Category: Uncategorized

[U] Spending In The “Big Leagues” — Full Year 2023 Pharma Style Lobbying…

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As we’ve done for nearly a decade here, we offer — as a series of posts, this week… commentary on the matters that the largest US pharma concerns have bent the ears of Congress-critters about. We compare, at right, the four we’ve tracked all this time. With the exception of one year (2016), Pfizer has always been about 20% higher on annual spend than the other three — this year, it is around 40% higher.

Here are the details from Q4 2023, as to Pfizer:

…Medicare Part D Rebate Reform, PBMs, Out-Of-Pocket Costs, Government Negotiation on Medicare, Antimicrobial Resistance, March-In….

Comprehensive Corporate Tax Reform, International Tax Reform, OECD Profit Allocation, U.S. Manufacturing Credits, Build Back Better Act, Minimum Tax…..

International Supply Chain/Buy America, Harmonize International Drug Manufacturing Standards, Global Access to Medicines, Foreign Market Access Issues (including IPR)….

TRIPS Waiver, Bayh-Dole March-in-Rights, General IP Issues….

Issues related to drug pricing; implementation of H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169), Issues related to COVID-19 response including vaccines and anti-viral therapies, Issues related to the 340B Drug Discount Program, Issues related to Antimicrobial Resistance, Issues related to Medical Supply Chain Resiliency Act (S.2115/H.R.4307), Issues related to Rebate Reform-PBMs; H.R.5378, Lower Costs, More Transparency Act….

[And one outside firm lists its $60,000 quarterly fee as going toward] “Provide guidance and strategic counsel with regard to regulations and legislation that could impact the pharmaceutical industry generally and/or Pfizer specifically….”

Now you know. Onward — and just consider that taxes are among the most heavily debated part of multi-national pharma’s footprint, in the US economy. Yet they pay next to no US income taxes, on their vast international income — as a rule. Fascinating.

नमस्ते

[U: Scott Rings Right In — True To Churlish Form!] Now Three US Soldiers Dead, In Widening Mid-East Attacks And Counter-Attacks… John? Paul? Scott? Steve?!

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UPDATED — not ten minutes after I posted the below, Scott Johnson took to blaming Mr. Biden, and the First Lady, for the acts of what he calls… mullahs, on the other side of the globe. Charmingly… feckless there, Scott. [For the life of him — he cannot honor war dead, because he doesn’t feel he owes any debt to them — ever. Damnation, son.]

He just now wrote: “…Dr. Jill may scare Joe and the staff, but the mullahs aren’t intimidated by her. And the rhetoric that has failed to deter Iran so far bodes continued failure in the future….”

Never miss a chance to make a tragedy into a political yammering point, there Scott (and there is zero evidence that “mullahs” did this). He’s a… stupid, infirm, impotent… has been. And a soulless, embittered old codger, at that. End, updated portion.

It will be… fascinating to watch these ditto-heads try to blame Mr. Biden — when they (and the Federalist morons, backed by hard right Israeli donations) are the ones most stridently advocating a widened overall war from the Sudan, all the way to Jordan, and through Syria — to the shores of Israel.

Damn.

See, boys, your BS rhetoric is getting US troops… killed.

Damnation. Out.

The European Space Agency Green-Lit Its “LISA” Mission, This Past Week… In 2035 Or So, It Will Measure Ripples In Space-Time

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The cube at left is a precision engineered marvel… of highly refined gold and platinum. One of six, in three small spacecraft — about the size of three eggs, each.

LISA will use pairs of these cubes as “test masses” — which free-float inside each of the three small ships, perfectly aligned as a vast… triangle, trailing Earth, in its orbit around the Sun by several million miles. Any gravitational waves passing through our local group will cause minute, temporary variances in the distances between the masses in these mini-ships, and the mission will track them, using laser interferometry.

This will require measuring laser beams from one spacecraft to the other and then superimposing their signal to determine changes in the masses’ distances down to a few billionths of a millimeter. Here’s the latest, from ESA.int:

…LISA is not just one spacecraft but a constellation of three. They will trail Earth in its orbit around the Sun, forming an exquisitely accurate equilateral triangle in space. Each side of the triangle will be 2.5 million km long (more than six times the Earth-Moon distance), and the spacecraft will exchange laser beams over this distance. The launch of the three spacecraft is planned for 2035, on an Ariane 6 rocket. . . .

“LISA is an endeavour that has never been tried before. Using laser beams over distances of several kilometres, ground-based instrumentation can detect gravitational waves coming from events involving star-sized objects – such as supernova explosions or merging of hyper-dense stars and stellar-mass black holes. To expand the frontier of gravitational studies we must go to space,” explains LISA lead project scientist Nora Lützgendorf.

“Thanks to the huge distance travelled by the laser signals on LISA, and the superb stability of its instrumentation, we will probe gravitational waves of lower frequencies than is possible on Earth, uncovering events of a different scale, all the way back to the dawn of time….”

Now you know. Grinning ear to ear — what a sight to see, that would be — if the Sun, and all our local system… suddenly shifted about ten feet, in the blinking of an eye, and then… shifted back. Of course, to see that, we’d have to be at least several hundred million miles or so above (or below) the local group, looking down (or up) with a JWST powered space ‘scope. Indeed.

नमस्ते

On A Quiet Sat. Morning: “It’s About The Information, Marty!” [Ref. “Sneakers” (1992).] New Merck Deep Data Mining Deal, In The West…

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So — it is said that the future belongs to those who… “control the information“. Doubly so (in life-sciences, at least), once that vast data store is deeply cross-indexed, and digitized for near real time retrieval and analysis. Last year, Merck put about $10 million into a spinoff from the mountain west based not for profit network of 33 hospitals — to index and digitize about four decades of patient records (something like five million bits of data, growing at a pace of 300,000 bits per year, now) — while being careful to de-identify the data.

Now that has been mapped onto the labs’ specimen samples, so sample data is connected to anonymous patient profiles — again, across a 40 year time span. That trove of US patient data not only helps identify future therapy approaches, but may aid in recruiting new study patients, for pembrolizumab’s ongoing flotilla of clinical trials.

Smart — but I will admit to being a little concerned about… data security, and privacy here. [Just how robust is the hardening of the database, vis-a-vis would be intruders? Of course, neither company will highlight that. See… “Sneakers” (1992).]

In any event, here’s the story — from FierceBiotech’s reporting, earlier this week:

…Merck & Co. signed a R&D collaboration deal with data and technology provider Culmination Bio, a recent spinoff from Intermountain Health.

Under the deal, Merck gets access to Culmination’s clinical records and bio specimen data collected from several cohorts….

Culmination has exclusive rights to a physical library and cloud-based data pool that spans more than 40 years of de-identified patient electronic health records and paired biospecimen data as part of a partnership with Intermountain. The data can be used to dramatically speed clinical trial recruitment for pharmaceutical research.

Financial terms of the agreement weren’t disclosed..

Onward, grinning — these hospitals span Utah, Colorado, Nevada and Idaho, at least — if memory serves. And as a rule, those patients will likely be… healthier, as a group, than their Southeast or Northeast counterparts. Fascinating. [I wonder if Merck has taken that into account. It might make the clinical trials’ side effect data… milder, compared to an overall less healthy co-hort.]

नमस्ते

Sadly, Intact Putative Asylee Families Are Still Occasionally Being Separated At The California Southern Border By CBP…

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We have covered this for going on a decade, now. And the litigation dates to the Reagan Administration (1985). While things have improved mightily under Mr. Biden, and most of the satellite class action litigation that resulted from Tangerine’s lawlessness at the border has now been settled… families are still sporatically being separated — and that is an ongoing violation of a standing USDC court order (one affirmed in the US S. Ct., in 2019).

So I write to note that the unfortunate reality is… the border policies are still a problem — but not due to letting “too many in” (as the idiot Elon Musk claims). No, the problems result from at least some (likely a very small number of) federal agents who still feel MAGA cruelty and lawlessness are acceptable policies. Here’s the latest:

…As far as may be discerned from the JCM report, CBP has not articulated an operational need for the continued separation of families nor made or recorded reasons for holding families apart. Instead, CBP cites generally “PREA” and “overcrowding,” without further explanation as to why either is an operational need that requires separation. Nor is there any evidence that CBP is making reasonable efforts to ensure telephonic or other contact between physically separated family members. November JCM Report at 5, 24-25. Instead, the JCM reports that children as young as 13 are held apart from their families for days at a time with little to no contact and, as the JCM notes,

“[C]hildren of any age could experience significant distress and potentially longterm harm by being held apart from their parents.” Id. at 23. The report underscores the Settlement’s clear mandate: “opportunities for interaction should not be viewed as optional; rather, CBP personnel should have the logistical and organizational support to ensure routine provision. CBP must also ensure that their personnel and contracted caregivers inform the affected families of their rights regarding visitation….

And so, even under a Democratic Administration — one committed to complying with the black letter law, at the top of the house, at least — we still have a long way to go. And more legislation may be needed in 2025, from an all Democratic triumvirate. That is… rather… disheartening.

नमस्ते

The Judgment Of The Colorado Supremes Was Rock Solid — And Sound…

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Do read the cogent, level-headed and — I predict — ultimately prevailing view of at least five US Supreme Court Justices, as just filed by Colorado.

…States have the power to enforce the U.S. Constitution, which is “supreme Law of the Land,” U.S. Const. art. VI, and “as much the law of the several states as are the laws passed by their legislatures,” Haywood v. Drown, 556 U.S. 729, 734 (2009). Trump cites no constitutional provision stripping states of the power to enforce constitutional qualifications for the Presidency. See U.S. Const. amend. X. To the contrary, states’ authority to do so falls squarely within their broad power to regulate presidential elections.

The Electors Clause provides: “Each State shall appoint, in such Manner as the Legislature thereof may direct, a Number of Electors” for the election of the President and Vice President. U.S. Const. art. II, § 1. This clause gives the states “far-reaching authority” to run presidential elections, “absent some other constitutional constraint.” Chiafalo v. Washington, 140 S. Ct. 2316, 2324 (2020); see also id. at 2334 (Thomas, J., concurring) (locating similar authority in states’ Tenth Amendment reserved power); McPherson v. Blacker, 146 U.S. 1, 25 (1892) (Electors Clause “convey[s] the broadest power of determination” over who becomes an elector).

Under the Electors Clause, state legislatures can (and historically did) dispense with presidential elections and appoint electors directly. Chiafalo, 140 S. Ct. at 2321. Similarly, a state’s power to “appoint an elector (in any manner) includes the power to condition his appointment — that is, to say what the elector must do for the appointment to take effect.” Id. at 2324. States may thus reject electors who refuse to pledge that they will vote for the winner of the state’s popular vote. Id. Just the same, states may reject electors pledged to candidates who are constitutionally barred from holding office.

This Court has also repeatedly upheld states’ interests in developing ballot access rules. To ensure that “order, rather than chaos, is to accompany the democratic processes,” states have developed “comprehensive” election codes regulating the “selection and qualification of candidates.” Storer v. Brown, 415 U.S. 724, 730 (1974). “States certainly have an interest in protecting the integrity, fairness, and efficiency of their ballots and election processes as means for electing public officials.” Timmons v. Twin Cities Area New Party, 520 U.S. 351, 364 (1997). And “a State has an interest, if not a duty, to protect the integrity of its political processes from frivolous or fraudulent candidacies.” Bullock v. Carter, 405 U.S. 134, 145 (1972)….

And So, USDC Alia L. Moses Will Spend 60 Days Developing A Factual Record, Since The Land Injunction Is Vacated…

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The Fifth Circuit has decided, tonight that it doesn’t want to hear from Ken Paxton, just yet — on his insurrection. [Was scheduled for February 8. No more.]

Hilarious. This is a very encouraging sign that the Fifth Circuit knows this will end badly for Abbott and Paxton, since the Supremes were so forcefully definitive, and Sphinx-like — in not issuing an opinion to explain. That’s… ominous for these abominable razor wire barriers’ future. Here’s the bit:

…On January 2, 2024, the United States filed an emergency petition before the Supreme Court to vacate the motion panel’s injunction. See DHS v. Texas, 23A607. The parties’ briefing strenuously disputed various factual issues, many of which concerned matters arising after the motion panel’s injunction. On January 22, 2024, the Supreme Court vacated the injunction by a 5-4 ruling unaccompanied by written opinions. DHS v. Texas, 23A607, 2024 WL 222180 (Mem), at *1 (Jan. 22, 2024).

In light of those developments, the panel orders a limited remand to the district court for 60 days. The panel respectfully requests the district court to make additional fact findings concerning the matters contested by the parties and any other matters the district court deems relevant.

The panel leaves the form of the proceedings to the district court’s wise discretion….

So, TXWD USDC Judge Moses is… back on the hot seat.

Will she be… up to it?

We shall see.

Out.

$83.3 Million!

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Very good news! That’s a staggering win for Jean Carroll!

A very sharp, swift (after ~ two hours of deliberations), steel toed Doc Martens’ kick in the junk, to Trump — from a unanimous federal jury.

Flawless!

नमस्ते

In Glossip v. Okla., The Supremes Seek More Counsel: Amicus Invited…

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This is a death penalty case, where the officials of Oklahoma now oppose the execution — due to clear prosecutorial misconduct at trial, that the state itself concedes was likely “outcome determinative”.

The only forces aligned against granting a new trial here are — yep, you guessed it! — Thomas, Alito and probably Kavanaugh.

The three think that even when we get it wrong — “finality” (that is, killing a human, promptly) is more important than actual innocence. Than… restorative… justice.

So the other six seek ever more amicus briefs today, to try to convince the three… that their views are deeply… flawed.

Do stay tuned.

Texas Gets “Schooled” In Fifth Cir. — Or, “The First Rule Of Holes…” Here Applies.

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Ahem. Confidential Note, to Gov. Abbott — when you’re in one… stop digging.

This (below) is a “hole” of the Governor’s own making. A lawless, and barbarous one.

He is lacerating children and their parents — asylum seekers, almost to a person. What sort of monster thinks that is lawful — let alone… a moral approach, to the problems he claims to face?

The law of the United States, and a 1848 Treaty between our nation, and the nation of Mexico… prevent this cruel course of action, by anyone — and certainly not by the governor of a rogue state (who had sworn an oath to “support the United States”).

Here’s the latest — on why Abbott and Texas will lose in the Fifth Circuit, from the able AUSAs’ appellate offices, overnight (and a bit of it).

…The circumstances of this case aptly demonstrate why a district court is free to proceed to the merits while a preliminary injunction appeal is pending. After the district court entered the preliminary injunction, the United States filed an amended complaint that pleads two claims. Only the first claim, alleging that Texas violated Section 10 of the RHA, is the subject of the preliminary injunction and this Court’s review in Texas’s appeal. The second claim in the amended complaint alleges that Texas’s installation of the barrier in the Rio Grande is contrary to Article VII of the 1848 Treaty of Guadalupe Hidalgo, which prohibits “construct[ing] any work that may impede or interrupt, in whole or in part,” the “free and common” “navigation” of the Rio Grande. See generally ECF 60 ¶¶ 17-21, 42-45 (First Amended Complaint); ECF 63 at 10-20 (United States’ opposition to Texas’s motion to dismiss). That distinct claim was not at issue in the preliminary injunction proceedings either in the district court or on appeal….

Even if this Court’s review of the preliminary injunction appeal were to resolve any purely legal issues as to the RHA claim (which it would not for the reasons discussed in the next paragraph), the resolution of the RHA claim will by no means resolve the treaty claim. The treaty precludes either country from impeding the free navigation of any part of the river without the other country’s consent. ECF 63 at 10. See id. at 17 (noting Article VII protects right of navigation across the river). Furthermore, the treaty claim does not require finding that any segment of the Rio Grande is commercially navigable, as “navigation” under the treaty’s terms includes any navigation and is not limited to just commercial navigation. Id. at 17-18.

Notably, Texas has not disputed that the treaty’s definition of “navigation” is broader than the RHA’s. See ECF 65 at 1-6 (Texas’s reply in support of motion to dismiss). Thus, although the treaty claim arises from the same factual occurrence — Texas’s unilateral and unauthorized placement of the barrier in the Rio Grande — the treaty claim is legally distinct from the RHA claim, and its success does not depend on the RHA claim….

Who are these feckless would-be dotards? And do they really think they can run out the clock — and bank on a Tangerine win in November, presumably to pardon them (from charges of crimes against humanity, among others… and as of Wednesday, now likely including inciting insurrection by ignoring a final US S.Ct. order)?

Wow. Out.