Tuesday, January 22, 2019

New Logistics/Supply Chain Issues -- For Ebola PCR (Viral) Diagnostics Tests...

This morning's news comes from the prestigious science journal Nature. I suspect it is published there, in no small part, to goad the rest of the life sciences community to pitch in and help -- as well as suggest that Biocartis, a molecular diagnostics company based in Mechelen, Belgium, should step up (again), and do some (more) largely pro bono, work here.

In truth, I am just a little skeptical -- that a diagnostic test, even with immediate availability on site, and speedy turnaround of the (genetically amplified) PCR result, is going to make a big difference -- in urban areas. Once a patient presents with fever and vomiting or bleeding in urban Beni or Butembo, the safest course is to monitor -- and isolate. And immediately vaccinate all contacts -- and contacts of contacts.

It seems a PCR diagnostic kit would be of most use -- if immediately available, in the field, in rural, or remote settings (where a return takes days or weeks, for MSF volunteers to find the contact anew) -- but any delay -- beyond a few hours' time, in any urban center, in isolating a feverish person. . . risks a spread of the dread, deadly virus.

Here is the story, though -- just the same:

. . . .[H]ealth workers and organizations trying to stem the current outbreak cannot obtain diagnostic tests fast enough. Even when funds from international donors are available to pay for them, it is taking staff at laboratories or health centres two to eight weeks to get hold of the tests.

There are two types of diagnostic test for Ebola. Rapid diagnostic tests detect a viral protein; those based on the polymerase chain reaction (PCR) identify the virus’s genomic material. By filling out company request forms, e-mailing manufacturers and searching their websites, we established that, of the recently approved tests provided by companies, only four are readily available to buyers. . . . All of these are PCR-based tests. OraSure Technologies in Bethlehem, Pennsylvania, has made its rapid diagnostic test OraQuick available to the WHO and the US Centers for Disease Control and Prevention (CDC), which are distributing the test to health workers in the current outbreak. But it is not available to other buyers.

Our analysis reveals that research and scaled-up production have been sustained for only a few of the company-provided tests that were developed and approved during the 2014–16 emergency. Indeed, we were co-developers of a diagnostic test for Ebola that is no longer available because the manufacturer [Biocartis] decided to focus exclusively on oncology. . . .

Consider that a dose of. . . moral suasion, from the editors of Nature. Onward to the trains -- on a gray but promising Tuesday. They do seem to slide on air, suspended all-but silently -- gliding over the white snowbanks, and swirling sugar behind them -- on days like today. Smile.


Monday, January 21, 2019

It Deeply Disturbed Me -- To Hear Faux-Christian Mike Pence Had Invoked King, In Favor Of Trump's Wall...

No graphic. [But I will re-run the eloquent "Hamilton" closing request video (the cast, speaking to Mr. Pence, who was that night in the audience in Chicago, from Thanksgiving 2016.]

..... Mr. Pence, please -- just read MLK's 1963 letter from that jail cell in Birmingham -- not a single word of it supports any wall -- nor does the Dream speech. . . nor does even a single day of King's life.

In sum, then -- every word Mike Pence uttered yesterday was false.

Apparently, he and 45 spent a little over two whole minutes today, at the King Memorial. They shot 30 seconds of video, and left. Here's the odious Pence quote, for posterity:

. . . .“One of my favorite quotes from Dr. King was, ‘Now is the time to make real the promises of democracy.’ You think of how he changed America. He inspired us to change through the legislative process to become a more perfect union. That’s exactly what President Trump is calling on the Congress to do,” Pence, 59, remarked. . . .

This is evil. And Mr. Pence well knows it. The real "promise of democracy" applies -- in full -- to refugees and asylum seekers. They DO arrive lawfully, Mr. Pence. Please read our own laws, Mr. Pence. Start with 8 U.S.C. § 1158(a)(1). I'm out.

Also, do recall what the cast of "Hamilton" asked of you, now a little over two years ago. It appears above, left.

[Re-Upping, For King Day 2019:] "A Pillar Of Fire" -- Is What He Became... But A Complicated One...

I will probably add no more to the blog -- until the date has passed, but please, I implore you -- do not collapse his life into a. . . cartoonish mythology.

He was a far more complex, and nuanced thinker than most of the press accounts would suggest. . . . do not lose him, in a sound bite.

If you really want to know the King that his fellow marchers knew (and cannot afford the time to interview them all, yourself) -- you must go read all of Taylor Branch's volumes, on his life. Throughout each volume, Branch's narrative is meticulous and poetic American history -- yet not watered down into the sound-bites so many today traffic glibly to and fro, as an excuse for analytical thinking. I'll quote just a bit of an older interview of Mr. Branch, to give you a sense:

. . . . "King had crossed over as a patriarch like Moses into a land less bounded by race. To keep going, he became a pillar of fire. . . ."

In an interview in his Mount Washington home, Mr. Branch said he found it striking how Dr. King, in the years before his assassination in April 1968, again and again chose a course that many around him considered wrong, foolhardy and even dangerous.

"To go from winning the Nobel Prize to Selma, to force yourself to do that against the wishes of not only your white allies but also of some of your own movement people -- you're really fighting to take yourself down," Mr. Branch said. "That 'downward King' is really full of passion and difficulty.

"In the early times, King is fighting for success, both for himself and his cause -- that is, for recognition. And, finally, it happens. He becomes famous, wins the Nobel Peace Prize, and so forth. Lots of people wanted to celebrate him for that. And the natural tendency is to not jeopardize all that, but that's precisely what he did. You get the picture of someone who is besieged on almost every side, and is willing himself downward to greater risk because he is driven by his conscience. . . ."

He cited several examples: Dr. King's involvement in the Selma voting rights campaign, his vocal opposition to the Vietnam War, his decision to move the civil rights campaign north in 1966, and his belief that an ambitious program was needed to end poverty in America.

"It was a revelation to me how controversial the poverty program was among his own people," Mr. Branch said. "His determination to make that an issue bothered them because it went against their status. It meant associating with the poorest of the poor. The leadership class -- the coat-and-tie set, whether they were ministers or NAACP types -- had to go out and make common cause with illiterate sharecroppers and the equivalent of the underclass. That was not popular among the movement, and it sure as heck was not popular among white liberals. They thought he was getting out of his element, talking about economic issues instead of morality and how to treat people.

"And, of course, the same was true about Vietnam. There he was altogether out of his element, and not only was he out of his element, but many people who had never shared his cause of civil rights repudiated him, reproached him for damaging his cause by getting out into an area where he didn't belong."

As for King's decision to lead civil rights marches in the Chicago area in 1966, Mr. Branch said: "You'd be surprised at the number of people who didn't think racism existed in the North and saw it as a peculiarly Southern phenomenon. But after those marches through Gage Park and the Chicago suburbs, they were too vivid for people to ever deny that there was something primordial about race in the North, too. . . .

It is with both joy -- and profound sadness -- that I will mark the day. Obviously the sadness, for a life stolen by an assassin -- far too short of King's own ambitions -- for a more just society. The joy though -- that so much of what he hoped for, and dreamed of -- has been been rekindled -- in a new generation (through the fires lit by an undeniably racist president, and his ilk):

May they, one day soon (in body and spirit) have crossed over, into a land less bounded by race -- and now, to keep going, they must become. . . pillars of fire. . . and a good Monday Tuesday morning, to all of like-minded good will.


Saturday, January 19, 2019

Well. All. Of. That. Was. Just. Silly...

Apparently, Trump spoke this afternoon. I didn't watch. Didn't need to. This will be brief, because his "big deal" is both devoid of substance, and what is there is. . . a silly mess. In sum, the great dealmaker offers. . . nothing we don't already possess.

DACA dreamers are, under an existing Ninth Circuit (federal appeals court) order, still continuing to seek and receive deferrals. The program continues, by federal court orders. Trump cannot change that. So his offer of three years, is actually a step backward, toward outlawing dreamers. Preposterous.

Here's an idea: maybe we let him build him a wall of cardboard, one that bio-degrades in about three years, into mulch for farming -- and then, we make DACA permanent, and we permanently revoke Muslim Ban 3.0 (the only Trump xenophobic measure the Supremes let take effect) -- oh, and he, McConnell and the Supremes agree to unseat both Kavanaugh and Gorsuch -- all in exchange for his $5 billion.

Oh -- one more thing: Merrick Garland is immediately a. . . Supreme.

Seems eminently fair, if we are to mirror, in reply -- the lunacy-laced Trump World political "thoughts". [More like "headaches, with pictures" -- as Frye (on Futurama) memorably said.]

I guess he pointed to San Antonio as a city where a version the wall has "worked". The map -- any map, actually -- would reveal to him that San Antonio is 150 miles away from any national border. He is. . . frighteningly stupid. And he is a felonious liar, to boot. Impeach. Now.

And. . . enjoy the seven inches, one and all. . . smile. नमस्ते

Thursday, January 17, 2019

[U X3] I Wish I Could Laugh At The Fact That The President Cannot Spell "Hamburgers"...

On any given morning, since at least late January of 2017, we have been treated to displays of willful presidential ignorance.

To be sure, many are trivial (mis-spellings -- like forrest, scott-free, countrty, madame and hamberder) -- but many are simply jaw-dropping, in the ignorance he displays about so many of the fundamental matters: the role (and more importantly, the Constitutional limitations) of his office, in the larger scheme of the American style of ordered liberty -- and the rigors of leading, on the world stage.

As just one example, I will note that now over 1,800 Chicago-based federal immigration hearing matters are indefinitely delayed -- putting DACA dreamers, refugees, asylum seekers and green card applicants in an awful limbo. The backlog grows longer, by the day. And that's before we talk about the 800,000 people living without a paycheck his administration owes them. Honest, decent hard working Americans all of them -- are facing terrible uncertainty, or worse, due to his vain and illogical tantrum.

[I will not run any original graphic today. But when a clean, embed-ready video of AOC's "Where's Mitch?" makes it to GIF land, I'll paste it here. Do go see it!]

I applaud Speaker Pelosi, for making it plain to Trump that our scheme imagines the legislative branch as a check on his hubris. He should not be invited to Congress, until he ends his own self-inflicted shutdown (with the aiding and abetting efforts, of course, of Mitch McConnell). The House has voted now nine eight times to end the shutdown, with specific CR measures. Mr. McConnell, at Trump's order, is preventing any Senate floor vote on any of them.

We truly are in 25th Amendment land, now. [Updated: I should have mentioned that President Eisenhower warned us, as he left office 59 years ago this morning, of the rise of the “military industrial complex”. . . now loaded with a gravy boat, of graft and self-dealing, under Trump. He was right.]

And here at day’s end, we are reliably informed that thousands more children were taken from their parents at the border, even before Trump announced his now enjoined policy change. . . While the opt out provisions of the Ms. L. settlement order mean these families are entitled to relief — finding the kids, to reunify and award damages to the families — will be a real obstacle. Deplorable.


Tuesday, January 15, 2019

The Able Judge Jesse Furman Rules Mr. Ross' Census "Citizenship" Question... Unlawful, Under The APA.

This is very good (if rather widely expected) news for those of us who believe Secretary Ross is acting with invidious racial and ethnic animus -- when he tries to aid Trump's DoJ, in "finding" undocumented workers, via the coming 2020 US Census. Now that will never happen, in all likelihood.

Based on half-century old amendments to the VRA, the sharing, and use, of the Census data collected -- with law enforcement -- has been essentially prohibited by Congress, to ensure that the most accurate data is obtained, for apportionment purposes. And essentially any future power to share such data, has been reserved by Congress, to Congress. Thus, in Manhattan, USDC Judge Jesse Furman correctly ruled (in a 277 page PDF opinion) this morning:

. . .[T]he last time that the census asked every respondent about citizenship was sixty-nine years ago, in 1950. Notably, that is before the VRA was enacted in 1965. In other words, for all fifty-four years that the VRA has existed, the federal government has never had a “hard-count” tally of the number of citizens in the country. Instead, consistent with the requirement to use statistical sampling techniques “if . . . feasible” for everything other than the constitutionally mandated “actual Enumeration,” see 13 U.S.C. § 195, the federal government has extrapolated from citizenship data collected from a subset of the population to model data for the population as a whole, see WILLIAMS, THE 2010 DECENNIAL CENSUS 3.

Since 1950, the Census Bureau and former Census Bureau officials have consistently opposed periodic proposals to resume asking a citizenship question of every census respondent. . . .

[T]here is no basis in the record to conclude that Secretary Ross “actually believe[d]” the rationale he put forward, Defs.’ PostTrial Br. 75, ¶ 49, and a solid basis to conclude that he did not. And while there may well be, as Defendants assert, “myriad” other “legitimate reasons more-precise citizenship data could prove useful to both the federal and state governments,” Docket No. 412, at 30; accord Defs.’ PostTrial Br. 65, ¶ 441, the fact of the matter is that Secretary Ross did not articulate even one. To the contrary, he cited one and only one rationale — DOJ’s request for more granular CVAP data to enhance VRA enforcement — in his decision memorandum, and he affirmatively testified before Congress, under oath, that DOJ’s request was the “sole[]” reason for his decision. See Hearings Before Subcomm. on Commerce, Justice, Science, and Related Agencies of the H. Comm. on Appropriations, 115th Cong. 15 (2018) (admitted as an audio file at PX-491).

In sum, the evidence in the Administrative Record and the trial record, considered separately or together, establishes that the sole rationale Secretary Ross articulated for his decision — that a citizenship question is needed to enhance DOJ’s VRA enforcement efforts — was pretextual. Because Secretary Ross’s stated rationale was not his actual rationale, he did not comply with the APA’s requirement that he “disclose the basis of [his]” decision. Burlington Truck Lines, Inc., 371 U.S at 167-68 (internal quotation marks omitted). As Defendants themselves have conceded, see May 9 Conf. Tr. 15, that by itself entitles Plaintiffs to relief under the APA. See, e.g., Woods Petroleum Corp., 18 F.3d at 859-60; Latecoere Int’l, Inc. v. U.S. Dep’t of the Navy, 19 F.3d 1342, 1356 (11th Cir. 1994) (noting that “proof of subjective bad faith” by decision-makers, including “predetermining” the awardee of a government contract, calls for relief under the APA). . . .

Now you know -- onward, with a spring in my step -- to the trains. Smile.


Monday, January 14, 2019

A Look Back, At Oumuamua: And What It "Might Have Been" -- With The Chair Of Harvard's Astronomy Department...

More than a year, on. . . I remain skeptical, because such extraordinary claims should require extraordinary evidence.

But I do quite enjoy reading about what it might -- emphasis might -- represent:

. . . .[What] if we discover remnants of advanced technologies? They will prove to us that we are only at the start of the road; and that if we don’t continue down that road, we will miss a great deal of what there is to see and experience in the universe. Imagine if cavemen had been shown the smartphone you’re using to record me. What would they have thought about this special rock?

Now imagine that Oumuamua is the iPhone, and we are the cavemen. Imagine scientists who are considered the visionaries of reason among the cavemen looking at the device and saying, ‘No, it’s just a rock. A special rock, but a rock. Where do you come off claiming it’s not a rock?’. . . .”

But it does fire my imagination -- just the same -- if in fact it is some archaeological evidence of prior intelligence (a solar sail) from near where Vega is now -- but it would have left that area, within our neighborhood, long before Vega wheeled into that space. . . you see, it seems it was floating relatively still, like a leaf on a pond, compared to its local group of stars, some 600,000 years ago.

And again, the professor argues this is more evidence of its non-natural origin or course -- it was not just a random rock thrown free of one solar system. . . or so the argument runs.

In time, we may know.

Indeed, in time. . . . even if it turns out to have only been a rock — this graceful, roughly Mount Blanc pen-shaped metal-clad rock, is likely from a cosmic ancient river, a river borne of the vestiges of one or more timeless raindrops — and under those raindrops, are the words — and some of those words, are mine to you. Travel well — and do travel light. So it all. . . may end, just this way: unknown.


Friday, January 11, 2019

Two-Thirds Of All The Current DRC Ebola Viral Infections Afflict Women, Where Vast Majority Live In Poverty...

. . .and so, it makes good epidemiological "combat" sense to have the "Mother Counsellor of Beni", a voice women trust -- a local, long time radio advice on-air persona give the people of Beni unfiltered truths. Between urban legends, and intersectional conflict, the truths about the hard realities of Ebola (safe burial practices, careful and comprehensive disclosures, about ALL contacts, for robust vaccination efforts, and fastidious hand washing, as examples) are more than occasionally swallowed whole, into little more than conspiracists' rumors.

Ms. Mawatatu is steadily fighting -- with the help of WHO -- to change all that. She has been on air twice a week since 2007, and is a trusted local voice. People listen and respect her take. This is how to win hearts and minds, in the DRC:

. . . .Twice a week, Mama Mwatatu rises early and makes a two-hour trek from her home in Beni’s Cité Belge neighbourhood in North Kivu, the Democratic Republic of the Congo to the local radio station. For the past 12 years, she has hosted a call-in radio talk show called “Women and Development” and has a devoted audience, earning her the nickname Mother Counsellor of Beni.

In normal times, she dispenses advice on health, relationships and child-rearing. But since this August, Ebola has shaken residents and the city is the base for outbreak response efforts in North Kivu. Mama Mwatatu’s mostly female fans have inundated her with questions: Why aren’t you talking to us about this? We don’t know what to believe. But if you tell us that Ebola exists, then we trust you.

“I told them: ‘Ebola is real, and you have to protect yourself and your family,’” Mama Mwatatu says. “But I wasn’t sure I had all the answers to the more technical questions so I got in touch with the World Health Organization (WHO) for assistance.”

And so Mama Mwatatu teamed up with WHO’s community engagement team and her two weekly shows expanded from 30 minutes to an hour.

The current Ebola outbreak in the northeast of the DRC -- the tenth since the disease was identified in 1976 -- stands out as the country’s largest. Response efforts have been complicated by insecurity and armed conflict. Another challenge is how this outbreak has disproportionately affected women. . . .

This is a very hopeful story for 2019 -- containing this urban outbreak is literally going to be achieved by shifting local perceptions. And those perceptions are not wrong, based on a historical record: more often than not, disease was used as an exploit, in these cities -- both by war-lords, and by foreign visitors (looking to run dubiously ethical pharma clinical trials -- as recently as the late-1980s). . . so re-building trust (that the Merck vaccine is the best way to arrest this scourge), and identifying all contacts of contacts, for vaccination -- will take time, in these cities. But it can be done.

And so. . . onward -- let the snow come -- "rage on -- the cold never bothered me, anyway. . ." smile.


Thursday, January 10, 2019

Put A Pin In This, For When The "Trumpian Adder-Wall®" Shutdown Ends...

Overnight, in San Diego, Ms. L's lawyers have set forth the rock solid 13 page explanation of why this is an "opt-out" rather than opt-in class action settlement. The clearly correct best bit is quoted in blue below. Of course, all the action on all these border cases is effectively stayed as Trump's lawyers cannot appear, even on a voluntary basis (nominally), for the government, under applicable federal law -- without being paid therefor.

[I also write separately related to Merck -- and post a graphic -- to note that the Supremes have decided not to take up a challenge to the fees Merck owes Gilead, for unclean hands and bad faith, in California -- on the patent case pending before Judge Labson-Freeman. Gilead gets to keep about $15 million, in legal fee reimbursement -- and need not pay the $200 million Merck was originally awarded at trial. Now you know.]

. . . .This [settlement agreement] is unambiguous that class members must take affirmative action to waive the procedures (“such waiver decisions”), and therefore class members who take no action are afforded relief. This language would be completely different if -- as the Government contends -- class members were required to submit claim forms to receive relief. The settlement agreement, and the Court’s orders approving the settlement, would describe a claim process, not a “waiver” process, and would likely articulate a requirement to submit a claim form and set a deadline for submission of claims, as is common in other types of class action settlements . . .

So, we now await the "Adderall® induced" idiot's end of his shutdown, to see what happens next in all this asylum/refugee/border litigation -- but the "brown people without papers" clearly hold the upper hand -- because they need rely on only three pieces of (very public) paper: the provisions of (i) 8 USC, (ii) our Constitution and (iii) the treaties signed as contemplated thereunder.

Onward, smiling -- as I look toward the Gulch this afternoon. . . ever, onward -- snow coming in, up here tomorrow night. Lovely. Truly lustrous -- and lovely.


Wednesday, January 9, 2019

Ignoring That DC Lunatic, Tonight -- We Will Look Some 300 Million Light Years Off, Into The Night Sky... Powdered With Stars

[Ahem. I prefer the unwasted grace -- of celestial events -- even half a Universe away, tonight. . . to those unfolding as the 45 faux-emperor throws another tantrum, in DC.] In this retelling, we have learned that a smallish white dwarf has donned a very powerful radiation emitting "coat of many colors" -- (or white-hot ballgown, if you prefer) and has become almost 40 per cent brighter (in x-ray emission waves) than the host black hole (which weighs in at over one million Suns' mass) it is whirring around -- at about half the speed of light. And the pirouette is likely to remain stable, for a few hundred years -- an eye-blink -- in celestial time, but an entirely welcome eternity, for the dancers invo-loved.

What a performance that would be to behold, from the edges of this far off system. Not unlike watching a long-lost then teen-aged friend, dance at a winter formal, some 22 years earlier, from the edge of some jet black obsidian clad ballroom floor. Whoosh. What a twistingly luminous. . . sight. From Discover online, describing the latest measurements, seen and confirmed by three separate interstellar observatories (Chandra, XMM-Newton and Swift), here:

. . . .The team thinks that these powerful radiation bursts are actually caused by two stars instead of one. The original sighting in 2014 still holds up: a black hole lured in a passing star and tore it to pieces. Some of these stellar shreds, which emit massive amounts of X-ray radiation, were sucked into the back hole. Others, though, remained in the innermost stable circular orbit (ISCO) — the closest spot where objects can orbit a black hole without being devoured by it.

In that dangerously close orbit lies another star, thought to be a tiny, dense white dwarf. Researchers think that the dwarf’s gravity pulled in the bright stellar remnants, creating a halo, or coat-tail, of X-rays around it. These X-rays can be seen every time the star orbits the black hole, which is once every 131 seconds. . . .

The night sky is a blackened road, "powdered with stars. . ." said Milton. And tonight, I can almost see the ballgowns shimmering as they float across that firmament. Smile. So, let's all forget DC, for a spin. . . I know I will.


Monday, January 7, 2019

Tuesday Night Networks' Prime Time: Time To Turn Your Tee-Vees... Off.

. . .If the networks do grant Trump 9 PM EST all airwaves access, that is.

[With a win on Fosamax pre-emption now looking all but assured for Merck, I'll offer a little political opinion/coverage.] The Donald wants to address the nation tomorrow night -- about his temper tantrum/self-inflicted shutdown -- and the corresponding illogical, wasteful wall demand. If cable covers it (reaching only a fraction of the US households the networks reach) -- so be it -- but the three networks should not. It is simply a litany of repeated, and oncoming. . . lies.

At a minimum, if ABC, CBS and/or NBC cover him, Speaker Pelosi or (even better!) Rep. AOC ought to get an "equal time" rebuttal (yes -- let's go all the way back to the early 1960s, and Newton Minnow's ideals, then). If they don't here is (according to The New York Times) what our real, adult, non-fascist leaders are working on, this week:

. . . .Speaker Pelosi has said the House this week would start considering individual funding bills to reopen the government. One such bill would be to fund the Treasury Department so that employees for the Internal Revenue Service could return to work as tax filing season begins.

Other bills would provide funding to reopen the Agriculture, Housing and Urban Development and Interior Departments. . . .

Of course, the Senate has (two weeks ago) voiced unanimous support for the Pelosi CR bill. Senate leadership (R) refuses to let it be put to a floor vote; and 45 had indicated three weeks ago he would sign it. Then he threw a tantrum. I say -- let him complain that the networks treated him badly -- don't carry this stunt. And I say -- let him try to build the wall with a Presidential slush fund without Congressional approval. Then, let's win in the courts, and impeach him for derogation of Constitutional imperatives.

Yes -- we are at the end-game for his feeble presidency, starting. . . now. And about it all, my step is appreciably. . . lighter. . . Lighter in part, because even Gov. Haslam -- in bright red Tennessee -- is granting this sexual assault victim clemency, now 15 years on, after being jailed for essentially her entire adult life, after she killed a man who bought her, for sex. That, is. . . justice. Let it continue.


Finally! It Is FINALLY Oral Argument Day -- On Fosamax® Femur Fracture "Pre-Emption", At The Supremes...

We've been covering this narrative arc pretty steadily for eleven years -- both as "Wyeth-style" pre-emption, as enunciated by the Supremes almost a decade ago, and in the Fosamax® femur fracture cases -- more generally. [Those links are but three examples -- of hundreds of posts here, just search Fosamax.]

So it is with some relief -- that we have reached argument Monday, at the SCOTUS, this morning. The Supremes are to decide whether Merck may be sued for failure to warn -- in the femur cases. [Merck will this morning tell the Supremes that Wyeth style preemption dismissals require only "clear" evidence that the label change/warning would not have been accepted -- not the tougher standard of "clear and convincing" evidence.]

In plain(er) English, then -- Merck suggests the FDA's instructions to it at the time made it impossible for Kenilworth to provide a warning. Here's a very cogent (third party) bit on it, from a recent entry at the fine SCOTUS Law Blog:

. . . .When state law and federal law conflict, the Constitution’s supremacy clause provides that federal law displaces, or pre-empts, state law. Pre-emption issues permeate prescription-drug safety litigation because the Food and Drug Administration regulates the safety and efficacy of prescription drugs under federal law, while state tort law provides the remedy for patients injured by the use of FDA-approved drugs. Prescription drug manufacturers frequently raise “impossibility pre-emption” as a defense in drug-injury cases, arguing that federal regulation would have prohibited the additional warnings plaintiffs allege state tort law required.

The Supreme Court has decided numerous pre-emption cases involving FDA regulations, bringing “impossibility pre-emption” into sharper focus over the past decade, starting with its 2009 opinion in Wyeth v. Levine. In Wyeth, a patient brought state tort claims against the manufacturer of an FDA-approved drug for injuries resulting from its failure to warn about the risks associated with intravenous administration. The manufacturer argued that the FDA’s extensive regulatory authority over its labeling made simultaneous compliance with state-law duties to warn impossible, thereby pre-empting the state tort claims. The Supreme Court held 5-4 that defendants asserting impossibility pre-emption had to produce “clear evidence” that the FDA would have prohibited an additional warning, and that Wyeth had not done so. . . .

I'll offer some live audio links, to the back and forth -- and questions from the bench -- as they become available, right here. Should be fascinating. Onward on a warm, if rainy, Monday.


Sunday, January 6, 2019

Final Prep, On Mars: Getting Ready To Detect "Mars-Quakes"...

At the moment, the now free-standing instrument is making minute adjustments to its foot-pads, to fine tune the computerized "level-bubble" -- and insure flawless readings. The instrument pack is clad in a copper sheath dress, to moderate temperature variations, and shield it from Martian wind-born dust and debris. Sometime in the next week, it ought to be ready for science operations -- primarily, listening for quakes.

Exciting times, for exo-planetary geological scientists -- so much new to learn, from these measurements. Here is a bit, from NASA, on the copper-clad beauty:

. . . .The seismometer, called Seismic Explorations for Interior Structure (SEIS), will measure seismic waves caused by marsquakes, meteorite strikes and other phenomena. Watching how these waves travel through Mars' interior will let scientists study how the planet's crust, mantle and core are layered. It will also reveal more about how all rocky bodies are formed, including Earth and its Moon. . . .

InSight is part of NASA's Discovery Program, managed by the agency's Marshall Space Flight Center in Huntsville, Alabama. Lockheed Martin Space in Denver built the InSight spacecraft, including its cruise stage and lander, and supports spacecraft operations for the mission.

A number of European partners, including France's Centre National d'Études Spatiales (CNES) and the German Aerospace Center (DLR), are supporting the InSight mission. CNES and the Institut de Physique du Globe de Paris (IPGP) provided the Seismic Experiment for Interior Structure (SEIS) instrument, with significant contributions from the Max Planck Institute for Solar System Research (MPS) in Germany, the Swiss Institute of Technology (ETH) in Switzerland, Imperial College and Oxford University in the United Kingdom, and JPL. DLR provided the Heat Flow and Physical Properties Package (HP3) instrument, with significant contributions from the Space Research Center (CBK) of the Polish Academy of Sciences and Astronika in Poland. Spain’s Centro de Astrobiología (CAB) supplied the wind sensors. . . .

Exciting planetary science, indeed. Now, on this quiet Sunday, the first of 2019, we are prone to. . . looking backward, six years, when our own copper clad seismometer fell silent now, for the first time. . . only to reappear, and repeatedly so, in the ensuing months and years, since. We are haunted by waters, of those memories too. . . . So. . . how long until she pings anew? We may never know. Indeed.


Friday, January 4, 2019

[U: Tests Negative] One Man In Sweden, Traveled From Burundi -- Being Tested For Ebola...

UPDATED: The patient's blood work now is back -- and there is no sero positive result, for the ebola virus. End update.

Even so, we should expect more of this -- as the months upon months of this latest DRC outbreak (still not fully contained), wear on. Here's a bit, from CNN's newsdesk:

. . . .He visited "mostly urban areas in Burundi, where there isn't thought to be any active Ebola as far as we know," Köhler said.

But the patient displayed potential symptoms of Ebola, including vomiting blood, upon arrival at the hospital, he explained. Köhler stressed that this is still only a suspicion and that test results are expected to be released about 6 p.m. local time. . . .

Now we must realize that political instability (ignored for decades by the US) will also lead to more pandemic instability. That's the medicine -- and challenge -- of the 21st Century, in the still developing geographies around the globe. Solve poverty and endemic violence first, to have a serious shot at solving a highly-lethal, and contagious -- but now increasingly treatable -- viral scourge.


Thursday, January 3, 2019

Big Bang! Or, "Crazy Big" M&A Is... Back, In Life Science Space... In 2019

I will -- in some future quiet (snowy afternoon) moment (there will be many of them, to come, here) -- offer some thoughts on the needed divestitures, in order for this deal to clear antitrust reviews, in the EU, UK and the US. . . but I do think some form of it will. . . actually close.

In that regard, do recall that Merck has $700 million in immuno-commitments, already (as of October 2018) tied up in a joint deal with lil' Celgene -- at Dragonfly (thus the faded lower left in my graphic). That, given the Merck vs. BMS head to head competition in immuno-oncology -- may be in need of some tweaking, here. Many have good rundowns on the broader landscape, here -- but I'll quote just a bit, from the ever-cogent Matt Herper, now in Boston, with STAT [Updated]:

. . . .The transaction — the fourth-largest ever in pharma — joins two of the largest companies in oncology, both of which have been facing setbacks. Bristol-Myers pioneered the use of cancer medicines that work by priming the immune system, but its flagship blockbuster drug, Opdivo, has been surpassed by a rival medicine from Merck, especially in the market for lung cancer.

Celgene has faced a string of clinical and regulatory disappointments over the past year. The stock has dropped 36 percent in the last 12 months, largely on concerns that Revlimid, its blockbuster multiple myeloma drug, is losing patent protection. . . .

Onward -- ever onward. Big M&A usually leads to smaller (anti-trust driven) divestitures -- so these will be very busy times, in Q1 2019. And even so, my mind. . . is awash in the unfolding celestial poetry, in graceful arching twists, now some four billion miles away from Earth -- as a lithe copper goddess. . . spins a pirouette, to say hello. . . . smile.


Tuesday, January 1, 2019

[U, End Of Wednesday] The Waiting Is... Sweetly... Excruciating. Smile...

Wednesday evening -- fireside UPDATE Edition: It looks like I won the Tweet pool, on shape of the body. Woot -- it is like a snowman, with two balls, mushed and joined. [End, updated portion.]

Even traveling at the speed of light, it still takes more than half a day for data transmissions to reach Earth, from New Horizons, now some four billion miles from home. So, at this very moment, the high res images of Ultima Thule snapped by it, as it flew by last night, are just now passing Saturn's orbit, and bending inward toward Mars. . . . and sometime in the early morning of Wednesday, they will reach an Australian sky dish.

Then, an hour or so after that, here in the US, we will begin to see (in crystal clarity) the exact shape and rotation dynamics of the planetissimal. [Over on Twitter, I've bet on a drawing labeled "G" -- something that looks like a pair of eggs, improbably smushed halfway together, end to end. I am hopeful to have won the space science Tweet pool, of about twenty-two alternative shapes.]

So now. . . for me at least. . . the waiting -- and the silence, are the hardest parts. But the darkness does make it all that much blindingly bright, when that sweet copper colored beauty twists onward, across the blacktop -- powdered with stars. . . to say a liltingly-soft "hello. . ."

"Hello". And onward. It's 2019, now baby -- rounded, even, and ending in zero numbers for us both, upcoming. Smile. . . .


Sunday, December 30, 2018

[U] Just Like 2014-16 Ebola Outbreak, A US Doctor Has Been Brought To Omaha...

UPDATED: 01.13.2019 -- The doctor has been cleared. He does not have Ebola -- and has been released, to go home, from the University of Nebraska medical campus, in Omaha. End update.

The affected MD was exposed to ebola in the DRC a week ago, and is not sero-positive, nor symptomatic, but is being monitored for the required 21 day period -- about two weeks of which remain, unexpired.

I post this solely to allay fear. This is a safe and effective way to address the real risks that Doctors Without Borders volunteers face. Here's the story, from the Wa Po:

. . . .An American health worker who was possibly exposed to Ebola while treating patients in Congo was evacuated to the United States on Saturday and placed in a secure area at the University of Nebraska Medical Center, hospital officials said. The person has no symptoms of the deadly hemorrhagic fever. . . .

The doctor "is not ill and is not contagious," said Ted Cieslak, M.D., infectious diseases specialist with Nebraska Medicine. "Should any symptoms develop, the Nebraska Medicine/UNMC team is among the most qualified in the world to deal with them."

No further updates will be given on the person's health status during the monitoring period, the release states. . . .

So it goes. Onward -- on a bright, clear and cold last Sunday of 2018 -- out, for one last workout. Take good care of all those who are precious to you. . . smile.


Thursday, December 27, 2018

[U] Shutdown Alert: Alternate (Private University) Live Feed, For NASA's Kuiper Belt Object Flyby, On New Years Day...

UPDATE @ 2 PM EST 12.28.2018: Not sure whether Trump decided to declare NASA-TV an "essential service", under the pre-arranged legislative rules, or if the team just decided to come back on air, gratis, but for now -- despite the shutdown, NASA-TV is back online. If it goes dark again, use the below backup links, come New Years Day. Namaste. . . . and onward.

What should be pure space science geekily-infused joy, on New Years, may well be partially occluded by Trump's ongoing shutdown.

New Horizons, which stunned us with Pluto photos three years ago, in the summer of 2015. . . now is passing a very interesting, double globular planetessimal endearingly named Ultima Thule. Use the Johns-Hopkins sponsored YouTube link in the pull-quote below, if NASA is still shuttered on January 1:

. . . .Should the federal government shutdown continue through New Horizons' Ultima Thule flyby – and NASA TV, nasa.gov and other agency digital and social channels remain offline – the New Horizons mission will provide coverage of live mission activities on this website and the Johns Hopkins Applied Physics Laboratory YouTube channel. . . .

I will refrain from ranting (again) about the lunacy that is Trumpian "shutdown sidereal motion". . . I will say that seeing more distant tiny orbital "golden flecks, at the edges" -- with eyes ablaze. . . will forever excite the space scientist in me. Onward.


Wednesday, December 26, 2018

Trump Appeals (Again!) To Ninth Circuit, In East Bay Sanctuary -- And His Lawyers Stop Working -- In San Diego, On Ms. L. Case Motions...

[Most recent backgrounder, on it all here.] After Trump was told the Supremes wouldn't take his extraordinary direct appeal, his lawyers filed yet another new appeal, this morning, to the Ninth Circuit, arguing that the preliminary injunction may be separately appealed, immediately, after Trump lost on the TRO. Seems silly, but okay [the arguments, and thus the outcome, will be. . . identical, in my experienced opinion].

Meanwhile, down in southern California, in the Ms. L. cases, the Trump attorneys have said that they lack authority to continue working (even pro bono, should they desire to), due to Trump's petulant wall driven shutdown. Here is the operative bit of that motion:

. . . .Absent an appropriation, Department of Justice attorneys and employees of DHS are prohibited from working, even on a voluntary basis, except in very limited circumstances, including “emergencies involving the safety of human life or the protection of property.” 31 U.S.C. § 1342. . . .

So, I suspect the case in San Francisco will also go into hibernation, until Trump ends his own self-inflicted shutdown. The motion asks the court to let all deadlines roll forward, on a day-for-day basis, to account for the ultimate period of missing funding -- the full length of the shutdown. The plaintiffs do not oppose the motion, so I suspect it will be granted, in all of these asylum border cases.

Trump's self-destructive tendencies are truly legendary -- and accelerating, apparently. But since all these cases are in a posture favorable to the would-be asylees, I think it actually helps them (in court, at least) to have a idiotic Trump shutdown.

Meanwhile, though -- out in the real world, in the rogue police state that comprises Trump's border (non-) policies -- now a second Guatemalan child has died (again, of medical neglect that could be charged as manslaughter in almost every state in America) -- a week after being detained (with his father), in ICE custody. The "fire. . . this time" -- is a boy, only eight years old, named Felipe Alonzo Gomez. Before him, just two weeks ago, now -- seven year old Jakelin Caal Maquin, also from Guatemala -- was, as a matter of gross medical negligence, manslaughtered, by Trump agents.

Speak up -- and act out, peaceably, to oppose this crackpot. Do it now -- continue to do so, into 2019. We all must lock arms and end this nightmare. . . of a now-failed dictatorship.


[U: See Comment] Year-End 2018 Update, On Congo's Latest Ebola Struggle: As Urban North Kivu Health Becomes... Political

Latest WHO statement (as of December 28, 2018) here.

To be sure, with over 50,000 people vaccinated, Merck and WHO have good reason to celebrate at year end, as efforts to contain the latest Beni and Butembo outbreaks are showing nice progress. But the epidemic also is infused. . . with the political, as the opposition party has campaigned (in part on a platform government reform spending, and thus) on local government doing more -- to help those most vulnerable to ebola infection.

In a fire last week that is at best suspicious, over a million of the ballots for the two cities were apparently destroyed. Non-surprisingly (to those of us who are students of darker uses of political power, the world over), the worst of the transmission chains are inside these two urban conflict zones -- the democratic elections in those cities are said to be officially delayed by several months (if not permanently), due to "fears of violence". The personal thus becomes political -- as improved support for ebola arrest and eradication has become in part as much political, as epidemiological. The results of the election are very likely to exclude the votes of over 1.2 million people, as the election's final results will be announced in January, but people in those two cities won't vote until March at the earliest. Here's a bit, from local news sources:

. . . .The election in and around Beni and Butembo in North Kivu province, and Yumbi in Mai-Ndombe province, will be in March (2019), the commission’s statement said. That’s long after Congo’s “definitive” presidential election results are set to be announced on Jan. 15, with the inauguration three days later.

Congo’s election has been delayed for more than two years, leading to sometimes deadly protests. Opposition parties have said they will not accept further delays of the vote to choose a successor to longtime President Joseph Kabila. . . .

“This is completely unacceptable,” presidential candidate Martin Fayulu, the leader of an opposition coalition, told The Associated Press after the latest delay. “We campaigned in those territories, life has not stopped. . . . We cannot erase 1.2 million voters just like that.”

Fayulu and seven other opposition candidates on Tuesday accused the electoral commission of being “determined to organize chaotic elections.” The commission’s president, Corneille Nangaa, on Monday said the election would take place on Sunday unless “there is a war and nobody can go out and vote. . . .”

As is often the case, human factors are once again predominating over pure biological science breakthroughs -- and making a controllable epidemic. . . less so, due to human conflicts. Still, we will hold out hope for a better 2019, on all fronts, just the same. . . . out on fun excursions with my grown family in town, until Friday night. . . thus -- the blogging forecast: light. Smile.