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Actually, This Past Quarter, Lilly Spent Even Less Than Merck — Lobbying (Despite The Insulin Pricing Battle In Congress)…

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Part Two, of the likely five part series on Q1 2024 Lobby-Spend trends, now appears for “Fourth Be With You” day….

Lilly has worked diligently since about mid-2021, to lobby Congress to preserve its right to price the later-gen insulin products (and very aggressively — on the weight loss ones). . . in any manner it likes, in the US. Some of that has succeeded — some hasn’t. And true enough, all the majors spend less during a presidential election year, as Congress is not likely to move major new initiatives, on either side of the coin during 2024.

Even so, Lilly (and to a lesser degree, Merck) are spending far less than would have been expected, here in Q1 2024. [We gave you some granularity on Rahway on Wednesday, here.] This is what Lilly was working to bend Congressional ears on:

…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; Pharmaceutical supply chain issues 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; Policy matters related to Artificial Intelligence in health care….

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; Pension and retirement benefit issues….

Hospital discounts; 340B program….

Now you know — but clearly patent evergreening is top of mind, for insulin products at Lilly, in Carmel, Indiana. Smile — now let’s see that Japanese champ come in No. One, or No. Two — as an exacta box, with Fierceness? Forever Young!

नमस्ते

More Hinderaker Revisionist History: COVID Edition

~ condor ~ 4 Comments

I will again point out that on average, eight times more people not vaccinated died of COVID, between ages 65 and 80… that those vaccinated.

John said it was just a flu — and, in July of 2020, the dying was mostly over — at 30,000 deaths in the US. He was wrong by about a sixty fold factor.

So… once again he’s justifying his endless ignorant bloviating… by saying the vaccine wasn’t 100% effective. [Nothing in bio- science ever is.]

Whatever, moron.

Good — As Far As It Goes: Paul’s Evolving Thinking, On Acceptable Protest Speech, About Israel.

~ condor ~ 2 Comments

Some may recall that shortly after October 7, Mr. Mirengoff tried to set rules, about what could, and could not, be said in debates about the latest eruption of this now over 3,000 year old conflict.

It was so utterly ironic, as to defy adequately mocking-description. I just mentioned it in passing — but he said that the right of Israel to exist could not be questioned, while the right to some version, somewhere… of some Palestinian state (or even the right of Palestinians, to their lives) was not a permissible topic. [Yes, I. Am. Serious.]

Overnight, thankfully — he wrote a new piece, lauding Dartmouth’s approach to current protesters (in which those views above are largely repudiated). Fine.

He closes then — and the reason I write — to say he suffered “consequences” for his takeover of Parkhurst, at Dartmouth, in ’69 — as did Hinderaker. Also fine (i.e., a few nights in jail). [Let’s ask the civil rights marchers in the South, just a few years earlier, Paul — about… “consequences“.]

So… my point: he fails to mention in his telling that all of them — all of them, as whyte kids of privilege, with high priced white collar lawyers, were released, their arrests expunged, and allowed to graduate on time, with all honors bestowed… and went on to multi-million dollar careers
in (ultimately — hard right) legal advocacy, as… big-business lawyers.

“…Fifty-five years ago, when John Sloan Dickey, Dartmouth’s formidable president, had those of us who took over the administration building arrested, I don’t think he issued a statement like this or, indeed, any statement at all.

I was in jail, though, so maybe I missed it.

Back then, I think students, including protesters like me, understood that actions have consequences. We boomers had many flaws, but we weren’t snowflakes.

But this isn’t 1969. Beilock was right to issue a statement explaining the arrests. And the statement she issued should be studied and emulated by college presidents far and wide….”

The point is… he, Hinderaker and Johnson are calling for a life-time black-balling of the kids (those who were actually students!) camping on the lawn at Columbia. Lots of them never broke into ANY Building — and took it, for three days, as these guys did, in 1969.

But the successful arcs — of their lives were singularly… unperturbed.

He should mention all of that, each time he tells this increasingly tall tale.

Out.

Tangent: Hopefully My Last Mention — Of Martin Shkreli’s “Troubles” — In Relaunching Some *.inu Token, Here In 2024…

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I elsewhere mentioned that Mr. Shkreli was apparently calling out what he regarded as other scammers, about token air-drops related to some AI project, over the past weekend.

Now it seems he’s saying that “a kid he met in prison” has scammed him, by the use. of. HIS. good. name(?)….

Erm. Okaaaaaay.

I’ll link this bit, because in it, Martin Shkreli’s x-itter feed is reportedly making multiple verifiable, factual statements — about the (now scrubbed) launch of… whatever this was going to be. And those better all turn out to be true, for Martin’s sake (in avoiding a second stay at FCI Allenwood Low).

Here’s the full story, out this morning — and a bit:

…The recipient of the gift, who goes by @_d3f4ult on X, allegedly dumped his coins while promoting the unreleased token to his Discord group, telling them he was bullish and buying into Martin Shkreli’s project.

Influential financial X account, Zerohedge, posted its take on the drama saying “Maybe don’t start crypto ventures with people you meet in prison?”

Whether legal action comes out of the alleged pump and dump is currently unknown, but it does add an example for cryptocurrency skeptics convinced the industry is full of fraud….

For what it is worth, this is much the same narrative we heard in the late Summer of 2022: that some unknown someone had gained access to Martin’s computer and crypto-keys, and rug-pulled the then Shkreli.inu. netting around $320,000.

That 2022 money is likely gone — and it would not be shocking to learn that the “kid he met in prison” doesn’t exist at all… and that it is all just another alt account of Mr. Shkreli’s, himself.

Obviously, if the kid is real — Martin could ID him to authorities, and they might pursue that guy for wire fraud (just as it did against Martin, in 2017-18!), and get at least some of the defrauded “investors’ funds” returned.

But if these latest funds have gone offshore, to Swiss accounts, via Mr. Shkreli’s other affiliated / alias accounts… that false-ID Will be useless (and another felony violation). Mr. Shkreli’s federal BoP minders should require, at a minimum, given that he’s made these affirmative factual statements in public, that he cooperate with law enforcement, and ID the supposed kid.

That would be / already is… a term of the order setting his continuing now two years of close monitoring.

Onward.

नमस्ते

Q.: Should We Infer An Anti-Competitive Motive, When A Needed Vaccine For ~80,000 Oncology Patients Remains Subject To Stock-Outs, For… A Decade? [Cough. Merck.]

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We’ve followed this for well-over eight long years — the odd little vaccine that is part of certain bladder cancer treatments, as a first line (for up to 80,000 patients a year in the US). But the stuff has been supply-constrained… for the better part of a decade (how is that even… possible?).

Rather than offer any wild eyed conjecture at the head, I’ll simply encourage the readership to read all of Fierce’s very well thought out, longish update, on the state of the play, in the US at least:

…BCG, originally developed as a tuberculosis vaccine, is also a standard treatment for NMIBC, which accounts for about 80% of around 80,000 new bladder cancer diagnoses each year in the U.S.

The FDA has cleared Anktiva and BCG to treat patients with BCG-unresponsive NMIBC with carcinoma in situ. And ImmunityBio is evaluating the combo in BCG-unresponsive NMIBC with papillary tumors and perhaps more importantly in BCG-naïve NMIBC.

In the current indication, ImmunityBio will go toe to toe with Merck’s PD-1 mega- blockbuster Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin, both of which are administered by themselves without BCG. Ironically, Merck is currently the sole supplier of BCG in the U.S….

Merck’s TICE BCG has been the lone BCG product in the U.S. since 2012, coming after Sanofi and another drug-maker ran into manufacturing problems. Sanofi officially pulled out of the market in 2016. Merck, which had before then not been the major supplier globally for BCG, was forced to pick up the slack….

Now, were I a cynical sort of gent, and were we living in a prior epoch (prior to the required negotiated drug-pricing executive orders) I might have suggested that Merck historically (by designed indifference) kept a shorted- / shortish-supply chain on BCG to make other competitors’ efforts at using it — in more-lucrative oncology settings, as a combo therapy… more difficult. Note that Rahway claims (at least) that you presently can’t get larger delivery quantities unless you’ve been ordering larger quantities since 2012 or so. [Yes, this is why I’ll post (again) on Mr. Shkreli immediately following, here.]

That all would have the effect of more or less “locking supplies in place“, and keeping upstarts largely off the field in the US. In the EU, Japan and UK… that would likely be frowned upon, and may even violate the EU Competition Commission’s rules. So, we will keep an eye on it.

[It is not too great a stretch to say that Martin Shkreli nakedly did this, with Daraprim — and thus earned a life-time FTC pharma industry ban… while, when much the same is accomplished… politely, with kid gloved large manufacturing facility cap ex, over a period of a half-decade, it is permissible in the US at least.]

नमस्ते

The Merck Lanham Act Name Spat Case Has Been Reassigned To A New Jersey Federal Judge: Hon. Jamel K. Semper

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And so, the trial date could possibly be moved forward — into late 2024, given the less-crowded calendar of USDC Judge Semper. He was only installed as a federal judge in December of 2023. [Judge Semper was nominated by President Biden.]

He is certainly capable of doing the job. And this, too (a trial date arriving on swift wings) may hasten a settlement in this potentially multi-billion dollar case.

…TEXT ORDER REASSIGNING CASE. Case reassigned to Judge Jamel K. Semper for all further proceedings. Judge Esther Salas no longer assigned to case. So Ordered by Chief Judge Renee Marie Bumb on 4/30/24….

[Ed. note: Wikipedia has his CV down thus] “…Semper received a BA from Hampton in 2003 and was an honors student at Rutgers Law School in 2007. Upon passing the bar, Semper served as a law clerk for Judge Harold Fullilove of the Essex County Superior Court from 2007 to 2008. From 2008 to 2013 he served as an assistant prosecutor in the Union County Prosecutor’s Office and from 2013 to 2018 he served as an assistant prosecutor in the Essex County Prosecutor’s Office.

From 2018 to 2023, he served as an assistant United States attorney in the U.S. Attorney’s Office for the District of New Jersey, where he served as deputy chief of the Office’s Criminal Division. During his time as an Assistant U.S. Attorney, Semper headed the Organized Crimes and Gangs section. In 2021, Semper was one of seven candidates under consideration to be the United States attorney for the District of New Jersey….”

Now you know. And okay — I cannot resist a lil’ snark.

Call me crazy, but I do not imagine that Tangerine would have ever considered his name. This, even though he is clearly pro-law enforcement (a claim Tangerine always makes — even as he himself commits a seemingly endless string of… felonies). Onward, grinning — ear to ear.

नमस्ते

The Curious Story Of… ECMO, And Access Questions In ICUs, Inside The US.

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This is not — in any sense — any new therapeutic option, but in fact one that dates (brace yourself) to… 1932.

It historically has been sparingly used, as a bridge to lung transplantation — because it does (in some ways) represent the blurring of a line — a line, between what it means to be alive, as opposed to… dead.

I’ll tease no more of it — but just link it, and encourage the readership to go parse it all. Here’s that finely-written long-form New Yorker story — and a bit:

. . .[In a fashion photo-shoot of a 23 year old woman, each image shows, in the background] a metal trolley stacked with medical equipment. Two large plastic tubes, one cherry red, the other dark plum, loop from the trolley to Arms, entering her body beneath her clavicle. She has cystic fibrosis, a condition that damages the lungs. Hers are failing, and the machine on the trolley has replaced them. . . .

But some physicians worry that ECMO is creating entirely new ethical conundrums. “The unfortunate reality is that, sometimes, people get put on this machine and they don’t get better,” Jessica Zitter, a palliative- and critical-care physician, told me. A patient whose heart has stopped could potentially live on the machine for months, awake, able to walk and read the newspaper. But he might never leave the I.C.U. “It’s a trap,” Zitter said.

ECMO is transforming medical care, saving lives. But it also complicates care when life inevitably begins to end, committing some patients to a liminal state with no hope for recovery. When should it be used, or withheld? And who should decide?. . . .

Indeed — who will make these calls / decisions? How old is… too old to be a suitable candidate? How sickly… is too sickly… to be placed into the bridge — we will keep an eye on this topic.

With that said, I suppose it is an essentially happy problem to have — if it means that there are options, for at least some of the more desperately, deeply-obstructed lung patients — in the major city hospitals around the nation. Your mileage may vary… in fact, it probably… does.

नमस्ते

Nah, Billings-Puss… “From Your Co-Bloggers, To Today.”

~ condor ~ 2 Comments

Lloyd has been pushing the false “Baby Scalia” equivalences argument hard here, on Columbia protests — and (churlishly) Munich 1972.

There are no terrorists, nor guns at Columbia (other than the ones the NYPD wear). No hostages. No dead athletes. No Olympics.

No, Mr. Puss… the analogy — taking over a campus building, and refusing to disperse… is to your co-authors, Hinderaker, and Johnson and Mirengoff — Dartmouth 1969.

Take a seat son.

More To Come, Shortly — On The Others, But Merck Has Been Very Judicious In Its Q1 2024 Lobby Spending…

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And that is true, when compared to peers — as well as to the prior year’s Q1 spend. Q1 2023 spend figures are in half tone grays at right.

It seems only Amazon is still spending heavily, on its Congressional jaw-boning — even in this Presidential election cycle year. [But that is likely to try to blunt any new legislation aiding the wins the Amazon Labor Union has secured, for the about 1.2 million workers at Amazon, and affiliates.]

As I say, more to come — on the others — but here is at least some of what Merck was lobbying on early this year:

…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. 1503/S. 2916, Prescription Information Modernization Act of 2023; 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. 3633, PREVENT HPV Cancers Act of 2023; H.R. 4368/S. 2131, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024; H.R. 4895, Lowering Drug Costs for American Families Act; H.R. 5376/S. 2474, Share the Savings with Seniors Act; H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act; H.R. 7174, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; H.R. 7635, The 340B PATIENTS Act of 2024; S. 150, Affordable Prescriptions for Patients Act of 2023; S. 1339, Pharmacy Benefit Manager Reform Act; S. 1895 (116th Congress) Lower Health Care Costs Act; S. 2333, Pandemic and All-Hazards Preparedness and Response Act; S. 2543 (116th Congress) Prescription Drug Pricing Reduction Act of 2019….

Issues relating to 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Anti-microbial Resistance; 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; Issues related to the Patent and Trademark Law Amendments Act (PL 96-517); FY-2024 Budget and Appropriations Legislation; Intellectual property protection and trade issues; 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 & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Farm Bill 2023; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms….

Now you know. Onward — for a mountain bike ride, in the warm Spring air… smile.

नमस्ते