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Never a truer word spoken.
Welcome back BB
Regardless of denomination, everyone who is a long on this board is a tacit follower of St Jude Thaddaeus LB
Well said, Alm
There is no greater or weightier issue at the centre of patent law. Graham theoretically sets out criteria for how to adjudicate obviousness but left vague the exact order and method of determination of such primary and secondary obviousness criteria. If primary versus secondary indicia and their sequential or simultaneous deployment is not adjudicated and defined also by SCOTUS, then a pandemonium of inconsistency and resultant chaos will ensue across all judicial circuits. For the SCOTUS that gave birth to Graham, perhaps the protection of their golden child from inappropriate abuse by politically motivated Hatch-Waxman schemers will weigh very close to their hearts...(that is if the petty politics doesn't float like scum to the very top)
Saying a prayer now,
HK
Great post Rose
Exactly what I was saying also and my own experience as a physician. In countries like India, I can tell you that colleagues recommend certain brands of medication (theoretically identical active ingredient) because of drug content and efficacy (ascribed variously to API dilution and additives). Indeed pharmacies offer a myriad of brand and generic drugs of varying price and efficacy. It's a crapshoot for the consumer.
HK
JG
FDA's statements regarding AB and bioequivalence are in my view misleading--AB implies bioequivalence which is really only pharmacokinetic data demonstrating pharmacokinetic equivalence in short term studies in small numbers of patients. What we are really interested in knowing is whether there is therapeutic biological equivalence--something no one seems to want to test for because it's too expensive to do and there is no impetus to generic drug makers to do so. They are leeches, they piggyback and the H-W act supports it. In radiation, we draw a distinction between the dose of radiation absorbed and the ensuing biological effects of that dose eg. two people may be exposed to the same ionizing radiation dose and experience entirely different biological effects (good or bad) despite an identical dose absorption by the body. This would be analogous to absorbing similar EPA levels but because of oxidizing or other unknown effects ending up with inferior therapeutic benefit. The irony is the FDA applied the same logic to deny Amarin's ANCHOR petition because the logic goes: "not all that reduces TG's reduces CV events". So all so, not all that looks like Vascepa or gives similar EPA levels is Vascepa. As Shakespeare put it: not all that glitters is gold.
The tragedy in the rush to generics is that we have bought a hope of therapeutic benefit which is in no way a guarantee...sad because the outcome determines life or death sometimes.
HK
Thanks jasbg
Great idea Ray! See if you and Captain Beer/Tucaman can get together and do the analysis...
HK
sts
Nissen is claiming that all "fish oil" products (that he loosely and cavalierly terms "fish oil"), and in which he includes Amarin (and de facto Epanova), do nothing for CV outcomes and increase the risk of atrial fibrillation. Since atrial fibrillation raises the risk of stroke and death (a proven fact by empiric observation), it follows that all these products as Nissen claims cause harm ( if that term suits better) with no benefit. If you recollect at the time of the EMDAC many physicians were pulling a Nissen and having difficulty approving Vascepa for primary prevention in diabetics because of this very same issue of risk: benefit.
HK
Kiwi,
The right population is being studied but the question is which are more interested to prove (1) Reduction in acquisition/severity of Covid-19 and other URTI's (for which MITIGATE is adequately powered over 1-year+ time frame) or (2) CV endpoint reduction for which I am not sure that 500 pts on Vascepa will cut the mustard--unless there is an extraordinarily high event rate even in this established CAD/"high risk" recruitment group...
HK
Welcome, from these references and from Bhatt's prior talk--the other key one you will need:
https://documentcloud.adobe.com/link/review?uri=urn:aaid:scds:US:898753f9-fce7-4769-8d0c-efe579d6f2db
I incorporated all the informationinto this:
sts
You have to look at it differently. No publicity is bad publicity for both politicians and Nissen. He sees himself as the great medical redeemer of the American patient interest--exposing evil pharma that plot to poison the public for profit. Nothing like a dramatic evangelist like Nissen when it comes to prime time in medical science. STRENGTH is no longer a story of therapeutic failure but a story about how fish oil kills and how Nissen will expose this, and save the public, by throwing water on everyone's version of "fish oil" medicine, including and especially Amarin's Vascepa. I like playing devil's advocate but Nissen is perilously close to playing a fool, and risks being laughed at by many in the serious academic community. As he has shown in the past, he is nothing if not flexible in his stated scientific positions, and will, of course, accommodate any pharma for any drug trial, or promote any drug for the right money--check his consulting disclosures...
HK
Mr 1979,
I don't know which way the wind will blow for GSK or TEVA but we will inch closer to these indolent appeal court judges finally addressing the rights and responsibilities of each party in the skinny label - carve out game.
HK
Listening to the kinks takes me back to my youth instantly:
Here are the key references:
https://documentcloud.adobe.com/link/review?uri=urn:aaid:scds:US:f7e44b80-8e50-4f18-beae-e8a549d3e390
Suvasini Lakshmanan, Chandana Shekar, April Kinninger, Suraj Dahal, Afiachukwu Onuegbu, Andrew N Cai, Sajad Hamal, Divya Birudaraju, Sion K Roy, John R Nelson, Matthew J Budoff, Deepak L Bhatt, Comparison of mineral oil and non-mineral oil placebo on coronary plaque progression by coronary computed tomography angiography, Cardiovascular Research, Volume 116, Issue 3, 1 March 2020, Pages 479–482, https://doi.org/10.1093/cvr/cvz329
Brian Olshansky, Mina K Chung, Matthew J Budoff, Sephy Philip, Lixia Jiao, Ralph T Doyle, Jr., Christina Copland, Alex Giaquinto, Rebecca A Juliano, Deepak L Bhatt, Mineral oil: safety and use as placebo in REDUCE-IT and other clinical studies, European Heart Journal Supplements, Volume 22, Issue Supplement_J, October 2020, Pages J34–J48, https://doi.org/10.1093/eurheartj/suaa117
https://documentcloud.adobe.com/link/review?uri=urn:aaid:scds:US:9dfdd0a5-0730-4921-bfac-77f415fa164f
HD Gabor
The man? nay a woman? Is Gabor a myth, a persona or a legend?
They seek him here
They seek him there
Those Amarin investors
They seek him everywhere
Cannot hear or get this to play Raf
Well said Zip,
Don Quixore de la Mancha (Cervantes)
“When life itself seems lunatic, who knows where madness lies? Perhaps to be too practical is madness. To surrender dreams — this may be madness. Too much sanity may be madness — and maddest of all: to see life as it is, and not as it should be!”
She said some web content creator did that-not her--I believe her--it seems SO disconnected....
BBoat,
The scientists like Bhatt cannot or will not get into an overt controversy let alone a brouhaha, with the likes of Nissen, whom they may have to 'live with" in the future academic arena. I, on the other hand, have no such compunction, and would gladly do it, but I need a journalist to be interested to investigate. We speak of fish oil and people seen vaguely knowing and interested. We speak about the differences and subtleties in the therapeutic benefit of EPA and DHA and resolvins etc and their eyes glaze over. Though as a journalist or even an intellectually interested reader, the story of Vascepa and Amarin has so many interesting facets to its evolution: high finance, the FDA, he twists and turns of science, the challenges and heartbreaks of litigation, the scraps with patent law and Hatch-Waxman, Vascepa's role in one, if not two of the world's great scourges (Dementia and Covid-19), the maneuvrings of its board and management, and the role of its highly proactive individual investors.
And the story hasn't ended yet. Who could not be drawn in?
HK
Pleasure
The Cleveland clinic feeds medical news items to ABC that then feeds it to all their affiliate and hence the proliferation of ABC affiliates all carrying this "Nissen" fish oil news item.
As a follow up to the wonderful summation slide by Capt Beer that shows that essentially every trial that has used EPA + DHA has failed and that those that have used EPA (96% pure) ie JELIS and CHERRY(no mineral oil comparator) and REDUCE-IT have ALL succeeded. Why? Is it that the EPA levels achieved in STRENGTH ASCEND VITAL OMEMI etc...all were inadequate (one definite possibility) OR is it also that DHA at whatever level of EPA NEGATES its effects. I suggest that the latter is very important. We know that from Preston Mason's basic science data that DHA has different and diametrically opposite "deleterious" effects (c/w EPA) on cell membrane structure/fluidity as well as lipid peroxidation and free radical generation etc..so the mechanistic basis for this argument is sound. What is interesting from the STRENGTH data is that at whatever level of EPA serum or RBC level achieved by patients on EPANOVA in STRENGTH there was NO benefit at all across all tertiles of EPA levels achieved. Contrast that with REDUCE-IT where at every level or tertile of EPA achieved on Vascepa there was a benefit, and further this benefit was incremental in proportion to the elevation in serum EPA:
The court is trying to explore the behaviour and motivations to infringe in the period after the "00 patent was issued and the FDA mandated the label change. After all their behaviour to infringe would not have been affected by any FDA compulsion during this time period. IF they marketed without shame a label they should not have been marketing, or shamelessly maintained the marketing materials for indications they shouldn't have even after the '00 was issued, ...then the court may have some bona fide indication as to what the real infringement motivations of TEVA were.
There are paid consultants, and then there is Nissen...and he works for a "Not for Profit" organization I believe.
I spoke with Ms. Surae Chinn of the ABC affiliate in UTAH that aired the piece with the Vascepa capsule picture juxtaposed with Nissen's party piece about fish oil etc...
https://www.abc4.com/health-2/prescription-fish-oil-doesnt-provide-heart-benefits/
She is, in fact, a very reasonable person and apologizes because it appears that the pick up was thorough ABC to all affiliates and fed from Cleveland Clinic central news relations to all media outlets because STRENGTH was based out of there under Nissen. She seeks further information (scientific) and the Vascepa/EPA view from Dr Bhatt. I have tried to put her in touch with Dr Bhatt and asked she contact Amarin IR also. I have educated her with regard to the VASCEPA/EPA science extensively and pointed out the areas of controversy vis a vis Nissen's proclamations. We await more developments...
HK
Great Work, Capt!
Thank you PDude--I will try it.
My pleasure...beating the table for this drug is a duty as a physician
This promises to be epic!
I have written to Raf volunteering to help in any way, anytime.
HK
Pharmacydude,
Great suggestion. I would be delighted to share your information with anyone including ABC who wants to know more about EPA science.
HK
Nissen will say that he had no editorial control over what Chinn put in the article--it's all on abc...
He is a colossal shit-stirrer and he delights in it!
In a 1 g capsule of Epanova, there is 850 mg Omega 3 FA's and of this 15-25% can be DHA
Neither Nissen nor Chinn seem to understand the difference between Fish Oil, 96% pure EPA, and DHA/EPA combinations biologically or semantically. There is dumbing down the facts, and then there is being downright dumb. One thing is certainly true: there is something very fishy indeed about Dr Nissen's motivations and persistence with distorting scientific facts
Thanks and well done all