Author: condor

Januvia®: [Diabetes Medicines, Generally] In Short Supply. Thus Merck Has An Okay From FDA To Remediate Tiny Nitrosamine Contaminant Levels By Year End 2023.

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First off, let’s define the itty-bitty scale here: this would amount to about 0.037 of a milligram per LITER of fluid, or powder. Thus this is effectively — and merely — a drop, in an ocean, here. [Your tiny aspirin pill contains about 250 ml of active ingredients in each small powder pill tablet — so, over 50,000 times more than this nitrosamine level.]

But that level of contaminant — at a top end of about 37 nanograms/ml — slightly exceeds the GMP specs that FDA originally approved for Merck’s Januvia® and Janumet®, as long term sales leaders in the diabetes space.

To be clear, though, in concentrations of many thousands of times higher than this… in animal study models, some excess cancer rates were observed. [Clearly then, the risk of “going without” one’s diabetes medications. . . greatly exceeds any risk from taking the drug.] But as I say, the whole space is undergoing a supply shortage, with similar contaminants turning up even in the generic versions at Lupin and Glenmark, out of India.

So, FDA has wisely given Merck a provisional green light (until year end) to continue shipping while remediating it. The company now knows the source of the contaminant, and while it will not disclose whether it is due to problems with an API supplier (possibly in India or China), or residing much closer to Merck’s own captive facilities — it says it will have it all fixed up, by January 2024.

Here is the bit, from FiercePharma, earlier today:

…In a report to the FDA, Merck says it has figured out how its blockbuster type 2 diabetes drugs have become contaminated with nitrosamine. And the company has told the regulator that it can fix the issue by the end of this year, a source told Bloomberg….

Now you know — off to the flannel sheets… chanting my name… sweet and low, but chanting, just the same. G’night.

नमस्ते

Scott Johnson, This Morning: “Stupid Is, As Stupid… Does.” Sheesh.

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Again, it seems the Powerline boys cannot grasp the difference between finding — and stealing.

And Scott would somehow believe that Mr. Biden meant to steal documents when he left the White House in 2017. Back in 2017. Ones he hasn’t even looked at — in now almost seven years. Let that sink in.

As we well know, Mr. Biden has (in contrast to Scott’s drivel) turned everything found over — to the proper authorities all within 24 hours of each discovery. And his lawyers have so sworn. [Note here that Tangerine’s didn’t — until after a search warrant was executed. And even then they were, at best — woefully ill-informed. More likely, they were gee–ing, for Donnie-T.]

But Scott wants us to think that this is a monumental crime by Mr. Biden.

He wants that so desperately, because he well-knows that the if the world focuses on the fact that Tangerine repeatedly lied about having documents, after holding the same for over 18 months — and forced a search warrant execution, after it became clear he was lying about having no more documents… well, that would look bad for all the GOP who were willing toadies for him, including all the Powerline chuckleheads.

[U: After Midnight] Erh, Yeah — John: The Hon. Rep. Is SHELIA — Not “Shirley”

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I won’t even read the rest, as Hinderaker cannot be bothered to get the first names of Democratic Black US Representatives… right.

Again, his sneering distain for people who don’t hate the way he hates (a la 1940s Alabama) is palpable. He says he doesn’t know what replacement theory is — and that he’s never met a whyte suprematist.

Yet he obviously sees one, every morning (in the mirror) when he picks up a razor, to scrape his beak.

Damn, John. You are one… burnt soul.

Updated, after midnight: Hinderaker is vexed later tonight, it seems — about Davos. He’s just butt sore than no one invites him to any serious economic forum. At all. But he and Steve and Scott are “teaching” their rubes a class in twisting Alexander Hamilton’s words beyond recognition — that’s all they’ve got going.

So when John cannot fathom why fewer burger flipping jobs will exist in the coming half century… we might just chuckle. His own attempts to dictate by fiat (in the early 1980s), half a century ago… have ironically now led young people to move in a counter-revolution against his “‘80s values”.

Yet… that later Anti-80s counter revolution…looks like… his own, circa 1969-1971, when he and others forcibly occupied the President’s offices at Dartmouth… to end the undeclared war in Vietnam.

Now he is dying out day by day, and… all that he rallied against, at age 21… has come back to haunt his embittered dotage.

Hilarious!

An Amazon USDC Injunction Opinion We Didn’t Cover Last Fall… Re JFK8 Unionization Efforts, And Amazon’s Retaliation.

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I won’t belabor this, as we were simply out of bandwidth to cover Amazon fully last year, but the federal courts are growing… stuffed, with evidence of Amazon’s bad faith, in violating the National Labor Relations Act (and rules set forth thereunder).

Here is that decision — and a bit:

…[T]he Court concludes that the record amply supports the conclusion that there is reasonable cause to believe that Bryson was terminated in violation of Section 8(a)(1). Indeed, when viewed in light of the required deference, the record evidence before the Court amply supports Petitioner’s position that Bryson was engaged in protected activity, that Bryson’s protected conduct was a motivating factor in his discharge, and that Respondent’s stated reason for discharging Bryson was pretextual….

Moreover, the ALJ’s findings and conclusion that Respondent violated Section 8(a)(1) confirm that a finding of reasonable cause is warranted. In analyzing whether Respondent violated Section 8(a)(1) by discharging Bryson because of his protected concerted activity….

Now you know. Smiling… and widely so… at nearly eleven pm, local — in the evening.

नमस्ते

Powerline Is Thrilled That The “New GOP” Champions… Felonies, And Felons.

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Charming.

Steve echoes Hinderaker’s prior sentiments tonight. He quotes a man who told him in 2016 that Tangerine would rid the US of supposed “reverse discrimination” characters like Mr. Obama.

Yep.

Just as crazy as it sounds: these malign, bitter, mediocre and decrepit whyte guys… somehow think Tangerine has (or worse, will) “save” them — from a world where… committing multiple felonies is STILL…

frowned upon.

Damn.

Gene Therapies To Effectively End Sickle-Cell Are Nearly Here — But Who Will Get Them, And How Will Our Health System Pay For Them? Questions Abound.

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To be sure, this is a watershed moment, after centuries of early-deaths, and more recently, life-long disability — largely inside the communities of Black African origin, in the US, UK, Europe and elsewhere… in addition to Africa itself. This is truly remarkable news. We could see sickle-cell relegated to the dust bin of history the way polio was, for over two thirds of a century. [But that’s a separate story, of emerging anti-vaccine non-scientific thought, in the US and EU, for another day.]

The real problem though, lies — as with all genetic therapies — in the daunting cost to be “cured”: best estimates put the cost of cure, including a year or more out of commission… at over a million dollars per patient. In the US, that still makes sense, because the costs of a life-time dealing with the effects of (uncured) sickle-cell, greatly exceed the therapy’s likely costs.

But in the developing world, there is not likely to be any way to incent any provider to deliver it, unlike the very cheap COVID-19 vaccines, by comparison. So it is likely that sickle-cell will continue to be scourge, outside North America and Western Europe. Here is a very thoughtful “Science Tuesday” story on it all, in The New York Times, this morning — and a bit:

…“This is what science has been working toward for 50 or 60 years,” said Dr. Lewis Hsu, chief medical officer at the Sickle Cell Disease Association of America and director of the pediatric sickle cell program at the University of Illinois at Chicago.

Sickle cell leads to a steady drip of costs over a lifetime, affecting caregivers as well as patients and often limiting the incomes of both because of time lost from work or an inability to work.

One report examined what private insurance companies paid and found that the lifetime costs of sickle cell were $1.7 million, including $44,000 that patients paid out of pocket….

Treatment starts with intense chemotherapy in a hospital to wipe the bone marrow clean, leaving space for genetically modified red blood cells that result from the treatment. Patients then spend about a month in the hospital waiting for the modified cells to grow. After they are discharged, the patients are immunocompromised for about six months while their immune systems recover.

Insurers are likely to pay for the part of the treatment that involves using a disabled virus to deliver the therapy. But whether they will pay for most of the chemo, hospitalization and other costs is uncertain.

Patients worry about bills from hospitals and doctors. Even if it is mostly covered, co-payments can be an issue.

Will wealthier people get the treatment while others look on longingly, patients ask?. . . .

The achievement of miracle cures — and, at “miracle prices“… will increasingly dominate drug delivery debates in the decades to come. Of that, we may all be certain. Onward, but smiling, just the same — at the progress we (as a species) have made.

नमस्ते

Of False Dichotomies: Hinderaker, Again — On Reparations Falsehoods.

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Hinderaker should learn to accept that two things can be true at once: the Irish were excluded from many trades 150 years ago; and still many thrived. That they thrived… doesn’t negate the wrongful conduct — of exclusion — by his ancestors.

As I’ve said before, reparations — real reparations — not John’s imagined version… is working in my own adopted town.

Hinderaker refuses to see that all sorts of people have since thrived, even in and after adversity.

He refuses, because he doesn’t want to pay for the benefits his family reaped from forced labor — and exclusionary practices.

Both can be true, Johnnie. [My community is — as I’ve said — is thriving in this inclusive spirit, here!]

And you John, are just… a bitter old codger.

Out.

Since Steve Hayward Cannot Seem To Sell His History Books, He Claims A “Decline” — In Thought. Hah!

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This evening, Steve Hayward would have us believe that history, as an academic discipline, is in decline.

Why?

Because he, and other hard right ideologues like him… can no longer easily find major publishers’ contracts to print (hardbound) and sell… their hard right form of claptrap.

It takes a special set of ego-infused reality distortion bubbles to be… Steve.

Or anyone like him — the boys of Powerline.

He cannot accept that no one cares what he twists old dead whyte guys’ words… into.

Go figure.

Govs. Abbott, And DeSantis — Both Committed FELONIES — But Hinderaker Doesn’t Care…

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Hinderaker apparently feels that the governors of two states, in wilfully forcing people under federal charges, to miss their local Texas and Florida hearing dates, by kidnapping them, and taking them thousands of miles from the hearing cities, and leaving them on curbsides, penniless, at Christmas Eve, in below zero weather… at the Veep’s home near the White House…

…was simply exposing the hypocrisy of sanctuary cities.

No, Johnnie, it is itself a felony under color of local law — by each state’s highest ranking law enforcement officer. Section 1983 damages lie.

And… Chicago and NYC and DC and Nashville… continue to accept busloads, despite his lies.

Gee — dig the new GOP! Wildly applauding felonious officials, like Abbott, DeSantis and now George Santos. [According to the Wa Po’s latest reporting, Santos’ money comes from Ponzi schemers connected to Russian oligarchs — now sanctioned by the world’s governments (except Russia!) due to Ukraine atrocities.]

Charming.

Andrew Torba, The Proprietor Of Gab.com…

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The malignant Mr. Andrew Torba wrote over the weekend that no “white European” nation can survive a scenario where black and brown immigrants (lawfully) become more than 30 per cent of the population.

Ahem. He points to the current US, where whytes are soon to be outnumbered by black and brown people.

He neglects to mention that, in the antebellum South, white land-owners were outnumbered by a ratio of over three to one, by black and brown people held in bondage — for about a century.

[Note that this absolutely refutes all of his “thesis” — such as it is.]

The man cannot even understand his own local history, let alone world history — or Western European learnings here.

We will leave him to his 40,000 or so viewers, site wide — as evidence of a failed ideological thesis. His supposed “alternate Christian nation” residing within the existing US freedom framework, but denying people of color their rights here… is a dead letter.

He’s just the reborn Aryan Nations, in a dopey frog suit.

Cheers, Andrew.