Thursday, May 25, 2017

Wham! I Am Joyously... In The WRONG!!! Fourth Circuit Just Hit It RIGHT Out Of The Park! The Fourth BEAT Ninth To The Punch! Muslim Ban 2.0 Is A Dead Letter!


[Silly me. I thought the Ninth's three judge opinion would appear, and be published, first.] The line-up is 10-3 AGAINST Mr. Trump's Muslim Ban 2.0. It would not surprise me to see the 3-0 opinion AGAINST it, tomorrow, out of the Ninth Circuit.

I had guessed a minimum of seven were going to lean that way -- in the Fourth -- and eight did, in full. The language Chief Judge Gregory (writing for the majority in the Fourth Circuit) uses is. . . towering, as the threats presented -- by the 45th President himself, were. . . unprecedented, in their audacity -- in at least the last three-quarters of a century:

. . . .The question for this Court, distilled to its essential form, is whether the Constitution, as the Supreme Court declared in Ex parte Milligan, 71 U.S. (4 Wall.) 2, 120 (1866), remains “a law for rulers and people, equally in war and in peace.” And if so, whether it protects Plaintiffs’ right to challenge an Executive Order that in text speaks with vague words of national security, but in context drips with religious intolerance, animus, and discrimination. Surely the Establishment Clause of the First Amendment yet stands as an untiring sentinel for the protection of one of our most cherished founding principles — that government shall not establish any religious orthodoxy, or favor or disfavor one religion over another. . . .

President Trump, in a speech at a rally [on March 15, 2017] in Nashville, Tennessee, described EO-2 as “a watered down version of the first order. . . .”

To the extent that our review chills campaign promises to condemn and exclude entire religious groups, we think that a welcome restraint. . . .

THACKER, Circuit Judge, concurring: I concur in the majority’s opinion but write separately for three reasons: (1) I would not consider remarks made by candidate Trump before he took his presidential oath of office; (2) I would nonetheless find that Appellees have demonstrated a likelihood of success on the merits of their argument that Section 2(c) of the Second Executive Order (“EO-2”) violates the Establishment Clause, based solely on remarks made or sentiments expressed after January 20, 2017; and (3) I would conclude Appellees have demonstrated a likelihood of success on the merits of their argument that Section 2(c), as it applies to immigrant visas, violates 8 U.S.C. § 1152(a)(1)(A) of the Immigration and Nationality Act (“INA”) [Ed. Note: that is the LBJ-era amendment I've written about at length here]. . . .




On to the Supremes. I read an advance sheet of this at [redacted] PM CDT today -- and wasn't taking or making any work calls, since I was of pro-bono aid, on one of the briefs (on the prevailing side, of course). Now it will be a GREAT Memorial Day Weekend, for those of us who still believe in ordered liberty, under the law. . . . Woot! Yep -- onward, to the Supremes -- where ("Condor predicts") 45 loses 6-3. As it is, he is 0-for-6, in the courts, if memory serves thus far.

[And with that, I've 'bout reached the end of the road, on celestial poetry -- I'll now take Mr. Wonder's fine advice above -- and. . . leave -- head for Saturn. Call it a day. That nonsense is decidedly over. Not worth it. I was ever just a joke (to her), apparently, anyway.]

नमस्ते

Wednesday, May 24, 2017

JPL And NASA To Discuss First Jupiter Scientific Findings, From Juno -- Tomorrow At 2 PM EDT


Yet again, a space science story has fired my imagination, anew. [Backgrounder, here.]

I'll live update, here -- if something extraordinary is disclosed. And with each new space science plunge (some 14 -- yet to go!), the little craft is more profoundly imperiled -- but onward she sails, at 129,000 miles an hour, just the same. Fearless. And that, too, is admirable. NASA will host a press gathering, tomorrow at 1 PM local time, to explain the first batch of science papers, from sweet Juno's data:

. . . .Scientists from NASA’s Juno mission to Jupiter will discuss their first in-depth science results in a media teleconference at 2 p.m. EDT Thursday, May 25, when multiple papers with early findings will be published online by the journal Science and Geophysical Research Letters.

The teleconference participants are:

Diane Brown, program executive at NASA Headquarters in Washington

Scott Bolton, Juno principal investigator at Southwest Research Institute in San Antonio

Jack Connerney, deputy principal investigator at NASA's Goddard Space Flight Center in Greenbelt, Maryland

Heidi Becker, Juno radiation monitoring investigation lead at NASA’s Jet Propulsion Laboratory in Pasadena, California

Candy Hansen, Juno co-investigator at the Planetary Science Institute in Tucson, Arizona

To participate in the teleconference, media must email their name and affiliation to Laurie Cantillo at laura.l.cantillo@nasa.gov by noon Thursday. Media and the public also may ask questions during the briefing on Twitter using #askNASA. . . .


Now you know -- and we will all know more, tomorrow afternoon. Smiling, as I too will twist through a clear, bright copper colored celestial-flight focused morning, tomorrow. . . awaiting word, about/from that shepherded moon-lette. Sleep well, one and all! Pax tecum.

नमस्ते

Tamping Down Some Of The MSM Hype -- This Is Very Encouraging Immuno-Oncology Regulatory News...


To be sure, Kenilworth has scored more than a PR victory here. This is a real regulatory policy advancement coup. Yesterday, in the US, Keytruda® was approved by FDA for all solid tumors (regardless of location, or origin) expressing either of a certain set of proteins, at high levels.

While more than a few writers (and many a smaller bio-science companies' hopeful PR departments) are now spinning this as some form of the second coming -- it is not quite all of that. I suspect FDA will not just start granting new companies FDA clearance based on one study that crosses two locations, for tumor origin.

Merck is nearly unique (save perhaps BMS) in that it can point to six to ten study outcomes, across many tumor sites, in which protein expression was a clear predictor of enhanced survival, while on pembrolizumab. Here's the bit, from Reuters -- minus the subsequent hype:

. . . .The approval marks a major step in so-called precision medicine, where genetic biomarkers may determine the course of therapy rather than the type of cancer. The hope is that advanced genetic information will one day be able to identify which patients are most likely to benefit from a specific treatment.

"Until now, the FDA has approved cancer treatments based on where in the body the cancer started - for example, lung or breast cancers," said Richard Pazdur, head of oncology products for the FDA's Center for Drug Evaluation and Research. . . .

The accelerated approval was for solid tumor cancers not eligible for surgery or that have spread in patients identified as having a biomarker called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). . . .

He said about 4 percent of advanced cancers, or 15,000 to 20,000 cases each year in the United States, carry the genetic traits addressed in the approval.

Tests for the specific genetic defects are widely available, costing between $300 and $600. . . .


Now you know -- and the sunshine in the graphic is designed to counter the chilly gray rain I find myself walking in, on this cool Chicago morning. I hope it brightens all your gray days, out there, as well. Smile. . . .

नमस्ते

Tuesday, May 23, 2017

Post Trial Hearings -- On Merck's $2.54 Billion Patent Win -- Now Set For August 31, 2017


Regular readers will recall the less than three hour deliberated, $2.54 billion verdict on matters patent, entered on December 15, 2016 against Gilead, and in favor of Merck's acquired sub Idenix. [Earlier background on post-verdict matters, here. And the briefs, here.]

Many will also recall that in late February, Merck filed an SEC Form 8-K disclosing a nearly $3 billion charge -- on a closely-related Idenix acquired Hep C molecule -- which charge/write-off will likely set-off (on a cash-flow basis) any taxable income, from any final order paying the $2.54 billion above -- if it should ultimately be enforced against Gilead -- after all appeals run out.

Below is yesterday's post-trial scheduling order -- entered by the able federal District Court Judge Stark, in Wilmington, Delaware, yesterday:

. . . .ORAL ORDER: Having reviewed the parties' letters regarding post-trial matters (see, e.g., D.I. 568, 569), IT IS HEREBY ORDERED that:

(i) the Court will hold a hearing on August 31, 2017 beginning at 10 a.m.; and

(ii) no later than May 26, 2017, the parties shall file a joint status report indicating (in addition to anything else they wish to advise the Court) the number of hours they request for their presentations at the forthcoming hearing, whether they request the opportunity to present live witness testimony at the hearing, and the basis (should there be any) for opposing a request to present evidence at the hearing.

ORDERED by Judge Leonard P. Stark on 5/22/17. . . .


Again, now you know. . . and as I post this, lil' Cassini is completing another plunge (a fifth dive), into the void between mighty Saturn's rings.

There now she twists, smiling mysteriously, and spinning to conceal her true purpose (and avoid being bashed by any of his micron-sized stray effluvia, too!) -- as she enters the shrouded-sleeping-tent of Lord Saturn, and uncovers all his scientific secrets -- plying him, with her long copper-legged dance -- a dance of clearly unwasted grace. . . all rather poetic, offered in metaphors far afield, from regular space science reporting, no?

I for one, plainly think so. . . smile -- and g'night now, to all you lil' polished river rocks, of good will and good cheer
. . . .

नमस्ते

No Surprise Dept.: "OrangeCare 2.0" Is STILL D.O.A. -- As Rep. MacArthur Bails From House "Tuesday Group" Leadership Seat


I post this updating item, primarily to suggest (once again -- confirming one of our longer term narrative lines, here) that it will be well-beyond 2018 mid-terms -- if ever -- that anything called TrumpCare 4.0 or 5.0 clears the reconciliation process. Moreover, in the nearer term, the Senate is highly unlikely to offer a package that appeases enough House members, and the House has already offered a "dead letter" bill -- one that the Senate will never pass.

So -- each will likely blame the other, and Mr. Trump will blame them both. Charming Kabuki Theater. But meanwhile, most of what these dolts called "ObamaCare" will roll onward with mostly minor tweaks, essentially as ObamaCare 2.0. That's my bet. [It is my additional bet (given last night's latest drop memos out of the US intel leadership ranks) that by late 2018, Mr. Trump won't be in the office, to sign whatever this mythical unicorn might look like -- so whatever it ultimately looks like, it will be called PenceCare. Or more realistically, and precisely. . . Nada-care -- since it will be a non-existent, all-vapor, no-law, anyway.]

From Politico, then, a bit:

. . . .Rep. Tom MacArthur resigned Tuesday as co-chairman of the caucus of GOP moderates known as the Tuesday Group in the wake of deep divisions among its members over the House Obamacare replacement bill he helped craft.

"You can’t lead people where they don’t want to go," MacArthur said in an interview with POLITICO New Jersey Tuesday morning. "I think some people in the group just have a different view of what governing is."

MacArthur announced his resignation as co-chairman moments ago during the group's regular Tuesday meeting in Washington. He said he alerted House Speaker Paul Ryan on Monday. . . .


It is. . . moderately puzzling, still -- that the electorate allowed all these nominal-GOP critters to lie to them -- and not even bother to tell remotely consistent lies, when they did so. Throughout the 2016 campaign, each wing of the GOP was telling mutually contradictory lies about the supposed "repeal and/or replace" efforts. And all the GOP faithful who voted Trump were incapable of, or (more likely) unwilling to do the rudimentary work. . . required to figure all of that out. And certainly unwilling to reconcile the language in the disparate positions.

That's how I see it -- and now you know -- exhausted, here. . . but full of joy -- and gonna' sleep solidly this evening! Onward, out into the luminous dawn tomorrow. . . .

नमस्ते

Unadorned By Any Graphic: Just Read -- "Well-Put, New Orleans" -- Courtesy Mayor Mitch Landrieu & My Long Faithful Commenter, "Salmon"


Feel free to scroll on by -- but know that I won't cheapen these words with any graphic, to try to hold the eyeballs.

Mayor #Mitch Landrieu should be read word for word.

Here it is:

. . . .Thank you for coming.

The soul of our beloved city is deeply rooted in a history that has evolved over thousands of years; rooted in a diverse people who have been here together every step of the way—for both good and for ill. It is a history that holds in its heart the stories of Native Americans—the Choctaw, Houma Nation, the Chitimacha. Of Hernando de Soto, Robert Cavelier, Sieur de La Salle, the Acadians, the Islenos, the enslaved people from Senegambia, Free People of Color, the Haitians, the Germans, both the empires of France and Spain. The Italians, the Irish, the Cubans, the south and central Americans, the Vietnamese, and so many more.

You see, New Orleans is truly a city of many nations, a melting pot, a bubbling cauldron of many cultures. There is no other place quite like it in the world that so eloquently exemplifies the uniquely American motto: e pluribus unum: out of many we are one. But there are also other truths about our city that we must confront. New Orleans was America’s largest slave market, a port where hundreds of thousands of souls were bought, sold, and shipped up the Mississippi River to lives of forced labor, of misery, of rape, of torture. America was the place where nearly 4,000 of our fellow citizens were lynched, 540 alone in Louisiana; where the courts enshrined “separate but equal”; where Freedom riders coming to New Orleans were beaten to a bloody pulp. So when people say to me that the monuments in question are history, well, what I just described is real history as well, and it is the searing truth.

And it immediately begs the questions, why there are no slave ship monuments, no prominent markers on public land to remember the lynchings or the slave blocks; nothing to remember this long chapter of our lives; the pain, the sacrifice, the shame … all of it happening on the soil of New Orleans. So for those self-appointed defenders of history and the monuments, they are eerily silent on what amounts to this historical malfeasance, a lie by omission. There is a difference between remembrance of history and reverence of it.

For America and New Orleans, it has been a long, winding road, marked by great tragedy and great triumph. But we cannot be afraid of our truth. As President George W. Bush said at the dedication ceremony for the National Museum of African American History & Culture, “A great nation does not hide its history. It faces its flaws and corrects them.” So today I want to speak about why we chose to remove these four monuments to the Lost Cause of the Confederacy, but also how and why this process can move us towards healing and understanding of each other. So, let’s start with the facts.

The historic record is clear: The Robert E. Lee, Jefferson Davis, and P.G.T. Beauregard statues were not erected just to honor these men, but as part of the movement which became known as The Cult of the Lost Cause. This “cult” had one goal—through monuments and through other means—to rewrite history to hide the truth, which is that the Confederacy was on the wrong side of humanity. First erected over 166 years after the founding of our city and 19 years after the end of the Civil War, the monuments that we took down were meant to rebrand the history of our city and the ideals of a defeated Confederacy. It is self-evident that these men did not fight for the United States of America. They fought against it. They may have been warriors, but in this cause they were not patriots. These statues are not just stone and metal. They are not just innocent remembrances of a benign history. These monuments purposefully celebrate a fictional, sanitized Confederacy, ignoring the death, ignoring the enslavement and the terror that it actually stood for.

After the Civil War, these statues were a part of that terrorism as much as a burning cross on someone’s lawn; they were erected purposefully to send a strong message to all who walked in their shadows about who was still in charge in this city. Should you have further doubt about the true goals of the Confederacy, in the very weeks before the war broke out, the Vice President of the Confederacy, Alexander Stephens, made it clear that the Confederate cause was about maintaining slavery and white supremacy. He said in his now famous “corner-stone speech” that the Confederacy’s “cornerstone rests upon the great truth, that the negro is not equal to the white man; that slavery—subordination to the superior race—is his natural and normal condition. This, our new government, is the first in the history of the world based upon this great physical, philosophical, and moral truth.”

Now, with these shocking words still ringing in your ears, I want to try to gently peel from your hands the grip on a false narrative of our history that I think weakens us, and make straight a wrong turn we made many years ago. We can more closely connect with integrity to the founding principles of our nation and forge a clearer and straighter path toward a better city and a more perfect union.

Last year, President Barack Obama echoed these sentiments about the need to contextualize and remember all our history. He recalled a piece of stone, a slave auction block engraved with a marker commemorating a single moment in 1830 when Andrew Jackson and Henry Clay stood and spoke from it. President Obama said, “Consider what this artifact tells us about history. … On a stone where day after day for years, men and women … bound and bought and sold and bid like cattle on a stone worn down by the tragedy of over a thousand bare feet. For a long time the only thing we considered important, the singular thing we once chose to commemorate as history with a plaque, were the unmemorable speeches of two powerful men.”

A piece of stone — one stone. Both stories were history. One story told. One story forgotten or maybe even purposefully ignored. As clear as it is for me today … for a long time, even though I grew up in one of New Orleans’ most diverse neighborhoods, even with my family’s long proud history of fighting for civil rights … I must have passed by those monuments a million times without giving them a second thought. So I am not judging anybody, I am not judging people. We all take our own journey on race.

I just hope people listen like I did when my dear friend Wynton Marsalis helped me see the truth. He asked me to think about all the people who have left New Orleans because of our exclusionary attitudes. Another friend asked me to consider these four monuments from the perspective of an African American mother or father trying to explain to their fifth-grade daughter who Robert E. Lee is and why he stands atop of our beautiful city. Can you do it? Can you look into that young girl’s eyes and convince her that Robert E. Lee is there to encourage her? Do you think she will feel inspired and hopeful by that story? Do these monuments help her see a future with limitless potential? Have you ever thought that if her potential is limited, yours and mine are too? We all know the answer to these very simple questions. When you look into this child’s eyes is the moment when the searing truth comes into focus for us. This is the moment when we know what is right and what we must do. We can’t walk away from this truth.

And I knew that taking down the monuments was going to be tough, but you elected me to do the right thing, not the easy thing and this is what that looks like. So relocating these Confederate monuments is not about taking something away from someone else. This is not about politics. This is not about blame or retaliation. This is not a naive quest to solve all our problems at once.

This is, however, about showing the whole world that we as a city and as a people are able to acknowledge, understand, reconcile and most importantly, choose a better future for ourselves, making straight what has been crooked and making right what was wrong. Otherwise, we will continue to pay a price with discord, with division and, yes, with violence.

To literally put the Confederacy on a pedestal in our most prominent places of honor is an inaccurate recitation of our full past. It is an affront to our present, and it is a bad prescription for our future. History cannot be changed. It cannot be moved like a statue. What is done is done. The Civil War is over, and the Confederacy lost and we are better for it. Surely we are far enough removed from this dark time to acknowledge that the cause of the Confederacy was wrong.

And in the second decade of the 21st century, asking African Americans — or anyone else — to drive by property that they own; occupied by reverential statues of men who fought to destroy the country and deny that person’s humanity seems perverse and absurd. Centuries-old wounds are still raw because they never healed right in the first place. Here is the essential truth: We are better together than we are apart.

Indivisibility is our essence. Isn’t this the gift that the people of New Orleans have given to the world? We radiate beauty and grace in our food, in our music, in our architecture, in our joy of life, in our celebration of death; in everything that we do. We gave the world this funky thing called jazz, the most uniquely American art form that is developed across the ages from different cultures. Think about second lines, think about Mardi Gras, think about muffaletta, think about the Saints, gumbo, red beans and rice. By God, just think.

All we hold dear is created by throwing everything in the pot; creating, producing something better; everything a product of our historic diversity. We are proof that out of many we are one — and better for it! Out of many we are one — and we really do love it! And yet, we still seem to find so many excuses for not doing the right thing. Again, remember President Bush’s words. “A great nation does not hide its history. It faces its flaws and corrects them.”

We forget, we deny how much we really depend on each other, how much we need each other. We justify our silence and inaction by manufacturing noble causes that marinate in historical denial. We still find a way to say, “Wait, not so fast.” But like Dr. Martin Luther King Jr. said, “Wait has almost always meant never.” We can’t wait any longer. We need to change. And we need to change now.

No more waiting. This is not just about statues, this is about our attitudes and behavior as well. If we take these statues down and don’t change to become a more open and inclusive society this would have all been in vain. While some have driven by these monuments every day and either revered their beauty or failed to see them at all, many of our neighbors and fellow Americans see them very clearly. Many are painfully aware of the long shadows their presence casts; not only literally but figuratively. And they clearly receive the message that the Confederacy and the cult of the lost cause intended to deliver.

Earlier this week, as the cult of the lost cause statue of P.G.T Beauregard came down, world renowned musician Terence Blanchard stood watch, his wife Robin and their two beautiful daughters at their side. Terence went to a high school on the edge of City Park named after one of America’s greatest heroes and patriots, John F. Kennedy. But to get there he had to pass by this monument to a man who fought to deny him his humanity.

He said, “I’ve never looked at them as a source of pride … it’s always made me feel as if they were put there by people who don’t respect us. This is something I never thought I’d see in my lifetime. It’s a sign that the world is changing.” Yes, Terence, it is. And it is long overdue. Now is the time to send a new message to the next generation of New Orleanians who can follow in Terence and Robin’s remarkable footsteps.

A message about the future, about the next 300 years and beyond: Let us not miss this opportunity, New Orleans, and let us help the rest of the country do the same. Because now is the time for choosing. Now is the time to actually make this the City we always should have been, had we gotten it right in the first place.

We should stop for a moment and ask ourselves: At this point in our history — after Katrina, after Rita, after Ike, after Gustav, after the national recession, after the BP oil catastrophe and after the tornado — if presented with the opportunity to build monuments that told our story or to curate these particular spaces, would these monuments be what we want the world to see? Is this really our story?

We have not erased history; we are becoming part of the city’s history by righting the wrong image these monuments represent and crafting a better, more complete future for all our children and for future generations. And unlike when these Confederate monuments were first erected as symbols of white supremacy, we now have a chance to create not only new symbols, but to do it together, as one people. In our blessed land we all come to the table of democracy as equals. We have to reaffirm our commitment to a future where each citizen is guaranteed the uniquely American gifts of life, liberty and the pursuit of happiness.

That is what really makes America great and today it is more important than ever to hold fast to these values and together say a self-evident truth that out of many -- we are one. That is why today we reclaim these spaces for the United States of America. Because we are one nation, not two; indivisible with liberty and justice for all, not some. We all are part of one nation, all pledging allegiance to one flag, the flag of the United States of America. And New Orleanians are in … all of the way. It is in this union and in this truth that real patriotism is rooted and flourishes. Instead of revering a four-year brief historical aberration that was called the Confederacy, we can celebrate all 300 years of our rich, diverse history as a place named New Orleans, and set the tone for the next 300 years.

After decades of public debate, of anger, of anxiety, of anticipation, of humiliation and of frustration. After public hearings and approvals from three separate community led commissions. After two robust public hearings and a 6–1 vote by the duly elected New Orleans City Council. After review by 13 different federal and state judges. The full weight of the legislative, executive, and judicial branches of government has been brought to bear and the monuments, in accordance with the law, have been removed. So now is the time to come together and heal and focus on our larger task. Not only building new symbols, but making this city a beautiful manifestation of what is possible and what we as a people can become.

Let us remember what the once exiled, imprisoned, and now universally loved Nelson Mandela and what he said after the fall of apartheid. “If the pain has often been unbearable and the revelations shocking to all of us, it is because they indeed bring us the beginnings of a common understanding of what happened and a steady restoration of the nation’s humanity.” So before we part let us again state the truth clearly.

The Confederacy was on the wrong side of history and humanity. It sought to tear apart our nation and subjugate our fellow Americans to slavery. This is the history we should never forget and one that we should never again put on a pedestal to be revered. As a community, we must recognize the significance of removing New Orleans’ Confederate monuments. It is our acknowledgment that now is the time to take stock of, and then move past, a painful part of our history.

Anything less would render generations of courageous struggle and soul-searching a truly lost cause. Anything less would fall short of the immortal words of our greatest president, Abraham Lincoln, who with an open heart and clarity of purpose calls on us today to unite as one people when he said, “With malice toward none, with charity for all, with firmness in the right, as God gives us to see the right, let us strive on to finish the work we are in, to bind up the nation’s wounds … to do all which may achieve and cherish a just and lasting peace among ourselves and with all nations.”

Thank you. . . .




नमस्ते

Will Merck See A $100 Million Fine, In The UK -- Just As Pfizer Saw?


While Kenilworth can certainly absorb such an amount, it is not optimal for its global reputation to be labeled "anti-competitive" -- by a UK regulator. [Just one of many backgrounders here -- this one from October of 2015.] Pfizer paid about $100 million, in fines for its pricing tactics, related to Epanutin -- an epilepsy drug, in the UK at Christmas 2016.

The finding regarding Merck is still preliminary, and through settlement negotiations (and appeals), may be reversed. Even so, Merck has seen bio-similar incursion, in this market as the graphic indicates, from its peak UK sales years of 2014-15. From The Independent (UK), then:

. . . .According to the Competition and Markets Authority’s provisional findings released on Tuesday, one of the US company’s European units - Merck Sharp & Dohme - abused its dominant market position through a discount scheme for the drug Remicade – generically known as infliximab – which is used to treat rheumatoid arthritis and Crohn’s disease.

"The CMA has provisionally found that MSD broke competition law by abusing its dominant position through a discount scheme for Remicade that was likely to restrict competition from 'biosimilar' versions of infliximab that were new to the market," the competition watchdog said in a statement.. . .


Now you know -- as the whole fam-damily evaporates, once more -- on a rainy train ride in. . . . smile.

नमस्ते

Monday, May 22, 2017

Congo Ebola 2017: WHO Situation Report No. 2


We continue with our Ebola 2017 reporting here -- slightly delayed by our off-the-grid weekend duties. Still some new cases being reported (and we should expect more of that, for a while); but slightly fewer confirmed contacts now, since some of the original suspected cases have tested negative, on a PCR assay -- and so those suspected contacts were cleared over the weekend.

Here's a bit more of the detail, from the latest WHO Situation Report -- a PDF list link:

. . . .As of 20 May 2017, a total of 37 suspected EVD cases and four deaths been reported, giving a case fatality rate of 11%. The reported cases are from five health areas, namely Nambwa (12 cases and three deaths), Muma (four cases and no deaths), Ngayi (16 cases and one death), Azande (three cases and no deaths), and Ngabatala (two cases and no deaths). . . .

As of 20 May 2017 the remaining 362 contacts (of 416 initially listed, 54 have completed the follow up period) continue to be monitored for signs and symptoms of EVD on a daily basis. All seven response committees are now established and functional at national level, namely Monitoring, Case management, WASH and biosafety, Laboratory and research, Pyscho-social management, Logistics and Communication. Additionally response teams have been established in the three most affected areas, Nambwa, Muma and Ngay. . . .

There is a shortage in the supply of thermo-laser thermometers [Ed. Note: any donations from J&J or Cardinal would be welcome, to be certain. . . .], key equipment for the daily monitoring of individuals listed as contacts. . . .

The government of DRC and MSF with support of WHO and other partners are preparing to offer access to the rVSV EEBOV experimental/investigational vaccine. The vaccine will be offered to contacts and contacts of contacts of a confirmed EVD case, including Health Care Workers and Field Laboratory Workers. This will be done under Good Clinical Practice (GCP) and with informed consent. . . .

Approval from the national regulatory authority and Ethics Review committee of the DRC is awaited before proceeding. . . .


Now you know. It is encouraging to read of progress -- on vaccination plans. Overall, still rather tough news, on a Monday -- as new cases are still being reported -- but. . . onward.

नमस्ते

Immuno-Oncology Market Updates: In Melanoma, Incyte/BMS Significantly Out-Performed Merck/Incyte...


While we were incommunicado, this story broke -- at the annual US cancer meetings. Do go read all the abstracts, if you intend to trade on any of this news, though -- to be sure.

From the Friday edition of the Investor's Business Daily, then -- a bit:

. . . .Incyte stock enjoyed a fifth consecutive day of gains Friday after its immuno-oncology drug, epacadostat, proved robust in combination trials with Dow component Merck and Bristol-Myers Squibb. . . .

Between the two, Merck's Keytruda and Bristol-Myers' Opdivo were tested in combination with Incyte's epacadostat in eight forms of cancer. Among those, Bristol-Myers' matchup in melanoma grabbed the best response and disease control rates.

At the 100-milligram dose, melanoma patients treated with the Opdivo and epacadostat combination saw a 75% response rate and a 100% disease control rate, according to Janney analyst Debjit Chattopadhyay. . . .


Now you know. Onward, on another (non-life-sciences) unexpected, and fast-breaking, divestiture deal, now. . . . thus, back in the saddle a little earlier than expected. Grin.

नमस्ते

Friday, May 19, 2017

"We Interrupt This Outage" -- For Mr. Trump's Remarks To The Russian Ambassador, Last Week. Treasonous? Maybe. Proof of Obstruction? Probably.


Well -- as Mr. Trump departs on Air Force One, for his pre-arranged nine-day Middle East visits -- his problems just deepened appreciably -- and from his own mouth (again). While I wait at a cell lot, for the airport runs -- The New York Times is breaking the following.

And as a side note, Mr. Trump plainly miscalculated, when he intentionally alienated the US intelligence community -- over and over, again. There is zero reason to think that this account is in any respect inaccurate. [And I am pretty sure Vlad Putin will offer us new transcripts to "prove it," as a second source -- if we but ask! That is only partially snark, BTW.] The upshot:

. . . .“I just fired the head of the F.B.I. He was crazy, a real nut job,” Mr. Trump said, according to the document, which was read to The New York Times by an American official. “I faced great pressure because of Russia. That’s taken off.”

Mr. Trump added, “I’m not under investigation.”

The conversation, during a May 10 meeting — the day after he fired Mr. Comey — reinforces the notion that Mr. Trump dismissed him primarily because of the bureau’s investigation into possible collusion between his campaign and Russian operatives. . . .

Many Democrats and some Republicans have raised alarms that the president may have tried to obstruct justice by firing Mr. Comey. The Justice Department’s newly appointed special counsel, Robert S. Mueller III, was given the authority to investigate not only potential collusion, but also related allegations, which would include obstruction of justice. . . .


What I glean from this is that Mr. Trump is more interested in currying favor, with the Russian oligarchy, than he is in defending America from foreign threats. But why?

That's the over-arching question, right? I strongly suspect that is driven not by principle, but because he owes the Russians potentially billions of dollars.

And I claim the right to make that comment, because Mr. Trump will not reveal his IRS filings, to show where, and to whom, his loans are owed -- on all his real estate, and other holdings. But we do know that 45's own son has previously said on the record that "a lot of it" came from Russia. You may draw your own conclusions. But this is a pure Amendment One-protected conjecture, now. And I bet it will prove out to be true, when Special Counsel Robert Mueller, III is all done. Have a great weekend, one and all! Out!

नमस्ते

[Auto-Post Generated Content -- Will NOT Be Monitored] Auto-Post: Federal (NJ) Fosamax MDL UPDATE -- Next Status Hearing On June 1, 2017


Sometimes, when I am off-grid, an algorithm will collect federal court filings on cases I monitor, and reprint them -- with a generic graphic, related to that case. It is an automated machine-only initiated routine, with no (other) human/user intervention -- after the algorithm is set up by this "particularly odd. . ." blog author. Grin.

And so, there may be some odd syntax/formatting, or posts of questionable relevance or importance.

This may be one of those times:

. . . .THIS MATTER having been opened to the Court sua sponte [i.e., on its own motion]; it appearing that this Multi-District Litigation (“MDL”) has been assigned to the Undersigned following the resignation of the Hon. Joel Pisano, U.S.D.J. (now-retired); it further appearing that the Third Circuit has recently vacated a summary judgment order previously issued on March 26, 2014, and remanded this MDL for further proceedings; therefore,

IT IS on this 15th day of May, 2017,

ORDERED that in light of the remand, the Court shall conduct a telephone status conference with the appointed-lead plaintiffs’ counsel and liaison counsel, as well as defense counsel, on June 1, 2017 at 10:00 a.m.;

ORDERED that prior to the teleconference, the parties shall submit, on May 30, 2017, a joint status letter, which shall include information regarding (1) defendant’s intention to seek certiorari from the United States Supreme Court; (2) any intended motion practice; (3) settlement discussions; and (4) any other matters the parties deem appropriate at this time. . . .

/s/ Freda L. Wolfson

United States District Judge. . . .


The "Defendant" here is. . . Merck. Now you know. I am off-grid; will not respond to comments before May 22,2017. Take care.

नमस्ते

Thursday, May 18, 2017

Switching Away From The Deadly Serious (Ebola) -- To Pure Farce -- Our 45th President's Tweet-Storms; And Presidency, More Broadly


I have decided this morning -- as I depart -- to close with a farce -- of epic proportions. [It is now a farce, primarily because 45 has been caught -- hand still in the cookie jar. See below.]

To be certain, there is more than a bit of a serious undertone here: as the revised masthead above implies -- I (albeit privately) found yesterday morning’s Russian/Putin “agitprop” salvo to be. . . just another in a long line of indignities to which Mr. Trump has willingly and fecklessly subjected the once-proud American people, before the world. Y A W N.

On the other hand, I suspect it was the last straw, for most of the elite GOP. In yesterday morning’s story, Mr. Putin offered to produce Russian-sourced but unspecified "transcripts" — ostensibly to exonerate Mr. Trump, in the Russian investigation.

With that, Mr. Putin achieved a master-stroke of Russian propaganda: offering the US Congress HIS Russian government resources, to help Mr. Trump hold on to his office — for at least a little while longer.

Genius, in the sheer audacity of it! In the cold light of the next morning, then, and setting aside Mr. Putin’s nonsense — let us consider what this says about the state of our (now, as of last night, clearly less-imperiled) Republic: the US Congress may at present be (at least marginally effectively). . . trolled, by the Russian President.

Why? Because our 45th President has gone out of his way to sidle up, and play "kissy-face" with him. [And that is the most charitable spin anyone can put upon Mr. Trump’s actions, taken as a whole.]

Our vulnerability to being trolled, or “agit-propped“, is a direct result of the amateurish positions our rank amateur President has taken, and continues to take. [Again, that is with a rosily charitable lens, as to his "on the record" remarks.]

And yesterday, by lunch, many elite Republicans (privately) I suspect -- declared what the rest of us long knew. This man — 45 — is unfit.

And so, by dinner time, we had word of a special independent counsel, with criminal charging authority -- who served under Bush 43rd, and our 44th President admirably -- as FBI Director for 13 years (yep -- Mr. Comey's immediate predecessor). Irony -- it's for me!

We will let the investigation go where it might -- but this is a post-Archibald Cox moment, Mr. Trump.

In truth, the warlock has already been "outed". He's. . . orange. And yes, I do think this morning marks the beginning of the end, of the Trump Presidency.

It may take eight more months, now. But likely not too much longer than that. Word.



नमस्ते

Wednesday, May 17, 2017

WHO: First Situation Report, On 2017 DRC Ebola Outbreak


To be sure, I do hate leaving -- for a joyously boisterous long weekend, on a relatively ominous global public health news note -- but sometimes. . . . that is just the way it is -- and the way it has to be.

So -- the first official and comprehensive tallies are up, at WHO: additional cases have been reported -- very near the same province that was likely the index location, of the long ago original outbreak of Ebola (or at least the first documented one), back in 1976.

Importantly, no inter-country African travel restrictions are recommended by WHO. That fact should be repeated widely by the MSM. From the full report, then -- a few snippets:

. . . .Following this cluster of illness and deaths, the health team carried out outbreak investigation and collected five blood samples that were transported to a laboratory, the Institut National de Recherche Biomédicale (INRB), in Kinshasa. Laboratory results released on 11 May 2017 showed that two of the five samples tested positive for Ebola virus of the Zaire sub-type using a technique call polymerase chain reaction (PCR).

As of 15 May 2017, a total of 19 patients suspected to have Ebola including 3 deaths (death rate of 15.8%) have been reported. The cases reported are from three areas, namely Nambwa (10 cases and 2 deaths), Mouma (3 cases and 1 death) and Ngay (6 cases and no death). A total of 125 close contacts have been identified and are being followed up on a daily basis. . . .

Likati health zone shares borders with two provinces in DRC and with the Central African Republic. The affected areas are remote and hard-to-reach with limited communication and transport networks. . . .

• At this stage, the overall risk is high at national level due to the known impact of Ebola outbreaks, remoteness of the affected area, limited access to health care and suboptimal surveillance.

• Risk at regional level is moderate due to the proximity with international borders and the recent influx of refugees from Central African Republic.

• The risk is low at global level. . . .

Depending on the evolution of the situation, the risk will be reassessed at the three levels. . . .

WHO advises against the application of any travel or trade restrictions on the Democratic Republic of Congo based on the current information available on this Ebola outbreak. WHO continues to monitor reports of measures implemented at points of entry. . . .


Still only a one word passing mention -- in a list -- of some future vaccinations (on page 4, at item 11, of 14); no concrete plan to vaccinate a ring around these 125 contacts -- to reach perhaps 1,000 to 3,000 potential future contacts, of contacts.

That is both troubling, and disappointing -- even allowing for the fact that the affected areas lie a fully-mountainous, forested 220 miles (350 kilometers) away -- on a terribly pock-marked (Jeeps only) dirt road -- just a path, really -- from any city of note.

We may well need a US airlift -- and drop-in -- operation. That's my $0.02 -- and sleep will certainly find me this evening, now. . . with a twinkling, green-eyed. . . g'night!

नमस्ते

Pre-Long Weekend Clean-Up: Etugliflozin News Due From Merck/Pfizer 60/40 Venture, In Early June...


This falls in the diabetes space, for the two companies -- which as we reported almost exactly four years ago -- involves a 60/40 split, in favor of Kenilworth, on this next gen Phase III candidate.

To be fair, this cooperative effort is running well behind the Lilly offering (in fact, we speculated that the entire "risk sharing" venture was born of Lilly's clear lead, back in the Spring of 2013). Merck does expect to report news (on this, and a host of other diabetes-focused studies) in early June at the ADA conference in San Diego -- so that is potentially good news. Here's the bit:

. . .Merck announced that 19 scientific presentations from Merck’s diabetes pipeline and portfolio – including Phase 3 data for investigational ertugliflozin, additional analyses of JANUVIA® (sitagliptin), and real-world research – will be presented at the 77th Scientific Sessions of the American Diabetes Association (ADA) in San Diego, June 9-13, 2017. Oral and poster presentations of ertugliflozin, a SGLT-2 inhibitor in development with Pfizer, include new data from two Phase 3 studies and 52-week extension data from three other studies in the VERTIS clinical development program.. . . .


Now you know. Scantly sleeping, As sleep fails to find me -- once again. . . oh well.

नमस्ते

Tuesday, May 16, 2017

More Ignoble, But Ancient, Schering-Plough History Put To Rest... 2001 K-Dur® Antitrust Suit Settles


The patent on this tiny coated crystal was first granted in September of 1989. It is, at base, simply a potassium chloride crystal, coated to dissolve slowly in the gut. While I do admire the 1980s era ingenuity it took to create that long-ago drug, nearly 27 years seems more than long enough to recoup the R&D, plus book a massive profit stream.

And so, K-Dur® it seems -- in what is actually a smallish settlement for Kenilworth to absorb -- has finally met its "pay for delay" end-game. The end comes in the form of a $60 million payment, in a 16 plus year old federal antitrust class action (as a successor to a legacy S-P class action).

Here is Reuters on it all, tonight:

. . . .The settlement, disclosed in papers filed in federal court in Newark, New Jersey on Monday, came in a class action filed in 2001 arising out of a settlement in patent litigation between Upsher-Smith and Schering-Plough Corp, now owned by Merck.

That patent deal, plaintiffs in the antitrust class action said, was an example of a "pay-for-delay" settlement, in which brand-name drug makers pay generic companies to keep their products off the market for a longer period.

Both companies continued to deny wrongdoing as part of the settlement, according to court papers. The settlement is subject to court approval.

Neither Merck nor Upsher-Smith immediately responded to requests for comment on Tuesday. . . .


Now you know. There are some things that I've. . . simply stopped doing. I long ago (like late May 2015) stopped caring -- stopped looking in. . . on this federal court file. So I learned of yesterday's settlement -- in today's papers. So it goes. And I am decidedly good with it all. A wide smile. . . with much excitement ahead, this weekend, indeed. So. . . whatever, S-P (and Mr. Prep. H.). . . .

नमस्ते.

Nigeria Returns To 2014 Border Screenings Policy -- With Ebola Re-Emerging In The Congo


This is, in truth, a very difficult time, in central Africa, from a public health policy perspective. Local in-country health ministers do not want to engender panic, but they also must move swiftly, given the severity of the situation. As you may see, at right, Nigeria does not even share a border-line with northern DRC -- and the affected Bas-Uele Province, of the DRC. Even so, it is tightening its border entry procedures -- in the same way it had, in 2014 -- in the last sustained viral event. I suppose that is wise -- but if the rest of Africa begins to clamp down, once again, the continent's economy will shudder -- from the effect of the clamp-down -- without even one more live Ebola transmission, continent wide.

Moreover, thus far (as CIDRAP notes), the governing body of the World Health Organization has not authorized the use of the Merck vaccine candidate, though it has said if/when it does -- it will be in a ring fashion -- as it was deployed in the last outbreak (but was not ready until 2016).

I admit to being puzzled, about that. There are 300,000 doses at the ready. At least 10,000 of those should (in my view) already be on their way, inside the tertiary rings of contact, in Bas-Uele Province -- even if reaching the rugged forested terrain in the far northern Congo is more than a bit of a challenge.

Refrigeration-equipped trucks (even if flown in by US military assistance) ought to already be rolling north, loaded with vaccine stock. [Under 44, they would already be. I cannot resist saying so -- and noting that Mr. Trump will likely never say anything about this topic.] But back to the main topic -- it seems to me that the moderate risk of some side effects is outweighed by the need to avoid another multi-year epidemic. I am hopeful the WHO Director General will say so, even later this week.

In any event, here is the Nigeria Tribune on it all, overnight:

. . . .Speaking during his visit to the Nnamdi Azikiwe International Airport, Abuja, on Monday, Minister of Health, Professor Isaac Adewole, asked Nigerians not to panic, adding that the Federal Government remained committed to ensuring that the virus was not imported to the country. . . .

As part of the measures being put in place, the minister was at the airport to inspect thermal screening machines located at the port health stand. . . .


Onward, on a suddenly very warm and humid Spring morning. Be well, one and all. [Late last night, Cassini made a fourth ring plunge -- around Saturn -- drawing ever closer. . . to her twisting demise.]

नमस्ते

Monday, May 15, 2017

[U] Ninth Circuit Oral Argument: Live Blogging, Later This Morning...


Mr. Trump: Time's Up. You. Are. A. Fraud.

Your "movement" is morally bankrupt -- and now largely non-existent -- gutted by your endless duplicity.

Watch it on C-SPAN, or. . . Look for my live coverage, in the blue pull quotes below (or if I am constrained by day-gig duties, look for the coverage initially in comments to this post -- as it is easier to post comments by phone, than edit the main post that way). Order here.

. . . .We are underway: the jurists are already probing Mr. Wall, over whether Mandel is the right standard. Exactly as it started in the Fourth Circuit.

It is clear that Mr. Trump will lose, unless Mandel is the standard. . . . Any other standard -- any first amendment case standard -- will be a death knell for Mr. Trump's putative order. . . .

Now on to questions of standing, and the panel is trying to understand how the Administration could even credibly claim the lower courts (all of them) were in error. Not likely. . . .

Now Mr. Wall has foundered, unable to explain away the fact that the 1965 Amendments to the NIA (signed by President Johnson, in the shadow of the Statue of Liberty) have not been repealed -- and that the "nationality" discrimination prohibition must be read consistently with subsequent amendments. Congress knows exactly how to repeal a prior law -- and it did not do so. Mr. Wall cannot clear that hurdle -- forgetting the constitutional violations. . . .

Now he is unable to explain Mr. Trump's campaign promises. . . .

[Oops! A work interruption here; back by 12:30 CDT. Ugh. Plaintiffs now underway. . . . Going well!]

Update: argument has concluded. On to the Supremes -- but I predict both the Fourth and Ninth Circuits will hold against Mr. Trump's Muslim Ban 2.0. . . .
[Graphic at right (and in today's masthead) derived from a legendary Reddit user, and all around great artist -- with courteous fair use claimed.] Be well. Be wise. Actively -- but peaceably -- resist the pumpkin-hued narcissist. Out.



नमस्ते

Sunday, May 14, 2017

Current Congo Ebola Outbreak: An Estimated 125 "Contacts" -- Of The Three Known Fatalities


More difficult news, tonight, from Bas Uele Province. We will endeavor to keep a near real-time series of updated items near the top, on this current outbreak.

CNN has the latest:

. . . .Bas-Uele province, with a population of 900,000 in 2007, is mostly inhabited by the Boa tribe, which subsists through farming and hunting and conducts some trade by way of the Uele River. . . .

Health officials are investigating 17 other suspected cases, Dr. Ernest Dabire, WHO's health cluster coordinator, said Sunday in Kinshasa. He further estimated that 125 people had been linked to the confirmed Ebola cases and urged the public to be vigilant and visit their doctor if they experience fever or other symptoms. . . .


As you fall asleep safe and sound -- whole and healthy, tonight, count yourself blessed -- we should all reflect upon just how lucky we are -- by purely unearned random chance, of variant viral biology -- and of. . . again, random geography, by birth. That alone should be. . . decidedly humbling.

नमस्ते

Saturday, May 13, 2017

Now Eleven Confirmed Ebola Cases... In Congo's 2017 Outbreak.


It is with some deep concern that I report this update -- as it signals a fully blossomed outbreak -- a new one -- but it seems that WHO health authorities are on-scene, very near in time to the discovery of the first case -- or the index case, as its called.

Specifically, it would seem that the index case patient was likely transported by cab to a health care facility, where he died. Then his cab driver succumbed, just a few days later. Now a third person, who cared for the likely index case, has died. Overall, in the far northern border province of the Congo, there are eleven confirmed cases -- just since April 23:

. . . .11 cases; 4 deaths. . . Personal Protective Equipment (PPE) for health care workers has been shipped on 12 May 2017 to Kisangani. Additional kits are currently being prepared and will be shipped as soon as available. . . .


The bulk-packed vaccine stock cannot arrive soon enough -- and the vaccinations cannot begin soon enough. Please keep the people of the Congo, and Bas-Uele province in particular, in your meditations, on Mother's Day.



नमस्ते

Friday, May 12, 2017

Hard Ebola News, Concerning The Former Zaire -- The Democratic Republic Of The Congo...


We knew this day would come -- as life always finds a way -- even (especially, perhaps) parasitic, destructive life. . . it adapts -- it evolves. . . it lays dormant, in the bush. . . for years. . . decades, even. Then it rises, anew. This is -- unfortunately -- one of those times.

The good news, however, is that the world now has what it believes will be a 100 per cent effective vaccine -- and 300,000 doses at the ready, all manufactured by Merck. [Back story, here.] Even a robust "ring vaccination" program throughout Bas-Uele province, in the northern part of the DRC (the affected country) will do nothing for those (dozens, potentially, already) who have contracted the full-on virus.

But we should be encouraged that a large epidemic in 2017 is now only a rather remote possibility -- assuming the vaccine still inactivates the virus, and that ebola itself hasn't stealthily-mutated -- to avoid the vaccine's killing instinct. I do think we have very good reason to be hopeful. From this evening's New York Times, then -- a bit:

. . . .Of the five blood samples taken from the newest suspected cases and analyzed by the Congolese National Institute of Biomedical Research, one tested positive for Ebola, according to the Health Ministry. Since April 22, the ministry has recorded nine suspected cases and three deaths.

Dr. Armand Sprecher, a public health specialist and Ebola expert who works with Doctors Without Borders — widely known by its French name, Médecins Sans Frontières, said by telephone from Brussels that unless a full investigation were conducted, it would be hard to know how severe the new outbreak could be. . . .


Do go do what ever it is you do -- this Sunday (or Saturday, or tonight), in meditation, communion, prayer or worship -- to ask for some biological favors -- to befall all the good people of the DRC. And in all of north central Africa, truth told. That's all I've got at the moment, as it has been quite a week for disturbing news, on many fronts. . . . sleep well all -- I'm out.

नमस्ते