Some areas which frustrated me most were:
1. Our 2 reps never brought up that the effects of V go well beyond trig lowering and that EPA is a whole different entity and effect than Omega 3 mixtures or DHA on its own. Why not mention Preston Mason's work and mechanism of action? Why not talk about EPA's anti-inflammatory effect compared to pro inflammatory effect of DHA? Why not mention Cherry study and Evaporate Study and their atherosclerotic protective effects as a very probable MOA?
Gary McVeigh was blasting that Omega 3's cause alot of fish burping and paraphrasing his words "I'll let you know that patients don't like fish burps and I should know having taken my share of Omega 3's". Our reps did not even know that this is one of the benefits of V! It got brought up a few more times and finally close to the end the Chairperson asked point blank if there were results from the Reduce It study as this being a side effect. The reps didn't know and would check into it. Finally Hakima found it (as the discussion continued) that this was not one of the side effects to EPA. We've been discussing this for years here.
The committee blasted over and over the secondary, tertiary and quintenary findings saying that they were concerned that AMRN was getting double and triple jeopardy for these events in the Reduce-It subgroups. Basically they are saying if someone has a stroke from arteriosclerosis or heart attack from athrosclerosis then of course they are going to be followed up with a revascularization procedure most likely. I don't think this is how the Reduce-It trial was run and the secondary events were recorded. There was no "support" from our reps on this. Were we double dipping? I even came out of there unsure how our secondary and so on events were recorded and need to go back and read the study.
When Mineral Oil was brought up, why didn't they have the studies showing MO insignificance in this and other studies. Why didn't they bring up if that is the case that those in the Reduce-IT arm taking Vascepa showed a decreased occurrence of MACE events which was proportional to their EPA levels in their blood stream. If it was a MO effect, that would not have any bearing and the V arm would have shown similar results regardless of EPA levels. Why didn't they bring up, along with it's limitations, the Jelis study (which was brought up but in a very negative light I believe by Gary McVeigh again if my mind recalls)?
I could go on about the Strength trial when they brought that up. About the Coppenhagen study toting MO as the possible cause of Reduce-It success. Silence on our end.
I know they haven't been trained fully yet, and part of me actually felt very sorry for them getting ambushed again. They haven't seen our first Ad Com and what an obvious ambush against Amarin that was. I'm not blaming them. Someone needs to prep these reps FULLY!
Here is my hope. This isn't the last time we will go through this again. We have a ton of other EU countries and ROW where this will be a similar experience. LET'S LEARN FROM THIS, PREPARE FOR THE NEXT ONE AND COME IN WITH GUNS BLAZING READY FOR ANY INSANE QUESTION THAT COMES OUR WAY. We've got a frickin life saving medicine that fights the number one cause of death in the world!!!! THAT'S IN THE WORLD!!! Let's act like a company that has been blessed with this incredible miracle drug! We know Strength, Copenhagen, MO, concerns on 2ndary, 3rdary, 4rdary will be brought up again. It's going to happen! Now is the time to be prepared so we NEVER get pushed around by misinformation or by purposeful lies at these settings again!
OK, I've vented. Sorry for the rant.
