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Thanks for the heads up STS.
Weird - for my mind anyway.
FDA says we cannot even sell V as a help to those trying to lower trigs for those under 500 and need some kind of outcome studies to prove cardiovascular benefit before we can.
I copy the following from a Quest Diagnostics site and they out and out state that higher EPA levels in the body equate to lower cardiovascular risk. Does the FDA know they are saying that?
"Treatment Considerations
The cardiovascular disease risk associated with various omega-3 indices are shown in the Table. The risk levels are based on quartiles of the reference population. Those in the lowest quartile are at high risk, those in the second and third are at moderate risk, and those in the highest quartile are at low risk.
Table: Interpretation of Omega-3 Index Scores
Interpretation of Omega-3 Index Scores
Consumption of foods high in omega-3 fatty acids (EPA and DHA), over-the-counter supplements containing omega-3 fatty acids, and prescription omega-3 fatty acids can increase the omega-3 index. An omega-3 index below the therapeutic target suggests either patient non-compliance or an inadequate dosage in individuals being treated with omega-3.
An arachidonic acid/EPA ratio and/or an omega-6/omega-3 ratio close to 1 suggests a good balance between the prothrombotic/ proinflammatory omega-6 FAs and the more protective omega-3 FAs. High ratios suggest a need for dietary modifications (decrease in meat, eggs, and dairy products and an increase in fish intake) and/or omega-3 supplementation."
Looks like the table did not paste. The link is:
http://www.bhlinc.com/clinicians/test-descriptions/Omega-3
Also does anyone know where I can get an AA/EPA blood test (saw something about a finger prick) and what would it be called? TIA
And even if Reduce-It is a success, she will then say that it was only proven in conjunction with a statin.
Thanks STS,
Interesting but unfortunately not much on the "this might". Just one Australian company mentioned and not sure if they are publicly traded or not.
Not sure if anyone has access to this journal. Critique of statin studies:
http://informahealthcare.com/doi/abs/10.1586/17512433.2015.1012494
So is that "total event number" communicated to them on an as it happens basis, or monthly or what?
TIA.
You are sure correct about the form of vitamin D.
My wife was put on a prescription version of vitamin D (ergocalciferol -vit D2) and it has raised her vitamin D level very slightly. My doc, who happens to be the wife of my wife's doctor, simply called me one day after looking at my lab report and told me to start taking vitamin D and left the details up to me as she knew I knew my stuff. Needless to say I started taking the cholecalciferol D3 form and by the next time I had my blood work done my levels had zoomed way up actually a bit past the upper limit.
Asked her why her husband put my wife on the D2 and she just got defensive, flustered or whatever and I never did comprehend her answer. Oh well.
Could, not sure where you have been but there have been a plethora of great buying opportunities. I believe most long term holders here are hoping for no more buying opportunities.
Zu would you say that there was not a very big difference between their low and high EPA/AA ratios?
0.29 vs 0.39. I would think the epa/aa ratio in the Japanese is considerably higher. Anyone have any ideas how much EPA incorporated daily would raise the ratio to the 0.39? Obviously it depends on where the starting level is and what amount of AA they consume.
Expansion of use of statins -- more customers by treating younger people. They would need an outcome study for me to buy in.
Reminds me a little bit of how high blood sugar has been treated. I can easily remember when a fasting blood glucose reading of anything below 140 was considered OK and no meds required. Then they lowered the threshold to 126 and now I have heard physicians say that if you blood sugar is above 100 they would start people on meds. Just get them to eat right and exercise.
So what happened? I mean was the last sentence ever followed?
" “I am sure that those of us who have responsibility for drawing up the next CHF guidelines will pay a lot of attention to the results of this trial,” he said. "
Of course statin supports will point to other studies to validate their case. But ultimately Big Pharma can push a lot of stuff. The wide variability in study outcomes has me thinking that Reduce-It is not as slam dunk as everyone here thinks. I take fish oils (and eat oily fish) but one never knows about A particular study.
I remember back I believe in the late 90's reading about a study ( I believe NEJM) which showed that Plavix was such a miniscule amount better than aspirins the authors concluded that when including cost of drug into the picture that it would be folly to take Plavix. I surely thought that was the death knell for Plavix. HA. Since then Plavix sales have grown immensely.
Raf,
This is the situation. The cholesterol screening that you were subjected to was one in which the LDL was not DIRECTLY measured. There are labs that measure LDL directly and others that use what is called a "calculated method".
Under the calculated method, it is taken that TRIGS divided by 5 equal your VLDL.
Then your LDL = Total Cholesterol - HDL - VLDL.
In your scenario with Total = 276, HDL = 34 and Trigs = 406 the calculation would yield LDL = 161, so your doc's calculation or estimate is off.
BUT BUT here is the thing. When TRIGS are HIGH (like yours at 406) then that relationship of VLDL equal to 1/5 Trigs does not hold very well. In that case there would not be much confidence in the calculated value of LDL.
Stay completely away from simple carbs and alcohol for 2 to 3 weeks and redo the blood work.
Rafun,
My first question would be what was the last triglyceride reading you go on your previous bloodworm and how long ago was it? Does it jive with this 406?
Secondly there are a lot of BCBS. Mine is the federal version and in the basic plan they have Vascepa listed as Tier 3 which means there is a 50% copay.
I would call them.
North,
I think you are both right in regards to the statement. The label is currently as they say, but you are also correct that the doc can do as he/she pleases.
Motley Fool story this morning. They talk to say nothing.
http://www.fool.com/investing/general/2015/03/17/why-amarin-corporation-plc-burst-today.aspx
Why Amarin Corporation Plc Burst Today
By Todd Campbell | More Articles | Save For Later
March 17, 2015 | Comments (2)
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: A week after announcing a marketing deal for its fish-oil drug Vascepa with a Chinese distributor, investors decided that Amarin Corporation plc (NASDAQ: AMRN) has run a bit too far, too fast. After more than doubling so far this year, shares in the company tumbled more than 15% earlier today.
So what: Investors' pessimism exiting 2014 has turned to optimism in 2015 on hopes that lackluster sales for its triglyceride lowering drug Vascepa can turn a corner.
Following news that the FDA had tabled a potential label expansion for Vascepa in October 2013 that would have significantly enlarged its addressable patient population, shares in Amarin had collapsed from $6 to less than $1 exiting 2014.
Sales of Vascepa climbed 17% quarter-over-quarter to $16.5 million in the fourth quarter, bringing full year sales to $54.2 million, up 105% from 2013. Importantly, the company's cost-cutting helped reduce its year-over-year losses too. SG&A dropped by $44.5 million last year, leading to a drop in net cash used in operating activities from $190 million in 2013 to $72.3 million in 2014.
Investors have also cheered news that the company had locked up an important deal with Eddingpharm ltd to develop and commercialize Vascepa in China. As part of that agreement, Amarin got a $15 million upfront payment and could eventually earn an additional $154 million in milestone payments, plus royalties.
Now what: Clearly, Amarin has had a remarkable move, but investors may want to pause before jumping in and using today's drop to buy. Although Vascepa's sales are growing, they're limited by the narrow label for use in hypertriglyceridemia, a rare form of high triglyceride levels. Amarin is also hamstrung by high expenses tied to the ongoing REDUCE-IT trial that it's conducting to eventually try to win that important label expansion. As a result, while the company's expenses have fallen, it's still burning through cash. For that reason, while things have been going Amarin's way so far this year, I'm content to keep watching this one from the sidelines.
Thanks Zu,
I wonder if anyone knows how their high EPA (>56 micrograms/ml) stacks up against what Reduce-It active group would have since they are taking 4 gm per day?
Yes Zu good find. Although I wonder if this also lends credence to the idea that ultimate market share for Vascepa will not be as high as some of the wild predictions here?
Unfortunately nothing above my neck (and probably below) working very well this Monday morning, so I can't seem to find the criteria of subjects in this study but the event rate for the placebo arm is seemingly much lower than what we are expecting in Reduce-It so are these very healthy patients compared to sicker subjects in Reduce-It?
What gets my goat the most are those supplement companies that market their fish oils as "pharmaceutical grade". As far as I know (I haven't checked the last couple of years) the United States Pharmacopeia has no specifications for such.
If stock price bounce back exceeds which fibonacci level do we then think the downtrend is over.
I am assuming after the retrace -either 50% or 61% then the downtrend resumes.
Bio,
I'll second that motion on the sardines. Used to eat them as a child and then for decades never had any and now I am back to my old childhood habits. Not cheap but cheaper than salmon .
Zu,
I understand that olive oil has about 10% omega-6 and a tiny amount of omega-3 fats but I assume that the monounsaturated fats (of which olive oil is mostly made up of) are not considered either an omega-6 or omega-3. Is that correct?
I wonder if we could get at least the same benefit from V in the Reduce-IT study as this one for the Med Diet. Of course different since it was not versus a statin:
http://www.nejm.org/doi/full/10.1056/NEJMoa1200303?query=featured_home
Whalatane,
To piggyback onto your comment about statin users, a portion of those on statins are on generics.
You talking Par Pharmaceutical?
STS,
Thanks for your input and testimony. I have long been familiar with DHEA and its nature of being a precursor hormone. Unfortunately it seems that clinical data is mixed - insofar as increasing testosterone in older guys - women yes. Here is one:
http://www.ncbi.nlm.nih.gov/pubmed/9876338
Now there are so many variables one does not know if there was something particular about this group of men that did not show an increase in testosterone. (or at least they did not say how much of an increase).
Your testimony runs counter to that and it seems that the biological cascade in the body leads to DHEA before becoming testosterone. It could very well be that some individuals have trouble with the conversion. I have not had my DHEA or DHEAs measured only T. When things calm down a bit I plan on having them checked. Thanks for the info.
Whalatane,
You were lucky.....only one winter in Montreal!!
I was born and raised there. Left in my mid-twenties for warmer climes.
Ra,
I too have a hard time to believe it is investors or traders piling in before RI Interim results. I believe AF made some inference that that might happen down the road, but for something that is still relatively far away a few days difference here is this week are insignificant in comparison to time to Interim.
Again as little investors we are last to know, but if I had to guess, I would pick something positive coming from FDA or a partnership with an outside chance of a buyout offer (to lame for AMRN to accept).
Assuming very good to great RI study results and not withstanding that a number of patients (just like now) will jawbone their docs into giving them V, I still worry about some stupid docs will just say: " Eat oily fish twice a week" and not bother.
I read a few years back that it takes on average 11 years for the latest advances in medical research to trickle down to the level of a doctor practicing medicine.
Zu,
An honest question that I do not know the answer to. If a generic (in this case we are talking generic Lovaza) is so inferior to the brand name does the FDA look into that or care??? I would assume it is still a prescription and that it is being prescribed because the active ingredient was approved for a specific indication and efficacy. Does not the FDA step in if they find out the generic is not up to snuff???
Jesse,
Thanks for taking the time for that lucid explanation. I suppose in some way the Reduce-It trial can speak to this question when after it is said and done we see the event rates and whether they end up matching the Jelis event rates. Let's hope so.
One other question about the trial (to anyone who knows). The company does not know (double blind) how things are going in the trial, but they are given notification of number of events on a monthly or weekly basis correct????
"if the results are comparable to JELIS"
Can anyone suggest any valid reasons why Reduce-It's results could possibly be inferior to Jelis???
Jesse,
This is something I was thinking about a couple of days ago and you sort of recrystalized my question. You said "We calculate the JELIS 2ndary risk at 2.2% in the control (placebo) and the R-T placebo rate at 5.2%.. Why shouldn't dropping the AA/EPA level in REDUCE-IT to the JELIS level, lower the risk to at least 2.2%"
So my question is if someone spends their entire life at a high AA/EPA level (like we assume the Reduce-It population is) is it reasonable to assume that being lowering the AA/EPA for say 2 or 4 years during the study that event rate would go down to the level of a group who had their AA/EPA levels low for their entire lives??? I do not know the answer to this and if anyone has data on this I would appreciate it as I believe it can help us understand what could be happening in Reduce-It.
What time is that presentation ? TIA
How do you do f'n control arm in this type of study? Come on.
Whalatane
I was asking only because statins apparently deplete CoQ-10 levels and was wondering if there was an attempt to either measure or replace in body.
There was a study that I once saw a few years ago and damned if I can find it now that showed that even in statin patients who did not complain of any muscle pain or weakness that upon muscle tissue biopsy damage was evident. So I suppose there can be damage without any outward symptom.
Kind of like me - getting older and loosing a lot of muscle even though I still work fairly hard. Checked my testosterone levels and they are very low, but resign myself to not bring it up to the doc because most of them get all panicky about testosterone and prostate cancer and all that stuff.
Whalatane,
A personal question that normally don't ask (none of my beeswax) but since you are rather liberal with discussion your personal health and medications. Considering you mentioned being on high dose statins for 28 years have you been on any CoQ-10 during some of that time?
Has that topic ever arisen with your cardiologist?
Try me.
Whalatane,
Very astute post. I feel very much like you do. Very cautious.
Zip. As a long time investor I suppose I have been much better conditioned to my positions sinking. Now seeing it begin to come to life the anticipation is a little harder to endure.
Let's all hope for the best and for the time being things are looking UP.