STS. Back at work this morning I rechecked the email and as of May 1 MSRP will become
$78. Now how long before some of these sellers work through the cheaper inventory and raise prices I can't tell you.

Carlson brought out the product but introduced it keeping the same prices as the much weaker EPA product they had to try to get it out there. As of May 1 wholesale prices will be significantly higher.

Prices should be fairly comparable to OmegaVie then.

Hoping that dosage is the key factor to explain conflicting study results:


"In contrast to these positive results, recent results from the Outcome Reduction with Initial Glargine Intervention (ORIGIN) study found that treatment with EPA plus DHA did not prevent death or any cardiovascular outcomes in patients with increased risk of cardiovascular events who had diabetes mellitus or who were at high risk for diabetes mellitus [41]. A potential explanation for the discrepancy in results between ORIGIN and JELIS is that the dose of EPA, or EPA plus DHA, in JELIS was 1.8 g/day, approximately twice that of ORIGIN (and indeed most of the earlier studies)."

What you are looking at is the old formula. The 1000 mg EPA per capsule is a brand new product.

Here is a link to an ad from Vitacost for the new product:

http://www.vitacost.com/carlson-elite-epa-gems

Carlson is having a price increase on May 1.

JL. The answer is obvious and goes without saying.

Problem is so many physicians are fixated on what I call "paint by numbers". Give everyone blood tests and zoom in on the cholesterol numbers.

On a side note, if you or any other posters could help me with a question I have it would be appreciated. Are there any guidelines as to how frequently blood tests should be ordered for patients who have all their blood work numbers in range? Would be nice to have some authoritative's body's guideline to bring to my doc to get her to relax on the constant blood work. I can understand doing so if something needs to be monitored. TIA

Got back from a little trip and saw this in my business email inbox:

Carlson's Elite EPA gems.

Introducing our newly formulated EPA GEMs!
Our new formula, is 2 1/2 times the potency at 1,000mg of EPA each soft gel!
This product is equal to the prescription strength product for high triglyceride levels.
See attached Product flyer with current pricing.

I realize they are not allowed to make the claims for the product but if it provides 1000mg of EPA per capsule how is it much different from Vascepa (forget about negligible amounts of other ingredients).

What are the Amarin patents for if people can sell virtually identical products?

Fishy, totally agree with your comment about the scientific illiteracy of the masses, but what is the explanation or verdict on the scientific literacy of the physicians who are the ones who are adamantly pushing this stuff on their patients?

Are they smarter than that but still doing it from a defensive position not wanting to be sued (actually they should be sued for not following their oath) or some other motive or are they that dumb too?

I hear famed neurosurgeons spout nonsense on other topics so wonder about their knowledge.

A little perspective here I think is warranted.

1. BMPEA should be closely scrutinized and removed from the market..... Just as ephedrine was a few years back

2. A couple of guys from the supplement industry get jobs at the FDA and a big stink is raised. Obviously most people recognize that there has been a revolving door between Big Pharma and the FDA for decades now.

3. The companies that are selling those weight loss supplements with BMPEA and other dubious ingredients are not the stalwarts of the supplement industry. These are scumbags who would sell anything for a profit and then go on to the next scam. They SHOULD be cleared out of the industry.
You don't companies like Solaray, Kal, Now Foods, Solgar, Nature's Plus, Nordic, etc., selling shit like this. So no need for big paint brushes. Just some balanced reporting and investigative journalism.

4. There are over 100 thousand deaths per year from PROPERLY prescribed and PROPERLY used prescription drugs. I have not seen any numbers provided for the harm inflicted by these suspect supplements.

http://commonground.ca/2012/01/prescription-drug-deaths/

I think everyone here concurs with your thinking. However we have to be careful about wanting things both ways.

What I mean is there are many posters here who have bashed fish oils and have elevated Vascepa as being something completely different from fish oils. So much so we want NCE status.

Duke University Economics Department..Generics 70% market share within the first full month
AEA CONFERENCE
Boston, Massachusetts
January 4, 2015

The provisions of the 1984 Act served as a cornerstone for the growth of the generic drug industry. In particular, easier generic entry requirements combined with automatic drug state substitution laws and managed care incentives (e.g. tiered co-pay formularies and differential pharmacy dispensing fees) significantly increased generic usage This is exemplified by the fact that generic products share of total prescriptions in the U.S. increased from 36 percent in 1994 to 84 percent in 2012. (IMS, 2013) The brand erosion curve after generic entry has also accelerated over time (the so-called patent cliff.) Specifically, generics that entered brand product markets in 2011-captured a 70 percent share of combined brand-generic total units within the first full month of generic competition, and over 80 percent by six months. (Grabowski, Long, and Mortimer, 2014) As the number of generic products for a particular entity increases, generic prices also decline toward marginal costs. This can yield substantial savings to patients and payers.
#
The first generic manufacturer to file a paragraph IV challenge resulting in entry prior to patent expiration (from either a court victory or settlement with patent owner) is granted a 180 day exclusivity period. The 180-day period of generic exclusivity generally is very profitable to a generic manufacturer because the firm can discount its price only moderately compared to the brand product and still gain most of the branded product’s sales. In this regard, the typical generic receives an “AB” rating from the FDA certifying that it is therapeutically equivalent to the branded product, and then can benefit from the automatic state substitution laws as well as managed care generic utilization incentive programs

Thanks AP, I had not actually seen that before (must be asleep at the wheel).

Will wait until we have some posters knowledgeable on statistical analyses of clinical trials opine on this. I know you get hit with statistical penalty for every "look" you take, but not sure if that p value at interim seems to be something that is quite hard to achieve.

Awaiting more info.

If the FDA is more interested in having a generic then it is as you say coming from another part of government dictating such.

Otherwise I don't believe the FDA gives a rat's ass about generics. Heck they don't want me saving money buying my drugs from Canada.

With all due respect, in AIM high baseline trig levels were 161 -- not something I would describe as high triglycerides. Not to mention that niacin is a completely different substance from eicosapentanoic acid.

Maybe everyone is tired of going over the whole Adcom fiasco, but I ask

What new unrecognized public health concerns came up between SPA issuance and rescission?

According to the new Performance Goals and Procedures adopted by the FDA for 2013 through 2017 it states (in regards to SPAs):

"The fundamental agreement here is that having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident."

http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf

Epen,

Does Reduce-It have to meet endpoints with statistical certainty or do they have to do that AND show a MOA?

The FDA did not seemed concerned about MOA when they rescinded the SPA. They supposedly based their move on on totally different substances in those ACCORD, Aim-High, etc studies that have different MOA than V, which of course they misread or mis-extrapolated those results to V.

STS I was thinking about that too when I read it. Now Jelis had the combo of statin plus EPA and I believe they saw the EPA/AA ratio go down in the EPA group. Did they measure that in that study or am I confused???

This unfortunately does not provide the actual document they signed (do the parties sign the SPA?) but is from the press release from Amarin:

August 10, 2011
Amarin Announces Agreement From FDA on Special Protocol Assessment for AMR101 Outcomes Study
Study Positions AMR101 to Potentially Address Patient Populations of More Than 70 Million in the U.S. Alone
MYSTIC, Conn. and DUBLIN, Ireland, Aug. 10, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) agreement for the design of the previously described cardiovascular outcomes study of AMR101 formally titled REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial). Amarin previously announced that it achieved the primary endpoints of two Phase 3 studies of AMR101, both of which were conducted under separate SPAs.

In REDUCE-IT, Amarin will evaluate the effectiveness of AMR101 in reducing the first major cardiovascular events in an at-risk patient population. The control arm of the study will be patients on optimized statin therapy. The active arm of the study will be patients on optimized statin therapy plus AMR101. All subjects enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. Amarin will be responsible for the study which will be conducted internationally. The Company will use an experienced clinical research organization (CRO) to help manage the study and is in the late stages of contract negotiations with a leading CRO for that purpose.

Consistent with prior comments, Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion. The Company anticipates that if, as intended, it commences Outcomes study activities in 2011 that it will be positioned to achieve approximately 50% enrollment before the end of 2012.

Once REDUCE-IT is substantially underway, the Company believes that it will have met all of the requirements to request approval of AMR101 for treating the mixed dyslipidemia patient population studied in the ANCHOR trial. AMR101 is positioned to be the first drug in its class approved for treatment of this indication. Upon completing REDUCE-IT, and assuming a successful result, Amarin anticipates being able to pursue an indication for the prevention of cardiovascular events; this population is estimated to be greater than twice the size of the combined indications studied in the MARINE and ANCHOR trials. The Company also anticipates that, similar to ANCHOR, a significant number of the patients in REDUCE-IT will have diabetes.

"We are delighted to have finalized the protocol for REDUCE-IT and to have the FDA agree to this via a Special Protocol Assessment, our third SPA for AMR101, which is remarkable," stated Joseph Zakrzewski, Amarin's Executive Chairman and CEO. "Based on the strong safety profile of AMR101, our positive Phase 3 results for AMR101 and success in Japan with an outcomes study of highly pure EPA, we believe that REDUCE-IT is positioned for success." Mr. Zakrzewski added, "The design of REDUCE-IT reflects the diligent evaluation of numerous other outcome studies by our clinical team, advisors and other interested parties all of whom are commended and thanked for their contributions to the very direct and efficient design of this study."

About AMR101

AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels.

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010, and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>200 and <500mg/dL] with mixed dyslipidemia), as reported on April 18, 2011. Both the MARINE and ANCHOR trials were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development.

About Special Protocol Assessment (SPA) Agreements

An SPA agreement is an evaluation by the FDA of a protocol with the goal of reaching an agreement that the trial protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval. The FDA agreed that, based on the information we submitted to the agency, the design and planned analysis of the REDUCE-IT trial adequately address the objectives necessary to support a regulatory submission. An SPA is generally binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing begins. However, there can be no assurance that this will be the case. If the FDA does not consider the SPA to be binding, the agency could assert that additional studies or data are required to support a regulatory submission.

Disclosure Notice

This press release contains forward-looking statements, including statements about the efficacy and safety of the Company's product candidates, likelihood of success of clinical trial, the timing of initiating, enrolling and completing a planned cardiovascular outcomes study and the status of negotiations with contract research organizations in connection with such study, and the potential market positioning and market potential for AMR101. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations and the planned cardiovascular outcomes study; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; risks associated with qualifying new contract manufacturers prior to commercial launch; the risk that SPAs are not a guarantee that FDA will accept an NDA or approve a product candidate upon submission; the risk that historical clinical trial enrolment and randomization rates may not be predictive of future results; risks associated with our intellectual property including the risk that our recently filed patent applications may not issue; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and other matters can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. The Company's product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials. Nothing in this press release should be construed as marketing the use of such product candidates.

CONTACT: Investor Contact Information:

Stephen D. Schultz

Investor Relations and Corporate Communications

Amarin Corporation

In U.S.: +1 (860) 572-4979 x292

investor.relations@amarincorp.com

No doubt you might be right about what he meant however the point was that in the sentence prior to that statement he states that there are precious few studies done with that kind of dosage, so what data does he base his conclusions on?

Well, failing to confirm is not the same as positive evidence showing that adding a second lipid-active drug to statin therapy won't reduce risk. That is the whole point of the Reduce-It trial and why it had to be predominately enrolled by that time. NOT to mention that from the data in those trials ( ACCORD, etc) there would be no way to gauge whether an add-on lipid-active drug would help in the category of patient which Anchor covered.

You are correct in everything you say, however, what changed between the time the SPA was granted and the time it was rescinded?

I wonder how many physicians and patients know that

Coumadin causes blood vessel calcification?

http://onlinelibrary.wiley.com/store/10.1002/clc.20865/asset/20865_ftp.pdf;jsessionid=4D0C3DDA4FB279129B6F865A64BA0E1F.f04t01?v=1&t=i81meglu&s=f657d6b9839a0e1efa1dd72f9369a556fbb5776f

Interesting too that in this story Dr. Nissen is quoted as saying that coronary artery scanning for calcium is medicine gone mad. The implication in the story was that those without calcium may not need statin treatment irregardless of their cholesterol level. He would not like that.

But obviously there are many confounding factors going on (hence why we see almost half of the people with heart attacks have "normal" cholesterol) possibly a number of things we don't even know about today.

This story was in 2011 and before the last story posted on the board:

http://abcnews.go.com/Health/HeartDisease/calcium-scores-best-predictor-heart-attack/story?id=14334633

What is one to think?

Just posted on our board was a study showing that treatment with statins increases calcium score. BUT Dr. Nissen says maybe that is good. Not sure if his opinion has anything to do with his ties to BP and their statin medicines.

If you just generally search for information on calcium score it seems that the standard view is that the higher the score the more CAD and greater chance of an event. Here is a study done almost 10 years that repeats that and also claims it is a better predictor (more accurate than standard risk factors and CRP) of CAD events:

http://content.onlinejacc.org/article.aspx?articleid=1136708

DR. Sears and doses,

What seemed to confuse me a bit was he seemed to be indicating doses as high as 8 to 10 gm daily but the sentence before mentioned that there have been virtually no studies done at more than 5 gm daily. So without the data I question his proposal of 8 to 10 gm.

Otherwise he did a good job putting that NYT article writer in their place.

Whenever I see studies or read about something that extends life for a few months or years I always think of this one customer of mine that cracked me up then and every time I think of him.

Can't remember what we were discussing but it was concerning increased longevity and then he blurts out " Well those are extra years at the end of life. Those are useless--- I'm interested in more years in the middle of life"

Harvard School of Public Health 2013 Omega 3 study:

http://www.hsph.harvard.edu/news/press-releases/higher-blood-omega-3s-associated-with-lower-risk-of-dying-among-older-adults/

Higher blood omega-3s associated with lower risk of premature death among older adults


Risk of dying from heart disease significantly lowered

For immediate release: April 1, 2013

Boston, MA – Older adults who have higher blood levels of omega-3 fatty acids—found almost exclusively in fatty fish and seafood—may be able to lower their overall mortality risk by as much as 27% and their mortality risk from heart disease by about 35%, according to a new study from Harvard School of Public Health (HSPH) and the University of Washington. Researchers found that older adults who had the highest blood levels of the fatty acids found in fish lived, on average, 2.2 years longer than those with lower levels.

“Although eating fish has long been considered part of a healthy diet, few studies have assessed blood omega-3 levels and total deaths in older adults,” said lead author Dariush Mozaffarian, associate professor in the Department of Epidemiology at HSPH. “Our findings support the importance of adequate blood omega-3 levels for cardiovascular health, and suggest that later in life these benefits could actually extend the years of remaining life.”

The study—the first to look at how objectively measured blood biomarkers of fish consumption relate to total mortality and specific causes of mortality in a general population—appears online April 1, 2013 in Annals of Internal Medicine.

Previous studies have found that fish, which is rich in protein and heart-healthy fatty acids, reduces the risk of dying from heart disease. But the effect on other causes of death or on total mortality has been unclear. With this new study, the researchers sought to paint a clearer picture by examining biomarkers in the blood of adults not taking fish oil supplements, in order to provide the best assessments of the potential effects of dietary consumption of fish on multiple causes of death.

The researchers examined 16 years of data from about 2,700 U.S. adults aged 65 or older who participated in the Cardiovascular Health Study (CHS), a long-term study supported by the National Heart, Lung, and Blood Institute. Participants came from four U.S. communities in North Carolina, California, Maryland, and Pennsylvania; and all were generally healthy at baseline. At baseline and regularly during follow-up, participants had blood drawn, underwent physical examinations and diagnostic testing, and were questioned about their health status, medical history, and lifestyle.

The researchers analyzed the total proportion of blood omega-3 fatty acids, including three specific ones, in participants’ blood samples at baseline. After adjusting for demographic, cardiovascular, lifestyle, and dietary factors, they found that the three fatty acids—both individually and combined—were associated with a significantly lower risk of mortality. One type in particular—docosahexaenoic acid, or DHA—was most strongly related to lower risk of coronary heart disease (CHD) death (40% lower risk), especially CHD death due to arrhythmias (electrical disturbances of the heart rhythm) (45% lower risk). Of the other blood fatty acids measured—eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA)—DPA was most strongly associated with lower risk of stroke death, and EPA most strongly linked with lower risk of nonfatal heart attack. None of these fatty acids were strongly related to other, noncardiovascular causes of death.

Overall, study participants with the highest levels of all three types of fatty acids had a 27% lower risk of total mortality due to all causes.

When the researchers looked at how dietary intake of omega-3 fatty acids related to blood levels, the steepest rise in blood levels occurred when going from very low intake to about 400 mg per day; blood levels rose much more gradually thereafter. “The findings suggest that the biggest bang-for-your-buck is for going from no intake to modest intake, or about two servings of fatty fish per week,” said Mozaffarian.

Support for the study came from the National Heart, Lung, and Blood Institute (NHLBI) and the Office of Dietary Supplements of the National Institutes of Health (R01-HL-085710).

“Plasma Phospholipid Long-Chain Omega-3 Fatty Acids and Total and Cause-Specific Mortality in Older Adults,” Dariush Mozaffarian, Rozenn N. Lemaitre, Irena B. King, Xiaoling Song, Hongyan Huang, Molin Wang, Frank M. Sacks, Eric B. Rimm, and David S. Siscovick, Annals of Internal Medicine, online April 1, 2013

For more information:

Marge Dwyer
617.432.8416
mdwyer@hsph.harvard.edu

###

Harvard School of Public Health (http://www.hsph.harvard.edu) is dedicated to advancing the public’s health through learning, discovery, and communication. More than 400 faculty members are engaged in teaching and training the 1,000-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children’s health to quality of care measurement; from health care management to international health and human rights. For more information on the school visit: http://www.hsph.harvard.edu

Why don't you put these 2 quacks in a ring and let them duke it out. One says omega-3 cause inflammation and the other says they reduce it.

http://articles.mercola.com/sites/articles/archive/2011/11/11/everything-you-need-to-know-about-fatty-acids.aspx

JL I can't argue with anything in your post. Up until my experience with Amarin I always thought that procuring an SPA gave the developer a safer framework within which to proceed clinical trials towards drug approval. Someone may know the answer to my question as to how many times something like this - a recision of an SPA - has happened?

If we can trust or believe the FDA (not much confidence in what they actually say) they based their decision in part on results from a few outcome trials such as ACCORD, AIM, etc. But to me either they were simply using those as an excuse or they demonstrated a sad lack of science acumen.

Those trials were not designed to show clinical benefits in the type of population Anchor covers. Most of the subjects in those trials had normal to borderline high triglycerides and so in interpreting those results and trying to apply them to Vascepa the FDA should have known better.

The SPA covered an outcome trial (Reduce-It) that was substantially enrolled and FDA would have their results in a few years. No logical or scientific reason in my book for the action they took.

Just a little side note. Just as it was pointed out (I believe by you) how the FDA says nothing about 180 mg EPA over the counter being touted for CVD, let's just look at the NIH. They categorize triglyceride levels partially according to CVD risk, calling 150 to 200 borderline high risk and 200 to 500 as high risk.

Let's not kid ourselves though. It is not only supplement companies that get compliance citations from the FDA. You are correct though that sometimes you get what you pay for but not always. People need to do a little DD when it comes to purchasing supplements just like stocks.

http://blog.fdazilla.com/2011/03/report-documents-dramatic-increases-in-form-fda-483-citations-for-pharma-and-biotech-firms/

http://www.raps.org/Regulatory-Focus/News/2014/12/08/20928/The-Top-15-Pharmaceutical-Deficiencies-Cited-by-FDA-in-2014/

Ra I agree with you that when it comes to the lipid markers that blood tests track (Chol, HDL, Ldl, etc) TRIGS seem to be the ones that can move the largest amount in the shortest amount of time.

It made me think of blood sugar testing. The fasting blood level test around for so long, but it appears more and more physicians are more interested in the Hg A1c levels as those give a more representative value of what is happening in the body.

Some here have provided studies showing high Trigs and low HDL is a recipe for CVD. I think genetics also has to be factored in. I always think about my wife who has a very high HDL and for many years did all the wrong things (things that are not supposed to help raise your HDL levels) yet I have struggled with a low HDL all the while exercising and eating correctly but to no avail. Of course my HDL could be worse without my proactive approach. As I used to say to many of my customers, if you could cut yourself in half and half of you do one thing and the other half another and then compare after a period of time LOL.

JL. A lot of this goes back to 1994 when DSHEA was passed. Here is a brief Q&A section from the FDA about the impact of DSHEA on what we are talking about:

Who validates claims and what kinds of claims can be made on dietary supplement labels?

FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail.

back to top

Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?

This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.

How are advertisements for dietary supplements regulated?

The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to the FTC web site disclaimer icon. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.


I worked as a pharmaceutical chemist after getting out of school so long ago that it seems as though it must have been in pre-Cambrian times. The last 22 years of my working life I have been involved in the supplement industry so I am more familiar with this stuff.

On a more philosophical note, with my knowledge of the function and structure claims permitted by FDA for supplements, I was unbelievable shocked (and not to mention decimated as an Amarin investor) at ADCOM and SPA recession. Totally unbelievable that Amarin could not use Anchor data on label after clinical study completed and agreement to have Reduce-It substantially enrolled. It made and makes no sense. I know I missed my chance to sell on the Marine approval news (ops had risen into the approval) but there is no way any thinking person could have argued that selling just before ADCOM made any sense -- it was the right thing to do obviously seen after the fact - but it just made no sense.

JL, this is what they are going by. Sometimes they just go over the line ever so slightly but this was granted a while back.

http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072932.htm

Hopefully they don't let the whole world in at a buck and then there won't be any more buyers to bid the price up any higher.

Unfortunately you are not him. Don't know much about Ostroff but there is always a good possibility (since he was appointed to the post) that he is of the same mindset has his predecessors.

We all respect JL's posts, however, in this case AP I tend to buy into you argument because as you indicate not only was it one of the paths forward mentioned by JZ but he had just done the same a few years prior with Omacor.

He said in his last post he has left on vacation.

Your personal study is of course just that, an individual response. But from the figures you post the only thing worthwhile taking is BOTH while individually both appear to work poorly. Of course you did not post any numbers while naive.

I used to prefer the old Sean Penn line: Cut off their head and shit down their neck.

Ray you ask a good question re: 1.8gm dosage. I believe that was also the dosage used in Jelis so for some reason the Japanese zero in on this dosage.

There are many secondary endpoints in the Cherry study that I find interesting and believe can give us insight into R-I. The key of course is MACE, but it will be interesting to see the lipid levels and markers of inflammation EPA/AA and CRP.

About the "when"..... assume like most that it mostly likely only comes after interim or full results of Reduce-It - your idea as well???

Coming before R-I results I would think would need something like Anchor, not to mention that I don't believe your target would be offered without some indication about Reduce It results.

AND if reports are true NCE was possibly the major sticking point preventing a sale of the company back in late 2013.