[Tangent: Pharma Lobbying, On Prices.] Here Is Lilly’s Full Year 2023 Spend ($7.96 Million): Much Of It To Blunt Price Caps On Lispro® (Next-Gen Insulin Injection)…

This appears here because there are lawful ways to increase drug prices — and we may argue about whether such moves are… strictly speaking, moral — on older drugs as to which companies have already made billions of dollars, selling them for decades at high prices. [Especially where fixed-income seniors need them just to… survive.]
But we should all agree that brazen market choking, via open violations (for several years) of the Clayton Act… are not to be allowed. This is — in truth — why Martin Shkreli finds himself where he is, this morning. Banned from life sciences, pharma and securities businesses — for life.

Okay, on to the main story then (cross-posted from my other properties).

With Lilly’s diabetes meds being used as an off-label weight loss treatment nationwide in 2023, it has had a hard time in 2023 manufacturing enough of it to meet the sky-rocketing demand for that very pricey product. [That’s a win-win, from the company’s perspective.]

And it is doubly concerned, about any legislation that might force it to decrease the price of its modified (next-gen insulin) — called Lispro® — offered at retail at eye-watering prices. [Lilly spent $2.53 million in Q4 2023 alone. And it chose to voluntarily cap the older insulin products at $35/month out-of-pocket, in order to avoid government mandated negotiations / legislation on Lispro pricing.]

Here are the details from Q4 2023, as to The Indiana-based multinational:

…Issues related to intellectual property protection and market access within current trade negotiations. Canada IP; USMCA implementation; Mexico patent linkage; Special 301; Trade talks: US-Japan, US-China, US-EU, US-UK, US-India, and US-Brazil….

[Senate version] Patient protection; Drug supply chain and shortages; Drug pricing, coverage, value and access; Transparency; Intellectual property; Health insurance accessibility; Implementation of the “Inflation Reduction Act” (HR.5376); Prescription drug approval; Affordable Insulin Now Act (S.954/HR.1488), The INSULIN Act….

[House version] Intellectual property; 340B Program; Medicare & Medicaid prescription drug reimbursement, coverage and value; Implementation of the “Inflation Reduction Act” (HR.5376); CMS National Coverage Determination on Alzheimer’s disease; The INSULIN Act….
Multi-lateral threats to IP and the biopharmaceutical industry; Drug importation; Prescription drug value and access….

Pharmaceutical intellectual property issues….

Hospital discounts; 340B program….

Implementation of the Tax Cuts and Jobs Act; Domestic manufacturing tax incentives; Expensing of research and development costs; Global minimum tax; Pension and retirement benefit issues….

Now you know — and this is a candidate for the next round of mandatory price negotiations (with federal government customers) in the US.

The first group of ten included Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, and Imbruvica.

Onward, into the… sunshine.

नमस्ते

I’ve Seen Some Silly “Analyses” Of Section 3 Of The 14th Amendment…

Some hard right chuckle-heads are claiming that the prohibition in Section 3 was effectively rescinded in 1878 and 1898, by acts of Congress. Not so. It merely pardoned (looking BACKWARD) former Confederate insurrectionists. It expressly left in place the FOWARD-looking power (without need of an impeachment, or other act of Congress) to have any state disqualify any “insurrectionist” — from holding office, including the office, at what is now… 1600 Penn. The testimony of the drafters amply supports the point that it was not — not — not limited to the Civil War facts.

The very-able historians (via an amici filing, at the Supremes, on Friday past) explain, thus:

…Contrary to many laws that targeted former Confederates in southern states, Section 3 enshrined disqualification in the Constitution with generic language that does not reference the rebellion or former rebels.

Unlike [mere] statutes, as part of the Constitution, Section 3 endures indefinitely, free of tampering by future Congresses. Republican Senator Peter Van Winkle of West Virginia said during debates over the 14th Amendment, “This is to go into our Constitution and to stand to govern future insurrection as well as the present; and I should like to have that point definitely understood….”

Section 3 was very explicit about what Congress was required to do and not to do: Congress could lift any disqualification for office only by a two-thirds vote. Strikingly, however, the Section did not require any action by Congress to disqualify insurrectionists. Section 3 mirrored other constitutional disqualifications based on age, residence, and birth that did not require any action from Congress….

No former Confederates whom Section 3 instantly disqualified from holding office were disqualified by an act of Congress or a criminal conviction for insurrection or rebellion. Former Confederate President Jefferson Davis recognized, for example, that Section 3 had automatically disqualified him from holding public office on the day the states ratified the 14th Amendment. Davis argued that the Congress to give it effect.” Thus, the disqualification “punishment of Mr. Davis commenced upon the date of the adoption of the fourteenth article, and he therefore could not now be punished in any other way….”

The government did not dispute the self-executing impact of Section 3 but opposed quashing the indictment. Chief Justice Salmon Chase, who was serving as a Circuit Court Judge, indicated he accepted Davis’ claim and would quash the indictment. Circuit Court Judge John Underwood did not agree to quash.

However, the prosecution dropped the indictment prior to any resolution of the matter. Davis lived freely, although still under disqualification for a presidential run should be immune from prosecution for treason because of the penalty already imposed by this disqualification. Section 3, said Davis’ lawyer, “executes itself….”

So yes — these people are pointy-headed know-nuthins’ — nothing more.

Out.

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

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?!

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

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…

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…

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…

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…

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!

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