Marcpw ....Frankly your view , and that of the no votes on the Adcom committee is absurd .
According to you ...no CV drugs should be approved until outcome data proves benefit ...right
So starting in 1985 I was on Statin drugs as soon as they rolled out ...no outcome data ...just improvement of my lipid panel ...improvement in my surrogate risk makers .
The Cardiologists were up front about it ....ie " This lowers your risk markers and should lower your risk of a heart attack ...but we don't have outcome data yet to know for sure " .....IT WAS MY CHOICE whether to take the drug or not.
I'm currently also on Zetia ...no outcome data yet to prove it will reduce my chance of a heart attack ...not until late 2014 . But I can get an "on label " prescription for it and was given the option TO TAKE IT WHILE I AWAIT THE OUTCOME DATA.
Now we have Vascepa ...the safest and most patient friendly of all the lipid altering drugs that may reduce my risk of a heart attack ......No ,no choice for you Mr /Mrs /Mz patient ....we know better ...we'll make you wait 3-4 yrs this time . We will keep it "off label " and make you try and find some one to prescribe ( it took me 3 MD's before 1 would prescribe )......even tho its probably the safest CV drug out there.
So my wish for you tonight Mr Marcpw is that you develop coronary artery disease with a life expectancy of say 5yrs ....so then I can get to tell you , Mr Marcpw, that you dont have a choice unless you can find some one to prescribe ...you will just have to wait
hetero famila hypercholestremia
Dr Miller ( on the Reduce it steering committee ) was thinking about mid 2015 ( John Hopkins conference )
Nuke ...Cool hand Luke ...As some one denied health care coverage for years because my father and grand father died of heart attacks ...I'm all in favor of Obama Care ...because people like me can not be denied coverage .
Not saying its perfect ...but folks like me were shut out before unless we could get employer group coverage or some thing similar .
In the 80's I only got coverage because I volunterred for a CV clinical trial at UCSF
To correct myself ...suggest only those willing to risk loosing all they have invested ...wait till interim analysis.
I'm willing to as I have CAD ( coronary artery disease ...inherited )
Suggest you hold to at least the interim analysis of the Reduce it trial ...see my note to Frankposting .
Currently the view of the FDA appears to be that only statins reduce the risk of heart attacks ...nothing added to statins ( beyond diet and exercise ) is believed to be of benefit ALTHO they allow that those with high TG's and low HDL MAY show benefit.
They also acknowledge that they don't fully understand how Omega 3's impact our CV health ...that something else may be at play ...lowering inflammation , changing the EPA /AA ratio etc ...which may in fact show benefit regardless of TG levels.
So I'm holding to interim analysis ....not suggesting anyone do like wise ...do you own DD
There are enough Outcome trials out there ( Jupiter being one ) to convince the FDA that using statins to reduce LDL cholesterol will result in fewer heart attacks .
The same can NOT be said yet ( according to the FDA ) for lowering TG's.
ie ...no data that they will accept that lowering TG's results in fewer heart attacks.
So give it your best shot
When do you expect to see enough "events " in Reduce It to warrant an interim analysis
Data I have is, 60% of 1612 events justifies a DMC analysis ...appreciate your comments
Currently I'm estimating DEC 15 but with the addition of patients from the Ukraine ( 40% of males have events by age 50 ) ...could be earlier .
Whats your take
Frank ..interesting post .
For those of us less scientifically sophisticated ...can you explain Errata , HTG etc . From what I remember of the Adcom ..200 events had occurred by Adcom We need to get to 60% of the 1200 ? expected events ...ie 720 events before an interim analysis by the DMC ...( data monitoring committee ) ...at which pt the trial can be
1) stopped for futility ( and our investment is worthless )
2) stopped for strong efficacy ( in which case its champagne all around )
3) continues because its safe and may be effective ( and we hang in until the end )
Are you sure we are past the placebo issue with the FDA ...and how about explaining "negative rate change with placebo " .....I think I missed that class : )
I've written a personal cover letter to Senator Feinstein ( who I met briefly years ago ) presenting the view of those on CV drugs . IE we want easy access to safe and effective drugs .
I included your letter ...thanks for your efforts
Anyone in CA interested in supporting the effort should go to Senator Feinsteins web site and address letters etc to the One Post st suite 2450 San Francisco CA 94104 office ...please fill out the required information forms
Thanks ...will chk it out ... I'm still very long in PCYC , have sizeable position in HALO and can not bring myself to sell TSLA ( love the cars and want to buy the Model X )
Congrats on that last big trade ( TRSX ? ) by the way ... to you and Jefferson .
I was out of AMRN for most of the last 12 mths ...buying back in mainly during the prostrate cancer scare ......so my loss is less then some on the board.
Frankly I was surprised by the Adcom decision . Historically they had approved drugs that lowered risk markers provided they were reasonably safe ...now that has all changed.
Re the current situation
IMHO .. now this is all about Reduce it Outcome trial . The questions are as follows
1) Will the FDA accept the current placebo ...mineral oil
2 )Once patients are at optimal statin therapy ...will lowering TG,s and other risk markers show benefit
The earliest we are likely to get an idea on 2) is the DMC ( data monitoring committee ) review after 60% of expected events ..ie about 960 events ...at which time I believe they can stop the trial for futility or efficacy or let it continue .
Since there were about 4,000 in the trial at the start of 2013 ( over 6,000 now ) ....by the end of 2014 going into 2015 ...if JELLIS sub group is any guide ...we should get a DMC review
AMRN has cash to last to then . If its not stopped for futility ...then its just a question of how effective Vascepa is . If it is stopped for futility ...game over for everyone long
Good to see you posting again...altho I prefer the posts without the personal attacks ...I appreciate reading all views
Thanks Kanaza .
I'll send a copy to Senator Feinstein who I believe is on an FDA over sight committee
Please make a pt of reporting back on the patient you just started on V ...the one with CRP at 3.49
Do you remember the details of the Jupiter trial ...I believe you had to have a very high CRP to be enrolled.
Dr Ballantyne ran the Anchor trial ...I have a hard time believing he would misled anyone .
Always appreciate your posts
Wow ...serious allegations " The authors of the ANCHOR ....and the editors of the Am J of Cardiology MISLED the medical community " Are you suggesting this was deliberate on the part of the ANCHOR authors
Alleg I believe they hold the patents as collateral against the loan ...so yes they keep the patents .
Amarin has room to move tho ...this won't hit the proverbial fan to late 2014 ( my guess )
You are buying the Reduce it trial
If you are Pfizer and wait until the end of 2014 for the Co to go bankrupt ..are you really going to buy the patents and start all over again....then you are looking at possibly 2021...before you know if you have an Omega 3 drug that when added to statins will reduce CV events
Time is money
You make a deal with AMRN in 2014 to ensure Reduce it is completed..late 2015 thru 2016 .
No one IMHO is going to be interested in AMRN, if Reduce it is cancelled.