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Whalatane check for Omegavia500 on Walmart.com I recently bought
4 bottles there. On Amazon.com says out of stock. Omegavia site says out of stock.
Was that Initial studies to establish cryolipolysis methods
performed on the Kardashians
AA:EPA Ratio https://omegaquant.com/omega-3-index-plus/
From now until midnight on Monday we will be joining in on the black Friday and cyber Monday madness for the first time ever as a thank you to you. Simply put in the promo code Thanks25 to receive 25% off your order.
In case anyone wants to check there AA:EPA normally cost is $79.95 with discount under $60.
Learn more from your cells with the Omega-3 Index Plus Test:
Your Omega-3 Index
Trans Fat Index
Omega-6:Omega-3 Ratio
AA:EPA Ratio
All in one drop of blood.
raf When my wife went to the doctor and had all the information with her on Vascepa her doctor had never heard of Vascepa but said she would read up on it. Her doctor wanted to know how she got her Tryglycerides to 70.
Also her HDL Cholesterol up to 78. She told her EPA. My wife who has worn glasses since she was 14 years old was told by the eye doctor that her eyes have improved so much that she doesn't even need gasses in one eye and her other eye has improved a lot. I would like her to take Vascepa but Omegavia500 is very good and I do take some also along with Vascepa as I can only afford 2 grams a day. When I turned 65 my cost for three months went from $90 to $370. We live in northern Wisconsin and Amarins salesman don't come up here because none of the doctors have heard of it. I don't think my doctor knows what it is but he wrote a prescription and I tell him how good Vascepa is. WE have told three people who had Dry Eye to try EPA and all three said after two weeks the Dry Eye went away.
Shadolane regular fish oil is not what Amarin wants the sale of stopped.
They want the sale of anything close to 100 percent EPA as OmegaVia500
https://shop.omegavia.com/products/omegavia-epa-500?variant=14633097351
Omegavia sells three different type of fish oil, Omegavia500, Omegavia dha500, and OmegaVia Fish oil. Amarin wants the Omegavia500 stopped because it is close to 100 percent EPA. The other two are fine as they are natural. There is about 25 companies that sell and claim one of there products is close to 100 percent EPA, those are what they want the sale of stopped. I take 2 grams of Vascepa a day and have for two years. My wife takes Omegavia500 because no doctor will give her a prescription. We both feel it is fantastic for our health.
Naked Short Report http://nakedshortreport.com/company/NNVC
Regular Volume 363,762 Short volume 172,598
Zone Labs $75 AA/EPA ratio http://www.zonediet.com/shop/omega-3-fish-oil/cellular-inflammation/ --- Or Omega Quant $79.95 Omega 3/Transfat/Omega 6/omega3/ AA/EPA ratio http://www.omegaquant.com/omega-3-index/
Either one will give you results for your AA/EPA. Zone Labs uses Omega Quant to do the testing, located in Sioux Falls, South Dakota.
Biobillionair I take 2 grams Vascepa a day. My wife doesn't have a prescription so she takes OmegaVia500 or GNC Triple Strength EPA1000.
I take some of those also added to my Vascepa. They are both good have no smell of fish and have no taste of fish. Both cost per month about the same as my copay insurance for Vascepa at $30.
Golf Stud after taking 2 grams of Vascepa per day with meals in one year I lowered my LDL from 142 to 68. Lowered my Trigs from 145 to 70. You will never have dry eye once you start taking Vascepa. My copay is $30 month for 60 1 gram tablets. My doctor knew nothing about Vascepa when he prescribed it. I have given him a lot of information
about Vascepa. I also the last 6 months have been taking 2 grams of OmegaVia500 which has maybe a little DHA in the tablets, probably about 80% EPA. Vascepa is 98% EPA. I want to get my EPA level higher. If you wanted to find out how healthy you are you get the EPA/AA test as I have. Then you would know how much EPA you should take. http://www.omegaquant.com/omega-3-index/
Joseph V. Gulfo would be the the one to head the FDA. Donald please name this guy to head the FDA. He knows everything that is wrong with the FDA.
Who will take the reins as next head of the FDA? Who would be the best choice for Amarin?
So who is under consideration to run the Food and Drug Administration? Over the last two months, a number of names have been floated by individuals associated with the Trump transition team and several have been spotted at Trump Tower and even confirmed as considered appointments by the Trump team. Here are a few:
Dr. Scott Gottlieb: former deputy commissioner at the FDA under President George W. Bush, venture partner at New Enterprise Associates, and resident fellow at the American Enterprise Institute (AEI). For those of you who may not know, AEI is almost as big a fan of vapor products and their consumers as we are at ATR. I know, I'm biased. But go read anything Dr. Sally Satel has ever written or said on the subject if you haven't. Hi Sally!
Gottlieb is advising the Trump transition team and as a former regulator would make a more traditional pick to lead the agency. I'm led to believe this guy gets it when it comes to harm reduction and the importance of innovation in the vapor space.
Jim O'Neill: closely connected to Trump supporter Peter Thiel, the billionaire businessman and venture capitalist who co-founded PayPal. O'Neill is managing director at Thiel's Mithril Capital Management. He isn't a doctor and doesn't have a deep background in healthcare but did serve in W.'s HHS between 2002-2008.
O'Neill has publicly expressed support for allowing drugs to hit the market after they've been deemed safe but before they've been deemed effective. See this Forbes piece on the "progressive approval" process. This would be what they call 'UGE. Picking O'Neill would be one of those extremely bold shake up the FDA with a guy opposed to the status quo kind of things.
Dr. Joseph Gulfo: the executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, and the former President and CEO of the medical device firm MELA Sciences. A defender of the FDA's underlying mission but big advocate for reforms that simplify the drug-approval process. Click here to read an interview he did this week and a piece he wrote for the Wall Street Journal in November. He's the newest name on the short list.
Balaji Srinivasan: another Silicon Valley entrepreneur connected to Thiel. He's a partner at the VC firm Andreessen Horowitz, CEO of a bitcoin startup, and lecturer at the Departments of Statistics, and Computer Science at Stanford.
Okay, what do all of these possible picks mean for the FDA and the vapor industry? There's clearly a push for someone from the tech/biotech industry to take the reins and it's likely that the next head of the FDA will come from the venture capital world, bringing with them a better understanding of entrepreneurship, economics, and the importance of innovation than recently departed Commissioner Califf or his predecessor Commissioner Hamburg. These guys aren't career practicing doctors, they're investors and innovators. We're on the verge of seeing big changes at the FDA.
Note: Mitch Zeller, the director of the FDA's Center for Tobacco Products is not a political appointee. He's under no obligation to leave the position and will likely stick around for a while. That's why we'll need a culture shift above him at the FDA and at HHS. Congressional action helps too.
Invest my Trigs the last time I went to my doctor were at 72.
My doctor still wrote prescription for 60 grams a month of Vascepa.
I brought into my doctor a year and a half ago information about Vascepa and he had no problem with me taking Vascepa since there is no side effects. If your doctor won't let you take Vascepa get a different doctor. Doctors have an agenda of Statins, Metformin and blood pressure medicine.
Kiwi, I do fast for over 12 hours whenever I get blood tests.
5/13/15 my LDL was 142, HDL was 34, Trig was 134, Hgb1 6.9%.
That is when I got my doctor to give me a prescription for Vascepa 2 grams a day. Of course he knew nothing about Vascepa but gave me a prescription anyway. 8/25/15 my LDL was 135, My HDL was 34, My Trig was 102, My Hgb1 6.9%. 2/19/16 My LDL was 116, My HDL was 39, My Trig was 112, My Hgb1 6.5%, 8/19/16 My LDL was 67, My HDL was 39, My Trig was 75, My HGB1 was 6.8%. My Cellular Inflammation Score total on August 4, 2016 is in Target at 2.9% which is excellent for future wellness. My EPA was 2.7% which is a little low. My AA 7.9% which is in range between 7-9%. What it shows to me is it takes over a year of taking Vascepa with statin for it to lower LDL also lower Trigs. Just taking Statins never lowered my LDL. I have never smoked but I do drink a bit. I also golf everyday at least 18 holes, except in the winter.
Thanks JL I have been taking 2 grams of OmegaViaEPA500 along with the 2 grams of Vascepa since my birthday and stopped taking the statin for now. My copay is $25 a month on Vascepa for 60 grams a month.
I had my epa/aa tested at Zone Diagnostics | Do You Have Cellular Inflammation? Cost was $75 well worth the cost.
I have been taking 2 grams of Vascepa for 1.5 years.
Also have been taking 10mg. Atorvastatin Calcium Tablets.
I have type 2 diabetes at age 64.
My Cellular Inflammation Score on my birthday from Zone Labs.
My AA was 7.9% within target range 7% to 9%.
My EPA was 2.7% Target 4.0% to 6.0%
My Cellular Inflammation Score 2.9% within target 1.5% to 3.0%
My triglycerides was 156 before using Vascepa is now 75.
My LDL-Cholesterol was 142 before using Vascepa is now 67.
My HDL-Cholesterol was 36 before using Vascepa is now 39.
Don't think Vascepa has had any effect on my Hemoglobin it is at 6.8
just under ADA guidelines of 7.0 and needs to be lowered.
Amarin
On Thursday, shares in Dublin, Ireland-based Amarin Corp. PLC recorded a trading volume of 1.39 million shares. The stock ended the day at $3.16, which was 1.56% lower from the prior session. The Company's shares have gained 0.96% in the last one month, 44.29% over the previous three months, and 67.20% on an YTD basis. The stock is trading above its 50-day and 200-day moving averages by 4.98% and 52.35%, respectively. Furthermore, shares of Amarin, which focuses on the development and commercialization of therapeutics for the treatment of cardiovascular diseases in the US, have a Relative Strength Index (RSI) of 54.75.
As per notes filed with the SEC, on September 22(nd) and 23(rd) , 2016, Amarin, through its subsidiary Amarin Pharmaceuticals Ireland Limited, received paragraph IV certifications from Roxane Laboratories, Inc. and Dr. Reddy's Laboratories, Inc., respectively, advising Amarin that such companies have filed abbreviated new drug applications with the U.S. Food and Drug Administration that seek regulatory approval for generic versions of Vascepa (icosapent ethyl) capsules.
On October 5(th) , 2016, research firm Cantor Fitzgerald initiated a 'Buy' rating on the Company's stock, issuing a target price of $6 per share. The free research report on AMRN is available at:
http://stock-callers.com/registration/?symbol=AMRN
Someone needs to contact Aaron Rodgers about Vascepa; this is from WCCO Channel 4 Twin Cities. It shows that the Green Bay Packers nutritionist does not have a clue about inflammation.
MINNEAPOLIS (WCCO) – Green Bay Packers quarterback Aaron Rodgers – the beloved king of cheesehead country – says he’s done with dairy.
The now cheese-forsaking 32-year-old told ESPN on Tuesday that cutting the cow products from his diet is part of a long-term plan to play in the NFL as long as possible. He also said it helps reduce inflammation, which is an issue for his knee.
Rodgers described his diet as being vegan-like, with the occasional bit of red meat or chicken. The Packer leader is reportedly looking slimmer and down to around “218-ish” – the lightest he’s been since 2007.
Rodgers said that the decision to cut out cheddar and cheese curds, among other things, happened after lots of research and discussions with the team’s nutritionist.
“I think that’s how I can extend my career if I can eat a little bit better,” he told ESPN. “Because it carries over not just in the offseason, but what you’re eating the night before the game and what you’re eating in the morning and the afternoon — if it’s a night game — just how that it affects your performance.”
Yesterday I went to the Red Cross and gave blood. The woman checking my blood pressure and Iron in my blood and I were talking about my blood pressure and how it goes up when I am at a doctor's office(although it didn't go up there). She said her husband has Triglycerides of 1400 and he has been that high for 5 years. I asked what drugs his doctor has him on. Her answer was
LIPITOR® (atorvastatin calcium) Tablets. I spent 10 minutes explaining about Vascepa, so I hope she looks on the internet and finds the information. My question is: are doctors that misinformed about how to treat people or is it that they just give Statins to everyone and think it cures everything? This was in Eau Claire, WI. How does his doctor not know about Vascepa? The salesmen need to get out to some smaller cities and get the information out. I have been taking Vascepa for a year and my Triglycerides were at 110; I haven't checked them in 6 months. I have lost 25 pounds, have no inflammation, and feel great.
Rosemount I have had White Coat Syndrome for 30 years. Every time I go to a doctor or dentist my blood pressure readings go up. I check my blood pressure at home for a week before I go to the doctor its 120-125/70-78 when the nurse checks my blood pressure its usually 160-180/90-110 my doctor knows I have White Coat Syndrome but put me on Lisinopril. The way I get a better reading at the Doctors office is arrive 30 minutes before your appointment and relax. If my blood pressure is real high I tell them to leave me sit there for 10 minutes and come back and check it. Then it is usually down to the 120-125/70-78 it is at home.
How to Keep Calm at a Doctor's Office If you truly have high blood pressure, make sure you are taking your doses of blood pressure meds on time. They really do help a lot in reducing your blood pressure. Do not use white coat syndrome as a form of denial for high blood pressure.
From the evening before you go to the doctor, stop drinking water. If you have less water, you will have lower blood pressure. The only reason you're not drinking water is so you can have a few uneventful doctor's visits without the high blood pressure speech. If you do this, make sure you test yourself so you know you don't have high blood pressure.
On the way to the doctor, listen to pleasant music. Smile. Enjoy life. Drive slowly. Do everything to be relaxed on the way to the doctor. Ignore the stresses of your life Do not think or worry about white coat syndrome. What's on your mind can have a huge effect on blood pressure, so it's best to be relaxed as much as possible.
Walk slowly into the doctor's office. Excessive physical exertion will raise blood pressure.
Stay relaxed the whole time at the doctor. Meditate. Smile at the world. Close your eyes. If you have somebody with you, fall asleep while you wait, which will make you very relaxed and lower blood pressure
After you get a normal blood pressure reading and avoided the high blood pressure speech, congratulate yourself on a job well done. You've conquered White Coat Syndrome on this visit.
Tell your doctor about your white coat syndrome. This is the most important step.
The doctor's job will be to determine how pervasive your white coat syndrome is. He calls it white coat hypertension, which is still just as serious as regular hypertension or high blood pressure. On one hand, your blood pressure may be normal during the rest of the day, which means blood pressure meds will give you hypotension (low blood pressure). On the other hand, high blood pressure during other stressful parts of the day (other than the doctor's visit) may warrant treatment of white coat hypertension. In many cases, the doctor will still want to prescribe you blood pressure meds anyway because if you're stressed from doctor's visits, you're probably suffering hypertension during the other stressful parts of your life. If you have other factors such as heart disease or overweight, your doctor might err on the side of caution and diagnose white coat hypertension. Your doctor will do what's right for you. If he prescribes you meds anyway, it's not a defeat. He's doing you a favor in treating white coat hypertension.
Motley Fool article about Amarin
I was a member of Motley Fool for two years. They advise you to buy well-run companies, but the stock prices usually go way down after they tell you to buy them. An example would be Nuance Communications (NUAN). They advised to buy in January 2012 at around $27; the current price is $16. Another one would be Westport Innovations (WPRT) in June 2013, when it was above $30 a share. Its current price is $3.44 per share. Then there is InvenSense, Inc. (INVN), their stock buy of the year. In September 2014, it was $23.00. It is now $10.06 per share. So, as far as what Motley Fool has to say about a stock's potential, I wouldn't worry about it. They really have no idea what they're talking about.
Amarin case could unleash flood. http://www.fiercepharmamarketing.com/story/amarin-case-could-unleash-flood-label-promos/2015-08-10
Hopefully: To the Senate HELP committee members message #47868 is correct now. The letter can be sent by anyone to Senators. Any address for Senators or email address posted would be helpful to all.
To the Senate HELP committee members.
Honorable Madams and Sirs:
I beseech you to consider a serious breach of conduct and contract by the FDA. The matter involves the FDA's shameful treatment of Amarin Corp. regarding its drug Vascepa. Vascepa is a highly purified ester of eicosapentaenoic acid (EPA), a principal omega 3 found in fish oil. Current scientific research overwhelmingly supports the notion that pure EPA in adequate dosage will cut the risks of heart disease and strokes. The evidence is bolstered by population studies in the Japanese and Inuit, which show a clear and convincing relationship between the amount of EPA in the diet and the risk of coronary heart disease.
Around 2009, the FDA and Amarin entered into a Special Protocol Assessment agreement (SPA). An SPA is a congressional creature designed to prevent the FDA from changing the goal posts in terms of what information or tasks a sponsor company must accomplished to get market approval by the FDA; this was a huge problem for biotechs prior to this congressional action.
The SPA is a written, binding instrument to which both parties agree and which cannot be changed except by mutual agreement. The only exception was the absolutely necessary proviso that the FDA could rescind the SPA if new evidence (i.e. after the commencement of the trials) indicated there were heretofore unknown safety issues, or information that the drug would not be effective. Obviously, if a legitimate concern regarding either of these issues emerged, there would be little reason for either the FDA or the company to wish to proceed. The agreed upon terms in the Vascepa SPA was that the sponsor would run a short clinical trial, ANCHOR, determining the safety and efficacy of the drug. After FDA approval of ANCHOR, then the company would have to design and implement an FDA- approved larger clinical outcomes trial (REDUCE-IT) where Vascepa would be an "add on" drug combined with patients taking statins. The FDA's requirement was that the company meets a 50% enrollment (4000 patients) in REDUCE-IT to complete the FDA's requirements.
In the spring of 2013 the FDA notified the company the conditions of the SPA had been met and that the company could now submit an application for marketing (sNDA) for the very large mixed dyslipidemia indication.
The company filed for the sNDA, and the FDA accepted the paperwork without comment and things appeared to be going smoothly. In the summer of 2013 the FDA notified the company it was scheduling an Advisory Committee (Adcom) meeting in October to consider Vascepa. This appeared routine as Vascepa would be the only FDA-approved drug for the dyslipidemia group. An Adcom meeting is one in which the FDA brings in people who are not full time FDA employees, but are on call to the FDA for such meetings. These people are physicians, epidemiologists, consumer advocates, statisticians, etc. They form a voting panel. On the Vascepa panel no more than two of the panelists had more than a layman's knowledge of the physiology of EPA, the principal ingredient of Vascepa.
The FDA then revealed they were skeptical of the fact that Vascepa would lower coronary risk because they considered only the triglyceride lowering effect of EPA. They based this skepticism on three drug trials testing the effect of trig lowering on cardiac risk. The three trials did not use EPA, but instead used either niacin or fibrates. These are active ingredients which bear absolutely no similarity to EPA and have vastly different physiological effects.
Not only did the FDA use drugs which bore little similarity to EPA, the FDA failed to notice in the three triglyceride (TG)-lowering trials the majority of patients did not have high TGs, but were in the low to borderline TG range. This error on the part of the FDA led to the incorrect conclusion that triglyceride-lowering treatment in patients with high TG levels would not be beneficial. The reality is niacin and fibrates did lower TGs, but this lowering occurred in normal range where patients were not considered at risk. The FDA conclusion was wrong, and cannot be derived from outcome trials having normal TG patients. Thus, the FDA reason for rescinding the SPA had absolutely no scientific merit.
This was subsequently pointed out to the FDA, which then countered the statement. They said that they were changing their opinion on the predictive value of blood surrogate markers such as triglycerides and concentrating only on low density lipoprotein cholesterol (LDL-C) following the lead of the AHA which is heavily subsidized by the statin manufacturers. Many other health experts disagree with the FDA, and feel that triglycerides are risk factors, including the American Diabetic Association, American College of Endocrinology, and the National Institute of Health.
Some days later the FDA informed the company it was rescinding the SPA based on its "new science.”
The FDA also ignored the only large scale outcomes trial based on EPA as a statin add on, JELIS. This is a Japanese study that showed an across the board 20% reduction in coronary risk. FDA denigrated the study because it was not double blinded and because the enrollees were Japanese.
FDA's actions in this case are exactly what congress intended to put an end to. That is the capricious, irresponsible, and penal changing of the expected requirements of a sponsor company. Furthermore the FDA has put the stall on Amarin, which is required to appeal the FDA's decision through six levels of FDA bureaucracy, each level taking months to render a predictable response. Of note, the FDA has not told or in any way suggested the company should terminate the REDUCE-IT study, nor has any of the FDA's "science” convinced the company to abandon the trial.
In the meantime, Amarin has lost millions in much need revenue to continue the trial and patients who could be benefitting from Vascepa are dying. There were no significant safety issues known before the trials began and none have emerged, so this is not a risk benefit matter.
Please, Senator, look into this. The life you save could be your own or someone you know.
Respectfully,
JL, your letter, message #47851, has been corrected by an English teacher. You did a great job conveying your message. Basically, I just cleaned up some grammatical errors and minor confusion. I reposted your corrected version letter as message #47853.
If you want to state that you're a doctor, please do so right away in the opening sentence. Ex: "As a doctor, I beseech you to consider a serious breach of conduct and contract by the FDA." The way it was originally worded made it sound like the members of Congress to whom you are writing are doctors.
To the Senate HELP committee members.
Honorable Madams and Sirs:
I beseech you to consider a serious breach of conduct and contract by the FDA. The matter involves the FDA's shameful treatment of Amarin Corp. regarding its drug Vascepa. Vascepa is a highly purified ester of eicosapentaenoic acid (EPA), a principal omega 3 found in fish oil. Current scientific research overwhelmingly supports the notion that pure EPA in adequate dosage will cut the risks of heart disease and strokes. The evidence is bolstered by population studies in the Japanese and Inuit, which show a clear and convincing relationship between the amount of EPA in the diet and the risk of coronary heart disease.
Around 2009, the FDA and Amarin entered into a Special Protocol Assessment agreement (SPA). An SPA is a congressional creature designed to prevent the FDA from changing the goal posts in terms of what information or tasks a sponsor company must accomplished to get market approval by the FDA; this was a huge problem for biotechs prior to this congressional action.
The SPA is a written, binding instrument to which both parties agree and which cannot be changed except by mutual agreement. The only exception was the absolutely necessary proviso that the FDA could rescind the SPA if new evidence (i.e. after the commencement of the trials) indicated there were heretofore unknown safety issues, or information that the drug would not be effective. Obviously, if a legitimate concern regarding either of these issues emerged, there would be little reason for either the FDA or the company to wish to proceed. The agreed upon terms in the Vascepa SPA was that the sponsor would run a short clinical trial, ANCHOR, determining the safety and efficacy of the drug. After FDA approval of ANCHOR, then the company would have to design and implement an FDA- approved larger clinical outcomes trial (REDUCE-IT) where Vascepa would be an "add on" drug combined with patients taking statins. The FDA's requirement was that the company meets a 50% enrollment (4000 patients) in REDUCE-IT to complete the FDA's requirements.
In the spring of 2013 the FDA notified the company the conditions of the SPA had been met and that the company could now submit an application for marketing (sNDA) for the very large mixed dyslipidemia indication.
The company filed for the sNDA, and the FDA accepted the paperwork without comment and things appeared to be going smoothly. In the summer of 2013 the FDA notified the company it was scheduling an Advisory Committee (Adcom) meeting in October to consider Vascepa. This appeared routine as Vascepa would be the only FDA-approved drug for the dyslipidemia group. An Adcom meeting is one in which the FDA brings in people who are not full time FDA employees, but are on call to the FDA for such meetings. These people are physicians, epidemiologists, consumer advocates, statisticians, etc. They form a voting panel. On the Vascepa panel no more than two of the panelists had more than a layman's knowledge of the physiology of EPA, the principal ingredient of Vascepa.
The FDA then revealed they were skeptical of the fact that Vascepa would lower coronary risk because they considered only the triglyceride lowering effect of EPA. They based this skepticism on three drug trials testing the effect of trig lowering on cardiac risk. The three trials did not use EPA, but instead used either niacin or fibrates. These are active ingredients which bear absolutely no similarity to EPA and have vastly different physiological effects.
Not only did the FDA use drugs which bore little similarity to EPA, the FDA failed to notice in the three triglyceride (TG)-lowering trials the majority of patients did not have high TGs, but were in the low to borderline TG range. This error on the part of the FDA led to the incorrect conclusion that triglyceride-lowering treatment in patients with high TG levels would not be beneficial. The reality is niacin and fibrates did lower TGs, but this lowering occurred in normal range where patients were not considered at risk. The FDA conclusion was wrong, and cannot be derived from outcome trials having normal TG patients. Thus, the FDA reason for rescinding the SPA had absolutely no scientific merit.
This was subsequently pointed out to the FDA, which then countered the statement. They said that they were changing their opinion on the predictive value of blood surrogate markers such as triglycerides and concentrating only on low density lipoprotein cholesterol (LDL-C) following the lead of the AHA which is heavily subsidized by the statin manufacturers. Many other health experts disagree that TGs are not risk factors, including the American Diabetic Association, American College of Endocrinology, and the National Institute of Health.
Some days later the FDA informed the company it was rescinding the SPA based on its "new science.”
The FDA also ignored the only large scale outcomes trial based on EPA as a statin add on, JELIS. This is a Japanese study that showed an across the board 20% reduction in coronary risk. FDA denigrated the study because it was not double blinded and because the enrollees were Japanese.
FDA's actions in this case are exactly what congress intended to put an end to. That is the capricious, irresponsible, and penal changing of the expected requirements of a sponsor company. Furthermore the FDA has put the stall on Amarin, which is required to appeal the FDA's decision through six levels of FDA bureaucracy, each level taking months to render a predictable response. Of note, the FDA has not told or in any way suggested the company should terminate the REDUCE-IT study, nor has any of the FDA's "science” convinced the company to abandon the trial.
In the meantime, Amarin has lost millions in much need revenue to continue the trial and patients who could be benefitting from Vascepa are dying. There were no significant safety issues known before the trials began and none have emerged, so this is not a risk benefit matter.
Please, Senator, look into this. The life you save could be your own or someone you know.
Respectfully,
Pot smokers show less inflammation
People who smoke marijuana may have lower levels of inflammation compared with people who have never smoked it, according to new research on one marker of inflammation.
In the study, researchers examined data from more than 9,000 people on their history of marijuana use and their levels of C-reactive protein (CRP), one marker of inflammation that is frequently linked with people's risk of heart disease.
About 40 percent of the people in the study said they had never smoked marijuana, while 48 percent reported having smoked the drug at least once in their lifetimes, but not in the past 30 days. About 12 percent (1115) said they smoked marijuana recently, or at least once in the past 30 days. The researchers found that the people who smoked in the last month had lower CRP levels than those who had never smoked the drug.
Great combination Vascepa and marijuana.
Rick Harrison, star of television's "Pawn Stars®", takes Vascepa to help manage his very high triglycerides (=500 mg/dL). For Rick, everything is about the art of the deal. https://vascepasavings.com/
With the Vascepa prescription savings card, you can get Vascepa for as low as $9/month. https://vascepasavings.com/
Expiration Date 12/31/2015
Fast Money - Weekdays 5p ET JJ is going to be appear tonight.
Dandreon ceo to appear on Fast Money tonight
Droxidopa story in the news. Last Year
http://www.cnn.com/2012/05/18/health/rare-disorder-head-rushes-dbhd/index.html?iref=allsearch
The value of FDA approved drug symptomatic neurogenic orthostatic hypotension drug, Northera. The full cost of bringing a new drug (i.e. a drug that is a new chemical entity) to market – from discovery through clinical trials to approval – is complex and controversial. One element of the complexity is that the much-publicized final numbers often do not include just the simple out-of-pocket expenses, but also include "capital costs", which are included to take into account the long time period (often at least ten years) during which the out-of-pocket costs are expended; additionally it is often not stated whether a given figure includes the capitalized cost or comprises only out-of-pocket expenses. Another element of complexity is that all estimates are based on confidential information owned by drug companies, released by them voluntarily. There is currently no way to validate these numbers. The numbers are controversial, as drug companies use them to justify the prices of their drugs and various advocates for lower drug prices have challenged them. The controversy is not only between "high" and "low" – the numbers also vary greatly at the high end.
A study published by Steve Paul et al. in 2010 in Nature Reviews: Drug Discovery compares many of the studies, provides both capitalized and out-of-pocket costs for each, and lays out the assumptions each makes: see Supplemental Box 2.[1] The authors offer their own estimate of the capitalized cost as being ~$1.8B, with out-of-pocket costs of ~$870M.
Studies published by diMasi et al. in 2003, report an average pre-tax, capitalized cost of approximately $800 million to bring one of the drugs from the study to market. Also, this $800 million figure includes opportunity costs of $400 million.[2] A study published in 2006 estimates that costs vary from around $500 million to $2 billion depending on the therapy or the developing firm.[3] A study published in 2010 in the journal Health Economics, including an author from the US Federal Trade Commission, was critical of the methods used by diMasi et al. but came up with a higher estimate of ~$1.2 billion.[4] So what is Chelsia Therapeutics worth in a buy out?
Acquisiton of Chelsea Therapeutics? Behind The Scenes Teva Pharmaceutical (TEVA) Board Of Directors Votes To Purchase Chelsea Therapeutics (CHTP) Following FDA Approval For Northera™ Ventures Sierra World Equity Review
HEADLINE: Behind The Scenes Teva Pharmaceutical (TEVA) Board Of Directors Votes To Purchase Chelsea Therapeutics (CHTP) Following FDA Approval For Northera™ Ventures Sierra World Equity Review.
Sierra's leads indicate that BOD Teva Pharmaceutical (TEVA) are no longer looking to partner with Chelsea Therapeutics instead an acquisition is now the option of choice. Sierra Israeli sources will be updating Sierra throughout the day and Sierra will be posting updates as warranted.
Acquisition Possible. Behind The Scenes Teva Pharmaceutical (TEVA) Board Of Directors Votes To Purchase Chelsea Therapeutics (CHTP) Following FDA Approval For Northera™ Ventures Sierra World Equity Review
HEADLINE: Behind The Scenes Teva Pharmaceutical (TEVA) Board Of Directors Votes To Purchase Chelsea Therapeutics (CHTP) Following FDA Approval For Northera™ Ventures Sierra World Equity Review.
Sierra's leads indicate that BOD Teva Pharmaceutical (TEVA) are no longer looking to partner with Chelsea Therapeutics instead an acquisition is now the option of choice. Sierra Israeli sources will be updating Sierra throughout the day and Sierra will be posting updates as warranted.
BUY 10 Day Short Term Target Price: $14.24
Keryx Biopharmaceuticals Inc. (KERX) Rating:
BUY 10 Day Short Term Target Price: $14.24
Sierra World Equity Review
Amarin Target Price: $3.07
http://www.sierraworldequityreview.com/
Amarin Corporation plc (AMRN) Rating: BUY 10 Day Short Term Target Price: $3.07
Dendreon buyout at what price?
Headlines: Onward And Upward_Johnson & Johnson (JNJ) Acquisition Financing Now In Place To Acquire Dendreon (DNDN) With US Regulatory Clearance Next Ventures Sierra World Equity Review. Sierra’s leads indicate that Johnson & Johnson will use financing through JPMorgan Chase Bank to purchase Dendreon. No comment has come from Johnson and Johnson regarding the potential acquisition but that may change soon once the budding deal get US regulatory clearance predicts Sierra.
Shares of Dendreon rose over 9% today and continued upwards in after hours trading, this could be a very nice Christmas for long shareholders of Dendreon! Check back for updates a team Sierra breaks the news first!
http://www.sierraworldequityreview.com/
Letter to Members of Congress/Senate
Here is a slightly improved version of the letter I have sent to my representatives in Congress. I would suggest that anyone interested in giving Anchor a fair shot of approval do the same. Please feel free to modify this letter.
Dear Congress/Senate Member,
I’m writing to inform of a rather urgent matter of public policy related directly to cardiovascular disease, one of the most pressing issues of American public health. There is a pending decision for Anchor, a treatment indication for the drug Vascepa, on December 20th, 2013, by the FDA’s Office of New Drugs. Vascepa has been demonstrated to be highly safe and well-tolerated in clinical trials. Moreover, there is an abundance of good scientific evidence implicating Vascepa’s role in reducing mechanisms, primarily related to lipids and inflammation, involved in the pathogenesis of and improving outcomes in cardiovascular disease (CVD).
Overview and Introduction of Issue:
The FDA has taken a very negative view, as evidenced in a recent advisory committee meeting, on approving Vascepa for use in a patient population that is estimated to range from 35 to 84 million Americans. This is despite Anchor having met agreed upon endpoints in a prior special protocol assessment (SPA) with the FDA. SPAs are used to mitigate risks and costs associated with new drug development and have been historically honored at a 100% rate given that the drug in question does not pose a risk to public health.
Vascepa, known chemically as Eicosapentaenoic acid (EPA), is an omega-3 fatty acid derivative protected by over 16 patents in the United States. In a surrogate trial conducted in Japan known as JELIS, EPA has been shown to lower the risk of adverse cardiovascular outcomes by 19%. Post-hoc analysis showed a 53% reduction in adverse outcomes among the treatment population being targeted with Anchor. It is expected that outcomes in American populations will be even better due to the lower baseline levels and higher dosing of EPA that will be used in the Anchor indication. GISSI-P was an Italian study using EPA and DHA at lower dosages that demonstrated a 20% reduction in risk of CV death, nonfatal myocardial infarction, and nonfatal stroke.
Another very recent study in a leading journal recognized as the authority on CVD has detailed the good scientific connection between Vascepa (EPA) and improved CVD outcomes. These studies are presented as supplemental information at the end.
The following are the most recent statistics on CVD released by the American Heart Association:
• Approximately 84 million people in this country suffer from some form of cardiovascular disease, causing about 2,200 deaths a day, averaging one death every 40 seconds.
• Almost one out of every three deaths results from cardiovascular disease.
• The direct and indirect costs of cardiovascular disease and stroke are about $300 billion. This figure is increasing every year.
• On average, someone in the U.S. suffers a stroke every 40 seconds.
• Stroke is a leading cause of serious, long-term disability that accounts for more than half of all patients hospitalized for a neurological disease.
• Cardiovascular disease is the cause of more deaths than cancer, chronic lower respiratory diseases, and accidents combined.
Rationale of Approval for the Anchor Indication:
The FDA reviewer formulated the panel question in a highly unusual manner for the indication being sought in Anchor, which is to lower triglycerides. The FDA’s stance seems to be that Vascepa should be rejected for Anchor until an outcome study known as REDUCE-IT is finished sometime after 2016. Despite protests from panel members as to the unusual wording of the voting question, they voted 9-2 against approval for Anchor. There are, however, several very serious problems with a decision to wait three-to- four years for the results of REDUCE-IT.
1) There is good evidence of a reduction in mortality and morbidity associated with CVD through the use of Vascepa. There is also a body of scientific knowledge implicating the role of inflammation and lipids in the pathogenesis of CVD. EPA has been demonstrated in clinical trials to lower some aspects of the inflammatory process and to definitively lower triglycerides.
2) Given that the side effect profile of EPA in the Marine and Anchor trials has been demonstrated as equivalent to placebo, there is no harm in offering Vascepa as a treatment option to patients.
3) Current treatment options for lowering triglycerides includes niacin, fibrates, and EPA + DHA, all of which have comparable efficacy to EPA, but much more serious side effects. Some of these risks include raising other markers known to be associated with worse CVD outcomes. This limits their usage in certain patients. Vascepa has none of these risks. By rejecting Vascepa as a treatment option, the FDA is effectively lowering the current standard of care.
4) The reduction in adverse events demonstrated in JELIS and other studies, if shown to occur in American populations, would lead to non-trivial reductions in the rates of death and morbidity in patients with CVD. Good scientific evidence points to the benefit of EPA in CVD outcomes in American populations and even more so than those shown in JELIS.
5) There already is an SPA in place for Vascepa for REDUCE-IT and that is scheduled to finish sometime after 2016. There is a risk that this study will be unable to continue if the FDA takes the unprecedented move to reject Anchor as the company which has developed Vascepa may be unable to continue to fund the study.
This brings us to the risk/benefit analysis of approving Anchor versus rejection. There are really two scenarios of interest with respect to the consequences of approving Anchor which are examined below:
1) Vascepa is approved for Anchor and is shown, against current scientific evidence, that it does not have a beneficial effect on CVD outcomes. The implication of this scenario is that no harm is done to the health of the general public as Vascepa has been shown to be essentially equivalent to placebo with respect to side effects.
2) Vascepa is rejected for use in Anchor and is shown, consistent with current evidence, to be effective in reducing the pathogenesis and improving outcomes of CVD. Two of the implications of this scenario are that even with small reductions in risk, many tens of thousands of people are spared from adverse CV outcomes including death and tens of billions of dollars are saved.
Conclusion:
This discussion centers on a treatment option that is safe and well-tolerated and presents little to no risk to the health of the general public; therefore, the analysis shifts to one of discussion of likely benefits to public health. Any treatment which is likely to show benefits and will not harm public health should be approved as an OPTION to patients. By not approving Anchor as an option to patients, the FDA will be effectively making patients jump through hoops as they will have to pay out of pocket and deal with the hassle of locating a physician willing to prescribe off-label for them. This would be particularly insidious of the FDA to allow tens of millions of patients to go unaware of a treatment option which is better tolerated and as efficacious as the current standard of care.
In summary, the FDA is poised to lower the standard of medical care, stifle innovation in therapeutics development, and likely put the American public at unnecessary increased risk of death and morbidity. Rejection of the Anchor indication would be an unprecedented commentary on safe and effective therapeutic development and would likely cause irreparable harm to the health of the general public. If the FDA is concerned about potential misuse or side effects, there are ways to more than adequately address this through labeling restrictions. Approval of Anchor would be the path of least risk to public health, and not the other way around.
This decision deserves full public scrutiny as I do not believe the FDA officials involved are adequately representing the public interest in this matter. I will include contact information of the committee chairperson on the FDA advisory panel that voted affirmatively to approve the Anchor indication. I believe that he has correctly assessed the risk/benefit profile of Anchor despite the unreasonable tone, cherry picking of evidence, and leading questions posed by the FDA. He should be able to provide the necessary perspective on this important issue of public health. I am also including contact information for management at Amarin, the firm that has been developing Vascepa.
Thank you for your time and patience in this matter.
Sincerely,
The committee chair, along with another, who voted “Yes” to approval of Vascepa for the Anchor Indication is;
Robert J. Smith, MD
(Acting Chairperson)
Professor of Medicine (Endocrinology)
Alpert Medical School of Brown University
Ocean State Research Institute
Providence Veterans Administration Medical
Center
Providence, Rhode Island
Phone: +1 401 444 3420
E-mail: Robert_J_Smith@Brown.EDU
US Office:
Amarin Pharma Inc.
1430 Route 206, Suite 200
Bedminster, NJ 07921
USA
Tel: 908-719-1315
Fax: 908-719-3012
Joseph S. Zakrzewski – CEO
John Thero – President
Steven Ketchum, PhD – President of Research and Development, SVP
Joseph T. Kennedy – SVP, General Counsel and Secretary, Chief Compliance Officer
It is important to note that in all outcome studies done so far, the dosing of omega-3s has been significantly less than that in the ongoing REDUCE-IT and already completed Anchor trials. It is expected that this higher level of dosing will magnify the cardioprotective effects of EPA supplementation. FDA materials relating to the advisory committee meeting can be found here under the October 11th, 2013 updates.
http://www.fda.gov/advisorycommittees/whatsnew/default.htm
Some Studies on EPA:
Eicosapentaenoic Acid (EPA) Reduces Cardiovascular Events: Relationship with the EPA/Arachidonic Acid Ratio.
Ohnishi H, Saito Y.
J Atheroscler Thromb. 2013 Sep 18. [Epub ahead of print]
Abstract
The clinical efficacy of fish oil and high-purity eicosapentaenoic acid ethyl ester (hp-EPA-E) for treating cardiovascular disease (CVD) has been reported. Fish oil contains saturated and monounsaturated fatty acids that have pharmacological effects opposite to those of ?3 fatty acids (?3). Moreover, ?3, such as EPA and docosahexaenoic acid (DHA), do not necessarily have the same metabolic and biological actions. This has obscured the clinical efficacy of ?3. Recently, the Japan EPA Lipid Intervention Study (JELIS) of hp-EPA-E established the clinical efficacy of EPA for CVD, and higher levels of blood EPA, not DHA, were found to be associated with a lower incidence of major coronary events. A significant reduction in the risk of coronary events was observed when the ratio of EPA to arachidonic acid (AA) (EPA/AA) was >0.75. Furthermore,the ratio of prostaglandin (PG) I3andPGI2 to
thromboxane A2 (TXA2) ([PGI2+PGI3]/TXA2) was determined to have a linear relationship with the EPA/AA ratio as follows: (PGI2+PGI3)/TXA2=?+p* (EPA/AA). Like PGI2, PGI3 not only inhibits platelet aggregation and vasoconstriction, but also is assumed to reduce cardiac ischemic injury and arteriosclerosis and promote angiogenesis.
Thus, the effects of EPA in reducing the risk of CVD could be mediated by biological action of PGI3 in addition to hypotriglyceridemic action of EPA. Compared with DHA, EPA administration increases the EPA/AA ratio and the (PGI2+PGI3)/TXA2 balance to a state that inhibits the onset and/or progression of CVD.
PMID:
24047614
[PubMed - as supplied by publisher]
https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_18002/_pdf
JELIS - Japan Eicosapentaenoic acid (EPA) Lipid Intervention Study
The JELIS trial, reported in 2007, suggested that treatment with 1.8 g/day of EPA reduced cardiovascular adverse outcomes in Japanese hypercholesterolemic patients on low-dose statins.30 In this open-label trial, 18,645 Japanese men and postmenopausal women with or without a history of coronary artery disease, with total cholesterol levels =6.5 mmol/L (>250 mg/dL), were randomized to either statin (pravastatin 10 mg or simvastatin 5 mg) + 1.8 g/day EPA or statin alone with a planned 5-year follow-up.
The primary endpoint was a cardiovascular composite, which included sudden cardiac death, fatal and non-fatal myocardial infarction, unstable angina pectoris including hospitalization, angioplasty, stenting, or coronary bypass grafting.
Mean baseline lipid values after a 4-8-week washout of any lipid-lowering drugs, included TC 7.1 mmol/L (~275 mg/dL), LDL-C 4.7 mmol/L (~182 mg/dL), TG 1.7 mmol/L (~150 mg/dL), and HDL-C 1.5 mmol/L (~58 mg/dL). During a mean follow-up of 4.6 years, a 19% relative reduction in the primary CV composite endpoint was observed (p=0.011). Among the components of the primary composite, only unstable angina including hospitalization for documented ischemic episodes, achieved nominal statistical significance (p=0.014). Lipid changes in the EPA + statin and statin alone group were similar, with the exception of triglycerides. As expected with the introduction of statin therapy, both groups exhibited decreases in LDL-C and small increases in HDL-C. Triglycerides decreased 9% in the EPA + statin group and decreased 4% in the statin-alone group (p<0.0001 between groups).
Although underpowered to evaluate subgroups, there were no apparent differences in the treatment effect on the primary endpoint across various subgroups defined using baseline characteristics, including whether baseline TG was below or above 1.7 mmol/L (150 mg/dL). A post-hoc analysis of the primary prevention cohort of JELIS suggested that EPA reduced the incidence of major coronary events by 53% (95% CI, 2% to 77%, p=0.043) in 957 patients with high TG (=150 mg/dL) and low HDL-C (<40 mg/dL)
Long chain omega-3 fatty acids and cardiovascular disease: a systematic review.
Delgado-Lista J, Perez-Martinez P, Lopez-Miranda J, Perez-Jimenez F.
Source
Lipids and Atherosclerosis Unit, Department of Medicine, IMIBIC/Hospital Universitario Reina Sofía/
Universidad de Cordoba, Cordoba, Spain.
Abstract
Introduction: Cardiovascular disease remains the commonest health problem in developed countries, and residual risk after implementing all current therapies is still high. The use of marine omega-3 fatty acids (DHA and EPA) has been recommended to reduce cardiovascular risk by multiple mechanisms. Objectives: To update the current evidence on the influence of omega-3 on the rate of cardiovascular events. Review Methods: We used the MEDLINE and EMBASE databases to identify clinical trials and randomized controlled trials of omega-3 fatty acids (with quantified quantities) either in capsules or in dietary intake, compared to placebo or usual diet, equal to or longer than 6 months, and written in English. The primary outcome was a cardiovascular event of any kind and secondary outcomes were all-cause mortality, cardiac death and coronary events. We used RevMan 5•1 (Mantel-Haenszel method). Heterogeneity was assessed by the I2 and Chi2 tests. We included 21 of the 452 pre-selected studies. Results: We found an overall decrease of risk of suffering a cardiovascular event of any kind of 10 % (OR 0•90; [0•85-0•96], p = 0•001), a 9 % decrease of risk of cardiac death (OR 0•91; [0•83-0•99]; p = 0•03), a decrease of coronary events (fatal and non-fatal) of 18 % (OR 0•82; [0•75-0•90]; p < 1 × 10?4), and a trend to lower total mortality (5 % reduction of risk; OR 0•95; [0•89-1•02]; p = 0•15. Most of the studies analyzed included persons with high cardiovascular risk. Conclusions: marine omega-3 fatty acids are effective in preventing cardiovascular events, cardiac death and coronary events, especially in persons with high cardiovascular risk.
GISSI-P Study
In 1999, the open-label Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico-Prevenzione (GISSI-P) trial was one of the first randomized clinical trials to evaluate the effect of omega-3 FA on CV outcomes.29 GISSI-P randomized 11,324 patients with a recent history (3 months or less) of MI to 1 g/day of EPA/DHA (n=2836), vitamin E (n=2830), both (n=2830), or no treatment (the control group; n=2828). Mean baseline lipid values included TC 211 mg/dL, LDL-C 137 mg/dL, TG 162 mg/dL, and HDL-C 42 mg/dL. Five percent of patients were on cholesterol-lowering drugs (authors did not provide percentage on statin therapy) at baseline. After an average follow-up of 3.5 years, a 20% reduction in the primary endpoint of CV death, nonfatal MI, and nonfatal stroke was observed in the EPA/DHA treated group compared with the no treatment group (RR 0.80, 95% CI 0.68-0.95).
Voting Question for the FDA Advisory Panel Meeting on October 16th, 2013
FOOD AND DRUG ADMINISTRATION (FDA)
Center for Drug Evaluation and Research (CDER) Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)
FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503), Silver Spring, MD
October 16, 2013
1. DISCUSSION:
In ANCHOR, 12 weeks of treatment with Vascepa 4 g/day led to an estimated median -21.5% (95% CI, -26.7% to -16.2%; P<0.0001) change in fasting triglycerides, compared with the mineral oil placebo, among statin-treated patients with mixed dyslipidemia at high cardiovascular risk. Changes in other lipid/lipoprotein parameters (selected secondary and exploratory endpoints) are summarized in the table below.
Median % Change from Baseline to Week 12
Median % Change (95% CI)
Placebo Vascepa 4g/day Treatment Difference
Fasting TG +5.9 -17.5 -21.5 (-26.7, -16.2)
Direct LDL-C +8.8 +1.5 -6.2 (-10.5, -1.7)
Non-HDL-C +9.8 -5.0 -13.6 (-17.2, -9.9)
VLDL-C +15.0 -12.1 -24.4 (-31.9, -17.0)
Apo B +7.1 -2.2 -9.3 (-12.3, -6.1)
Tot. Chol. +9.1 -3.2 -12.0 (-14.9, -9.2)
HDL-C +4.8 -1.0 -4.5 (-7.4, -1.8)
Apo A-I +3.6 -2.9 -6.9 (-8.9, -4.9)
Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population.
2. VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation.