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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

May 1 UPDATE: Amazon / NLRB Wrangling Update, Related To AMZN / JFK-8 Lawless Union Busting Tactics…

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Here is our monthly check in, to highlight the NLRB staff counsel’s very cogent brief in defending a post decision ruling, out of Phoenix, against Bezos’ serial labor relations violator, called Amazon.

Here, the staff counsel argues that seizing union literature, and destroying it cannot be re-cast as permissible “tidying up” of the lunchrooms, because the VIDEOTAPE shows security guards stealing only the union pamphlets and posters, and leaving garbage on the tables… untouched. Charming, thus:

…Spence then returned to the breakroom and saw [Security Guard] Hill holding copies of the Notice that Spence had distributed. See Tr. 543:7-12. Spence approached Hill and asked Hill why he removed the papers from the tables. See Tr. 1064:12. Spence told Hill that the papers concerned a union. See Tr. 1064:12-14. Spence further said that Hill didn’t “work for Amazon,” and that it’s not Hill’s “job to break the law.” Tr. 543:13-17. Approximately 20 Amazon associates were present in the breakroom at the time….

[Security Guard] Koplevich took photographs of ALU activity taking place at a public bus stop adjacent to JFK8. See Tr. 1067:10-18, 1081:19-21. Troy immediately asked Bertone to have Metro One remove Koplevich from JFK8 because she was acting outside of her authority, as Metro One guards are only allowed to take photographs or make videos during an active investigation….

There is much more at this link. But truly, the union will keep its win — on that you may rely. Onward.

नमस्ते

Hinderaker Believes Tangerine Can Ignore NY Criminal Court Orders.

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Astonishing.

Hinderaker thinks Trump would just “have to stay out of New York for a while” — but could get back to the campaign trail.

It is (objectively) hard to believe John ever passed the bar, now. Here’s that Hinderaker junk:

…I think that he would be legally and constitutionally justified in refusing to cooperate. He could ignore Merchan’s partisan orders and decline to have anything to do with the proceeding. He could get back on the campaign trail, where he belongs. On [sic s/b “In”] this scenario, Trump presumably would be convicted in absentia, which would mean that he couldn’t enter New York State for a while. But he is going to be convicted anyway, in all probability…

A very public felon — by then, holding rallies… can be arrested by federal or state authorities, for fleeing. So Trump could not cross into any blue state; or any battleground state — since any cop in any of these states could arrest him as he left the stage, and hold him for extradition to New York.

Jail is not an easy place to campaign from.

And perhaps all Hinderaker really thinks… is he’d do better to get a few weeks of campaigning in, before he’s convicted, and ordered not to leave the state, at a minimum — while his appeals run their course. [But fleeing means it’s a near certainty he’d be jailed in New York during the appeals. Wow.]

To be clear, the truth is Trump will be convicted on a mountain of documentary evidence (not politics). And John knows it.

It may be that John WANTS him in jail, and before Milwaukee, so that an alternate may be shoved forward.

That — at least — makes what John wrote… make sense. It’s a dumb argument, but Trump is dumb enough to believe he could successfully… flee. And… I love it!

Amazing! And… disgusting, all in one.

Out.

Tangent: The Supremes Tell Musk… “Tell Your Story Walkin’, Bub…”

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Welp. This has turned out just as we said it would. When you lead a public company, and take the public’s funding — you are subject to certain very sensible duties — like not lying — about your stock.

Mr. Musk got off very easily after 2018-era tweets that misled the public, and his shareholders, about Tesla stock. In his settled action with the SEC Enforcement staffers, he agreed to do certain things, to avoid a worse outcome. Specifically, he agreed to a $20 million fine for making misleading tweets, related to his ’34 Act registered stock — and agreed to have his GC pre-approve all tweets that mentioned his stock.

Then, several years later, he tried to argue that his own agreement violated his free expression rights. Hilarious.

What a churlish cad.

He AGREED, in writing (while being advised by some of the best lawyers in the US) — all to avoid a loss at trial (and an order removing him as an officer, director or any other role of power at Tesla); with hundreds of millions of dollars in fines possible (he had lied about a potential multi-billion Dollar buyout offer) — and even a chance of jail time (sorta’ like Martin Shkreli).

After losing on appeal in the Second Circuit, the Supremes… laughed at his petition for cert., thus:

…Musk’s settlement resolved the SEC lawsuit accusing him of defrauding investors. Under the agreement, Musk and Tesla each paid $20 million fines and he gave up his role as the company’s chairman. Musk also agreed to let a Tesla lawyer pre-approve some posts he made on the social media platform then called Twitter before Musk bought the company and renamed it X.

Musk later sought to terminate the pre-approval mandate, with his lawyers in a court filing calling it a “government-imposed muzzle” that amounted to an illegal prior restraint on his speech….

Now you know. This chucklehead… geez.

[More recently, he’s been spouting whyte replacement paranoia themes / crazy conspiracy theories — on his cash burning platform I call X-itter. Not exactly the kind of expression that we all should be rushing to protect, overall — as it often strays very close to intentional hate crimes, against protected classes.]

Onward.

नमस्ते

Of “Vampire Facials”… That End Up Being… Debilitating, Life Long Medical Problems.

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It has been a minute since I put up an “unlicensed, unapproved” medicines post.

But this one. . . is so egregious, it rivals Jim Bakker’s colloidial-silver solution being sold on cable-TV as “a cure” — for COVID-19 — back in 2020. Despicable.

In this current case, at least three women have tested positive for HIV, the virus that causes AIDS, apparently after being micro-needled, in a “vampire facial” from an unlicensed supposed med-spa, in New Mexico. Understandably, the owner is facing jail time. Here’s a bit, from NPR:

…Many popular cosmetic treatments are delivered with needles, such as Botox to iron out wrinkles and fillers to plump lips. A “vampire facial,” or platelet-rich plasma microneedling procedure, involves drawing a client’s own blood, separating its components, then using tiny needles to inject plasma into the face to rejuvenate the skin….

The New Mexico Department of Health began investigating the spa in the summer of 2018 after it was notified that a woman in her 40s had tested positive for HIV even though she had no known risk factors. The woman reported exposure to needles through the procedure at the clinic that spring.

The spa closed in fall 2018 after the investigation was launched, and its owner was prosecuted for practicing medicine without a license….

The idea that a “lip plumper” (or similar) treatment could / would lead to AIDS…? Damn. Just… Damn. Be careful out there. Always — always, demand to see every license, on paper before sitting down. Out.

नमस्ते

Anon. Points Us To The Layoff News At BMS — As Its Keytruda® (Pembrolizumab) Competitor, Called Opdivo®, Saw Declining Sales Last Year, And In Q1 2024…

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From about mid-2014 to late-2017, the immuno oncology “horse race” was on, between Merck’s bio-engineered PD-1 inhibitor (branded as Keytruda) and BMS’s… theirs being called Opdivo. We covered it with at least 100 posts in that time frame. [Search the upper left dialog box if you’d like some background, from our perspective — here. And, Merck has hit the $22 billion a year mark a year ahead of Wall Street’s estimates — here in 2024, not 2025.]

But as the markets matured in immuno-oncology, in the main, Rahway’s has shown stronger statistically better (longer term) survival data than BMS’s agent has. [In the US, it is difficult to get full reimbursement for a “second best” agent, with a winner already available, in many solid organ tumors.] And so — as of last Thursday, Bristol Myers Squibb began retrenching, thus:

…Bristol Myers Squibb on Thursday said that around 2200 staff will be impacted by cost-cutting measures designed to save about $1.5 billion by the end of 2025, with two-thirds of the savings coming from R&D. The initiative will reduce management layers in an effort to speed decision making, along with pipeline rationalisation and site consolidation….

However, revenue from Opdivo fell 6% to $2.1 billion.

Chief commercialisation officer Adam Lenkowsky explained that the PD-1 inhibitor was hit by changes in buying patterns in the US, but the company is “confident we will see accelerating growth this year….”

I would not bet on many more high growth quarters for BMS’s Opdivo — Keytruda has become the gold standard choice here (especially inside the US). So we extend our best meditations, to the families of the 2,200 BMS people being let go. Onward — now you know.

नमस्ते

It Seems Dark Energy — Universe-Wide — Is… “Thawing?” That Is, It Seems To Be… Waning.

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As ever, first — the caveats: the data is strong, but the universe is very vary large. Very large. So over billions of light years, small differences in measured assumptions. . . can become magnified. That is, it could be a measurement error. [But two independent sources are now converging on this, as being real, and not an artifact.]

Moreover, this is approaching five sigma, nearly a gold standard for significance. More to come, of course — but the notion is that maybe the universe is a closed system — an endless series of big bangs and big collapses. [In a poetic/metaphorical sense, confirming endless “reincarnations” of all that we will ever see.] That we are not flying apart, never to fall back in, to a center.

Here’s the latest, via Wired.com:

…If dark energy is weakening, it can’t be a cosmological constant. Instead, it may be the same sort of field that many cosmologists think sparked a moment of exponential expansion during the universe’s birth. This kind of “scalar field” could fill space with an amount of energy that looks constant at first—like the cosmological constant—but eventually starts to slip over time.

“The idea that dark energy is varying is very natural,” said Paul Steinhardt, a cosmologist at Princeton University. Otherwise, he continued, “it would be the only form of energy we know which is absolutely constant in space and time.”

But that variability would bring about a profound paradigm shift: We would not be living in a vacuum, which is defined as the lowest-energy state of the universe. Instead, we would inhabit an energized state that’s slowly sliding toward a true vacuum. “We’re used to thinking that we’re living in the vacuum,” Steinhardt said, “but no one promised you that.”

Joshua Frieman, a cosmologist at the University of Chicago and a member of the DESI collaboration who didn’t work on the data analysis, said he would be glad to see Lambda CDM fall. As a theorist, he proposed theories of thawing dark energy in the 1990s, and he more recently co-founded the Dark Energy Survey — a project that searched for deviations from the standard model from 2013 to 2019 and created one of the three supernova catalogs DESI used. But he also remembers being burnt by disappearing cosmological anomalies in the past. “My reaction to this is to be intrigued,” but “until the errors get smaller, I’m not going to write my [Nobel] acceptance speech,” Frieman joked….

The beauty of all this is that Einstein (were he alive) would celebrate wildly, if the next-gen data refutes his “constant” definitively. He always said that we learn the most when our best presumptions turn out to be… in error. Onward, grinning into a busy week ahead.

नमस्ते

The Sole Reason Mirengoff Feels Today’s Columbia Protests Are “Inconsequential”?! They Aren’t Being Drafted…

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Well now… I’ve seen it all.

I can’t be sure whether Paul believes what he says about today, or whether he’s just looking to justify his own life’s arc, looking back — toward 1969 at Dartmouth.

But he would tell us today’s protests on campuses don’t matter — or at least are not of the gravitas that prevailed against the War in Vietnam, by 1969-’70.

For Paul, it all comes down to… he and John and Scott might have been… drafted.

These students mostly don’t have the right to protest, today — as at least in his mind — they cannot be forced to go fight.

One small point Paul may have here: it was true, that the rising sentiment against the War in Vietnam… by 1969 — enjoyed very broad public support (excepting only in very small towns in the West and the deep South). And so, in this present case, I sense that supporting the right of Palestine to even exist… is still a minority view in the US. [In that regard, Bibi is doing a masterful job of painting all who disagree with his aim as “antisemitic”.]

But even on that point, I think most Americans support the idea that Palestinians have a right to some land — near or on… the Mediterranean. Where, and how much, is the rub — just as where, and how much… is the rub about… yep, Israel.

But I see nothing in Amendment One that says only popular views will be allowed to set up tents on campus lawns. Geez.

So it goes. Onward — and my important footnote, now mentioned repeatedly: Paul seems blissfully unaware of the immense privileges that were conferred on him, related to Vietnam protests — ones not enjoyed by peaceful civil rights protesters just five years earlier. [Same, as to John and Scott.]

He finished with honors, and went to Stanford Law. Many of the other young college kids, mostly of color in the South were beaten bloody, or worse… and blacklisted from any and all meaningful jobs (outside of civil rights activism groups, which thankfully eventually won the day — and led to Mayor Andrew Young, in Atlanta — and Rep. John Lewis in Congress, as two examples)… all for saying the they had the same rights as their whyte counterparts.

Peacefully.

Damn, Paul.