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Sorry I got that backwards.
So am I right in saying that it is primarily or only the LDL particles that we need to worry about size?
Or does the reduction in size of the VLDL and HDL cause any concern? Can't they get stuck in and around the vessel wall?
Any concern with the increase in LDL particle size? Or is that offset
by the decreased size in VLDL and HDL???
under a buck is the line not 3 bucks.
You can say that again. Wouldn't be great if the government would force people to buy the stuff I sell. Would be great for business.. for sure.
Stupid situation where the rest of the advanced world has pretty much figured out health care but our entrenched system can't be changed. American exceptionalism on display.
Apologies if this has already been mentioned
But I came across an interesting post on another message board that highlights that in the
IMPROVE -IT trial triglycerides as well as LDL-C were lowered in the drug combo group.
The author's point (or at least suggestion for thought) is that possibly the benefits seen in the study could be not only due to the LDL-C lowering but also/or the trig lowering, which might bode well for Vascepa in the Reduce-IT trial. Anyway here is the post:
http://www.investorvillage.com/smbd.asp?mb=2294&mn=1662&pt=msg&mid=14398093
I am pasting the post below but unfortunately the paste does not show the graphs he posted.
The million (no, billion) dollar question
This week results from IMPROVE-IT were released. The trial enrolled 18144 high risk patients and observed over 5000 events. It was able to detect a very small (“modest”) outcome benefit by the addition ezetimibe to statin therapy.
This modest benefit, as measured by a decrease in cardiac events over 7 years in a huge trial, was attributed to the LDL-C lowering effect of ezetimibe. In addition, many claim the trial “confirmed” the LDL-C hypothesis: the lower the LDL-C, the better. Hard to argue with that conclusion (but I will) considering that the control group (just statin) had incredibly low LDL-C and the ezetimide group had even lower LDL-C. In the words of the lead researcher, Dr. Cannon: “We took patients from a clinically appropriate target LDL-C to even lower. We now have solid evidence that lower is good, and even lower can be even better”.
Seems like common sense that the reduction in risk is attributed to the further reduction in LDL-C that the ezetimibe group realized. But perhaps there is more to the story.
It is generally recognized that most of the benefit of lowering LDL-C is achieved in the population of those who have high LDL-C. The CTTC meta-analysis suggests a diminishing benefit with lower baseline LDL-C. There were very few (if any) data points on the lower end of the curve below to demonstrate that there is not a point, below which, further reduction in LDL-C is beneficial. Cannon’s statement is basically saying “we provided that point”.
But there is something else interesting (and relevant to AMRN shareholders) about the IMPROVE-IT results: Not only was LDL-C lowered in the treatment arm, but trigs were lowered too.
Yet the benefit of ezetimibe is attributed (by virtually everyone) to the fact that it lowered LDL-C.
How do we know it’s not due to the lowering of trigs?
Maybe, just maybe, there is no benefit to further reducing already low LDL-C. There was no enrollment requirement for trigs, perhaps the benefit is attributable to trig lowering in the high trig population. And perhaps that modest benefit was only observed because of the very large size of the trial.
One way to shed light on this, of course, is to look at a Forrest plot for different values of baseline trigs. Was the benefit observed in the high trig sub group? We don’t know because that data has not yet been presented.
When you look at similar subgroup data (high trig) from the 3 trials the FDA used to shoot ANCHOR down (AIM-HIGH, HPS2-THRIVE and ACCORD-LIPID) you see, in each one, suggestion of greater benefit (though not SS) in high trig populations. And, while it’s risky enough trying to interpret sub-group data, it is extra questionable when the subgroup data come from failed trials (trials not meeting their primary endpoint). The FDA, in particular, does not like to do that.
But here, for IMPROVE-IT, we have a trial that did indeed hit their primary endpoint. Unfortunately they have not presented the subgroup data to see what effect reducing trigs had on the high trig subgroup. Sure would be interesting to see.
Maybe its nothing.
You guys are both right. Something causes or triggers the inflammation. The body's response to the inflammation includes packing cholesterol onto the site which in turn narrows the clearance through the vessel. But, taming inflammation (even without knowing or attacking the "cause" of the inflammation), appears to reduce harmful CV events. As evidenced by Jelis and a reason for measuring CRP.
Can we easily agree that insurance companies do indeed deny claims?
If so my only logic is that they are in the business to make money for themselves (albeit providing a service like many other businesses in many other fields). I have yet to hear a plausible argument showing that denying claims loses them money, so denying claims must make them money?
The answer to your question is one word:
Money
Absolutely right about how small short trials can give rather quirky (not duplicatable sp?) results.
In this case what really bothers me is the number of CV events --36% in a year?? Need an explanation of that.
About the AF tweet.
Just to keep it in perspective, he states that the price move in AMRN yesterday was likely due to a "market belief" in a relaxed FDA allowance of Anchor claims. He is not specifically saying that HE necessarily believes that or that he has heard from his sources that this is an assured outcome.
Kind of reminds me of the first time many years ago that I came across the knowledge that coumadin actually increases plaque calcification in patients. Ridiculously it is usually given to the patients that least need that sort of thing.
But how many physicians know that or tell patients that or realize the negative risk it poses.
Seems AZN thinks the science shows increased CV risk with increased TRIGS.
Two to three times the risk when trigs are between 200 and 500. Of course nothing like the risk when trigs are over 500, but somehow the FDA may not feel the same way as AZN about the science since they told AMRN and their ANCHOR indication to bugger off.
When it comes to statins I always think of Dr. Malcolm Kendrick's quote:
‘What I say to people is, statins may add fifteen years to your life – they won’t make you live fifteen years longer, but they make you feel fifteen years older"
Fully agree.
That is why I shake my head when I see the typical situation with patient/primary care physician. They order routine blood work which usually does not include measurements for CRP, spa/aa ratio, nor particle size, etc.
Half of all people who have a stroke or heart attack would be from the group they would deem normal vis-a-vis cholesterol numbers.
So, without question there is a lot of genetic control over this. We try our best - some of us do - and hope to mitigate that to some degree.
I am anxiously awaiting knowledgeable responses to your post. I have read many opinions and statements here on this board and still not sure how these results directly impact V.
I believe the meds in the IMPROVE - IT study generally reduce cholesterol and triglycerides so not sure if:
a) study is successful then does it obviate the need for Vascepa, or
b) study not successful then does mean that lowering TG by Vascepa would not be helpful either?
From what I understand, V has a couple of other benefits and mechanisms of action (such as reducing inflammation) that may make it valuable when these other meds don't help much, but I am a little in the dark with the relationship of tomorrow's results and if/how they would impact AMRN.
Your last sentence caught me by surprise......pleasantly I need to add.
As I am entering the last years of my life I think about many things and one thing that sticks with me
is how confounded I am that in the year 2014 --- with all the knowledge gained by mankind particularly over the last few hundred years - that the vast majority of humanity follows or adheres to mythological nonsense. On so many logical levels anyone who really cares to think about it would not spend their entire lives following the dictums of something so false and imaginary.
One can only hope that your last sentence comes to fruition, but I am not that confident since I would have thought it should have happened by now. Only thing I can think of is that people are so afraid of death that they cling to something like this.
Jesse,
In regards to AA/EPA ratios, it is a little bit like your post about DES. The FDA works on the basis of studies designed to prove something and then they decide on approval or not for a drug for a specific indication.
Nothing that I am aware of has been placed in the FDA's lap in regards to AA/EPA in regards to that indication so they are not just going to go off on a tangent to look for stuff to push. Not aware of any instance of them using population studies.
Design a study get an SPA and NDA and then the facts will tell the tale.
Yea sure. Until they try the combo and then
Find out that there is a third pathway that gets activated to grow the malignancy.
Neverending.
Informal Poll
Would I be right in saying that most of the people complaining about the health insurance premiums are against a single payer plan???
Well your numbers don't seem to match
What this article indicates about rate increases for NC BCBS.
http://www.wral.com/blue-cross-to-reveal-2015-health-insurance-rates/14102936/
Unfortunately V is not approved for arthritis. Any stories your docs tell would be anecdotal and most would shy away from that.
It is only permitted to be marketed for the indication for which it is approved.
Wish I shared your confidence.
I have seen situations in biotech where companies came out and stated they were going ahead with phase III more than 6 months before results of phase II were out. Then even top line results came out and they were touted as excellent and investing community pushed the pps higher.
Well, a couple of months later upon presentation of full phase II results, stock cratered and the opinion of almost all scientific observers was that the trial failed.
So I guess we are all colored by our experiences and my experience with the case I mentioned above will never permit me to be so sure of anything anymore.
Staying long in the stock may be a mistake but I look at the risk vs reward potential. At a buck I can't lose much more -- already lost the vast majority of it. Maybe they muddle through and something good happens at the end. Who knows.
Well this seems to refute your assertion.
Europeans may not need statins, but sure enough they are being prescribed them and they are using them in greater and greater numbers:
http://www.telegraph.co.uk/health/healthnews/10537507/Britain-becomes-statins-capital-of-Europe-according-to-study.html
Thanks for the post and question.
It appears that it is only Nov. 3 to Nov 5 so this obviously means that today's drop is NOT related to that. For some reason the date Oct 23 stuck in my mind but that looks to be dead wrong.
Is it possible the drop today
Was related to AMRN striking out in terms of making a deal with someone in Europe during this conference???
heysfguy. You say best in class.
What class of drug is Lovaza in? Because it sure doesn't have the same crappy sales as Vascepa.
Do we know if they are even interested in doing so??
Looks like your fun Sunday
Started with too many hits of the bong.
I am sure there are a number of examples.
But back in 1998, Entremed rose almost 700% after a story in the NY Times:
http://www.nytimes.com/1998/05/10/business/investing-it-focus-biotechnology-cautionary-tale-reality-punctures-entremed-s.html
Obviously not something Amarin was able to accomplish or be involved in.
Wow we're sunk. Don't need any other drugs as it makes it sound like statins are a miracle drug.
What happened to the listing of the side effects?
That famous Iceman they dug up apparently had plaque buildup
I should have provided at least one link:
http://www.researchgate.net/publication/6984453_Statin_therapy_induces_ultrastructural_damage_in_skeletal_muscle_in_patients_without_myalgia
You can say that again.
But here is what gets me. There have been some muscle biopsy studies that have shown muscle cell destruction by statin drugs even in people who are not experiencing muscle pain, weakness, fatigue, etc.
Things I have seen over my lifetime would lead me to say that most doctors are not scientists. Somewhere I read where the average time for some new medical development is about 11 years before it trickles down to the physician who is treating patients. Sad.
Sorry for the Rant.
Need to let off steam after working my butt off today.
New niacin scrips higher than new Vascepa scripts in the latest reporting period or so I heard.
Amazing. After all the data presented docs are still prescribing niacin in greater numbers than V.
Reminds me a number of years ago when a study published in the New England Journal of Medicine showed that Plavix showed only a minuscule advantage over aspirin in terms of outcomes. The authors concluded that because of those results and the astronomical price difference between Plavix and aspirin that there was no practical reason to use Plavix. Of course when I read that I thought it was the death knell for Plavix. Big mistake. Ever since Plavix is selling boatloads. Docs illiterate, stupid, or really conned by pharma salespeople????
Probably a bit of all three. Example that retired brain surgeon who is waiting for word from the Man Upstairs to tell him whether to run for President is a big believer in Creationism and not at all in Evolution. For a very smart surgeon he sure is a stupid man.
Good thing if the buyout price was high enough. Big supporters of the stock may claim that it would be more lucrative for the company to go it alone but some of us have been stockholders for a long time and the company continually seems to sputter. A good buyout offer lets a shareholder put money to work elsewhere.
No, I hold it as well, but this board is quite empty. Seems to be some potential for SPPI to move up now and if it does I assume posters will be back.
I second that emotion and of course there are tons of shareholders that would too.
I have very often gotten burned by seminal events and was hoping that an Anchor label would have given us an acceptable stock price long before Reduce It results.
Not sure if people noticed the news story about Otzi the Iceman. At a young age (and definitely not a couch potato nor eating the crap our society eats today) he was found to have atherosclerosis. I worry that genetics trumps all and Reduce It results may not be as stellar as we hope.
Sorry, for maybe obvious reasons my mind read the word "shareholders" rather than stakeholders.
Although, to some degree my point still holds. In every case of a drug submission, there will always be stakeholders. FDA is supposed to do their job with certain goals in mind and not the interests of the stakeholders.
Yes, and to be straight on this even the mention of shareholder interest should be irrelevant if the mission of the FDA is to oversee drugs and their proper use. That should be their objective - safe, effective drugs approved - not worrying about who is making money and who is losing.