Lilly’s Lobby Spend — Vs. Amgen’s: Both Well Below… Each Of Merck And Pfizer.

Here is the Lilly spend details, for Q2 2023. . . pretty unremarkable, overall.

We will cover Amgen’s — tomorrow, but this is the Indy firm:

…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….

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.3700/HR.6833), The INSULIN Act….

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….

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

Hospital discounts; 340B program….

Now you know. With last quarter’s Lilly spend, immediately above. Smile….

नमस्ते

Merck Is Spending Heavily In A Quarter That Larger Competitor Pfizer Decided… To Back Out Of, On Lobbying. Fascinating.

Perhaps this will reverse in Qs 3 and 4, but it is odd that Merck as a much smaller by market cap entity is outspending the gorilla Pfizer, in a quarter when it is also actively litigating against the very payors who feed it: CMS and HHS. Odd, indeed.

In any event, here is what Merck spent its millions urging. [With analogous posts about Amgen and likely Lilly, tomorrow. Do see at bottom, for what the trend looked like, last quarter — almost a complete… inversion, in spending!]

…H.R. 3, (117th Cong.) Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19, (117th Cong.) Lower Costs, More Cures Act of 2021; H.R. 830, Help Ensure Lower Patient (HELP) Copays Act; H.R. 1418/S. 1844, Animal Drug User Fee Amendments of 2023; H.R. 1503/S. 1844, Prescription Information Modernization Act of 2023; H.R. 1550, (117th Cong.) PREVENT HPV Cancers Act of 2021; H.R. 2679, Pharmacy Benefits Manager Accountability Act; H.R. 2691, Transparent Prices Required to Inform Consumer and Employers (Transparent PRICE) Act; H.R. 2816, Pharmacy Benefit Manager Sunshine and Accountability Act; H.R. 2880, Protecting Patients Against PBM Abuses Act; H.R. 2940/S. 1355, Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act (PASTEUR) Act of 2023; H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; H.R. 3285, Fairness for Patient Medications Act; H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 S. 150, Affordable Prescriptions for Patients Act of 2023; S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019; S. 1895 (116th Congress) Lower Health Care Costs Act; S. 4348, (117th Cong) Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022….

Issues relating to: 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Anti-microbial Resistance; Vaccines; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines catch up; Vaccines issues; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical Supply Channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2023 Budget and Appropriations Legislation; Intellectual property protection; WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; WTO IP Waiver for COVID therapeutics….

Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: ADUFA and Funding for Electronic Animal Traceability; Animal Drug User Fee Reauthorization; One Health Issues….

General pharmaceutical issues; Farm Bill 2023; Vaccine Injury Compensation Program (VICP); Step therapy requirements in commercial health plans; Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues….

H.R. 1613, Drug Price Transparency in Medicaid Act of 2023; H.R. 2666, Medicaid VBPs for Patients (MVP) Act; H.R. 5376, (117th Cong.) Build Back Better Act; S. 476 (116th Congress) Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019….

Issues relating to: Medicare; Medicare Part B and D drug pricing issues; Prior authorization process under Medicare Advantage plans; 340B program integrity; 340B of the Public Health Services Act; 340B drug pricing program; Drug Pricing; FY-2023 Budget and Appropriations Legislation….

Issues related to: Tax reform and tax policy, generally; Tax Cuts and Jobs Act of 2017 (P.L. 115-97); Inflation Reduction Act (P.L. 117-169), provisions relating to taxes….

Now you know. What a weird ride this has been — against a solid, two-decades-running… trend.

And just to make plain how off the grid this Q2 2023 was, look at Pfizer, last quarter (in my legacy graphic, immediate right) — it spent nearly double what it spent this quarter. Wow.

नमस्ते

And Twitter Has Fixed My Sidebar Feed [On The Longest Running Legacy Site]…

I cannot confirm whether anyone at NASA mentioned this to him, but Musk has “unbroken” the feeds to non-paid users’ external websites (like this pne), at least for now.

True, it is all pretty trivial in the grand scheme of things, but it did seem unwise. . . to piss off the SpaceX partners at NASA, as we mentioned… over such petty nickel grabbing.

Now — hopefully — all is well that’s ended… well. Smile….

नमस्ते

First Time In 15 Years(!) — Pfizer Spent LESS Than Merck, On Lobbyists, In Q2 2023… Only $2.48 Million [Merck Hit Nearly $3 Million].

We will offer the analogous Merck Senate.gov LDA disclosures tomorrow — but I wanted to give Pfizer its due here: despite being about 30 per cent larger than Merck, for the first time in my memory, it refrained from spending a ton on lobbyists in Q2 2023.

Of course, it could be that the company has assessed (likely correctly) that very little legislation will pass in this fractured, partisan environment. [OTOH, Pfizer has filed no strike suit against US health agencies, in contrast to Merck’s / Mr. Davis’ choice to do so — in what is now widely regarded as largely a bit of MAGA/GOP infused political grand-standing.]

So — the lower spending may be transitory here — if Democrats recapture all chambers and keep 1600 Penn., in 2024. We shall see — but Pfizer’s categories of ear-bending involve the following:

…Drug Pricing, Support of Biosimilars, Out-of-Pocket Costs, Rebate Reform, Vaccine Infrastructure/Excise Tax, PDUFA, Pandemic Preparedness/PAHPA….

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)… and

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

Now you know… but do note that Pfizer is lobbying on negotiating with Medicare, rather than litigating about it. Grin…. G’night.

नमस्ते

So… Hinderaker Admits: Nixon Would Have Despised Tangerine.

In a supposed defense of Mr. Clinton (imagine… that?!) and indictment of Mr. Biden tonight, John reads from a three decades old letter Nixon penned to Clinton.

Fine — as far as the letter goes, in that Nixon openly recognizes Clinton’s own masterful foreign policy chops.

Putting aside the fact that everything Nixon said post Watergate was intended (by him) to try to regain some relevance… it is clear Nixon would have said he knew Trump was selling American policy to the highest frenemy bidders — in Russia and the Persian Gulf.

He would have praised Mr. Biden in the same way he praised Clinton.

But as I say, it all is of scant moment — and proves how low John has to reach — given his own assessment that Trump is like… ricin, to the GOP’s future chances.

Poisonous.

Out.

In Which Paul Mirengoff Churlishly Plays “Bait And Switch” — On The Harvard/UNC Cases…

Paul’s aim, such as it is (overnight), is to defend the practice (which highly favors largely mediocre whyte kids!) of legacy admission criteria, as a “booster” — at elite colleges and universities.

But as ever, he starts from a false premise. Then he argues whataboutism.

The false premise: there is no purely race-based admission in the US after the Supremes’ Michigan cases (Grutter v. Bollinger) in 2003.

The Supremes there held — and as we’ve pointed out, re-affirmed in the Harvard case last month — that using several factors to sort applicants (some of which might correlate with a particular racial background) IS PERMISSIBLE.

The Chief Justice clearly wrote just that — but Paul then FALSELY labels that “race-based”.

That is no more “race-based” than an ear of corn, grown in soil that might also have been fertilized a season ago or more with manure… is “cow-based” corn.

But from this false premise, Paul then claims legacies are less odious than “race-based” admissions.

What a stupid, non-logical argument.

Sit down, Paul. No one believes your… unctuous bullsh#t.

Out.

Just Published In Nature… We Have New Evidence That Around 3 Billion Years Ago, There Could Well Have Been Life In Rivers On Mars…

The Perseverance rover at Jezeero Crater — in what is almost certainly an ancient and now long dessicated river bed… has used an instrument called SHERLOC to establish that at least a few of the rocks there contain mineral trace signatures, signatures that would be the fingerprint of… organic biological processes — life. That’s exciting, but not definitive.

Here’s the latest, from NASA:

…The new Nature paper looks at 10 rock targets SHERLOC studied, including one nicknamed “Quartier.”

“We see a set of signals that are consistent with organics in the data from Quartier,” Sharma said. “That grabbed everyone’s attention.”

SHERLOC’s capabilities center on a technique that looks at the chemical makeup of rocks by analyzing how they scatter light. The instrument directs an ultraviolet laser at its target. How that light is absorbed and then emitted – a phenomenon called the Raman effect – provides a distinctive spectral “fingerprint” of different molecules. This enables scientists to classify organics and minerals present in a rock and understand the environment in which the rock formed. Salty water, for example, can result in the formation of different minerals than fresh water.

After SHERLOC captures a rock’s textures with its WATSON (Wide Angle Topographic Sensor for Operations and eNgineering) camera, it adds data to those images to create spatial maps of chemicals on the rock’s surface. The results, detailed in a recent paper in Nature, have been as promising as the instrument’s science team had hoped….

Onward, to a sunny, mountain bike riding weekend, now — by my own ancient, vast fresh water body… the fifth largest on the planet. Smile.

नमस्ते

Tucker… Scorched — By USDC Judge Lamberth — On The “QAnon Shaman” Conviction — And So Too, Then… Is Bitsy And Hinderaker!

Well, this will leave a mark. And thanks to EW for sourcing it, in the first instance.

Here’s a long serving, hard boiled but completely fair USDC Judge re-affirming the QAnon Shaman’s sentence, and felonies conviction — and rejecting the outright lies Tucker told on-air, in the process:

…Finally, the Court would be remiss if it did not address the ill-advised television program of March 6, 2023. Not only was the broadcast replete with misstatements and misrepresentations regarding the events of January 6, 2021 too numerous to count, the host explicitly questioned the integrity of this Court — not to mention the legitimacy of the entire U.S. criminal justice system with inflammatory characterizations of cherry-picked videos stripped of their proper context….

In so doing, he called on his followers to “reject the evidence of [their] eyes and ears,” language resembling the destructive, misguided rhetoric that fueled the events of January 6 in the first place. The Court finds it alarming that the host’s viewers throughout the nation so readily heeded his command. But this Court cannot and will not reject the evidence before it. Nor should the public. Members of the public who are concerned about the evidence presented in Mr. Chansley’s case and others like may view the public docket and even attend court proceedings in these cases.

Those of us who have presided over dozens of cases arising from, listened to hundreds of hours of testimony describing, and reviewed thousands of pages of briefing about the attack on our democracy of January 6 know all too well that neither the events of that day nor any particular defendant’s involvement can be fully captured in a seconds-long video carelessly, or perhaps even cynically, aired in a television segment or attached to a tweet….

Mr. Chansley has not made a substantial showing of the denial of a constitutional right. The Court will therefore decline to issue a certificate of appealability for Mr. Chansley’s claims….

V. CONCLUSION

For these reasons, the Court concludes that Mr. Chansley’s motion and the record in his case do not show his entitlement to relief. No evidentiary hearing is warranted, see 28 U.S.C. § 2255(b), and the Court will DENY Mr. Chansley’s motion….

Smoke that, Bitsy, Johnnie and Tucker… Wet-End.

Out.

It Is Unclear Whether He Still Works As A VP Of Quality At Amgen, But Is That An “Officer” Level Title, There?

I post this here, from another property, to ask why it is that the minnows get three year bans, but the whales — like Musk — remain as D&O of public companies, even after very solid evidence of insider trading in several Howey-type securities. That is a vexing difficulty of limited enforcement budgets, but old Elon should see the same rigor applied, given his outsized impact on the Doge coin markets, for example.

In any event, on the main topic, I do ask, mostly because his settled charges at the SEC forbid him from being an officer of a ’34 Act reporting public company, for the next three years.

And obviously, Amgen is a ’34 Act public company. In any event, here is the latest — from the fine reporting at Fierce:

…Nirdosh Jagota, 61, who was a vice president of global regulatory affairs at Merck when the Pandion buyout was announced, has agreed to a deal with the SEC. Jagota will return the $39,660 he made from the two stock purchases he made on Feb. 9 and Feb. 17, ahead of the Feb. 25 merger.

Jagota, who left Merck in August of 2021 and has since held positions at three other biopharma companies, also will pay a civil penalty of $39,660 and prejudgment interest of $3,605. He also has agreed to not serve as an officer or director of a public company for three years. Jagota has been Amgen’s VP of quality for the last 13 months….

I would imagine that the role at Amgen — though called VP of Quality — is not an actual Section 16 officer slot, at least not as appointed by the full Amgen board of elected directors.

But we will know, soon enough. [Interestingly, the SEC settlement is not limited to being a Section 16 “executive” officer (see page 4, at IV.B) — it says any officer position. Hmm….] Onward, smiling on a sunny Thursday… with a probable indie documentary shoot coming up next week, on Wednesday here. Heh.

नमस्ते