pay for it at least the FDA would never give it an indication without primary endpoint that or so then the other thing they did with that coronary drug project is they published like 1012 years later the most ridiculous post hoc analysis done on question e or sent to people who they could round up who they discovered you you were in the original trial small number and lo and behold mortality was improved in that group of people coronary mortality so there we have evidence that niacin improves coronary mortality this election by it's the worst it wouldn't even be published today it would be laughed at if you ever submitted it to a journal the coroner a drug project might I don't think a drug company would even send the carnage or project to a journal nowadays I mean they almost have to nowadays no trials they tries to hide them in the end but you know it get publish and thank God it did so we learned a lot about a lot of drugs in that trial so there was no evidence in a trial designed to prove nice and reduce coronary heart disease at least the level one evidence then of course guy said well angiography got introduced and they could start doing regular angiograms on called quantitative angiogram where you're basically looking at the lumen of an artery and seeing how much plaque may be extruding into the lumen you're doing nothing to what plaque may be this thing in the coronary artery walls and in that trial using quantitative angiography they did see a statistically significant improvement in the lumen of arteries in people with coronary artery disease who took nice and that's the hats it's a small well under a hundred people giving niacin no statins or anything and they come to this inclusion was a