Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The FDA now permits this statement:
“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
B - I am positive that there were political implications and complications at stake - we obviously don't know the specifics. I cant defend the FDA's move of granting ANCHOR SPA - could simply be because different people were charge. But lets go to the step where someone (FDA? WhiteHouse? Congress?) has realized that the FDA should not have an approved indication for 36 million people until they have definitive evidence (CVOT). When that realization has occurred, what should have been done?
one rag
For me at least, it's (ANCHOR SPA rescindment) the best thing that could have happened. Hopefully someday you will feel the same.
you don't believe in wonder drugs nor do i.
drugs are developed in labs to mask symptoms and/or alter biomarkers.
https://www.ncbi.nlm.nih.gov/pubmed/26435012
Remember that various types of fibrosis (pulmonary, kidney, heart, liver etc etc) account for 1/3 of global deaths. It looks like EPA prevents fibrosis as well
raf "I made a mistake" is not a good enough reason to rescind the SPA. IMO.
you don't believe in wonder drugs nor do i.
drugs are developed in labs to mask symptoms and/or alter biomarkers.
You make an excellent point - on one side a simple med like ASA has proven very useful on the other side Niacin is useless - thus there are two possibilities for EPA - it is entertaining that so many people can only see one possible outcome - I happen to believe there are two possible outcomes - or as is true with most things the answer will lie somewhere in between
But Ralph you seem to be assuming that Vascepa will be a replay of Niacin. What if it isn't? What if Vascepa is the new aspirin instead of the new Niacin?
Thank you for making my point - yes I remember well the days when cardiologist were touting niacin as the new wonder drug why it reduced inflammation increased HDL and it was going to cure atherosclerosis .... and then what happened ..... I think the only difficulty is you are unable to see the reflection
My mistake HDG, thanks for correcting me.
zip..
Quote...""let's admit that the FDA used Amarin for a punching bag and then tried to put them down for the count....all because of CYA."
You and BB feel it was personal...I don't...The FDA did what they had to. It was never about Amarin or JZ...It was a "business decision"..The FDA made a mistake...an in house thing...to continue would have compounded the error...
Get over it..
":>) JL
ralph....
FYI...Please read...http://www.nejm.org/doi/full/10.1056/NEJMoa1300955#t=article
This humongous study should disabuse you or any objective person intelligent enough to comprehend this report that Niacin is not something you want to take in quantity over a period of time....The THRIVE study involved at one time or another over 40,000 souls....
The AE events in this study were legion and very serious meaning they sent the enrollee into a hospital...Also the medication is hideous...
Time you considered moving on to some other site...
":>) JL
Bolio,
I for one do not believe the FDA made a mistake on the SPA or Anchor. You have to go back in time and look at the landscape then, not now or 2013. They gave the SPA to foster competition. You had Fibrates and Niacin already approved, and were in the process of completing outcomes studies. Now, did they think ahead that maybe those 2 studies would fail. Maybe...either way, they decided that they would require an outcomes studies since those other trials failed in between the SPA being issued and the Anchor results. Again, someone could have come up with this plan of action before the SPA. The reality was it was handled poorly, but their intent was to always foster competition. They did not succeed and damaged AMRN in the process. For me at least, it's the best thing that could have happened. Hopefully someday you will feel the same.
I really like that approach but my pet peave is places like Canada - we basically built theri health care system - almost every piece of technology they use was invented by us - then they get it for pennies on the dollar The US consumer pays for all the research then they get the meds for pennies - its time the rest of the world started to chip in for this research from which they all benefit !
J.L......."Did the FDA back pedal and change the goalposts...Violate the SPA and then stonewall by using the FDA's built in four corner press...the answer is yes..yes..YES.."
As long as we're mixing metaphors, let's admit that the FDA used Amarin for a punching bag and then tried to put them down for the count......all because of CYA.
Trigs over 500 are treated to prevent pancreatitis
Yea I am aware of all the anti-inflammatory effects lowering of inflammatory markers etc etc - niacin lowers inflammation as well https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4804877/ - yet has no effect on coronary artery disease outcomes
so you are convinced that we have elucidated the entire mechanism of atherosclerosis and it is via inflammatory pathways and EPA will solve it all ... that is indeed your right to believe this
but it is also my right to say ..... I'm just not that certain or convinced at this time
If they were that certain that lowering trigs had no effect than why keep the Mari ne indication label. That would indicate that they were not so certain, if they were not certain they then why take away the Anchor SPA. It would lead one to believe that very high Trig levels are dangerous, but there exist no value in preventing one's trigs from going from high to very high. Doesn't seem to be logical.
As time goes by , to me it appears clearer and clearer that Vascepa should target many more indications and patients than the High Trigs patients on statins. In fact that population might not be the one in which EPA is more effective, although I expect to see a significant RRR also in the RIT population.
A huge amount of scientific literature has been accumulating on EPA much higher efficacy in reducing CVD death risk linked to chronic disease (heart/kidney failure, Infartcuated patients , liver cancer etc) and I bet many other diseases could be targeted by EPA such as liver disease, IPF, etc etc where inflammation plays a central role in the fibrogenetic process. My bet is that reducing inflammation also fibrogenesis will be slowed or maybe even reversed.
Fibrosis is thought to cause 1/3 of global deaths in the world. So if we add CVD and Cancer, we basically cover ca 90% of all deaths.
Do we know if EPA has been tested in any fibrotic condition so far?
raf...
Useless speculation...
JT's previous comments and behavior tell me they are not worried about the PE.
If the PE was in doubt this would pretty much rule out anything any other of the 30 plus data points being OK with the possible exception cancer...The realities being cancer would most likely be out too..
Fact is most of the additional data points are dependent on fractions of the PE with some help from non-PE events. Everything is dependent a sufficient number of events with the caviot that the higher the RRRs the fewer number of events you need to get strong significance.
":>) JL
They made a mistake accepting the ANCHOR SPA. The way they went to remedy their error is controversial, but needed to be done.
Wondering if RI can fail in meeting its primary endpoint but become a huge success nonetheless, due to something else that it shows? Ex: 75% less cancers (P < .001) in the V arm.
The bipolarity on the board is interesting: V isn't about TG lowering, more than TG lowering (e.g. inflammation) on one hand, but should be approved based on TG lowering on the other hand ...
zip...
The horse is dead....Why do you keep beating it?
The FDA made a mistake when they agreed to the "ANCHOR" SPA..
The mistake was promising Amarin (and yes I am long the stock) the marketing rights to treating a 35 million cohort (mixed dyslipidemia) for which there was no viable competition as far as other drugs (a defacto monopoly). There was no clinical proof whatsoever that V would be an effective therapeutic agent other than one clinical trial (JELIS) that was run in Japan and was not widely accepted by the USA medical establishment who felt there were significant flaws in the study..
This in a background of healthcare cost spinning out of control.. To approve a medication that would have major effects on these costs without an acceptable CVOT would have been irresponsible..
Did the FDA back pedal and change the goalposts...Violate the SPA and then stonewall by using the FDA's built in four corner press...the answer is yes..yes..YES...Did it cost me and a lot of you some money...yes..yes yes..
Was it the right thing to do...yes ..yes ..yes...
I would bet serious money that the FDA struggled internally over this issue and I would not be surprised if Eric Colman was the one who made the mistake and this might of played a role in his cancer and subsequent death...
Timed to move on...Vasceps needs this great R-I trial to shut up the critics ...Meanwhile if you were smart and not wasted by your bitterness..you took the opportunity to buy some very cheap Amarin stock....And your reward will be coming next year...
":>) JL
Now I understand what you meant and I concur with you.
40 percent of US cancers linked to excess weight
About 40 percent of all cancers in the United States -- more than 630,000 in all -- are associated with excess weight, health officials said Tuesday, urging a renewed focus on prevention.
In a nation where 71 percent of adults are either overweight or obese, the findings by the US Centers for Disease Control and Prevention "are a cause for concern," said the agency's director Brenda Fitzgerald.
"A majority of American adults weigh more than recommended -– and being overweight or obese puts people at higher risk for a number of cancers," she said in a statement.
"By getting to and keeping a healthy weight, we all can play a role in cancer prevention."
Carrying excess weight has been shown to boost the risk of 13 types of tumors, including cancers of the esophagus, thyroid, postmenopausal breast, gallbladder, stomach, liver, pancreas, kidney, ovaries, uterus, colon and rectum.
The rates of these overweight- and obesity-related cancers are rising, in contrast to the overall rate of new cancer cases which has dropped since the 1990s.
Colorectal cancer was the only weight-associated cancer that decreased from 2005-2014 -- falling 23 percent, due in large part to screening, said the report.
All other cancers linked to weight rose seven percent in that decade.
About two-thirds of the 630,000 weight-associated cancers diagnosed in 2014 occurred in people aged 50 to 74.
Women were particularly susceptible, with 55 percent of all cancers diagnosed in women associated with weight, compared to 24 percent of those diagnosed in men.
According to the latest CDC data, 32.8 percent of people in the United States are overweight, and 37.9 percent are obese.
Being overweight is defined as having a body mass index of 25-29.9 kg/m2, while obesity means a BMI of 30 or above.
BMI is calculated by taking a person's weight in kilograms divided by the square of the person's height in meters.
https://www.afp.com/en/news/23/40-percent-us-cancers-linked-excess-weight
stacs...
Quote: "I am with you that chronic inflammation is the immediate cause of many diseases, like heart disease but I doubt that inflammation is the root cause of all diseases."
Nowhere do I say inflammation is the root cause of all diseases...Pneumococcal pneumonia is caused by a gram positive bacteria... All manner of infectious diseases are caused by viruses, bacteria, plasmoids, nematodes, prions and other vectors...The Black plagues and the 1918 Influenza pandemic were not caused by chronic inflammation. Diseases can be caused toxins slow acting and fast acting or on the other end by dietary deficiencies in conditions like Scurvy or Pellagra.
FYI: In medical terminology the suffix "itis" is used to indicate an inflammatory condition...So hepatitis means inflammation of the hepar which is the liver.
Chronic periodontitis raises systemic inflammation...which then accelerates the atherosclerotic process. The infection in the mouth is not the proximal cause of the injury in the vessels of the heart. Anything which raises systemic inflammation whether it is a distal chronic infection, a diet too rich in fast acting sugars, high insulin levels or n-6s in processed foods..will have a similar effect on the heart and all other body tissues...The point is that if you have untreated periodontitis, a poor diet or other causes that increase your risk for degenerative diseases...improving the EPA/AA ratio will moderate the chronic inflammation and slow down the degenerative process.
PS...That doesn't mean I'm against treating the periodontitis...
":>) JL
G-"efficacy should be proved also" There was a high degree of data pointing to the efficacy of Vascepa to prevent CVE. If a drug is ultra-safe it becomes a risk/reward medical decision that's should be left up to patients and physicians...something the pencil pushers at the FDA don't understand. Instead the FDA cancel an entire surrogate marker due to unrelated studies on different drugs not even studying the same biomarker. Very bad science.
BB
Akanz...Deal.
BB
z-
Safety: nobody questioned the safety of V ... but safety (alone) isn't enough, efficacy should be proved also
SPA: They have the right to "cancel" in case of lack of enough evidence ("substantial scientific issue essential to determining the ... effectiveness") which is the case here ... TG reduction isn't a substantial scientific issue.
TG: Meanwhile, Anchor showed that Vascepa lowered triglycerides, which is a good thing, not a bad thing, it is unknown (YTD) that TG reduction will be resulted in event reduction or not. No study (inc. JELIS with 5% TG reduction ...!) proved the theory ... all study (about add-on therapy as matter and related) failed to prove the hypothesis ... and maybe R-IT won't prove it either (just like JELIS) ... FDA did not say anything about EPA / V ... they moved based on TG lowering / add-on science.
The bipolarity on the board is interesting: V isn't about TG lowering, more than TG lowering (e.g. inflammation) on one hand, but should be approved based on TG lowering on the other hand ...
Best,
G
HDG:......"FDA did the right thing with ANCHOR already."
IMO they did the WRONG thing with Anchor on many levels:
1. Marine and Anchor had proven Vascepa to be safe
2. They had signed a SPA which dealt only with lowering trigs, not lowering events.
3. Anchor showed that Vascepa lowered triglycerides, which is a good thing,not a bad thing
4. They used unrelated studies as the basis for changing their minds on the SPA
5. They demanded an events study even before they would consider Anchor for approval......contrary to the SPA
6. They conducted an Adcom, in which they had already decided it should result in rejection of Anchor
7. They conducted the Adcom, not as a neutral party, but as an adversary of Vascepa
8. They framed the questions for the Adcom in order to get the result they had already decided on.
BB-
There's 0% chance the FDA will do the right thing with ANCHOR
JL I am with you that chronic inflammation is the immediate cause of many diseases, like heart disease but I doubt that inflammation is the root cause of all diseases.
Ac a matter of fact if you have an infection or a virus that is not cured/ controlled, for instance a HBV or HBC then you liver gets inflamed, you get fibrosis and then cirrhosis.
If you look at the immediate cause of fibrosis then you can say that inflammation causes fibrosis, but in fact the root cause is hepatitis. In theory with EPA supplement in this type of patients we should be able to attenuate inflammation (tbc), but we would not eliminate the root cause , ie hepatitis.
The same I think it may happen if you have a parodontitis which with time can cause heart disease. The infection in your mouth, if not cured, will cause the cause of a persistent inflammation which in turn can cause heart disease.
Inflammation is the immediate cause of heart disease, we can reduce MACE risk with EPA, but it is not the root cause of it, which is the infection in your mouth.
Am I missing anything?
HDG, question for you. If I remember right you were in CLSN years ago, correct? I got decimated when that trial failed, and am wondering what your confidence level was going into their results.
Was it comparable to your feelings about REDUCE-IT? More, less? Just curious.
Thanks.
D - I appreciate your posts calling him out
BB ...thx ...but just buy me a coffee instead , if you are ever out here on the Left Coast
Akanz2
stacs.
You are headed in he right direction but you need the specifics....
First of all it is not the chronic disease causing the inflammation it is the inflammation that is causing the disease.
The inflammatory system is a system that operates for the organism the way the military operates to protect a country...Without a highly functioning inflammatory and immune system we would not last very long because our environment is loaded with dangerous microbes and the normal replication of cells in growth and aging produces a steady stream of genetic mistakes that can lead to malignancies...so we need an army, navy, and airforce...
These forces need to be able to discern self from non self, because our armed forces are very strong and can easily kill our own cells if they turn on them..Germane to EPA is the control of the inflammatory system...The first thing to know is the inflammatory system is very ancient and was present in basic design in the very first multicellular animals in the Precambrian oceans 500 million years ago...And this primitive inflammatory system was membrane based and yes it also used EPA...Because multicellular animals can not survive without an inflammatory system.
Although there a many different biological agents that will trigger the inflammatory system (essentially anything organic which is not "self" or is toxic) the over all sensitivity of the inflammatory system is effected mainly by dietary considerations, This includes the quantity of certain essential amino acids as one control...The most important system however is the eicosanoid system which uses cell membrane receptors (COX and LOX) and nuclear membrane receptors (PPARs) to set the sensitivity of systemic inflammation either high or low like a thermostat adjusts the room temperature...These receptors are the controls of systemic inflammation and are present on all cells except RBCs...
Although there are a number of agents which can interact with these receptors (eg. aspirin, NSAIDs, and steroids)...The principal actors are EPA and arachidonic acid (AA) and these two PUFFAs compete for the receptor sites. Both tend to increase inflammation...but AA has a much greater effect so EPA lowers systemic inflammation when compared to AA...
So what cause increased systemic inflammation which leads to all these degenerative conditions is anything which increases the AA/EPA ratio on the membrane receptors...These factors include low dietary intake of EPA...High intake of AA....but Obesity and insulin also increases AA . Obesirty particualarly abdominal actually produces chemical that increase AA and insulin expedites the conversion of ALA and other plants chemicals into AA...
":>) JL
Akanz. I will reimburse your fee for 1 bottle, apply for the coupon and let me know the cost. There's 0% chance the FDA will do the right thing with ANCHOR. There's 100% chance if ITC action doesn't get granted Amarin will eventually win "takings" claim. You'll likely be long before the end of the week IMO.
BB
Rosey ...from my reading I get the impression that the FDA is OK with Dietary Supplement fish oils ( DHA/EPA etc ) consumed at 2-3 gms a day ...but wants MD's to meet with patients for higher doses to treat specific conditions
Just my impression from random readings
Thx for your citations
Kiwi
Kiwi,
Do you think the more recent pronouncement you provided, omitting a qualification about maximum dosage not to exceed 3 gms daily, is due to the prescription drugs Lovaza and Vascepa being dosed at 4 gm per day and the FDA becoming comfortable with that?
There's that good old passive-aggressive behavior of Whal's.
Rosey There is also this from a more recent DS petition to the FDA asking to advertise health benefits
Based on FDA's consideration of the scientific evidence and other information submitted with your petition, and other pertinent scientific evidence and information, FDA concludes that there is sufficient evidence for a qualified health claim, provided that the qualified claim is appropriately worded so as to not mislead consumers. Thus, FDA will consider exercising enforcement discretion for the following qualified health claim:
Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food] provides [ ] gram of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat, and cholesterol content.]
Dietary supplements may declare the amount of EPA and DHA per serving in "Supplement Facts," instead of making the declaration in the claim.
----------------------
Kiwi
Rosey
Re the following
The FDA went on to recommend that consumers not exceed more than 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day derived from a dietary supplement.
Could you link the actual FDA statement ...thx
Hope alls well in Florida
Kiwi
But STS the FDA pretty much already permits these types of claims for omega-3's. You wrote:
"I have no doubt that if/when R-IT is a success AMRN legal team starts searching online for high purity EPA DS websites and immediately starts filing complaints with FDA and FTC for improper/illegal advertising mentioning anything related to "heart healthy", let alone "preventative", if DS is dumb enough to actually go that far."
The FDA now permits this statement:
“Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.”
On September 8, 2004, the FDA announced that it would allow an expanded health claim on products containing the omega-3 fatty acids eiscosopentaenoic acid (EPA) and docosahexaenoic acid (DHA).
According to Acting FDA Commissioner Dr. Lester M. Crawford, “Coronary heart disease is a significant health problem that causes 500,000 deaths annually in the United States. This new qualified health claim for omega-3 fatty acids should help consumers as they work to improve their health by identifying foods that contain these important compounds (EPA and DHA).” The FDA went on to recommend that consumers not exceed more than 3 grams per day of EPA and DHA omega-3 fatty acids, with no more than 2 grams per day derived from a dietary supplement.
Now BB ...remember our bet
Which comes first
Anchor reinstated or the R-IT results .....a bottle of Vascepa to the winner ..and don't be doing a Raf on me ( welching ) if I win ...
Akanz2
STS re your view
It's black and white - I've posted the FDA regs multiple times that make it clear they are drugs and not DS, and so have others - why you refuse to or can't understand them is beyond me.
------------------------------
Well if its black and white why the delay till Oct 20Th ? If the ITC were that certain, they would have accepted the case already .
Re chiding you for being slow to respond. My apologies ...I thought I had added a to that statement to indict I wasn't serious .
Let me lighten your load ...and ask you not to bother to respond to any of my posts until after the ITC makes their decision .
Kiwi
PPS- Despite the likelihood Amarin prevails the street could give a crap about buying this stock...see all my posts Re: Amarin not fully completing ANCHOR SPA rescindment appeal. The method of completing SPA appeal has past, Amarin has chosen the ITC route...both end with Amarin taking the US Government to court for "takings" claim IMO. It's likely I missed the ITC action when considering exhausting all administrative actions prior to "takings"....I think all bases are covered for Amarin stakeholders (Amarin & shareholders) v. US Government Re: stealing Vascepa lifecycle and giving to generics causing harm to millions of cardiovascular patients, ignoring public safety concerns, numerous arbitrary and capricious acts..........NCE, First Amendment, censorship of CP, not accepting lawful appeal.....the list is long.
BB
Followers
|
1111
|
Posters
|
|
Posts (Today)
|
2
|
Posts (Total)
|
425915
|
Created
|
03/12/07
|
Type
|
Free
|
Moderators ziploc_1 zmanindc golf stud Number sleven |
AMARIN TICKER RELATED LINKS
Amarin Webpage
NASDAQ AMRN Quote
Y! Finance AMRN Landing Page
Seeking Alpha AMRN Landing Page
FinViz AMRN Landing Page
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |