For several years now a drug company called Amarin has been trying to get their drug Vascepa accepted by the FDA for several medical indications.
Before we get to this there are a few things you should know.
First there was a long long delay in the FDA approval even though the drug was approved in other countries.
It depends on who you believe! IF you believe the FDA its because the study design did not show enough data to prove efficacy. If you believe people who view the politics and economics of the situation you think the FDA was stalling to give major drug companies a chance to develop other statin alternatives and allow the statins to go generic and continue to make billions of dollars. Everything about the statin market, the known side effects and the marginal outcomes benefit suggest this drug was stretched to its maximum in terms of earning and time on the throne.
Of note the REDUCE-IT trial contained data that showed an additional 25% benefit (which far outweighs any statin benefit) in reduced overall vascular mortality. This drug Vascepa is a slightly modified form or ETHYL ESTER fish oil.
Note that when you hear people lash out against this form of fish oil BS claims that this molecule does not exist in nature and is not even a natural product should fail in the face of these new findings.
Or are they new? The GISSI Prevenzione study done in 1999 showed almost the same numbers in risk reduction as PREVENT-IT. 28% reduction on ethyl ester fish oil at a dose of 2 grams a day.
Note also the latest study was done at 4 grams a day! How often have you heard me say that all of the publicized “fish oil no good for heart disease” were done with way to low a dose. Somehow when it’s a “drug” its ok to use bigger doses. Smell fishy?
Also be aware of the tirade of “Don’t even dream these results can be generalized to regular fish oil”.
Again, if you could get the same results out of a natural product as a drug it would wreck an industry that is too big to fail.
Speaking of which I recently priced numerous drugs including statins and metformin in Mexico. Generic or brand US citizens who buy their medicine in the US are paying up to 20X the price. And they say we don’t have subsidized health care. We do… we are simply subsidizing the cost of drugs in other countries by paying far more than they do.
Don’t you love Big Pharma!
Sub group analysis of the latest trial mentioned above basically showed that all on its own the drug fish oil reduced mortality and events in complete absence of statins and if you figure it all together you get another GISSI like finding. Most of the mortality and even reduction was due to the Omega 3 not the statin.
As a matter of fact its scary how drugs affect the mortality end points. In many cases its minimal or non existent, but they pick numbers like blood pressure below 130/80 and cholesterol less than 180 as the end point, not mortality or morbidity. Drugs do hit the target numbers while doing little to improve morbidity and mortality.
One final interesting point: Amarin the company that makes the “new drug” Vascepa was screaming bloody murder when they were multiply rejected. Now they “thank the FDA” and its Kumbaya all around! The indications of this drug are mainly for reduction of very high triglyceride levels. It remains to be seen if it will be OK to use it for cardiac prevention.
But remember only the drug fish oil can help you. The parent compound ( an example of which is Lovaza) or really even fish oil should not be substituted in any way. Remember fish oil doesn’t work for anything especially any condition where there is an expensive high profit margin drug available. All fish oil does is give you expensive urine, even though its metabolites are excreted in the stool.