The next time you hear someone talking markets being efficient and rational, remember this date 12/20/2012....On this day you saw a sell off in a stock (AMRN) after the announcement that one of its major competitors had been eliminated...
": ) JL
Sentiment: Strong Buy
Assuming you cycle back and read responses to your post .
I 've had an email exchange with a friend/client who is a Cardiologist at a local hospital .
His comments on Mercks Niacin drug failure ----not surprised , he stopped prescribing Niacin after the Aim High results and no longer prescribes Lovaza.
Said he is basically down to prescribing statins and Trilpix and was cautious on Vascepa until he had outcome data.
My reply to him was the trial data on Fibrates ( Trilpix ) ---ACCORD and FIELD --showed no outcome benefit when added to the existing statin dose --- and in fact showed increase risk of elevated liver enzymes .
In particular --in the treatment of very high TG's --Trilpix ( not concurrent with a statin ) is shown in prescribing data sheet to RAISE LDL cholesterol --- so I don't understand why he would still prescribe Trilpix when Vascepa at 4gm dose will lower the TG's by 33% ( from memory ) with no risk of raising LDL.
I'm waiting for his response --- it just seemed to me that many in the field will be having this discussion once Vascepa is avaliable ----thought you might have comments
Well , I'll reply to myself re an update on using Triplix.
My Cardiologist friend replies " I agree with your reasoning ( Vascepa is better then Triplix for very high TG's because it doesn't raise LDL ) and have been moving towards fish oil based "( therapys )
Since he no longer prescribes Lovaza ---that leaves Vascepa .
He's sold on the very high TG patient ---not so on the mixed dyslipidemia patient --at least not yet.
Now if the rest of you can get out there and sell a few Cardiologists on Vascepa ---we'll get this stock moving : )
Hey j.l. Remember last month you told me "don't let the screen door hit me in the az,,,as i posted (why i sold my shares today) well i'm back fellow long @8.27 will double down if it goes to 7.27
You didn't believe this would happen if they announced Gia. Welcome to reality.the shorts and the market will continue to pounce here with no nce decision and no catalysts to move the stock until they prove they can sell the drug!
The current state of affairs with the share price is a combination of the market situation (and the numb nuts in Congress again with their heads buried in the sand .. or somewhere else just as dark, but much smellier)..... and the disappointment that Amarin wasn't sold. Of course the NCE is still an issue too and even if the Company wasn't sold a positive resolution of the NCE issue would have propelled the share price higher (because investors were assuming this was a key Buy Out factor so they would still be expecting a buy out even with the GIA moves). The shorts are pouncing on the uncertainty and unfortunately they are having a field day. I don't know who is selling, but likely many are selling just planning to get back in at a lower share price. If I had known what would have happened the last few days I would have sold even at $9.5 and bought back in myself, but not now... not at these levels. I think the floor is at about where it is now (although mid 7s are possible short term).
The science is complicated enough that most investors don't understand it so any negative Scientific spin makes them even more nervous even though it has been pretty much irrelevant.
As of this point I still believe a buyout is inevitable since the major Pharmaceutical Companies interested in Amarin aren't stupid and they do know the Science. They just want a lower price... probably high teens as opposed to Amarins mid to high 20s (minimum). Joe is stubborn as he's shown so many times in the past.
I am sure that things will turn around next month.
Sentiment: Strong Buy
Being a heart patient, I personaly would trust the word of a specialist in Cardio Imaging rather than a Lipitologist. What the he** is a Lipitologist? Never heard of that specialty. Although I am long AMRN and have been here for 2 1/2 years, I am concerned about the drug's ability to lower events. Study after study of fish oil has shown that is does nothing to lower risk. Will highly "purified" fish oil be any different?
A lipidologist is a doctor who has received additional training in cholesterol management, cardiovascular risk assessment and intervention. In addition to a medical degree, a lipidologist has a written certificate attesting to the completion of this special training. As this field is still very young, fewer than 400 certified lipidologists nationwide. The American Board of Clinical Lipidology, the group that oversees this certification curriculum, recognized its first graduating class in 2005. However, lipidologists have yet to be recognized by the American Board of Medical Specialties, a governing organization of medical specialty groups.
Chaz and tabloid
Happy holidays by the way.
Chaz --sorry about my spelling --- Lipidologist - an MD with special training in cholesterol mgt , CV risk assessment and intervention.
Cardio imaging -- Dr Thomas - is who you want when having a cardiac cath -- which I hope you will never need by the way.
Re Studies that show fish oil does not lower risk .
The main problem Chaz is that these studies were usually low dose ( 2gms or under a day ) and an eps/dha mix.
The American Heart assoc. recognizes that you need at least 3 gms a day to have any significant effect . The Reduce it trial is testing 4gms a day of 96% pure EPA
That has a significant effect on lowering TG's and hsCrp ( inflammation ) ---the question is "will this lower events ".
The Jellis Trial as JL points out indicates that it should .
The only difference from JL's view that I have come across from the Cardiologists I have talked to, is if there is a "trigger " effect ----that you need a high fish diet ( Salmon etc ) first , then add the high dose of EPA onto that ---- before you get the drop in "events ".
Hi chaz13335 or akanz,
if the TGL's were reduced considerably without raising LDL's and by doing so,the over all lipid profile improves with that, shouldn't the CV events be less likely to occur? i have been looking at few articles stating that Fish Oil's doesn't prevent attacks or strokes..these are the generic ones which are not effective and Lovaza does increse LDL's, there is not an effective medicine out there from fish oil's..and by lowering these numbers and if there is still such an event, is it tied directly to cholesterol or could it be anything else besides that like hypertension or diabetes? could you please share your thoughts on this?
Bottom Line: The market is rigged in favor of "the house" (aka large investors and insiders) and against the gamblers (aka retail investors). That being said, this stock has lots of promise in the near future whether it goes it alone or is bought out. It's just a matter of time when "the house" decides to change the tide and the stock price will increase.
Well some may have been bothered by Mayo Clinics Dr Thomas 's comments " will be surprised if Vascepa reduces events " .
Forbes neglected to mention that Dr Thomas's speciality is CardioVasccular Imaging - not Lipidology or managing residual risk
--- A comment from Dr Deepak Bhatt would have been more informative .
I'd be surprised if Dr. Thomas is more insightful than Dr. Sears.
About Dr. Barry Sears
Dr. Barry Sears is a leading authority on the impact of the diet on hormonal response, genetic expression, and inflammation. A former research scientist at the Boston University School of Medicine and the Massachusetts Institute of Technology, Dr. Sears has dedicated his research efforts over the past 30 years to the study of lipids. He has published more than 30 scientific articles and holds 13 U.S. patents in the areas of intravenous drug delivery systems and hormonal regulation for the treatment of cardiovascular disease. He has also written 13 books, including the New York Times #1 best-seller "The Zone". These books have sold more than 5 million copies in the U.S. and have been translated into 22 different languages.
Meta-analysis study on fish oil effectiveness is fatally flawed
One of the events in the food industry you never want to see is the making of sausage where sometimes good cuts of meat are combined with items you would never want to eat.
The same is true of meta-analysis studies in medical research. Meta-analysis means that you take a lot of different studies (some good, some not so good) using different patient populations, different inclusion criteria, different protocols, and different outcome criteria and mix them together to get a conclusion that often demonstrates a non-result. The best example of this is the recent study in the Journal of the American Medical Association that combined a wide number of studies using fish oil supplements to come up with the conclusion that omega-3 fatty acids have no benefit (1). So let’s take a look at this study in a little more detail.
First, it is always useful to look at the investigators. In this case, the authors are from Greece (not exactly a hotspot of high-quality clinical research since Aristotle), and to my knowledge none of them has been involved in any actual cardiovascular intervention studies in the past, let alone any work with omega-3 fatty acids. (I believe a little background is a good foundation to build from, but then call me crazy.)
Second, the average dose used in these studies was 1.5 grams of omega-3 fatty acids per day. Surprisingly, the American Heart Association recommends more than double this dose to reduce triglycerides, a known risk factor for heart disease (apparently not in Greece since the authors ignored this fact). This would indicate the authors were making conclusions based on placebo doses of omega-3 fatty acids. Usually a placebo dose gives placebo effects, which was confirmed in their meta-analysis. Furthermore, just giving a dose of anything is meaningless unless it is reducing a measureable clinical parameter in the blood that has a relationship to the disease condition being studied. For example, if I gave a statin dose that reduced LDL cholesterol levels from 250 mg/dl to 245 mg/dl, I wouldn’t expect any therapeutic benefits unless I gave enough statin drug to reduce the LDL cholesterol level to less than 130 mg/dl, if not much lower.
So what is a good dose of omega-3 fatty acids? As I have already mentioned, the American Heart Association recommends 3.4 grams of EPA and DHA per day to lower triglyceride levels. However, I believe a better marker is the amount of omega-3 fatty acids needed to reduce the AA/EPA ratio to the levels found in the Japanese population, which has the lowest levels of cardiovascular events in the world. Recent studies with healthy Americans indicate that would take between 5 and 7.5 grams of EPA and DHA per day (2). Again, this indicates that the dose of omega-3 fatty acids in this meta-analysis was providing a placebo dose.
Third, another problem with meta-analysis is conflicting protocols. In this study, almost half the patients came from two just studies: The GISSI study and the JELIS study. The GISSI study (more than 11,000 patients) indicated that omega-3 fatty acid supplementation on the foundation of a Mediterranean diet could reduce sudden cardiovascular death rate by 45% versus a placebo and reduced overall cardiovascular death by 20% (3). This study was criticized because the care that all groups were receiving didn’t include statins (since they were not yet approved). After all, the thinking for a typical cardiologist is that there is no reason to use omega-3 fatty acids if you can simply give a statin drug instead.
That faulty thinking was addressed by the JELIS study in which all the patients (about 18,000) were getting statins (4). Unlike the GISSI study, the AA/EPA ratio was measured in these patients. The initial AA/EPA ratio was 1.6 (a level requiring Americans to take about 5 to 7.5 grams of omega-3 fatty acids per day just to reach that starting point), and then even more EPA was added to the active group. After 4 ½ years, those Japanese patients getting the statins and extra fish oil had another 20% reduction in cardiovascular events over and above those getting the statins and an equivalent amount of supplemented olive oil. The take-home lesson from the JELIS study was that any physician who didn’t prescribe supplemental omega-3 fatty acids along with statins was simply practicing bad medicine.
Meta-analysis studies are supposed to make up for potential shortcomings in small clinical trials (like the ones used to approve virtually all pharmaceutical drugs). In the hands of unqualified researchers who have little understanding of the field or compound being studied, a meta-analysis can become an instrument for the mass confusion generated by this recent article in the Journal of American Medical Association.
The bottom line is that you need adequate doses of natural compounds to generate a therapeutic effect. The levels of these doses of natural compounds will always be far greater than with drugs, but also with far fewer side-effects. If you give a placebo dose of a natural compound, then expect a placebo result. But please don’t try to pass off such an obvious result as “science”.
Rizos EC et al. “Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events.” JAMA 308: 1024-1038 (2012)
Yee LD et al. “Omega-3 fatty acid supplements in women at high risk of breast cancer have dose-dependent effects on breast adipose tissue fatty acid composition.” Amer J Clin Nutr 91: 1185-1194 (2010)
GISSI-Prevenzione Investigators. “Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial.” Lancet 354: 447-455 (1999)
Yokoyama M et al. “Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomized open-label, blinded endpoint analysis.” Lancet 369: 1090-1098 (2007)
Sentiment: Strong Buy
More "brilliant thinking"...we already know from the JELIS that EPA does reduce CVD "events". It was 20% in JELIS...a population of middle aged Japanese females, most of who eat fish at least once a day. From a statistical standpoint it is more difficult to prove statistical significance in reducing "events" when the events occur infrequently which is the case in JELIS and also what makes JELIS all the more impressive..JELIS has been criticized because a large number events were recurrent angina...When considering the array of cardiac events..angina, fatal and non fatal AMIs, CABGs etc....of course angina is going to be the most frequent.
If you study the JELIS results...there is a consistent difference in every measured event which averaged out to about 20%..in favor of the EPA treated group. The one exception was the "sudden death group" which was even for both treated and placebo. Truth is "sudden death" can be the result of many things besides CVDs...berry aneurysms. poison, suicide..etc. The biggest flaw in JELIS was the population addressed in JELIS was too healthy...but given that JELIS is an awesome study...and if doctor Thomas...or any other doctor wants to debate that I will be glad to oblige...
The reason the other Trig lowerers have been so unimpressive in events studies is they do not have much of an effect on lowering inflammation..which is the root problem in atherosclerotic heart disease...
PS...Was not the Forbes article out several days ago....Also why is Forbes writing about AMRN.?? Have they stopped making new Gulfstreams? is Polo dead??
": ) JL
Sentiment: Strong Buy
oh geez, splitting hairs to come up with conclusions you want to hear. if that doctor said positive things then you wouldn't comment on his credentials. But, if he says something negative, then you have to come up with a reason why he is wrong.
Hey jesse: How is that GIA thing working for ya! Your getting exactly what ya asked for! Exactly what you were told would happen!
AMRN has to spend your money to commerialize and its just getting started! You have a medical degree in round trips!
I got news for you---this isn;t your grandpas market that he once knew! "Long and strong" in this market is on Medicare!
What happened today is standard fare in bio land---where ya been?