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Amarin must conquer these part D plan contractors--preferred network agreements and pricing will be the key to Vascepa acceptance..
Here is a great article outlining the domestic risk of COVID transmission at somewhere between 10-20% or more depending on household size. What a golden opportunity for Vascepa (if efficacious in this regard)
“However, based on data from hospital settings, we believe that social distancing, hand hygiene and mask wearing all contribute to risk reduction during the 10 day window of presumed infectivity after diagnosis.” MAYBE VASCEPA ALSO?--AWAIT PREPARE-IT AND MITIGATE
HK
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776908?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=022621
https://documentcloud.adobe.com/link/review?uri=urn:aaid:scds:US:8479edbc-dfeb-4ae7-aa57-3cc877a7c5fe
Thanks Ralphey
Great article--I do so agree--sick of doing contortionist acts as you say.
HK
Ralphey,
You struck a nerve...thanks for your hard work BTW. We are the last of the era who will TRY.
Raf
It is with all professions as with physicians-some try, some succeed, and some create chaos. Wisdom comes with effort of learning and some God-given ability. The crime worth correcting is to make life-determining decisions for others based on ignorance, or callousness.
As Ben Franklin said:
"Of learned Fools I have seen ten times ten, Of unlearned wise men I have seen a hundred"
In the context of our discussion he added:
"God heals, and the Doctor takes the Fees"
never a truer word spoken.
HK
I believe that ACC 2021 and AHA 2021 will bear this hypothesis out.
Wonderful lineup Captbeer
I think the Main Themes that will be proven by data from all these investigators at ACC 2021 will be:
(1) DHA negates the beneficial therapeutic effects of pure EPA as shown BOTH in (a) laboratory demonstrations of nitric oxide release (endothelial cell function), protection from the lipid peroxidation etc..) and (b) clinical scenarios such as CT derived measures of plaque volume or angiographic endpoints of clinical CAD.
(2) That both in basic science investigations (Preston Mason data) and in clinical trials (R-IT and EVAPORATE) there is a direct unmistakeable correlation between EPA levels and clinical outcomes.
To summarize all the themes: DHA is detrimental and EPA is incrementally beneficial.
Points well taken North
North,
I could not agree more. The generic Lovaza threat is equally menacing if not more than the generic IPE threat. It is also a perfect legal route to attack the unethical substitution practices of the PBM's and the third-party payors. Simply put, IF a third party payor authorizes/ mandates a generic Lovaza substitution for a bonafide pre-established DAW prescription of rVascepa on an R-IT CV reduction basis, they open themselves up for a clear-cut class-action suit by multiple patients for pre-meditated injury- this is so because there is no construct in which Lovaza adds anything for CV risk reduction clinically in the presence of statin, and the additional DHA load (using CAD evidence of the kind to be presented at ACC by Viet Le) can be validly stated to be toxic--even Nissen would not debate this.
HK
North
PDude,
I believe like you that EPA benefits will likely be a mixture of cell membrane effects. EPA may interfere with SARS-CoV2 viral cell membrane and spike protein structures as well as host cell membrane structure in ways that interfere with viral binding endocytosis and replication. EPA may also interfere with receptor-mediated signalling and downstream inflammatory cascade activation. Direct activation effects of EPA on Toll-like receptor 4 and NF kappa B inhibition leads to inhibition of inflammatory gene transcription:
North
This is all good. It means that the ACC has deemed the abstract novel enough that the authors and the ACC abstract reviewers have agreed to shield the findings form public view until the day of the ACC presentation--it has of course been separately and confidentially reviewed by other peer reviewers.
This has nothing to do with Nissen. Many late-breaking trials are embargoed until the day of presentation and simultaneously released by journals like the New England Journal of Medicine to correspond with the abstract release. This is essentially a small piece of scientific sensationalism that the ACC plays along with on the alleged grounds that otherwise the journal would be "pipped to the post".In fact, the journal has acquiesced in waiting till the ACC abstract release with the consent of the editors and the authors. Everyone benefits and the crowds are swelled... (ye Gods!)
HK
Agreed--just like every other third party payor...pay lip service to the client and line their pockets at every turn.
PDude
I think the mechanisms by which Vasscepa could retard SARS-CoV2 transmission versus reading mild to moderate disease and the different interleukin pathways activated will vary. This is clear from the differential effects of IL-1 vs Il-6 inhibitors like Anakinra and Tocilizumab and the varying positive effects of Tocilizumab in moderate vs severe pneumonia forms of Covid-19. It is fortunate that Vascepa is being tested in these two different trials to test different potential efficacy modalities against SARS-Cov2 transmission and prevention vs ameliorating disease severity etc...
HK
https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30164-8/fulltext
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30556-7/fulltext
https://ccforum.biomedcentral.com/articles/10.1186/s13054-020-03364-w
Done
Thank you PDude,
Am I reading this correctly to mean that if Vascepa boosts the Resolvin E series especially Resolvins E1 and E3, IL's especially IL-1beat IL^ tNF alpha and others decrease thereby improving the clinical consequences of covid induced cytokine responses?
There is an additional possibility that Vascepa by altering cell membrane fluidity and structure could interfere with spike protein access to the cell.
HK
Look at this one sstyles...why not Vascepa?
I wrote him.
https://www.cnn.com/2021/02/27/health/covid-19-drug-repurposing-gupta/index.html
https://cdcn.org/corona/
https://cdcn.org/leadership-team/david-fajgenbaum/
Fingers crossed!
PDude
Thanks for the chart--but we cannot see it that well. Can you upload a high-resolution picture?
HK
Birdbrain,
I think it is easy to see a difference and prove it.
We as prescribers, all submit a pre-auth for Vascepa to many of these third-party payors- they frequently ask the TG level. R-IT scripts grew 93% because we could prescribe for DM + Tg>150+ 2 CV risk factors OR DM + any evidence of established CAD or established PAD by actual prior event or ultrasound documentation.
There is no way you can justify prescribing or substituting generic IPE unless you can document TG>500 ab initio and that isn't going to exceed 10% of the available patient population by science or imagination.
Now if HIKMA says prove that we compelled or incited infringement rather than passively supplied/encouraged (by leaving in AB and leaving out the not to be used for CV event reduction phrase)--you have the debate at the Delaware trial...
HK
This is an elegant summary of how covid effects endothelial activation and dysfunction with consequences for all target organ damage from endothelial dysfunction and downstream signalling events be it the lungs, heart kidneys or any part of the vasculature. From a signalling point of view, all the cell adhesion activation and cytokine events are potentially blockable by EPA (Vascepa) pre-treatment IMHO.
Now for the proof, PREPARE-IT and MITIGATE will be crucial.
HK
Superb idea Zman; let's gather cases, I start today
Confirms what we all either suspected or knew. HIKMA Teva DrL .
The litany of lies collusion and broken promises to Congress and the American Public is sad and revolting.
Bravo Attorney Tong!
“Our case is built on unassailable evidence from multiple cooperating witnesses that paint an undeniable picture of the largest domestic corporate cartel in American history. The Diary of Collusion contains meticulous, contemporaneous notes that corroborate and support what we see across millions of other records compiled through our investigation. These executives knew what they were doing was wrong and that there could be legal consequences for those actions. Americans pay too much for their prescription drugs, and that won’t change until we restore fair and honest competition across the generic drug industry,” said Attorney General Tong.
I agree --great article and great background dig.
I enjoy all you and Iryo put out
many thanks to you both
HK
Their reps acknowledged that they already know this!
I agree--Amarin needs to fire a shot across their bows, so to speak
Coronary artery disease prevention --classic Reduce-It
Meanwhile back at the ranch...
My PPO Blue Shield plan has gone Healthnet infringement way...a substitution without a care about indication --tested or otherwise. Wrong from a therapeutic viewpoint and wrong from an intellectual property viewpoint, the charge to the patient is not that much lower and varies according to the copay plan involved.
Great job Jasbg
We should all collate the prior evidence and the current clean-up as a comprehensive file and send all the "clean up" evidence directly to Singer and the Amarin legal team.
A lot was previously cataloged on the site---someone should just put it all together and forward ASAP to the Amarin counsel.
HK
Great analogy
The current increase in gen Lovaza substitutions for Vascepa are just an attempt by the third party payors (insurers) forcing the pharmacies to substitute generic Lovaza for generic IPE which in turn was supposed to substitute Vascepa. There is a basic intolerable inequity (one could even say iniquity) in foisting a product that has NO CV therapeutic benefit for a prior medical prescription that was prescribed by a physician to achieve just that, using an inappropriate indication (lowering Tg's) and which in fact risks not only death by preventable action but incurs adverse additional side effects ie atrial fibrillation and stroke. This is unethical on so many levels. It is precisely this playing God by insurers, PBM's, and the Hatch-Waxman extended family of thieves, that must be stopped, for the public good. If Amarin litigation achieves nothing else, it hopefully achieves this.
A jury of common sense Americans will always see the truth of this principle, even if the lawyers and the judges quarrel over the petty points of proving precedent of infringement by skinny label, and/or try to enforce their party politics...
HK
CBB and PD
Knowing what has been revealed so far about cardiovascular outcomes and EPA levels from JELIS, the steady-state EPA levels achieved are critical. The Japanese population had far higher starting EPA levels than the REDUCE-IT population and data on the baseline levels in the Chinese population are awaited. There are several reasons the lower 1.8 g/day dose worked in JELIS: (1) higher EPA starting levels and (2) the consistency of plasma levels. EPADEL is available as sachets of granules in 300mg, 600mg and 900 mg forms. The three times a day dosing in JELIS of the 600 mg dose may have yielded more consistent plasma levels of EPA although three times a day dosing is a challenge for patient compliance over several years of a study. Nevertheless, as we see below EPA levels went up two-three fold on therapy of 600mg TID and resulted in a proportional reduction in CV events. This relationship between EPA levels and outcomes was borne out in R-IT also. It is also the reason why Bhatt et al were keen to try a loading dose of 4g po bid in the Covid19 PREPARE-IT and Cardiolink9 trails, so as to ensure high therapeutic levels early on in therapy.
Thanks jasbg
Can someone summarize what Teva said and how the judges responded to it?
Ah Yes The Wall!
Hindu Kush was still a lad with the sounds of Floyd ringing in his ears at school:
We don't need no education
We don't need no thought control
No dark sarcasm in the classroom
Teachers, leave them kids alone
Hey! Teacher! Leave us kids alone!
Yes Sleven
The issues are intertwined: On the one hand, we have an ongoing uncertainty and a certain laxity in the way in which judicial decision making is rendered regarding the prior art being obvious or otherwise...Classic Graham criteria are applied but where and how do prima facie vs. secondary objective criteria analysis and how to fit these in the analytic approach? I see this as an analytical issue for judgement by SCOTUS (very appropriate to the entire field of patent law that since Graham vs Deere, has strayed into partisan camps at the CAFC level, largely due to SCOTUS inaction in providing guidance since Graham vs Deere was enshrined into 35 U.S.C. § 103.,circa 1952. Fast forward 69 years, and we are still in limbo and long overdue an update.
Rule 60 addresses a different question and that addresses clear legal error. An uncorrected clear error by all legal and scientific standards. I believe that Judge Du was genuinely taken in by a superficially plausible prior art analysis by Heinecke that was unrebutted (reasons for which we can speculate ad nauseam). The problem arises that when prima facie obviousness (Mori Hayashi and Kurabayashi) is negated by fallacious science AND the backstop of secondary indicia is removed by further erroneous analysis (Kurabayashi)then it really doesn't matter if you place primary objective criteria before secondary objective indicia or vice-versa or take both together, you end up with the same result-obviousness.
Therefore, if you take Judge Du's decisions as flowing from the scientific analysis she accepted, they are entirely logical. I know this isn't the party line, but it must be stated in fairness. It was after all the duty of the Plaintiff attorneys and expert witnesses to point this out!
HK
I agree
Elegant analysis Capt Beer
I agree with others here that the enemy is more inappropriate Lovaza prescription/substitution than it is generic Vascepa at this time.
HK
Meowza
The EMA decisions re Vazkepa approval are on a different timeline to NICE. NICE is a different but related organization in the UK. NICE stands for National Institute for Health & Care Excellence. The role of NICE identifies good practice using the best available evidence-based information for health, public health and social care professionals.NICE is an executive non-departmental public body, sponsored by the Department of Health and Social Care.
NICE has three main roles:
Technology appraisals - guidance on the use of new and existing medicines and treatments. These appraisals decide whether it is cost-effective for the NHS to make licensed treatments available. The MS Trust takes an active role in NICE consultations.
Clinical guidelines - guidance on treatment and care of people with specific diseases and conditions. These NICE guidelines are utilized extensively in the UK for statements on "best clinical practice"
Interventional procedures - guidance on whether procedures used for diagnosis or treatment, such as surgery or x-rays, are safe enough and work well enough for routine use.
For many drugs in the past (pre-Brexit) NICE had a mandate to appraise drugs approved by the EMA in a timely fashion with a view to making recommendations regarding their routine use in the National Health Service (NHS) UK. Post-Brexit presumably NICE and MHRA (Medicines and Healthcare Products Regulatory Agency) are the government agencies that will regulate pharmaceuticals, etc., in the United Kingdom.
HK