I shut this down after reading, "DHA fish oil product". If this writer had any credibility before hand he lost it with that statement, as it is the differential between Lovaza and Vascepa. Maybe he needs to spend a little more time researching the product, or maybe go back to driving a cab.
I thought for sure everyone would jump all over him for calling Vascepa a "DHA" fish oil product.
Now, it is an easily understandable mistake to make when typing very fast and thinking about all the facts you want to include, but anybody who knows anything would see it instantly.
So, he obviously doesn't know anything.
Better logic problems are pointed out below, but accidentally calling it DHA and then not catching it is pretty bad too.
Author fails to realize that the SNDA is for Vascepa to be used WITH STATIN therapies. His argument is flawed to say the least. Junk article.
Although the FDA notes that these trials have been controversial and are subject to different interpretations, the burden of evidence now remains on those wishing to prove that reducing residual risk with non-statin therapies is beneficial.
From Amarin PR
The "sNDA submission for the Anchor indication, which supports the potential expansion of the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499"
Why The FDA Probably Won't Approve An Expanded Indication For Amarin's Vascepa
On Wednesday an FDA advisory panel will consider an expanded indication for Amarin Pharmaceuticals’ Vascepa, a DHA fish oil product currently indicated only for people with severe hypertriglyceridemia ( 500 mg/dl). The new indication would greatly expand the patient population eligible to receive Vascepa, from the relatively few people with severe hypertriglyceridemia to the many millions with elevated triglycerides ( 200 mg/dl) and existing CV disease or at high risk for CV disease. The NDA for this indication is based on the ANCHOR trial, which showed that Vascepa lowered triglycerides in the target patient population.
The FDA review (available here) raises 2 troubling issues. The first is fairly simple and relates to the performance of the placebo in ANCHOR. In its briefing documents the FDA raises the disturbing and unusual possibility that the mineral oil placebo used in the trial may not have been biologically inert. LDL levels in the placebo group went up 9% in the placebo group and this will make it difficult to assess the true effect of Vascepa. It’s unlikely that this issue by itself will entirely derail the NDA, but it may well serve to undermine confidence in the trial and put the panel in a critical frame of mind.
More significant, to my mind, is the lack of any evidence for any important improvement in clinical outcomes that can be tied to Vascepa. Now some people believe that ANCHOR provides enough data to justify the expanded indication, as it technically met its primary endpoint and reduced triglycerides. The argument here is that improvements in lipid parameters have traditionally been accepted by the FDA, and that there is no current approved and effective treatment to treat high risk people with moderately elevated triglycerides.
The counter-argument against approval is made clearly and strongly in the FDA briefing documents. Although the FDA agreed to the ANCHO
Another drive by journalist who scratches the surface of a contempory event, writes an article and makes enough coin to pay this months grocery bill. He apparently couldn't dig up enough facts to educate himself and write a real informative article. Vascepa's core value centers around its EPA only composition and this gentleman calls it a DHA "fish oil", lol. Sad but true....anyone can apparently write for Forbes and eek out a living.
Here is a start Mr. Larry Huston. Google the Journal of Atherosclerosis and Thrombosis and look for the title "Eicosapentanoic Acid (EPA) Reduces Cardiovascular Events" published this year Sept/2013. Get back to us with something intelligent. Maybe you'll make enough coin to buy something alittle extra at Walmart, next month.