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JL,
You should be a school teacher. That is simple and easy to explain. Thanks a bunch!!
Can anybody provide a clear concise synopsis on why diabetics should be taking Vascepa in. I'm having a hard time getting this across to one of my friends.
Feel free to contact the Institute of Medicine and let your voice be heard.
iomwww@nas.edu
Institute of Medicine
Interesting article from awhile back.
Fish Story
Best Part: "They're in the Dark Ages," says Bill Lands, Ph.D., a retired National Institutes of Health (NIH)
biochemist who has written extensively about omega-3s and is widely considered the field's elder
statesman. "The science was very clear 15 years ago. But they're not interested in science. All
they're interested in doing is preserving the status quo, when they could be saving lives."
I guess some things never change!!
The positives of EPA keep on coming!!
Omega 3's
The backlash continues. Love It!!
Anyone live near a college. Take your laptop to the library and ask the students to sign the petition. I'm sure many would!!
Have Joe call me when you're done. Question, why would NIH and VA want to take over a study that costs tens of millions of dollars for it to be completed but have no drug to sell at the end???
BB,
Make sure you forward this to the company if that is your concern.
Email sent to Abigail Damoulakis, B.A., contact for the EPA study:
I am writing you to inquire your thoughts on the recent FDA and AHA guidelines regarding statins. It seems with the position currently proposed, the FDA and AHA have decided that lipid control medicines no longer provide a benefit for cardiovascular disease. I am especially interested to see if you have seen the results of the Marine and Anchor trials submitted to the FDA for Amarin Corp.'s drug Vascepa, which is 4gm per day.
If you believe that EPA has a future, it would be nice if you would show support for EPA drugs by requesting the FDA to reconsider their current position with Amarin. The FDA held an ADCOM on October 16th of this year and directed and steered the panel into a negative vote by challenging the efficacy of EPA in reducing CVE's. Not long after, the FDA rescinded it's SPA agreement with Amarin for the Anchor Trial citing 3 studies, ((Accord-Lipid, Aim-High and HPS2-Thrive) which according to the FDA challenged the science of lipid control and positive CVE correlation. Amarin already has a multi-year study currently with 6000+ patients enrolled to demonstrate the efficacy of Vascepa on CVE's called the Reduce-It Trial and has spent 10's of millions of dollars on this study already. Because of the FDA's position and rescission of the Anchor SPA, Amarin has potentially lost revenue that would have helped fund the Reduce-It Trial to end.
This study is important to millions of people and needs to be finished. Cardiovascular disease, as I'm sure you are aware, is the number one killer in the U.S. today. Again, I am asking for your support. Please visit epadruginitiative.com for further information. Time is of the essence.
BB,
Looking at the primary and secondary outcomes of this study, it seems reasonable that it will only help Vascepa's case. From what I see, this is not a CVE outcomes based trial. I imagine they will see positive effects in the measurements of lipids and inflammation markers. Of course the study results will not be ready until 2016.
DR. Oz Facebook page has topic on new statin guidelines. I put the epadruginitiative website in for discussion. Please post to further educate as he gets a lot of visits.
Definitely need to look at pushing Vascepa across the pond
The European Atherosclerosis Society
JL,
Very good read. Although it isn't an endorsement for EPA, the backlash against the new guidelines sure is nice to see and may help Amarin in the near future.
Letter to the Editor NYTimes:
Heart disease is complex. Inflammation, metabolic disorders, genetics and lipid disorders play a role in its development and progression. In treating heart disease, “population medicine” is not the answer; individualized treatments are needed.
Given that 50 percent of patients who have a heart attack or a stroke have normal LDL cholesterol, it’s clear that increasing the use of statins alone will not produce the positive clinical outcomes we are looking for. Furthermore, studies have shown that more than 50 percent of patients stop taking their statins in the first year.
The new guidelines provide excellent lifestyle recommendations, but do not provide adequate guidance with regard to targets of therapy, treatment of patients under age 40 or over 75 years, or how to manage the many statin-intolerant patients whom physicians encounter on a daily basis.
ERNST J. SCHAEFER
Chief Medical Officer
Boston Heart Diagnostics
Framingham, Mass., Nov. 19, 2013
Thanks Sts66, I have forwarded that info to CDER as well. I will let you know when they respond.
To all: We need to be proactive in getting the word out about Vascepa. Visit all the facebook pages and leave comments, such as American Heart Association, National Lipid Association, American Diabetes Association, Dr. Oz, The Food and Drug Administration and any other facebook or websites you can think of. We can become a small salesforce just by getting the word out about vascepa. The marine indication with off label sales can be enough to get this stock going in the right direction.
Article from Robert Weisman
FDA Lobbying
Of course I sent him an email:
Mr. Weisman,
I appreciate your story "Patients's advocates press FDA to retain lifesaving drugs", and would like to tell you about another company and drug that is going through similar problems with the FDA.
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl) is Amarin's first FDA approved product and is available in the United States by prescription. Vascepa is the first and only pure EPA omega-3 fatty acid that has been clinical proven to significantly reduce TG levels without increasing LDL-C levels and provide a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo.
Beginning this year, Amarin began selling Vascepa in the Marine Indication (trigs >500 mg/dl) and submitted an sNDA to expand the label to the Anchor Indication (trigs 200-500 mg/dl). In both studies, Vascepa proved its efficacy in lowering Trigs, Cholesterol and Inflammation Markers while maintaining a safety profile compared to a placebo. The FDA ordered an ADCOM for Oct 16th. At this meeting it was clear what the intention of the FDA was and how it stacked and steered the Panel to a negative vote. The FDA questioned whether or not this drug would reduce Cardio-Vascular events even though it was never the intention of the sponsor. Amarin and the FDA were already involved in the Reduce-It study that would determine outcomes. Just as important, the FDA used the results of three different studies (Accord-Lipid, Aim-High and HPS2-Thrive), using different compound (fibrates and niacin) with a different patient subgroup (trigs <200 mg/dl) to rescind the SPA agreement it had with Amarin. These studies were well known by the FDA prior to the ADCOM and were never mentioned in the sNDA letter or at any point prior to the ADCOM.
Interestingly enough, earlier this year a Citizens Petition (Lovaza Citizen Petition, Feb 2013) was filed by John Fuson and Crowell and Moring LLP. This petition it seems, was nothing more than an attempt to delay the New Chemical Entity decision by the FDA for Amarin's drug Vascepa. The petition's main goal was to have Vascepa's API listed into the OB retroactively by GSK drug Lovaza. In August, the FDA failed to rule on the petition, ignoring it's own rules, therefore resulting in a further delay in the NCE decision. John Fuson also happens to be a former employee of the FDA and has represented GlaxoSmithKline in an antitrust case in 2005. Keep in mind the Citizens Petition has delayed the NCE decision for Amarin's Vascepa benefitting it's competitor GSK's Lovaza.
Vascepa, with the safety profile of a placebo is needed in the mixed dyslipidemia group, especially for diabetics such as my mother. The FDA is refusing to balance the risk/reward with the use of this drug to the outrage of many patients and clinicians. Recently a group at http://www.epadruginitiative.com/ has released more information regarding this topic. Getting this corrupt story out into public view would be a great service to the patients and doctors who support this drug. For this, I ask your help.
June National Lipid Association Highlights
Notice EPA was talked about. I've sent an email to them to find out what they think about the FDA's position on lipids and it's treatment of Amarin.
JL,
Do I continue to email or am I just waisting my time?
I remember some poster stating that somebody on the Adcom had a possible conflict of interest because of a connection to a competitors drug. If anybody can get me the information I would also like to forward that to CDER as well. Much appreciated!
Email from CDER:
Thank you for your emails of October 17, 2013, November 14, 2013 and November 20, 2013, regarding the October 16, 2013 Endocrinologic and Metabolic Drugs Advisory Committee meeting, which discussed granting the drug Vascepa (icosapent ethyl) an indication for co-administration with statin therapy to lower serum triglycerides and other lipids in patients with mixed dyslipidemia and coronary heart disease or its risk equivalent.
The Food and Drug Administration (FDA or Agency) takes seriously all comments and concerns about advisory committee proceedings and FDA personnel. The Agency is committed to ensuring that the drug review and advisory committee processes are conducted professionally and in accordance with applicable statutes and regulations. Furthermore, the Agency recognizes the value of making these proceedings transparent to the American public. Part of the FDA's mission is to help the American public get the accurate, science-based information they need to use medicines that maintain and improve their health.
To that end, FDA rigorously evaluates all data submitted in support of a New Drug Application treatment indication. A team of FDA physicians, statisticians, chemists, pharmacologists, and other scientists independently and objectively evaluate the data in the application to determine whether the drug may be approved for the proposed indication. As a part of the review process, the FDA often requests outside advice from an advisory committee when the data raise challenging or novel scientific issues relating to the drug's use.
FDA strives to have broad representation of appropriate medical and scientific specialties on its advisory committees. The Agency screens advisory committee members for financial conflicts of interest and relationships that could present even the appearance of a conflict. After thorough review of the background materials and consideration of comments made by the applicant, the FDA, and the public, the committee members provide the Agency with their informed judgment. FDA highly values the expertise of the independent experts on the committee and incorporates the advisory committee assessments into its decision-making process; however, advisory committee votes and recommendations are not binding on the Agency.
My Reply:
To whom it may concern,
Thank you for your response. It is nice to know ordinary citizens can still communicate with government agencies. One question regarding your response. You state, "As a part of the review process, the FDA often requests outside advice from an advisory committee when the data raise challenging or novel scientific issues relating to the drug's use", to which I assume translates into whether or not the FDA believes reducing triglycerides in the Anchor Indication will have a positive effect on coronary heart disease or its risk equivalent. My question is what was the date that the FDA came to this conclusion? The reason I ask is that the FDA quoted the three studies (Accord-Lipid, Aim-High and HPS2-Thrive) as the reason for the "new science" and these studies results were available to the FDA prior to the sNDA letter being sent and obviously before the Adcom. Why would the FDA, with this information, allow a public company to continue on a dead end path if the decision was already made?
BB,
IMO, there was no fatal mistake made. The company is exhausting all available options due to the FDA mishandling of the SPA agreement and Adcom. Because the meeting was denied due to procedural missteps does not imply incompetence. In the end however, you may be correct that JZ needs to go for Amarin to have any chance going fwd.
goseek,
I would be interested but I think consulting somebody in the know would be paramount so that we aren't wasting time and resources. There are many avenues that can be taken with the CP and I'm sure many here do not have the education to make it worthwhile.
goamrn,
Unfortunately for Amarin, high trigs 200-499 was a target population in that reducing trigs was thought to reduce CVE's according to the FDA at some point in time prior to the Adcom, most likely before the SPA agreement was made.
At the adcom, the FDA changed the reason for treating this population from lowering trigs (which Vascepa excels at) to the reduction of CVE's (which at this time cannot be proven until Reduce-it)
Where Amarin got caught up in the crosshairs is with the failed Niacin and Fibrates trials that showed no positive CVE outcome. These are totally different medicines but since they are listed as lipid drugs, the fda has decided to say no to any lipid drug in the 200-500 until it can prove outcomes.
JZ stated in the CC "The FDA has changed their stance base on outcomes files conducted with other drugs. Yet there was no specific or pertinent mention of this change at any point leading up to the AdCom including the sNDA acceptance letter for ANCHOR also known as the Day 74 letter or in any of the various communications and interactions between Amarin and the FDA over the last year, even though the majority of this outcomes data was available for some time.
Those other outcomes trials involve different classes of drugs in patients with lower or normal triglyceride levels, holding Amarin accountable for results of other agents studies in the wrong patient group. None of those outcome studies prospectively enrolled patients who had elevated triglycerides in spite of statin control with LDL cholesterol. This is exactly the type of thing the FDA historically frowned upon, trying to compare totally different agents or classes of agents across groups or drugs.
This is where the fight begins....
Chabo,
The marine indication of treating trigs over 500 is actually for pancreatitis. During the Adcom, the FDA and Dr Hiatt were saying how having pancreatitis as an endpoint was laughable but at the same time believed treating trigs over 500 would be beneficial. Science has never questioned that. However, because of the failed Fibrate and Niacin trials for CVE's, the FDA is now questioning the actual benefits of treating 200-500 even though none of the studies cited by the FDA studied this patient population. I believe the FDA's logic is flawed and I hope that Amarin is able to prove that without waiting for Reduce-It. The SPA is critical and that is why Amarin is going to fight tooth and nail to have it restored.
jk29,
Amarin never asked or intended for "lowering CVE" in the anchor indication. The FDA added it. That is the problem. Because of the failed studies, they believe this too will fail for outcomes.
If that is the case, the company should have been notified prior to the Adcom and also in the sNDA letter. It never happened. The FDA set Amarin up to fail.
johnking29,
I'm sorry but I totally disagree with you. Amarin never asked for the label to include "reduce CVE's". Therefore it stands to reason that the FDA added it. Why? My thoughts are since the other studies failed with outcomes (fibrates, niacin) they are concluding that this to will fail. Why prescribe a drug to lower lipids if it doesn't reduce cve's. During the adcom, it was repeated over and over again...You would only prescribe this medicine in this group (trigs 200-500) to lower cve's. The battle with the FDA is the SPA agreement and the rescission of it due to "new science".
Dr. Oz Show facebook page has the triglyceride story. I have copied the epadruginitiative pr and the petition there. Feel free to comment and educate others
My email has been sent to the following places: Wall Street Journal, Newsday (with the help of Anne Michaud from "letters" department)NY Times and Boston Herald. I figure if anyone does contact me, I will have time to add pertinent info. Here's hoping for the best.
great idea to link the epa initative in the email. Done!
I am not on SA. Maybe I could provide a link to epadruginitiative for more info which includes that link
To all: email me alaurin@sbcglobal.net with any updates or edits. If you would copy to your email and highlight your edits or additions would be appreciated.
Title: Who's pushing the FDA this time?
Ms. Mundy,
I am writing you because an article of yours came up in some research regarding FDA corruption. The article written March of 2009 titled, "Political Lobbying Drove FDA Process" was a very well written article and because of recent events, seems to be timeless. I am hoping you would be interested in another story regarding possible FDA corruption. A little history:
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl) is Amarin's first FDA approved product and is available in the United States by prescription. Vascepa is the first and only pure EPA omega-3 fatty acid that has been clinical proven to significantly reduce TG levels without increasing LDL-C levels and provide a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo.
Beginning this year, Amarin began selling Vascepa in the Marine Indication (trigs >500 mg/dl) and submitted an sNDA to expand the label to the Anchor Indication (trigs 200-500 mg/dl). In both studies, Vascepa proved its efficacy in lowering Trigs, Cholesterol and Inflammation Markers while maintaining a safety profile compared to a placebo. The FDA ordered an ADCOM for Oct 16th. At this meeting it was clear what the intention of the FDA was and how it stacked and steered the Panel to a negative vote. The FDA questioned whether or not this drug would reduce Cardio-Vascular events even though it was never the intention of the sponsor. Amarin and the FDA were already involved in the Reduce-It study that would determine outcomes. Just as important, the FDA used the results of three different studies (Accord-Lipid, Aim-High and HPS2-Thrive), using different compound (fibrates and niacin) with a different patient subgroup (trigs <200 mg/dl) to rescind the SPA agreement it had with Amarin. These studies were well known by the FDA prior to the ADCOM and were never mentioned in the sNDA letter or at any point prior to the ADCOM.
Interestingly enough, earlier this year a Citizens Petition (Lovaza Citizen Petition, Feb 2013) was filed by John Fuson and Crowell and Moring LLP. This petition it seems, was nothing more than an attempt to delay the New Chemical Entity decision by the FDA for Amarin's drug Vascepa. The petition's main goal was to have Vascepa's API listed into the OB retroactively by GSK drug Lovaza. In August, the FDA failed to rule on the petition, ignoring it's own rules, therefore resulting in a further delay in the NCE decision. John Fuson also happens to be a former employee of the FDA and has represented GlaxoSmithKline in an antitrust case in 2005. Keep in mind the Citizens Petition has delayed the NCE decision for Amarin's Vascepa benefitting it's competitor GSK's Lovaza.
All of these actions have resulted in major financial ruin for the company and it's shareholders. Unfortunately, main street media has chosen to ignore this story completely but I am hoping with your history of uncovering FDA corruption, that the story may grow. If you have any questions, please email me and I will do my best to provide answers. Thank you for your time.
Respectfully,
Help needed: Edit and include pertinent info
Rough Draft
Ms. Mundy
I am writing you because an article of yours came up in some research regarding FDA corruption. The article written March of 2009 titled, "Political Lobbying Drove FDA Process" was a very well written article and because of recent events, seems to be timeless. I am hoping you would be interested in another story regarding possible FDA corruption. A little history:
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl) is Amarin's first FDA approved product and is available in the United States by prescription. Vascepa is the first and only pure EPA omega-3 fatty acid that has been clinical proven to significantly reduce TG levels without increasing LDL-C levels and provide a spectrum of additional lipid treatment benefits with a tolerability and safety profile similar to placebo.
Beginning this year, Amarin began selling Vascepa in the Marine Indication (trigs >500 mg/dl) and submitted an sNDA to expand the label to the Anchor Indication (trigs 200-500 mg/dl). In both studies, Vascepa proved its efficacy in lowering Trigs, Cholesterol and Inflammation Markers while maintaining a safety profile compared to a placebo. The FDA ordered an ADCOM for Oct 16th. At this meeting it was clear what the intention of the FDA was and how it stacked and steered the Panel to a negative vote. The FDA questioned whether or not this drug would reduce Cardio-Vascular events even though it was never the intention of the sponsor. Amarin and the FDA were already involved in the Reduce-It study that would determine outcomes. Just as important, the FDA used the results of three different studies (Accord-Lipid, Aim-High and HPS2-Thrive), using different compound (fibrates and niacin) with a different patient subgroup (trigs <200 mg/dl) to rescind the SPA agreement it had with Amarin. These studies were well known by the FDA prior to the ADCOM and were never mentioned in the sNDA letter or at any point prior to the ADCOM.
Interestingly enough, earlier this year a Citizens Petition (Lovaza Citizen Petition, Feb 2013) was filed by John Fuson and Crowell and Moring LLP. This petition it seems, was nothing more than an attempt to delay the New Chemical Entity decision by the FDA for Amarin's drug Vascepa. The petition's main goal was to have Vascepa's API listed into the OB retroactively by GSK drug Lovaza. In August, the FDA failed to rule on the petition, ignoring it's own rules, therefore resulting in a further delay in the NCE decision. John Fuson also happens to be a former employee of the FDA and has represented GlaxoSmithKline in an antitrust case in 2005. Keep in mind the Citizens Petition has delayed the NCE decision for Amarin's Vascepa benefitting it's competitor GSK's Lovaza.
All of these actions have resulted in major financial ruin for the company and it's shareholders. Unfortunately, main street media has chosen to ignore this story completely but I am hoping with your history of uncovering FDA corruption, that the story may grow. If you have any questions, please email me and I will do my best to provide answers. Thank you for your time.
Respectfully,
yes, google FDA subcommittee and a list of all Democratic and Republic members will show.
It would be nice if the initiative would agree to these and write something up. I would be willing to help. But yes, It would be a great idea to contact her again.
question to all.....Is it possible to get in contact with the EpadrugInitiative and possibly go on a Senate/Congressman facebook blitz. This may put the initiative right into their own back yard and may force them to act for their own constituents
JL,
The only thing politicians hate more than money, is another politician with more money. Therefore I emailed every single Senator on the FDA subcommittee including Senator's Johanns and Boozman. Here's hoping that all 15 different Senators do not get along and it's worth one of their efforts to look into this.
Your reasoning?