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Family doc .... The lowering of trigs is not substantial - yes it does lower but not significantly - there seems to be rebound - one patient with MI while on, no proof that OTC does not work as well - one patient with CVA while on .... having said all that as previously indicated I do think we will get some results in diabetics with high trigs low hdl - also I am not only going on numbers alone I do think the general reduction of inflammation has potential
The real tragedy is poor study design. AMRN could have had statin intolerant branch - likelihood of success in statin naive patients would have been much greater . Treating remnant lipids is less likely to show success if effects of med are marginal. They may have eclipsed an entire market based on this flaw of design - but being but a humble rural family physician such complexities lie far beyond my cognitive capabilities
Individual cases do not a science make - yet please note - I posted about my individual experience with substitution of OTC by cardiologists and patients - and this was confirmed somewhat serendipitously by AMRN itself and their law suit.
Does my experience with the above patients make a science... hardly ... however a true scientist, a true analyst would have sat back and examined the information without anger without fear ... and tucked the knowledge away to see if more came forth to confirm the possibility
Will my patient experience go the same way as the confirmed OTC debacle that AMRN is now trying fight - I dont know I simply communicated my reality.
The real issue that AMRN will face if there is failure of REDUCE IT - is the possibility of law suits by investors for study design failure as noted above
Because I can make more money .....
AS I have stated I think there will be success in subgroups ( diabetics with high trigs low HDL) - this will result in initial surge in stock price - then reality sets in and price will drop . I will ride that initial wave in and then hop off.
I see this often with biotech. Several years ago a few weight loss drugs came out. I knew they were useless - weight loss not as good as older treatments and significantly more expensive - yet there is a huge desire in this country for an effective weight loss medicine - sure enough the hype drove stock prices up then reality set in and they collapsed - I rode the initial hype knowing the drugs were not what they proposed to be.
as you know better than me stock prices often initially reflect more on human emotion rather than value to society - this is most true in young biotech. In older established industries I do believe stock price is much more reflective of a companies true value to society rather than emotion - in new biotech emotion reigns.
There are several types of poker players - there are you true savants that can memorize every card and know the exact odds of every move - and there are those who can simply look across the table and read your face ....
... and AMRN doesnt have a real law suit ... ahh it so fun to get you guys all worked up - one little comment - rattled you all ... especially when I was proven right
so a DOC says -
"hey I note patients and docs are recommending OTC Omega 3"
just an observation of his reality
your responses
no no you are wrong - no you cant be a real doctor - on and on
and then what happens ??
AMRN goes through the huge process of attempting a law suit to block OTC
and you all ended up with mud on your face
DOC was right you were WRONG - period - evidence is clear
so sorry that only one of you had the manhood to say you know what Doc you were right - we were wrong
a good lesson though for you all
see if you want to seek truth - you have to be willign to examine the subject from 360 degrees - even the side you dont agree with - otherwise you are simply a cult member -
keep eating that humble pie stuffed with OTC Omega 3
Actually I bought at $1 sold near $4 looking to get back in at under three -
Knowledge and experience accumulates ... thoughts advance and change ... it must be very boring living with a static mindset .... the world would still be flat ...
You missed the point - you are correct statins are the mainstay of treatment and you cannot deny people that treatment .... but ...I have numerous patients that are statin intolerant .... you use that group as a means of leveraging in on the statin market. Likelihood of success in statin naive people should be much higher
Yea Agreed ...as a doctor I too hope for success , however, AMRN really screwed up by not having a statin intolerant branch - do they have any realization how serious this oversight is ?
In statin naive patients there may have been much better potential for success than in patients already taking - and success here would have opened the door for direct competition against statins
THIS IS A MAJOR FLAW AND MAY COST INVESTORS HUGELY
it would have been so easy - this is incompetence and investors have a right to be upset over this study design for having missed this very basic point.
yes I did ...read previous posts
Would you like to lay money down on that ?
Well thats good ... there do you feel better now?
This is impossible -- members of the cult of AMRN are discussing OTC Omega 3!! We already determined that this is impossible and the doctor who suggested that this might occur was a heretic!
ahh keep eating that humble pie stuffed with OTC Omega3 !! yum yum and remember ..... the cult already figured out .... that pie cures cancer as well!!!
so sorry that he confirmed with accuracy what I experienced in my practice ... perhaps truth is more revealed by those who choose not to respond .... but I do understand ... it is indeed difficult to talk when your mouth is full of OTC omega 3 humble pie .... yum yum
Duly impressed by your intellectual honesty
hmmm... let me try to remember - seems there was some doctor that was posting here that cardiologists and insurance companies were trying to substitute OTC omega 3 - this caused church of AMRN members to heap scorn upon the heretic as this was a lie and no such problem existed .......
so if it doesnt exist why would the company go to such lengths to prevent this substitution ???
Seems the good doctor may have been onto something and is due an apology ... but that would take class
in the meantime please do enjoy that humble pie stuffed with OTC omega 3 ....... yum yum
.... and your evidence that it is effective in reducing CAD ? YOu have none... you seem to be missing the point - the point is I started out enthusiastically using this med - one of the very first but i am noting failures in reduction of trigs over time and I am noting subtle irregularities that are causing me to question this. AS a matter of fact thanks to all of you here, I have begun (after seeing the two failures of increasing trigs over time ) to review all of my patients and see if this is a pattern and if I need to report this to the FDA
YEs - I cant believe the misunderstanding of what is happening in our health care system - this happens ALL THE TIME INsurnace companies dictate the game - you cant fight every battle the battle of using vascepa over OTC is minimal to most docs and they wont take the time - the patient who I think may have a brain tumor and they are refusing the MRI is the one I will spend my time on fighting
So a cardiologist has no problem with OTC Omega 3 - interesting - confirms what I have been saying and confirms my experience with local cardiologists
Again - recall my original post - even if REDUCE IT Is a success in the general population (which I know you dont believe but I hope it is) insurance companies will default to OTC omega 3
Now if cardiolgists are ok with OTC Omega 3 - what do you think insurance companies who can save millions by doing so are going to do ?
Its so entertaining watching these posts from people who have no idea of what they are talking about -- routine questions are posed to patients before blood draw how long have you been fasting, when did you last eat etc etc . Can patients lie ? Sure but then you effect your health care in a negative manner - so it doesnt behoove them to do such and few do - most admit it - oh yea I had coffee with cream and sugar this am - No problem we will get it tomorrow etc etc MUnchausen and Munchausen by proxy occurs ... but not that often ...
I wish it was that easy ....
Of course - you are telling a detective that has been on the force 30 years - this is something I do every day and have done every day for a long long time I can tell you of countless odd cases something like this is rather mundane - the irony is often you dont find an answer -
You obviously have no concept of what occurs in the daily practice of medicine ... treating with a statin and treating diabetes reflects an interest only in trigs? There are courses on reading comprehension available
ONce again - when facts are presented instead of an analysis of why how etc etc instant aggression - like mother hens - its all rather entertaining -
Shaking in my boots ... you dont know how hilarious you sound to someone who has practiced medicine for 30 years
IS that why all of our local cardiologists are telling the patients to take OTC ?
Todays case
64 yo male prexisitng hx of dm2, hyperlipidemia and sleep apnea
Non compliant diabetic hgbaic at 10.4 – refuses injectables
Vascepa initiated 4/14 trigs 442
5/14 trigs 271
trigs 8/17 449
taking meds as prescribed
again isolated case - trigs have increased back to original levels as if med has become ineffective (odd it mimics last one ??) – could it just be worsening of diabetes which is out of control ? Certainly – yet other trig lowering meds dont seem to lose their capability in the face of escalating loss of glucose control ?
What does this mean ?
I dont know - its an observation of an existing reality in my daily practice ....
How does it make me feel ?
It give me an uneasiness about vascepa – because as stated - with other trig lowering meds I dont see this loss of control.
What did I do ?
This is a bit of a quandary as a diabetic hes on a statin - FDA says no to statin and fibrates (ineffective) using gemfiobrozil with statins – risks of side effects
My guidance?
Concentrate on controlling diabetes – stop vascepa, increase statin concentrate on diet and recheck lipids in 8 weeks
Unfortunately many of the patients that I had prescribed vascepa for were denied by insurance - ultimately about 50% or less got it -
you question asks ? DO I have a study that would replace REDUCE IT - no - no scientific study to replace REDUCE IT - I hardly think if I had 80 million odd dollars laying around I would spend it on such - but I have isolated cases - One person with MI -
One person with artificial heart valve - numerous strokes despite being on coumadin, despite being at therapeutic levels at time of stroke - extensive w/u for hypercoag state ( ie antithrombin III, lupus anticoagulant factor V leydig etc etc - all negative) w/u for structural abnormality in cerebral vasculature negative) no cause found ... remember FDA concerns about clotting ? - yea - was that the cause - I dont know ....
and then the odd cases where it seem to have lost its effect on trig levels over time as I revealed yesterday. In general I see about a 25% reduction - however, that level of reduction can easily be obtained with dietary change ( as opposed to ldl where dietary manipulation has little benefit).
Of course the easy answer to your ? is what have you seen that is positive - ie how would anyone know that they were going to have a heart attack and vascepa stopped it ? You do see how illogical such a statement would appear to an outside observer?
Thats my whole point - we cant know until the study is completed - thus to have unbridled enthusiasm that it will work is illogical to me - I am simply saying there is a possibility that this is not going to be as successful as we think.
Again my position is I believe it will have limited success mainly in subsets ie diabetics with high trigs and low HDL
I found the article very fascinating it opens up one more of the trillion puzzles we need to decipher to understand the workings of the human body. From what I recall there was a Danish study that revealed genetic defects which caused either a lower or higher ( cant recall which one ) trig level which resulted in a higher or lower rate of CAD - suggesting direct correlation of Trigs and CAD.
Does this mean that Vascepa will be an automatic success in lowering CAD - hardly - from what I recall a recent study on PCSK9-s revealed that the reduction of atherosclerosis was not what was expected for the reduction in LDL . Look at NIacin it raises HDL and HDL was touted as being one of the strongest markers for CAD - no effect on CAD - Zetia initially shown to have no effect on CAD after reducing LDL - repeat study suggested mild benefit .... which of course gets into the whole issue of outcomes studies vs just looking at markers the role of inflammation in CAD etc etc
After practicing medicine for many years one point becomes clear - biological systems are immensely complex - controlling and isolating factors to determine cause and effect is extremely difficult. Whereas , in the electronic, mechanical perhaps even chemical world this is rather easy.
Absence or variation of a gene, resulting in variation in a marker chemical, may not necessarily be the direct correlation we believe it is for disease induction. That gene alteration may be having countless other effects that we are unable to identify - IN many ways we are the blind man who can only feel one part of the elephant - then run out insisting that the elephant is a snake because the only part we felt was the trunk. (Unfortunately, the guy upstairs who made us - never gave us the blueprints).
So this study is great news and perhaps it will lead to the development of a med that has success in lowering the incidence of CAD. However, let me perhaps reflect onto your own experience. WHen you hear about a great breakthrough for cancer - what do you think ?
Currently , I am very jaundiced about such claims - I have heard them for over 30 years. Perhaps there are great breakthroughs in our knowledge and understanding - yet the reality is - cancer has become the #1 killer and our progress is painfully slow as compared to CAD. ( OF course CAD was mainly a plumbing problem - open the pipes - Cancer is so much more complex)
The proof is in the pudding ...and the pudding is still in the oven .......
(dictated with Dragon Dictate excuse errors)
Sorry .... he was fasting .... like I said there are many many reasons this could happen and its just one case - and one case does not a science make ... but the problem is, its not the first time I have seen this ... I have seen it multiple times ... now do I have the time and resources to do an extended scientific study on this ...hardly ( if that is what is required to advance science than I am afraid most observations would be relegated to the useless pile and we would have stagnated in out advancement of such )... none the less that does not make the observation false - the observation is what it is - but - what amazes me is that people who believe they are scientific become so upset when someone makes an observation that does not fit their hopes ... they would much prefer if we all kept saying 'yes the KING IS wearing clothes' - maybe he is maybe he isnt all I am saying is from what I can see ....the clothes are falling off ......
keep getting upset at the canary that is dying and dont pay attention - why its the canaries fault! - get MAD at THAT canary - he should have never died !
(for those of you who dont know - the canary was what miners carried into the mines to alert them of dangerous gas - when the canary dies its a warning system to get out
the king is a fable about a king who wore no clothes but everyone was afraid to say so and they all kept saying he had clothes on when he didnt - I guess they dont teach these moral fables and stories anymore ...too bad )
Hilarious - A doctor is going to call every patient to see if they fill the rx, to see if they take it, to make sure the pharmacy has not purchased a foreign substitute, to make sure the baby sitter has not opened the capsules and changed the med, maybe martians got in there ..... I now understand why you cannot believe your own personal experiences in the world ...
OK I am going to start posting some actual real world info - obviously no names - to explain why I am changing my views - todays case
patient age 45 started vascepa 2013 trigs 409 - fu readings 294 284 reading today 411 yes they are taking med as prescribed - just an isolated case - many possibilities why this occurred ...problem is I am running into more and more such "ISOLATED " cases.
SO now you can all get upset at the canary who just died in the coal mine - its the canaries fault - get mad at the canary ....
Once again I am just making observations about the reality that I am experiencing - I am sorry that this reality does not match your dreams
This reminds me of specialists who will see a patient and say 'they cant be having those symptoms - they don't fit in "
I often have to explain to them that the patient is experiencing what they are experiencing - just because it doesnt match our model of the disease does not mean its not occurring - you cant deny the patients reality because of your theoretical model - perhaps the model of the disease is wrong or there is another disease present etc etc
Personal experience is false ..... wow it must be an amazing world you live in then - you dont believe anything you experience ?
AS I clearly stated I am only reacting to my own real life experience. This is no different then when I bought underarmour years ago when I noted all the young people wearing it - it is my methodology of investing - examining the reality that lies about me.
Such investing may not work for you and that is fine - use your own methodology
AS to Rx's going up - well that means little - a lot of thalidomide was sold years ago as well - the rx's are rising on an unproven assumption - this means little other than good marketing - a lot of pet rocks were sold as well
Hmmm... somebody better tell my 8000 patients. I have written for vascepa over 300 times ... but you dont want to hear my reality ... go ahead believe all you want ... that's your choice. I do wish you the best of luck - my experience however, which is what I use to guide me in most investments has not been one of great results .
One point that you may wish to remember in life - to seek truth you must be willing to examine an issue from 360 degrees - even the side you dont want to see or disagree with - if you cant do that you wont find truth. I can clearly say that I have looked at this from all sides - from being a great supporter to one of doubt as my experience continues to accumulate.
I find it odd that people who believe they are rational get so upset when someone says - I dont think the way you do. You are still welcome to think and invest any way you want - if your belief in this 'medication' is so strong why would you let let my statements alarm you so much ?
Like I said I wish you the best of luck and hope that REDUCE IT does come through - I too am being a realist - speaking from first hand experience of over 300 patient experiences .... would you have me ignore my experience and continue to cheer on the sinking ship or would you prefer to have someone that says - I'm not certain this ship is going to stay afloat much longer you might want to take a look - if you were confident in your position my statements woudl not have bothered you - the fact that they have suggests to me you too are rather uncertain but perhaps afraid to admit it perhaps. Once again I wish you the best of luck
This is true and my experience has revealed that this med is not the game changer I had originally believed it would be - (learning from experience is a valuable tool - on the other hand one can simply keep repeating the same mantra over and over and convince yourself that you have made a good investment)
Vascepa does not lower trigs very well - actually its rather dismal and insurance coverage is ridiculous and if OTC provides the same benefit - why not use it - as a matter of fact that is what most of the cardiologists are saying to patients - get OTC Omega 3
There remains a possibility that REDUCE IT does have some modest success ... and for all the poor chumps who invested in this hope I do wish them the best of luck - in the meantime I will continue to buy low on reality and sell high on hopes - (I must say I have made some profits off this debacle.)
AMRN has a lot of issues it has to get by to be a success. AS a Family Doc I used the drug a fair amount. Its trig lowering capacity is not significant. However, as you have said that may be irrelevant if the outcomes study reveals great results.
The current issues I see are;
If the drug were a booming success study probably would have already been stopped. That leaves us with the ff possibilities:
1.) Moderate success in general population ( best choice)
2.) Success only in subsets ( ie diabetics with high trigs low hdl - personally I think this is what we will see )
3.) No success
Lets look at all three
no success - then it reverts to the trigs >500 market where it doesnt do a very good job - and the company fails
success only in subsets - currently docs are prescribing the med based on an understanding that it is reducing CAD risk in people with trigs 200-500. If it proves only successful in subsets then the potential market actually shrinks from current usage - rx numbers will decline - as will the stock
Thus REDUCE IT must be a success in the general population - but wait - even if it is the last hurdle is that about 60- 70% of my Rx's for vascepa get returned from the insurance company indicating that the patient should use OTC omega 3. So if the study does show moderate success the insurance companies just substitute OTC omega 3 - and believe me no docs are going to spend any time fighting that battle - The study may ultimately have been named ...for the stocks value
VAscepa ... the statin of Triglycerides -
Vascepa ... Your statins best friend
over one year ago I posted the ff on SA (http://seekingalpha.com/instablog/1077258-ralphey/3082365-amrn-sitting-on-a-gold-mine)
heres the issue:
The new standard for treatment and reduction of CAD will not just be statins - it will be a combo pill of a statin and EPA. Doctors will no longer just prescribe Lipitor or Crestor etc - they will prescribe them with EPA - AMRN captures nearly the entire statin market as an add on to every statin ! This is monstrous . The statin market can be estimated to be 35 billion worldwide. Lets say VASCEPA only captures ¼ of the new combo market - roughly 9 billion dollars of it. The company is currently burning 80 million per year . Quadruple or quintuple those expenses , that still leaves a potential of 8.5 billion per year on 180 million shares - of course that makes the stock invaluable.
HI:
just posted a letter that anyone can send to their insurance company and if you need me to argue the point with them just let me know
Response to INsurance companies
Hello: I was asked for a response to insurers who deny vascepa here it is. Denial will be based on one of two suppositions -
a.) Substitution of substandard treatment
b.) Belief that trigs in the 200- 500mg / dl range need not be treated
this letter covers both - feel free to copy and use
***************************
I am writing to request the medication Vascepa for patient …... .
You have either denied the treatment of offered substitution of niacin, fenofibrate, lovaza or over-the-counter FISH OIL
1.) Offer of Substitution:
If you have offered a substitute for Vascepa then you have automatically negated the FDA supposition that trigs in the 200- 500 mg/dl range need not be treated . Therefore the question becomes which medication is best for this issue:
a.) Niacin
Outcomes studies with Niacin reveled it to be useless to lower CAD associated with elevated Triglycerides. Do you really want me to prescribe a medication that was shown to be useless ?
b.) Fenofibrates
With respect to fenofibrates :
1. Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. This risk is increased when taken in combination with a statin
2. Tricor can increase serum transaminase. Requiring Monitor liver tests, ALT periodically
3. Tricor can reversibly increase serum creatanine levels. Monitor renal function with renal impairment
4. Fenofibrates have mixed outcomes studies
a. FIELD STUDY
Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events. It did reduce total cardiovascular events, mainly due to fewer NFMI and revascularizations.
Do you really want me to prescribe a medication that has this many side effects when it is unkown whether it works or not ?
c.) Lovaza
Lovaza increases the highly atherogenic particle LDL by 49%.! You cant seriously expect me to substitute Lovaza to reduce triglyceride in the hopes of reducing CAD when it increases LDL by 49% - it may very well be inducing the very disease I am trying to prevent
d.) OTC Fish Oil
To match the efficacy of Vascepa the patient would have to take over 18 capsules of otc fish oil per day – do you really seriously want them to do that ? Also OTC fish oil may be both DHA and EPA. DHA has been shown to elevated LDL significantly thereby actually inducing the very disease we are trying to prevent.
EPA (Vascepa) the medication I have chosen has an outcomes study in Japan – JELIS which revealed 50% reduction in CAD. Vascepa has almost no side effects
In summary , (ins company ) agrees contrary to FDA findings that trigs in the 200 – 500 range should be treated. The medications they offer either have no outcomes studies or negative outcomes studies and have very serious side effects. The medication I have chosen has positive outcome studies and no side effects. I therefore ask to allow vascepa utilization for those patients with trigs in the 200- 500 range giving them the best medication in this class .
2.) Coverage of Vascepa decline based on the highly controversial belief that TRIG in the 200- 500 mg/ dl need not be treated
Newest guidelines (ATP IV) have simply ignored the triglyceride issue. They have neither said treat or do not treat. Since triglycerides were not addressed it is entirely logical to continue with the existing standard – ie if there is no change this DOES NOT mean cease treating – It means no changes are warranted.
You are well aware that recently , NEJM published groundbreaking studies showing an almost definitive link between high triglycerides and extremely high risk of heart attacks (study showed 40pct reduction in heart attacks for those w normal triglycerides versus high levels.) This clearly reveals the need to treat triglyceride elevations . In addition, you are well aware of the JELIS study involving 18,000 individuals in Japan that showed almost a 50% reduction on coronary events for individuals already taking statin to which EPA (Vascepa) was added . There are a plethora of studies revealing EPA’s benefits in lowering inflammatory markers associated with CAD. Most recently The Journal of Cardiology published research that revealed pre-treatment with EPA in addition to statins significantly reduced the incidence of type IVa MI compared to statin therapy only.
Therefore, in either situation – offer of substitution or denial of treatment for trigs in the 200- 500 mg/dl range you are offering your customer substandard treatment. If you prevent your customer access to Vascepa you are potential contributing to the development of CAD and their early demise. All substitutions are of substandard efficacy and lack of treatment is contrary to the existing mounting scientific evidence. Your failure to cover this medication will require me, as my patients advocate, to ask for a State Insurance Commissioner investigation of such
Sincerely,
The FDA ombudsman is as useless as teats on a boar / a screen door in a submarine /
PDUFA Limbo for all intents and purposes yes BIO B - however, the official PDUFA has not yet occurred - meaning that the FDA is still obligated ( sorry such terms have no meaning with gov officials ) to render a decision - it is still possible they will right the ship and do their own evaluation of the science independent of the ADCOM recommendation - it rarely has happened