Show Me The Data!!

Just a short note, to tell y'all to go do some reading. As most of you are aware, the fish oil vs. heart disease story has been public for at least years, if not decades. The wiki page on the Mediterranean Diet alludes to fish oil benefit from the 1960s. Exactly when fish oil capsules took off, sometime later. (A bit of surfing revealed "cod liver oil"!! Of course. My Mama didn't force it on me, but yeah, it's been widely consumed nearly forever. According to the wiki, specifically to children as a source of vitamin D.)

What type, and possible mixes, of fish oil has been debated since then. One company, Amarin, has been developing a single oil type, EPA. FDA gave them clearance some time ago to sell it, but to a limited population with skyrocket triglycerides. FDA wouldn't label it for general cardiovascular disease reduction. Amarin was pissed. FDA demanded a large population, long term study; by their nature, CV studies have to take a long time and mostly are post-approval for that reason. We're talking thousands of people for years.

Not the least reason: all the studies on near-similar fish oils have failed. Ummm. The arguing, on a host of venues, between the believers and dis-believers was something not often seen. The MoA of EPA in general CV prevention has never been rock solid; why FDA wouldn't label in the first place, and why pundits were, mostly, predicting the trial would fail. Badly, most said.

The data has been known to be nearly ready for some months, so the bickering intensified, waiting for the shoe to drop. It did this morning. Boy howdy. Not only did it meet the primary endpoint, but with a p-value<.001. Now that's stat sig!! Here's Amarin's PR. There'll be a whole lot bickering for a while. I expect the dis-believers will look to dredge up some contrary conclusion as the data is revealed. Ain't quant fun? To add to the mix, Amarin is one of those USofA corporations that fled to Ireland (in name only, of course; the facilities and work remained stateside, naturally).