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your wish is my command
Senator Grassley,
In a letter you had written to Dr. Torti on March 24, 2009 you stated,
“Your memorandum appears to run contrary to many statutes protecting executive branch communications with members of Congress. I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA’s regulatory mission. [This] could be viewed as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower
protection laws. Whistleblowers are some of the most patriotic people I know—men and women who labor, often anonymously, to let Congress and the American people know when the Government isn’t working so we can fix it.”
Well to put it bluntly, the Government isn't working! You see Senator Grassley, history seems to repeat itself and again the FDA finds itself in the bulls eye. Just recently the FDA held an ADCOM meeting Oct 16th to determine whether the panel would approve Amarin's drug Vascepa for the expanded ANCHOR indication. The FDA states that "new science" is the reason they rescinded their SPA agreement days later with Amarin (listing the Accord-Lipid, Aim-High and HPS2-Thrive studies ), but it is clear that the science they are using is not new at all. First, their was no mention by the FDA of this new position at any point prior to the ADCOM and it was also missing in the FDA's sNDA acceptance letter. Again, this "new science" existed prior to the ADCOM but was never mentioned. Secondly, when agreeing upon the REDUCE-IT SPA, the results of ACCORD and AIM-HIGH were used by the FDA and Amarin to design REDUCE-IT. Amarin Corp has spent tens of millions of dollars in good faith based on a SPA agreement with the FDA and now has nothing to show for it.
Finally, there are many that believe a far more sinister reason for the FDA acting this way towards a company that has done all in it's power to do what has been asked of it. The reasons for this begins with the well known "Lovaza Citizen Petition, FEB 2013". This petition was drawn up by none other than John Fuson who happens to have ties to the FDA. This petition was nothing more than an administrative loophole to delay the New Chemical Entity decision for Vascepa and in essence was asking to have Vascepa's API listed retroactively in the OB . . 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. Oct 16th, the FDA steered the ADCOM panel to a negative vote by questioning whether their Anchor Indication will reduce CVE's. The SPA agreed upon by the FDA and Amarin never had CVE outcomes as it's endpoint. Amarin and the FDA had a separate SPA agreement for the Reduce-It Study that would provide this information.
All of these actions have resulted in major financial ruin for the company and it's shareholders. It is important for the American people to know that Big Pharma drug companies cannot use improper legal/administrative actions to secure their monopolies in their respective markets. The American people are losing faith in government. Here's hoping you receive this email and provide a timely response.
Respectfully,
AL
P.S. My Grandpa was born in Iowa and I have many family members that live in your great State. They all vote-Grassley
Email From CDER
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER), regarding PCSK9 drugs.
We greatly appreciate you taking the time to share your opinions with us. Your comments and concerns regarding PCSK9 drugs have been forwarded to the appropriate group within the Agency for further consideration.
Best regards,
KDe
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
MY REPLY:
To whom it may concern,
My comments and concern do not only apply to the PCSK9 drugs and I am offended that it has been dismissed as such. Please reread the email and understand that this involves how the FDA is interpreting "new science" that is affecting the decision and recission of the SPA for Amarin's Anchor Indication. The studies involved (Accord-Lipid, Aim-High and HPS2-Thrive) should not allow the FDA to extrapolate outcomes without an apples to apples comparison. I look forward to an honest and open discussion with the FDA regarding this issue.
no mo,
I totally agree with you that the company needs to keep complete focus. Any and all legal steps will need to be taken after Dec. 20 if all goes wrong. This is about compromise. However, those of us on the outside should be raising hell and if their is any truth to these theories, we need to keep the pressure on.
No, Amarin has not announced any meeting. That is why i'm wondering about the price action today. The type A meeting was announced by Rosenman on stocktwits. I've always been a firm believer in "follow the volume" and today with almost double the Avg. Daily volume, I assume something is up (other than pps) Was wondering what others are thinking.
What are everybodies thoughts regarding the price action today. Is this a result of the Type A meeting being announced, or is there any connection to the AHA Conference? I can't believe the JZ buy has anything to do with this.
richinjun,
All I stated is what many people believe. That is not an accusation on my part nor have I convicted Mr. Fuson of any wrongdoing. Now if they want to find who my many people sources are, they can try. Maybe at that time, we'll find out who Crowell and Moring aka Mr. Fuson was representing with the Lovaza Citizens Petition.
p.s. Response for DOJ
Thank you for your continued correspondence with the U.S. Department of Justice Antitrust Division. We have your information on file and should the legal staff need further information, they may contact you in the future.
We appreciate your interest in the enforcement of federal antitrust laws.
Which part should I be worried about. That many believe there is a connection, that GSK has acted this way previously, or that the FDA has not followed it's own rules in the NCE decision.
Bio,
Hope you don't mind, but I changed and resent your template letter to the DOJ
To whom it may concern,
It is clear to many people that John Fuson, a former FDA employee, is collaborating with GlaxoSmithKline (GSK) in an attempt to monopolize the EPA prescription fish oil industry and therefore violating the U.S. Sherman Act.
GSK has a history of this type of behavior (Chemi Spa VS. GSK) and the connection of Mr. Fuson to the FDA and the recent behavior of the FDA towards Amarin Corp. and it's proposed anchor indication needs to be investigated. The citizens petition that Mr. Fuson filed (Lovza Citizens Petition, Feb 2013) 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. 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.
All of these actions have resulted in major financial ruin for the company and it's shareholders. It is important for the American people to know that Big Pharma drug companies cannot use improper legal/administrative actions to secure their monopolies in their respective markets.
This information has been forwarded to the Health and Human Services Office of Inspector General and I have been unable to verify any actions being taken. The American people need to be protected by this type of behavior and the responsibility to enforce this protection falls within the duties of your office. I respectfully ask the DOJ and FTC look into these allegations that may include Criminal Antitrust violations against Amarin Corp, by conspiring to create an unfair restraint of trade
Per Stephen Rosenman FDA appeal meeting / Amarin to have all new FDA players
would love to be a fly on the wall in that room. Bio, AF and John Fuson sitting at a table. Outside the room of course is a mob of underwater longs begging to get their chance at the crooks.
any chance we can connect AF with Fuson and the Lovaza CP?
zman,
I went on a FaceBook blitz to many friends and asked them to have their spouses and friends sign up as well. I agree with you. If everybody here pushes this on 10 or more friends who also have their spouses or friends sign the petition, this could explode. It takes everybody here taking their own initiative. It can't hurt us to push the petition.
Hope it helps. I've placed the petition on WebMD under fishoil and Vascepa and also placed it on the FDA facebook page. Under Lovaza on WebMD I put the website buyvascepa.com for lovaza patients to check out these 2 drugs side by side.
Any and all that will go to the FDA facebook and WebMD page and comment are appreciated. You never know whose interest you may find.
Done, Done and Done. Thanks!
great. I think anytime we can put Vascepa and Lovaza side by side, we will win out. I don't know much about facebook but can we put a Vascepa Vs. Lovaza poll or something to that effect and allow patients to put comments regarding their complaints/compliments. My thought process here is that if we can generate enough interest in the page Lovaza patients (it would seem, insurance pending) would want to switch if they seen these drugs side by side. And if I remember, lovaza just posted over 80,000 scripts compared to Vascepa 6,000. Maybe we can become de facto salespersons for Amarin. Or maybe I'm a bit crazy.
It looks like there is a Vascepa Vs. Lovaza under www.buyvascepa.com however I do not see anywhere where patients themselves can post.
any web geniuses that could start a Vascepa vs. Lovaza website or facebook page. Could ask all users for side effects and positive outcomes. Maybe by grouping the info together, we can influence Lovaza users themselves to talk to their doctors.
you sir are correct! 10 words later I have the right dosage. To be human....
well labner,
it all comes down to the "new science" issue which is still an important part of my letter.
lab,
do you have a link to the adcom. I would like to watch that part.
Sorry to repost... but currently sent to NYtimes, Chicago tribune, wall st journal, La times, newsobserver.com, newsday..
FDA-Public Health or Personal Profit
I am very concerned and troubled by Deputy Director Eric Coleman's position on PCSK9 drugs as it relates to the FDA's position on Amarin Corp.'s Vascepa. Just recently this same Deputy Director led an ADCOM panel for Amarin's drug Vascepa for the expanded Anchor indication. Using the FDA's decision to rescind Amarin's SPA agreement after the ADCOM due to new medical science and required outcomes, I find it hard to believe that different standards are being held for different companies.
Further more, looking at the statement Director Coleman made regarding PCSK9 drugs, "These drugs will only have to meet existing standards for FDA clearance, including whether they cut cholesterol, lower blood pressure or inflammation", it seems logical that other drugs with the same efficacy should be treated the same. Looking at the data presented at the OCT 16 ADCOM for Amarin's Vascepa, it clearly shows that with 4mg dosage, Vascepa cut's cholesterol and lowers inflammation markers. AMR101 4 g/day decreased LDL cholesterol by 6.2% (p = 0.0067) and decreased apolipoprotein B (9.3%), total cholesterol (12.0%), very-low-density lipoprotein cholesterol (24.4%), lipoprotein-associated phospholipase A2 (19.0%), and high-sensitivity C-reactive protein (22.0%) versus placebo (p <0.001 for all comparisons).
I'm trying to comprehend the FDA's inconsistencies with regards to these different drugs. Again, the FDA states that "new science" is the reason they rescinded their SPA agreement with Amarin, but it is clear that the science they are using is not new at all. First, their was no mention by the FDA of this new position at any point prior to the ADCOM and it was also missing in the FDA's sNDA acceptance letter. Again, this "new science" existed prior to the ADCOM. Secondly, when agreeing upon the REDUCE-IT SPA, the results of ACCORD and AIM-HIGH were used by the FDA and Amarin to design REDUCE-IT.
Please try to help me understand why an effective drug like Amarin's Vascepa, which does cut cholesterol and inflammation with the safety profile comparable to a placebo, has had it's SPA agreement rescinded when the Deputy Director himself agrees that drugs that produce these results will not need outcomes studies.
Jesse,
If you were neutral going in, you would have to follow the FDA as the question was phrased for that outcome. Amarin became the New England Patriots preparing for the superbowl only to find out that morning they are playing Liverpool in a soccer match. Has JZ and the company failed in certain areas, for sure. But, the FDA is the one changing the game and should be held accountable. Only time will tell...
sent to cderombudsman@fda.hhs.gov
To whom it may concern,
I am very concerned and troubled by Deputy Director Eric Coleman's position on PCSK9 drugs as it relates to the FDA's position on Amarin Corp.'s Vascepa. Just recently this same Deputy Director led an ADCOM panel for Amarin's drug Vascepa for the expanded Anchor indication. Using the FDA's decision to rescind Amarin's SPA agreement after the ADCOM due to new medical science and required outcomes, I find it hard to believe that different standards are being held for different companies.
Further more, looking at the statement Director Coleman made regarding PCSK9 drugs, "These drugs will only have to meet existing standards for FDA clearance, including whether they cut cholesterol, lower blood pressure or inflammation", it seems logical that other drugs with the same efficacy should be treated the same. Looking at the data presented at the OCT 16 ADCOM for Amarin's Vascepa, it clearly shows that with 4mg dosage, Vascepa cut's cholesterol and lowers inflammation markers. AMR101 4 g/day decreased LDL cholesterol by 6.2% (p = 0.0067) and decreased apolipoprotein B (9.3%), total cholesterol (12.0%), very-low-density lipoprotein cholesterol (24.4%), lipoprotein-associated phospholipase A2 (19.0%), and high-sensitivity C-reactive protein (22.0%) versus placebo (p <0.001 for all comparisons).
I'm trying to comprehend the FDA's inconsistencies with regards to these different drugs. Again, the FDA states that "new science" is the reason they rescinded their SPA agreement with Amarin, but it is clear that the science they are using is not new at all. First, their was no mention by the FDA of this new position at any point prior to the ADCOM and it was also missing in the FDA's sNDA acceptance letter. Again, this "new science" existed prior to the ADCOM. Secondly, when agreeing upon the REDUCE-IT SPA, the results of ACCORD and AIM-HIGH were used by the FDA and Amarin to design REDUCE-IT.
Please try to help me understand why an effective drug like Amarin's Vascepa, which does cut cholesterol and inflammation with the safety profile comparable to a placebo, has had it's SPA agreement rescinded when the Deputy Director himself agrees that drugs that produce these results will not need outcomes studies. I impatiently await your response.
The Open Letter to the FDA has been put in the comments section of a different topic. I'm hoping many on you will go to the FDA facebook page and start commenting on it. Bring the attention right to the doorstep.
I'm guessing they don't allow others to post topics. Doesn't mean we can't hijack other threads. The more people that see the inconsistent decision making going on the better, IMO.
The Open Letter to the FDA has been put in the comments section of a different topic. I'm hoping many on you will go to the FDA facebook page and start commenting on it. Bring the attention right to the doorstep. Thanks
Well I put the letter in a different topic which I'm sure will be deleted, but I'll continue to try.
Well, they keep deleting my letter on the FDA Facebook page. I have reviewed their "comment policy" and don't see any trouble. Wonder why they don't want a discussion on this topic?
Thanks. I've submitted the letter to the Washington Post and also posted it on the Food and Drug Administration Facebook page. Lets see if any discussion takes part there?!
It's a long shot, but I sent my FDA email (touched up a little) to the USA today letter to the editor.
Open Letter to the FDA,
I am very concerned and troubled by Deputy Director Eric Coleman's position on PCSK9 drugs. Just recently this same Deputy Director led an ADCOM panel for Amarin's drug Vascepa for an expanded label. Using the FDA's decision to rescind Amarin's SPA agreement after the ADCOM due to new medical science, I find it hard to believe that different standards are being held for different companies.
Further more, looking at the statement Director Coleman made regarding PCSK9 drugs, "These drugs will only have to meet existing standards for FDA clearance, including whether they cut cholesterol, lower blood pressure or inflammation", it seems logical that other drugs with the same efficacy should be treated the same. Looking at the data presented at the OCT 16 ADCOM for Amarin's Vascepa, it clearly shows that with 4mg dosage, Vascepa cut's cholesterol and lowers inflammation markers.
I'm trying to comprehend the FDA's inconsistencies with regards to these different drugs. According to the standards that Director Coleman is stating, Amarin's Vascepa, while already involved in a long term outcomes study, should be approved for the Anchor indication.
Please try to help me understand why an effective drug like Amarin's Vascepa, which does cut cholesterol and inflammation with the safety profile comparable to a placebo, has had it's SPA agreement rescinded when the Deputy Director himself agrees that drugs that produce these results will not need outcomes studies. I impatiently await your response
JM,
The way I look at it, if we all sit quietly the FDA will just continue on with the status quo. If we bang the pots and make a lot of noise, they may continue with the status quo but at least I can say I went down with fighting. My email should not offend or piss off anyone at the FDA that can back up their decisions with facts. If they get pissed off, well that says all I need to know.
Sent to the FDA via email
I am very concerned and troubled by Deputy Director Eric Coleman's position on PCSK9 drugs. Just recently this same Deputy Director led an ADCOM panel for Amarin's drug Vascepa for and extended label. Using the FDA's decision to rescind Amarin's SPA agreement after the ADCOM due to new medical science, I find it hard to believe that different standards are being held for different companies.
Further more, looking at the statement Director Coleman made regarding PCSK9 drugs, "These drugs will only have to meet existing standards for FDA clearance, including whether they cut cholesterol, lower blood pressure or inflammation ." Looking at the data presented at the OCT 16 ADCOM for Amarin's Vascepa, it clearly shows that with 4mg dosage, Vascepa cut's cholesterol and lowers inflammation markers.
I'm trying to understand the FDA's inconsistent standards with regards to these different drugs. According to the standards that Director Coleman is stating, Amarin, while already involved in a long term outcomes study, should be approved for the Anchor indication.
Please try to help me understand why an effective drug live Amarin's Vascepa, which does cut cholesterol and inflammation with the safety profile comparable to a placebo, has had it's SPA agreement rescinded when the Deputy Director himself agrees that drugs that produce these results will not need outcomes studies. I impatiently await your response.
Doesn't Vascepa cut cholesterol and inflammation?? I'm confused.
Absolutely. I will be faxing a copy of the DOJ reply email along with the original.
Bio, email I received from DOJ
Thank you for contacting the Antitrust Division of the U.S. Department of Justice. Upon careful review of your complaint, the Citizen Complaint Center has determined that your concerns are more appropriately handled by the Health and Human Services Office of Inspector General (HHS OIG). The HHS OIG is an independent office within HHS that is dedicated to combating fraud, waste and abuse and to improving the efficiency of HHS programs, including the Food and Drug Administration (FDA). If you have not already done so, you may wish to express your concerns to the HHS OIG. Please see below for the HHS OIG’s contact information.
We appreciate your interest in the enforcement of the federal antitrust laws and we hope you are able to resolve your concerns.
Sincerely,
Citizen Complaint Center
Antitrust Division
Department of Justice
1 Samuel 17
David said to the Philistine, “You come against me with sword and spear and javelin, but I come against you in the name of the Lord Almighty, the God of the armies of Israel, whom you have defied. 46 This day the Lord will deliver you into my hands, and I’ll strike you down and cut off your head. This very day I will give the carcasses of the Philistine army to the birds and the wild animals, and the whole world will know that there is a God in Israel. 47 All those gathered here will know that it is not by sword or spear that the Lord saves; for the battle is the Lord’s, and he will give all of you into our hands.”
48 As the Philistine moved closer to attack him, David ran quickly toward the battle line to meet him. 49 Reaching into his bag and taking out a stone, he slung it and struck the Philistine on the forehead. The stone sank into his forehead, and he fell facedown on the ground.
I agree. However, at the end of the day, any compromise that expands the label will only help. IMO, Reduce-It results are the gold mine, but need to get there.
The FDA has put themselves in the position of a Defense Attorney trying to defend a client that everyone knows is guilty. The facts related to the cancellation of the SPA agreement and the FDA direction of the Adcom has put them in a predicament. Would love to see the FDA trying to defend their position in Federal Court.
Really makes me feel better that JZ and co. feel that they are in the right. The FDA is using non-EPA related science as ammunition for rescinding the SPA agreement. In the end, compromise by the FDA might be in their best interest IMO.
JZ says it best..."at the end of the day we have "right" on our side.
EMDAC@fda.hhs.gov
To whom it may concern,
I am appalled and disheartened that a circus show put on today (Vascepa Adcom) was able to destroy the future of small bio's searching for medicines to solve our nations number 1 and 2 killers. The decision today to not only violate the SPA agreement and set Amarin up for failure has led many to believe that you or the Adcom panelists were on the take. I tend not to believe these conspiracy options but maybe you can help to educate me further.
First, has any other lipid drug surpassed this bar that has been set for Vascepa, such as the Fibrates or Niacin? The bar being Reduce-It being needed to be finished prior to adding a new label to Vascepa.
Second, how can mineral oil become such an important discussion point when that data show clear statistical changes ignoring the mineral oil?
My last question is this, If the drug is safe and has proven efficacy and the company has done all in it's power as Dr. Hiatt stated, why was the goal post moved in regards to the needed outcomes trials? Your belief that "new science" exists is a wrongful comparison considering the information available (Jelis Study) and the drugs used in those studies.
How unfortunate that your decision to breach a contract will probably result in the termination of a much needed scientific look into the outcomes of the Reduce-It Trials and probably result in the bankruptcy of a company that depended on your honesty to provide them the opportunity to continue this testing.
I implore you to look at the safety and efficacy of this drug and realize that although all the answers are currently not available, the rewards far outweigh the risks with Vascepa.
Thank you for your time,