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NS
The “A” is a grading of the quality of evidence
Consistent results, sufficient sample size, adequate control, and definitive conclusions; consistent recommendations based on extensive literature review that includes thoughtful reference to scientific evidence
https://amedd.libguides.com/c.php?g=476751&p=3259506
TTE
I agree with you for COVID. I was commenting on Kiwi’s opinion wrt CVD and coverage in Germany and Australia. He was talking about how the CVD curves would separate within 2 years and that would be the evidence needed to swing government approval for coverage in secondary prevention.
Kiwi
“about $450 Aussie dollars a month in Australia”
In the US Amarin’s real price averages around $135/month. In UK they are getting approximately $170/month.
Still pumping MITIGATE as an important CVD trial…
If you read the Austrian approval you will see they fully believeV works. They don’t need more/new data. Germany also knows V works they just don’t want to pay for it. Questioning the data/science is purely to create an excuse for not paying for it. Steve is the only person claiming V doesn’t work. Nobody else actually believes him (in the decision making positions) but they use his opinions to negotiate pricing or as an excuse to not pay for it. MITIGATE won’t change that no matter how strong the data. If they don’t want to pay they will find a reason or way to not pay.
NS
The Australians appear to have a clearer understanding of the relevant issues and stayed focused on the facts and chemistry. I particularly liked “Systemic and localised anti-inflammatory effects of EPA may result from displacement of pro-inflammatory arachidonic acid (AA), directing catabolism away from eicosanoids (2-series prostaglandins and thromboxanes, and 4-series leukotrienes) to non- or anti-inflammatory mediators. However, the direct clinical meaning of individual findings is not clear.”
North
Going from memory, Dr Bhatt said there were many of the roughly 8,500 Pts in R-It who, over the 4.9 years of being in the trial, stopped their statin. They found no difference in efficacy in those that had stopped their statin. V is approved in Canada for Pts on maximally tolerated statin, which includes if the maximum tolerated is zero.
Ralphey
I was working. I was paid $25 for my home visit. It was not a profitable venture but it was time well spent.
I put together a simple info page for Pts at my pharmacy who have had an MI for them to bring in to their physician’s office and start a conversation.
If you know anyone who might have a use for it, here it is:
https://drive.google.com/file/d/1QP9lHvy2Rhg_Npd7I5Jn88gTB2sgLUxp/view?usp=drivesdk
I spent an hour and a half at a Pts house today talking about ASCVD because he just got discharged from the hospital after quadruple bypass. I told his doctor 10 months ago to put him on V. The doctor never replied nor did he discuss it with his Pt. I wanted to tell the guy to sue for malpractice, but I held back.
Duke
Here is an old V for COVID presentation I put together in 2021. My opinion has changed. V works on COVID.
PREPARE-IT showed 22% reduction in hospitalizations, it just wasn’t powered to get stat sig (p=0.18). They expected 30% hospitalization but only got 8%.
https://docs.google.com/file/d/16-OHA4Ke7u0WGLIfwhkMXk8s4zXrCNHL/edit?usp=docslist_api&filetype=mspresentation
Duke
I put in a comment:
“Omega6’s produce pro-inflammatory cytokines (prostaglandins, thromboxanes,leukotrienes) whereas Omega3’s produce anti-inflammatory mediators, particularly E-Series Resolvins from EPA that resolve the inflammation. 2 clinical trials (CardioLink-9 in Toronto and PREPARE-IT 2 in Argentina) showed benefits of IPE (ethyl ester of EPA) in treating COVID. Benefits were in anti-inflammatory, anti-clotting and Pt symptoms as well as Major Adverse Cardiac Events (although the p value failed to reach stat sig because the trial was under powered). The key element appears to be the serum EPA level achieved which requires doses of 4gms of IPE/EPA per day. 3 separate CVOT RCT have shown benefits of pure EPA (JELUIS, REDUCE-IT and recently RESPECT-EPA by the Japanese Heart Institute -ie zero involvement by pharma) as well as imaging trials EVAPORATE and CHERRY and EVERY RCT of mixtures of EPA and DHA have failed to show any benefits. (Note: fibrates should be for TG over 500mg/dL or 5.6mmol/L ONLY and only if IPE has failed to lower TG below these numbers. The recent failed PROMINANT trial at AHA showed fibrates have zero cardio benefits while potential harms.
IPE works on COVID, has clear and strong benefits in CVD (25% reduction in MACE with p= 0.00000001) while mixtures of EPA and DHA have NEVER shown any benefits beyond lowering TG’s.
All the science and the data is here:
https://drive.google.com/file/d/18qJRGKXo9gOZeenv7I7Ji2aqKpFLGImF/view?usp=drivesdk
Very important note: oxidized EPA is not just less effective it may actually be harmful. All dietary supplements are heavily oxidized and I never recommend them to my Pts. Prescription Vascepa is the only safe and reliable option
(I have never received a single dollar from Amarin, the maker of Vascepa. I am a cardiovascular Pt & have have been taking Vascepa for over 4 years)
ORBAPU
Totally agree on all points
ORBAPU
After 2 years on 4gm/day of V and intermittent fasting with low carb/high fat diet I reached 0.98 EPA/AA. Almost there
TTE
IIRC from calculations I did 6-9 months ago, Amarin was making a net revenue (after rebates, discount cards, incentives etc) of about $125/bottle at a cost of about $30/bottle. Profit of around $95/bottle. I believe Capt has more current/accurate data. My GUESS would be that with 3 generics now competing against Amarin and against each other, gV probably nets $90/bottle at a cost of $40 for a profit of $50/bottle.
Just my best guess
One problem (of many) with my settlement idea is that other insurance companies that committed to Amarin as their supplier may have included a clause that they would receive the lowest cost Amarin offered to other insurers (ie: lowest price guarantee). Would this settlement force Amarin to lower their prices to others?
Bolio
Only for HN clients. Just a theory on how they could settle.
The announcement could say “Amarin and HN settle - HN does not admit to any wrongdoing but agrees to use V for all IPE scripts for the remainder of the R-IT patents”. Sounds like a win-win, they just don’t mention the pricing discount publicly.
Rose
Several insurance providers have decided to reimburse only gV and Amarin can’t do anything about it. I don’t see why the reverse situation would be a problem.
Ralphey
One possible settlement would be HN admits no wrongdoing but agrees to use V exclusively for all Rx. Undisclosed in the details would be that Amarin lowers it’s price of V for HN to being equal to current gV. Amarin gets all the scripts (slightly lower margin) and HN does not incur any extra costs. This would certainly be a win for HN but for Amarin I would consider it “not losing” considering a jury trial verdict in Amarin’s favour would have been a huge victory.
With no revenues from either Germany or Spain, Amarin might have to settle with securing sales vs risking a trial loss and significant market erosion.
Kiwi
“Other Outcome Measures”
a side note, nothing more.
CVD Pts taking a CVD drug, of course they are going to list it as something they will look at. Not the focus of the “trial” just a side note
Kiwi
“finds no CV risk reduction”
That is absolutely BS! R-IT, RESPECT-EPA, EVAPORATE, and especially ANY MI data Bhatt presented at ESC proves beyond doubt there is CVD benefit. It’s really tiring listening to you try to make MITIGATE something it IS NOT - a CVD trial. It’s a COVID/respiratory infection trial.
GIVE IT UP. MITIGATE has never been IMO a relevant trial. KP was offered free drugs to Pts that already should have been prescribed V but KP was too cheap to pay for. Amarin gives them millions in free drugs and in return they keep tract of respiratory infections.
It’s always about the money
NS
Unfortunately, bureaucrats and payers are primarily focused on “this quarter’s expenses” and preventative therapies cost money now while saving money occurs in 5 years. They rationalize it by saying they will just wait a year or 2 for more data or some change in economics but the reality is they just don’t want to pay.
It’s always about the money
BBI
Another reality is that it takes several years for even a great drug to get significant uptake/acceptance. Right now Ozempic is starting to fly off the shelves because it has amazing results in DM2 and WEIGHTLOSS (an absolute goldmine indication). It was approved in Canada in January 2018 - almost 5 years ago. Doctors are incredibly slow to try something new and very resistant to move away from the “tried and tested” old standards. WS knows V is an amazing drug with a great future but they realize it will be several years before it gets traction and starts to fly off the shelves. Ozempic took 4 years to get accepted by the medical community in spite of strong data AND RESULTS YOU SEE right away (blood sugars do down right away and people start to lose weight within a month, 20 pounds a year is what I am seeing).
An even harder sell for V which , if all goes perfectly, won’t change anything or make any difference in your APPARENT health.
WS is in no rush to jump in because they know it will take time. Let Amarin spend the time and money to get it accepted (not by regulators and payers but by prescribers) then they will step in and take over once the money is coming in.
zmanindc
This may be helpful, a spreadsheet of the IPE trials:
https://docs.google.com/file/d/1TcjxoXuOT_2srcLqJ9KQERCvWxs96Dy2/edit?usp=docslist_api&filetype=msexcel
I will be doing a presentation to a group of local pharmacists on Thursday night at 7:00 EST about the benefits of Vascepa in cardiovascular disease. We had more people sign up than the small room can fit so it will be a hybrid presentation on Zoom. Everyone welcome (HLS/Pfizer are not aware I am posting the meeting info to the public). Nothing fancy or professional, just me talking while showing a bunch of slides.
I’m trying to cut down my 3 hours worth of information into under 50 minutes and hoping not to put too many people to sleep.
If you know someone with cardiovascular disease please feel free to pass on the meeting ID and password.
PLEASE, no stock market questions, comments or slandering of Amarin management or they will never let me do this again. The only reason I am doing this presentation is to spread some knowledge and educate people about cardiovascular disease prevention- not to sell a drug, pump a stock or make money in any way.
Meeting info:
Thursday at 7:00 Eastern time
Zoom meeting ID 825 3606 1444
Password: Vascepa
Kiwi
So your logic is that if preventative therapies don’t show results within 24 months, but show great results in 72 months, then there is no point to even starting.
Or: if running 5 miles will save my life but I’m not going to get any benefits for the first 2 miles of the run then I’m not going to run at all because the first 2 miles are a waist of time.
I get it. Your right, again.
In case anyone hasn’t already got access to the slides in the presentation:
https://docs.google.com/file/d/15oDBv-zUa_PHihBvaBM43r0h0UvH-moY/edit?usp=docslist_api&filetype=mspresentation
Kiwi
“The analysis was conducted on 1225 patients in the EPA group and 1235 patients in the control group, although at 6 years' follow-up there were fewer than 400 patients in each arm. “
NOT ENOUGH PEOPLE. Go back and reread day 1 of your class notes
Kiwi
Sorry. I forgot you took a stats course once. I’m totally off base. Those clearly separating lines are meaningless.
Laurent
Very well summarized!
The low number of Pts completing the trial was the killer.
The data left room for haters to hate but I agree with you, I’m happy with the results
Kiwi
P=0.05 is stat sig
P=0.0547 not TECHNICALLY stat sig
P of 0.0047 difference NOT clinically relevant
The lines are clearly separating and if the trial had gone on for another 1 or 2 months the p value would have been under the ARBITRARILY chosen 0.05. What is so damn magical about a 5% chance the difference was by chance vs 6% or 4%?
The separation and general plotting of data clears mimics and supports R-It without any outside BS like MO.
When combined: JELIS, CHERRY, R-IT, EVAPORATE, CardioLink-9, P-IT 2 and now RESPECT clearly show that in every trial using IPE at high doses the result was a visible and consistent difference between treated and untreated.
We now have an independent second CVOT to back up R-IT. This helps to persuade the uncertain and it definitely helps negotiations like Germany, France, Spain, etc.
Regardless of whether there is a positive impact on the stock price tomorrow or not, this news significantly improved the long-term financial position of the company
NS
Thanks for the link.
From this simple definition it would appear “obvious” (couldn’t resist the irony) that Amarin has a strong case against HealthNet. The fact that HealthNet continues to use gV and approximately 50% of all insurance companies continue to risk being included in the suite merely to save $20-$30/bottle tells me they feel confident they have a solid “loophole” for the corrupt judicial system to protect them.
Bradyisgoat
“Less than half the EPA (when we all know it is the EPA stupid) and this trial is going to verify Reduce-IT.
Come on”
My name is Brady so I am definitely not going to disagree or argue with you but I will point out a relevant data point: serum EPA levels in JELIS were slightly higher than R-IT due to much higher baseline in the Japanese population. See graph:
https://drive.google.com/file/d/18ppwe3r8n9ibR6FwJ_th4OfTaBXYld1O/view?usp=drivesdk
The RRR may not be as dramatic but I am hoping it follows the same trend line as seen in the ANY MI data:
https://drive.google.com/file/d/1JGtapX89k82QjyCjvJvK3I3ulYBjhRbf/view?usp=drivesdk
The other key point is that RESPECT-EPA is reporting the AA:EPA ratio which IMPO is more important and more accurate.
We will see soon enough
Capt
Didn’t notice the autocorrect on a fat finger typo :)
Thanks Lrich!
What’s the saying? Lies, damn lies and statements
Kiwi
Yes, that’s me. Who else would I put? Granted, it’s an old photo, taken before Amarin’s stock caused my hair to go grey
Kiwi/ORBAPU/ anyone knowledgeable in stats
Given that the 109% increase in plaque volume appears concerning, the more recently and more frequently used graphic uses the log-adjusted (see link below) plaque volume. I don’t know/understood statistics well enough to comment on which is more accurate so I will put the question out to the board. Is the log-adjusted plaque volume data more accurate and does it provide more clarity on the significance and relevance of the increase in plaque.
https://drive.google.com/file/d/1YUjneqBk3kcOzMs4yWXq6lf2CSe59nXt/view?usp=drivesdk
The log-adjusted chart looks much “better”
Note: plaque volume tends to increase quickly in the later stages and is not a linear progression. For example, the plaque volume can double in a short period of time prior to rupture although the progression up to that point may have taken 2 decades. In a small study like EVAPORATE a few pre-rupture plaques could cause a significant increase in total plaque volume for that arm. The fact the V arm showed reduced plaque volume suggests few or no spiralling inflammatory plaques which would be expected if V was stopping the inflammatory spiral.
Thoughts from the stats people???
Zip
That is great! Please provide me with the source/link.
Rose:
She was talking very specifically about gV. She even implied there was data available that showed lower serum EPA levels from gV than from V (this is the first I have ever heard of this). As far as I know Dr Preston Mason never produced any data that showed gV to be inferior to V.
I agree, with any standard, lab derived STABLE molecule, a generic will almost always be identical to the brand. SOME special release, extended release tablets/capsules may have different pharmacokinetics (eg: Concerta, Effexor XR, etc) which I recommend sticking with the brand.
IPE is a very unstable molecule. Exposure to oxygen can cause oxidation which changes the number of double bonds , and therefore the physical structure of the molecule, which can render the molecule unable to attach to enzyme binding sites or sit properly in the lipid bilayer. The fact that BASF, a company Amarin had to fire because they couldn’t produce API that met Amarin’s QA specs, is the manufacturer of generics does make me suspicious.
Kiwi
First and foremost: i snowboard
Second: the CardioNerds podcast was sponsored by Amarin
Third: she went as far as implying there was clinical data showing gV was less effective and stating “I don’t use generics”
There is no way this woman presents data that contradicts her very public and very positive endorsement of every aspect of Vascepa (against DHA, against fish oil, against EPA/DHA mixtures)
Scxj
There is no way she would present negative or even neutral data after so strongly and publicly endorsing Vascepa. To go so far as to mention Hickma and how she doesn’t prescribe generics it is obvious she is on the Amarin payroll. Which also means she has told KM (within a NDA) what the data says so HOPEFULLY they are prepared to jump all over this opportunity.
In a perfect world, Amarin would be prepared with the EPA/AA ratio data from the reduce a trial because RESPECT has the EPA/AA ratio as an endpoint (an endpoint I personally think is at the heart of Vascepa’s benefits)
For CardioNerds interview you can skip straight to the 20:00 minute mark and get right to the good stuff.
Great episode of “CardioNerds” available here: https://www.cardionerds.com/194-lipids-omega-3-fatty-acids-the-battle-of-the-oils-with-dr-pam-taub/
Dr Pam Taub (about to present RESPECT-EPA) giving a VERY PRO IPE vs EPA/DHA, loves REDUCE-IT and against EPA/DHA, fish oils. Really focuses on EPA being unique from DHA and how import it is to look at the specific trials and the data. She is even ANTI generics. She says “I don’t use the generic”
I feel much better about RESPECT presentation
Enjoy!
Zip
Denner’s primary objective is to make money for himself and his fund. If he sees better prospects coming up he may feel Amarin is tying up his cash and want to move on. The more companies he can flip the more money he makes.
Amarin got screwed by a corrupt legal system and by a German government that had no plan to actually negotiate (selecting a $30/month comparator doomed the process immediately). They slashed expenses and did a great job negotiating UK reimbursement.
China is a lost cause that will never generate any money. As soon as Amarin lost the patent case, the Chinese government inexplicably delayed approval by at least a year. They obviously had a plan to allow for a Chinese generic to enter the market.
Negotiations with other countries are moving along as scheduled.
What else can Denner do? Secure a $100M loan to ensure no dilution? That is what Amarin needs. He may be able to do that but that doesn’t appear to be his specialty. He carves up companies, trims fat, focuses on profitable aspects of a company. Amarin as a single drug company doesn’t have these options.