When Dr. Colman bamboozled Arena investors by leading the panel to a negative vote in 2010, investors, physicians, patients, and researchers alike did not take it laying down. They organized and created a petition. Below are two sites all Amarin investors must witness. Once the petition is complete, we need as many signatures as possible. I am meeting with Joe Bruno to discuss this petition as well try and obtain the contacts of all presenters on Amarin's behalf yesterday.
The payoffs in this country are sickening .... I for years have said that the people/groups that run this country are the OIL/GAS .. INSURANCE .. AND BP. ...... The top brass from those companies are the ones that should be running for office .... it would clean up SOME of the despicable fraudulent "practices" (for lack of a better term at the moment) ...
I'm not one to sit back and get tucked without a kiss, but please don't tell me that $$$$$$$$$$$$$$$ didn't change hands in the past 1.5 years ... BP, MM FDA ...... So .. do they take the money, and then change horses mid stream .... The power is with the money ... and this rejection isn't big enough to get our decision makers attention ..... it happens all the in the pharma/bio world. There are just simply too many areas that can be manipulated by too many people over the course of a 4-5 yr span .. just with the trials alone for god sake.
Listen, I agree, we can sit back and do absolutely nothing, or jump on the "not taking this sitting down band wagon" ..... I guess feel like I just had the pee knocked out of (my bank account) me ** BECAUSE OF THE WAY IT WENT DOWN ** and pretty much have zero faith in the powers that be ...
The FDA’s disposition at an Advisory Committee meeting that took place on October 16th, 2013, is that Vascepa(EPA) should show clinical benefits before approval is granted for the lowering high triglyceride indication, otherwise known as Anchor. There are several serious problems with this approach.
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 demonstrating 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 include niacin and fibrates, both of which have similar efficacy to EPA but have much more serious side effects which limits their usage in certain patients. 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, if shown to occur in American populations would lead to very non-trivial reductions in the rates of death and morbidity in patients with CVD. Scientific evidence points to even better outcomes in American populations due to their low levels of omega 3 consumption as compared to the reductions observed in Japanese populations in JELIS.
Another excerpt from my letter.. this is still in rough draft form but is just to give others ideas.
Thank you for sharing your amazing knowledge and perspective with this board, Kanazawa.
The following comment is for the AC and the FDA:
While other drugs (Niacin and fibrates) lower trigs it seems obvious that THE WAY that they lower trigs is what is not showing improvements in CV outcomes The AC and the FDA are ignoring the fact that there's more than one way to skin a cat, vis a vis lowering trigs. In other words, if trigs are lowered using niacin/ fibrates, this method will not result in lowering CV events. However, if Vascepa is used to lower trigs, it is very likely that it WILL lower CV events (due to its lowering of systemic inflammation).
Why, in your opinion, would these so-called medical/science professionals skim over what should be an obvious and accepted fact?
The FDA is poised to reject approval of Vascepa in a patient population that is estimated to range from 35 to 86 million Americans. Vascepa is an Omega 3 fatty acid derivative protected by over 16 patents in the United States. In surrogate trials in Japan known as JELIS, it has been shown to lower the risk of fatal cardiovascular outcomes by 19%. This trial enrolled over 11,000 patients and was conducted over the course of 3.5 years. This was at a dosage of less than half that being used in the trials for Vascepa in the United States. Post hoc analysis of this trial showed a 53% reduction in fatal outcomes among the treatment population being targeted with Anchor. There are other studies that have demonstrated improved outcomes using Omega 3s along with a body of scientific research implicating the role of lipids and inflammation in the pathogenesis of CVD. Vascepa has been demonstrated to lower not only lipids but also lower levels of inflammation. It is important to note EPA’s role in reducing inflammation as an important potential mechanism in reducing CVD risk, independent of lowering triglycerides.
More excerpts, some of the content has not been fully vetted yet, especially the treatment population for Anchor but feel free to use this as a guide.
First and foremost is the matter of public health as it relates to the ongoing burden of cardiovascular disease mortality and morbidity on the American public. The following are the most recent statistics 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.
Excerpt from the letter I'm writing to my local representatives.
Help needed from the super talented experts. Looking for templet letter to send to Senator Diane Feinstein (subcommittee member of FDA). Would like to see her muscles exerted on FDA for a conditional approval of Anchor. TIA
Sentiment: Strong Buy
It would serve the Acdom members and the FDA right to be responsible for ending Reduce-it and delaying for years the questions regarding beneficial outcomes. Everyone loses as result and it potentially also costs thousand of lives to those that might have otherwise been treated sooner. If the outcomes prove to be positive at some point in the future those lost lives will be the burden that the AdCom members and the FDA will have to bear. Had Amarin been prepared to tell this scenario to the AdCom the vote may have turned out differently
Let me know how to sign on and what you would like me to do. I am using Vascepa as a CVD patient and live in Maryland. I plan to send my own letter with experience to the FDA by Tuesday.
Sentiment: Strong Buy
Your local congressional representatives are there for reasons JUST LIKE THIS. I can almost guarantee that there are more than a few that would love to investigate the FDA's motives behind potentially denying a SAFE and WELL-TOLERATED drug that would do the following;
1) IMPROVE the standard of care at the very least from a tolerability standpoint, when compared to current triglyceride lowering medications
2) LIKELY reduce the incidence of CVD morbidity and mortality in the American population. 500,000 Americans have their first heart attack in any given year and even a SMALL decrease in risk would translate to thousands of lives positively impacted and many billions of dollars saved
3) Put the brakes on drug development and innovation in the United States with the FDA setting a precedent of denying SPAs for drugs with BENIGN side-effect profiles and have met their prior agreed upon endpoints
Kanaz: I agree somewhat with your logic. The squeaky wheel syndrome. I have personal experience with Senator John Kyl. Of course it was for a different issue, but in the end our issue was resolved. IMHO it would all come down on wording the Intro (Letter). For starters the letter needs to talk directly about heart disease, family history, concern as John "Q" citizen for due process. How that Vascepa is available & safe yet Doctors will not prescribe because of off-label, insurers...etc. Cite examples; Jelis, Dr. Ballantyne. Go about the reason for harm to the public the FDA has caused. Do not come at it from aninvestors viewpoint. Financial harm or loss muddys the waters. I guess you could defend Amarin a little and say that they will be put out of business due to cash problems. Perhaps you could elude to the corruption of Wall St and their tactics, but all this again may muddy things. Keep it on point, your writing to them to talk about American Health issues and preventive medications...etc.
I get your drift. I will work on this today. Thanks for the suggestion.