Archive for the ‘Uncategorized’ Category

An Update… The Brexit Saga: Another Delay, Past End Of March 2019?
February 23, 2019

I will simply note (again) that the mid-2016 “sky is falling” journalists, lobbyists and consultants got this one. . . wrong. All wrong, in fact.

Here we are at the end of Q1 2019 — and the latest delay manuevering looks to take it to the back half of 2019, minimum. Much as we posited. [My mid-2018 Merck-related backgrounder may be found, here.]

Not entirely coincidentally, we also posited that our brothers and sisters in Ireland would turn these Brexit lemons. . . into lemonade. And that seems to be exactly the case.

Onward on a warmer, blustery, rain-swept Saturday — with a baby sleepover ahead! . . . smile. And, I see you — in over an inch and a half of rain(!). . . stay safe — and dry. Fondly. . . .

नमस्ते

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[U] ICE & ORR Intentionally Violating Court Orders — To This Day, At Trump’s Direction. THESE ARE… CHILDREN.
February 22, 2019

UPDATED 02.23.19 @ Noon: Late on Friday in San Diego, the able Judge Sabraw entered the following order:

“. . .IT IS HEREBY ORDERED:

1. On or before February 28, 2019, defense counsel shall provide to Class Counsel the list of persons subject to removal. Counsel shall meet and confer on the best way to cull that list down to persons with expedited removal orders.

2. Defense counsel shall advise Immigration and Customs Enforcement that class members subject to the settlement agreement in this case may not be removed without first providing them with notice of the settlement and an opportunity to decide whether they wish to take advantage of the settlement procedures or waive those procedures.

3. Counsel shall provide the Court with an update on these issues in the next Joint Status Report.

4. The Court will reserve any ultimate decision on Plaintiffs’ motion pending the outcome of the meet and confer efforts set out above.

SO ORDERED. Dated: February 22, 2019. . . .

[End, updated portion.]

I cannot fathom the mind, of a president (apparently) that feels it is “his right” to continue to direct federal agents at ORR and ICE to separate very young children from their parents or guardians at the southern border — after being explicitly ordered by a federal court to stop doing so.

It is time for contempt orders, in my opinion. There was a status hearing late yesterday in San Diego. Orders are supposed to issue, according to the minute entry. I hope they start to include more severe sanctions, for intentionally ignoring court directives — by Trump’s administration. Here is the latest from the ACLU, and a bit of it:

. . . .Plaintiffs’ primary unaddressed concern is with the 218 separations that reportedly took place after this Court’s injunction, through December 26, 2018. OIG Report (Dkt. 344-1) at 14, 21. OIG noted that these separations are happening at “more than twice the rate that ORR observed in 2016.” Id. at 11. The Report analyzed 118 of these separations and found:

69 percent of these separations were of children under 13 years old; 23 percent were of children under 5 years old;

Some children were reported by ORR as separated on the basis of “immigration history only”; or because the adult lacked proof of legal guardianship; or with so little detail provided that OIG could not determine the reason for separation. . . .

This concern is particularly salient in light of recent disclosures from the government’s counsel of purported criminal exclusions from Ms. L — one parent was reported as excluded on the basis of a littering conviction, another for a fake ID — which raise concerns that ongoing separations may not be in compliance with the Court’s orders. Plaintiffs are also hearing from advocates that the government is separating a substantial number of families, and thus there may be more than 218 post-June 26 separations. In light of the OIG Report and information from advocates on the ground, plaintiffs intend to raise with the Court the need to ensure that there are (1) clear standards for future separations by DHS, and (2) a meaningful process to ensure that families can contest separations.

Finally, as the Court is aware, in December the government reported 149 additional separated children. Most were released from ORR care after the June 26 preliminary injunction and before the government certified a list of separated children on July 11. The OIG Report found about 300 potentially separated children did not appear in the July 11 list, and were released from ORR care in the same June 26-July 11 window. OIG Report at 9-10. The difference between about 300 and 149 additional separated children is not addressed in the government’s response. . . .

It is appalling. Simply appalling that week after week, month after month, these government agents violate US law, and court orders, at Trump’s explicit direction. These are. . . babies.

नमस्ते

[U] Trying To Decide Whether I’ll Closely-Cover The Coming Congressional Pricing Hearings…
February 18, 2019

Updated 10 PM EST on 02.19.2019: Merck saw a surprise null result in HCC, one difficult cancer, with pembrolizumab tonight — after getting FDA priority review for the indication. It won’t change the big picture here — but worth watching, should we see other null results. Cancer is a bafflingly complex disease — and it varies greatly by affected organ or system. That’s the object lesson. [End, updated portion. H/T to my buddy Matt Herper for the lede.]

I am honestly conflicted — and more than a little jaded — after PhRMA was largely able to blunt the pricing measures we designed into what ultimately became the ACA of 2010. There will be many voices, with equally cogent insights, on it all. So, we shall see — if I see a void in the coverage.

[I do like that STAT has labeled Merck’s Mr. Frazier as the “Saint” — heading into hearing day, on next Tuesday.  By way of background, a little over a decade ago — and around two million visitors ago, I closely covered the Congressional hearings and resulting investigations, into what was then “Fast” Fred Hassan’s / Schering-Plough’s Vytorin® (dubious efficacy, coupled to ridiculous pricing). I did also follow several lower profile post 2009 US health care reform moves, more generally for pricing effects, in some detail. So I have done this dance, more than once before. . . .]

But however this one rolls out — at least I have a snappy graphic, piping hot and ready to rock, from my pixel oven — for the hybrid approach big multinationals ought to adopt. . . as a mantra. See at right. It is a riff on the last one I made, from the good pembrolizumab renal carcinoma results. Turn-about it seems, is fair play, here.

Onward — and. . . sleep tight, all you little buck-a-roos and buck-a-rettes. . . . smile.

नमस्ते

[U] Keytruda® Continues To Shine — This Time, In Kidney Cancers… With (And Without) Pfizer.
February 17, 2019

Updated 10 PM EST on 02.19.2019: Merck saw a surprise null result in HCC, one difficult cancer, with pembrolizumab tonight — after getting FDA priority review for the indication. It won’t change the big picture here — but worth watching, should we see other null results. Cancer is a bafflingly complex disease — and it varies greatly by affected organ or system. That’s the object lesson. [End, updated portion. H/T to my buddy Matt Herper for the lede.]

This past week, two separate clinical trial results suggested that Kenilworth’s mega-blockbuster pembrolizumab (branded as Keytruda®) is significantly improving survival durations as a standalone-, and as a combo-therapy (with a Pfizer agent), in hard-to-treat kidney cancers (or, renal cell carcinomas) — measured over current standard treatments.

[The below pull quote suggests these developments may add to the market penetration erosion of BMS’s Opdivo® — in immuno-oncology, though Opdivo will (of course!) remain a mega-blockbuster — garnering multiple billions in annual sales, well into 2025.]

Here’s a link, and just a bit, from BioPharmaDive:

. . . .Better-than-expected positive results from a late-stage study could position Merck & Co’s immunotherapy Keytruda to play a large role in the treatment of metastatic kidney cancer, putting pressure on rival Bristol-Myers Squibb at a critical time.

Combining Keytruda with Pfizer’s Inlyta nearly halved the risk of death in previously untreated patients with metastatic renal cell carcinoma (RCC) when compared to Pfizer’s older drug Sutent, currently the standard of care. Notably, the combination’s benefit was consistent across risk groups and levels of PD-L1, a biomarker frequently correlated with response to immunotherapy.

While Merck has largely wrested a leading position in the immuno-oncology market from Bristol-Myers, RCC is one cancer type Bristol-Myers’ rival Opdivo still holds a marked advantage in, having secured approvals in 2015 and 2018. Analysts view Merck’s data as highly competitive, however, and likely to position Keytruda well versus Opdivo. . . .

Now you know. . . it is an exciting time to be. . . alive. Off, to shovel again — as another measurable snowfall passed through overnight; an added workout. Smile.

नमस्ते

With Gratitude — For NASA, JPL And… Thee, “Opportunity”.
February 16, 2019

We are grinning, ear to ear — on this quiet cloudy Saturday afternoon (with dustings of snow due in shortly), here (even as we know others are marking profound passings, tomorrow):

The echoes of your past vibrate through space,

And secrets lie beneath your broken skin;

The cracks and rimless craters on your face,

Reveal to us what’s hidden deep within.

Now frozen underground in super lakes,

Under a pitted surface lined with breaks;

A reservoir of life within our sight,

To reach for when we know the time is right.

— Samuel Illingworth
Plains of Paradise
December 2, 2016

Yes. Opportunity has fallen silent, into eternity. And we will miss that rover’s lilting little “voice“, to be sure — so filled with knowledge, wonder and. . . the sweet new undiscovered country. But — even so — onward, to. . . tomorrow, and drilling on Mars with the Insight science deck pack. Ever. . . onward.

नमस्ते

Of Forcing The Corrupt Trump Admin. To Identify Parents & Children Separated At Border Since Early 2017….
February 14, 2019

As we celebrate the Saint’s day decidedly quietly, we will link to a fine reply brief in the Ms. L. class settlement in San Diego, a 12 pager that once again makes plain that Trump’s administration is trying to prevent refugees and asylum seekers from benefitting under the settlement it had to agree to in October 2018, given the brazen violations of law by 45’s team, then underway.

The notion that the ACLU and others must go “find” people Trump is effectively “hiding” — by not sharing information — is simply. . . jaw slacking. But so like. . . Trump. [Last night, he preposterously tweeted that he thought he had the authority to ask California to “repay” money Congress (i.e., not the Executive Branch!) granted it, for bullet trains — because he is desperate to find his Luddite Adder-wall money.] He is a monster.

. . . .[T]he issue before the Court is two-fold: (1) if a parent class member was given an expedited removal order while separated, was not issued a notice to appear, and has not submitted a signed waiver form, is he or she nonetheless entitled to relief under the settlement, and (2) if so, what are the obligations of the Government under the settlement? Recently reported numbers show why these questions matter. . . .

. . .[T]he class notice list includes 1,202 parents who were in the United States as of last year and who are potentially entitled to relief, which means that at least 991 parents on the class list have not submitted forms. . . .

Even if “many” of these 991 parents were released into the community with notices to appear (and thus do not require settlement procedures), there are almost certainly others who require the settlement relief agreed to by the parties. Class counsel have no way of knowing how many additional individuals are entitled to relief or who they are. Only the Government has the ability to identify them. . . .

The threshold determination for the Court, as acknowledged by the Government in its Opposition, is “what must happen to trigger the government’s obligation to provide” settlement procedures. Defs.’ Opp’n 4:24-25. The Government takes the position that each and every class member must submit an executed waiver form to trigger his or her right to relief under the settlement agreement. Although the Government characterizes its position as providing class members with “the opportunity to make an affirmative election whether or not to accept the rights,” the Government’s substantive position is that class members are not entitled to relief unless they submit forms. Id. at 3:13-22 (proposing “a procedure in which class counsel is responsible for determining the election of each and every settlement class member before any action is taken in his or her case”). Stated differently, the Government is trying to convert the agreement to a “claims-made” or “opt-in” settlement. . . .

Now you know — off to catch a jet bound for points north and east, from a rainy warm tarmac. . . do love those you love — in honor of the fine Saint’s day. . . smile.

नमस्ते

AMERICAN History: 110 Years Ago, This Morning — AND… 210 Years Ago…
February 12, 2019

In response to endemic lynchings (primarily) in the south, the National Association for the Advancement of Colored People was formed, by Ida B. Wells and W.E.B. Du Bois, among others.

And while it is Black History Month, I also celebrate this as a milestone of American History, writ large(r). One step, in bending the arc of history, toward — progress:

. . . .In 1908, a deadly race riot rocked the city of Springfield, the capital of Illinois and resting place of President Abraham Lincoln. Such eruptions of anti-black violence — particularly lynching — were horrifically commonplace, but the Springfield riot was the final tipping point that led to the creation of the NAACP. Appalled at this rampant violence, a group of white liberals that included Mary White Ovington and Oswald Garrison Villard (both the descendants of famous abolitionists), William English Walling and Dr. Henry Moscowitz issued a call for a meeting to discuss racial justice.

Some 60 people, seven of whom were African American (including W. E. B. Du Bois, Ida B. Wells-Barnett, and Mary Church Terrell), signed the call, which was released on the centennial of Lincoln’s birth. . . .

Now you know. Out, into the warm, clear Sonoran breeze. . . .

नमस्ते

A Sad Ebola Milestone Passed In DRC; And An Inspiring New Name, For ESA Exo-Mars Rover…
February 11, 2019

I’ll mention two disparate stories this morning, as we head off to the desert museums.

The first, and sadder, one: the death toll has eclipsed 800 in the current DRC ebola outbreak, with over 100 of them. . . children. Even with over 80,000 people now vaccinated, it will still be several months until the dying is arrested, there.

In brighter news, the long-overlooked British discoverer of the double helix of DNA, Rosalind Franklin, is being honored posthumously, by having the next ESA Mars rover named after her. She was long ignored, even though she was prior in time to Watson and Crick. No more (arriving in 2020):

. . . .Rosalind Elsie Franklin was a British chemist and X-ray crystallographer who contributed to unravelling the double helix structure of our DNA. She also made enduring contributions to the study of coal, carbon and graphite. . . .

The ExoMars rover will be the first of its kind to combine the capability to roam around Mars and to study it at depth. The Red Planet has hosted water in the past, but has a dry surface exposed to harsh radiation today.

The rover bearing Rosalind Franklin’s name will drill down to two metres into the surface to sample the soil, analyse its composition and search for evidence of past – and perhaps even present – life buried underground.

The rover is part of the ExoMars programme, a joint endeavour between ESA and the Russian State Space Corporation, Roscosmos. . . .

Now you know. Onward — out into the warm (temperate 60s) afternoon sunshine — and musical museums. Smile.

नमस्ते

Justice Kavanaugh’s FUNDAMENTAL Error: His Dissent In Louisiana, Last Night
February 8, 2019

There has been much coverage of Chief Justice Roberts’ vote (with the liberal wing — to reach the required five Justice majority), to uphold the stay on the would-be highly restrictive Louisiana anti-abortion rights law from taking effect while the case progresses through the courts.

I am certain that “law” is utterly indistinguishable from a Texas law the Supremes invalidated in 2016. So, if the legal doctrine of binding precedent is to mean anything, the Louisiana abomination will go down in flames. As it ought to.

I write briefly though to note for the record, how hard Kavanaugh is straining to get to a spot — any spot — to take up Roe v. Wade. So much so, that his “dissent” makes the astonishing error (almost certainly intentional). . . that any Louisiana law, as written — applies to only the current four doctors offering abortion services. Rightly the majority recognizes that this unconstitutional Louisiana measure will impact an entire class of future doctors, if allowed to take effect. So it has placed the law on hold — until it returns, on the merits to strike it — under the 2016 precedent. Here is Kavanaugh:

. . . .On the other hand, if the [four] doctors can obtain necessary admitting privileges during the 45-day transition period, then the doctors could continue performing abortions at the three clinics both during and after the 45-day transition period, as envisioned and predicted by the Fifth Circuit. And in that circumstance, the Louisiana law as applied would not impose an undue burden. . . .

So — Justice Kavanaugh, not joined by any other Justice in his dissent, by the way — believes a woman’s right to bodily integrity hinges solely on whether specific doctors may readily comply with a purported new law. It does not turn on rules of general applicability of that law. That frankly, is insane. I can guarantee that he will not express this view of a law purporting to add regulatory hurdles to (for example) people claiming environmental harm from dioxin spills into the water table of a community.

Off now — to enjoy the desert’s beauty. . . .
नमस्ते

[U] This Level Of Trump Administration “Foot-Dragging” — In Delaying Implementation Of Clear Court Orders… Is Stunning
February 6, 2019

UPDATED: 02.07.19 @10:35 AM CST — Now pending before the court is an order, for the able Judge Sabraw’s signature, to clarify that a cramped reading of who might be entitled to relief under the Ms. L. October 9, 2018 settlement should not prevail. The proposed now signed and entered order broadly defines essentially all people claiming refugee or asylum status (since early 2017) at the border as eligible for the protections of the settlement — not just the narrow, cramped, patrician reading advocated by the Trump lawyers. End, updated portion. Oh — if you care — here is the mostly specious 22-page-rationalization, offered by Team Trump, for opposing this clarifying order. Me? I. . . don’t. Onward.

It is gravely disheartening to see the Executive Branch actively “slow-walkingany binding nationwide federal court order (for example, in regard to environmental remediations, related to ethylene oxide levels, in Chicago area medical waste facilities).

But. . . it is unprecedented — in the modern history of the Presidency, since the end of WW I (1919), to see this sort of foot-dragging where defenseless children are literally still in cages — being kept away from their parents and guardians. The Japanese American Korematsu plaintiffs saw speedier relief (late in WW II). This is equally unlawful — and nearly 75 years have passed, since the nation learned that awful lesson. Here is a bit from the status report filed this afternoon, in San Diego:

. . . .At the November 30 Status Conference, the Court requested the parties to agree upon a baseline of the total number of parents who were removed following separation from their children, so as to provide the Court with a complete accounting of the reunification process. The government has not yet provided their proposed baseline to the Steering Committee.

Moreover, since November 30, the government has disclosed that 149 additional separated children were in ORR custody on June 26, 2018. Despite the Steering Committee’s requests, the government has not reported whether any of these additional 149 children’s parents were removed, nor provided identifying information for any such additional removed parents. The Steering Committee requires this information to ensure the needs of those families can be addressed. . . .

The Steering Committee remains very concerned that more than 50 children remain in ORR custody and have not yet been placed with appropriate sponsors. At the November 30 Status Conference, the Court requested the government monitor the pace of release and provide the Steering Committee with information regarding the status of releases.

The government provided the Steering Committee with general information regarding the kinds of issues that delay placement with sponsors on December 11, but did not provide any information about particular cases or report on the number of children who had recently been placed with sponsors. In light of the passage of time and the number of children who have not yet been placed with sponsors, the Steering Committee asks that the government provide more particularized information and identify any roadblocks to expeditious release. . . .

I am appalled by Donald Trump’s personal, unblinking, unthinking savagery — appalled. He is the most pernicious (non-) “leader” in the history of our nation. And history will write him down as not appreciably different than the likes of. . . Idi Amin, insofar as he has conducted himself, in the border matters. Disgusting.

नमस्ते