This was: https://www.nejm.org/doi/full/10.1056/NEJMoa1812792
A single purified component of fish oil - EPA, did lead to a 25% relative risk reduction on top of statin treatment. This is a huge result with off the charts p values.
> Among patients with elevated triglyceride levels
Much like low dose aspirin its possible this is a bad idea for the average person unless you are already showing signs of heart disease.
The effect is stronger in individuals with elevated triglyceride levels, but it seems to lower triglycerides in those with more normal levels as well.
There's a small dollar cost, and there's this whole section: https://en.wikipedia.org/wiki/Aspirin#Adverse_effects
Think 1 teaspoon of blood per day that you bleed from stomach.
Vitamin C can prevent some of that but it still exists.
(see my comment below).
Does having one product (that sold $xxx mil last year) make a bad company? Or one that put all of it's chips into this long term outcomes study? (which has now paid off)
Why do you care so strongly about this?
No, but something can be both FDA approved and fraud, e.g. snake oil. It just can't be particularly dangerous.
>Why do you care so strongly about this?
Wasn't you who devoted 4-5 arguments to a single comment the parent made? Why add this pop-psychology facile dismissal? What does "care so strongly" even means as an argument?
"On 10/16/2013 after FDA's ADCOM panel had voted 9-2 against recommending to expand Vascepa's label for treatment of cardiovascular disease, shares dropped over 60%"
"In March 2016, after losing a court case, the FDA agreed to allow some off-label marketing"
So, it's not like FDA approved it as a drug for cardiovascular disease. They overwhelmingly rejected it as so, and then were forced to allow it to market it self off-label as such (for "free speech" purposes, as opposed for medical reality).
A way to scam money out of Medicare.
Using mineral oil in the study to make their product look superior.
I'm not the only one to share those concerns: https://www.forbes.com/sites/matthewherper/2018/11/10/fish-o...
The biomarkers of patients in the PLACEBO group decreased significantly (up to 30%). Why?
"But what seriously bothered five of the six cardiologists I spoke to was that the mineral oil had not behaved as a placebo at all. In other studies of cardiovascular drugs, blood test results on placebo do not budge. That’s not what happened here. Patients who received mineral oil saw their levels of low-density lipoprotein, the bad cholesterol, increase 10% to 84 milligrams per deciliter, 6% more than in the Vascepa group, according to the New England Journal of Medicine paper. What’s more, other blood test results used by cardiologists also went in the wrong direction. These changes were included in a supplement to the scientific paper, but not in the study itself. Levels of c-reactive protein, a measure of inflammation that is used to help calculate heart risk by some doctors, increased from 2.1 milligrams per liter to 2.8 milligrams per liter, a 30% increase. Could the placebo be causing some heart problems or strokes, making Vascepa look better than it really is?"
Shame on NPR for the sloppy reporting.