On DACA: This Is What REAL Leadership Looks Like… Thank You, Mr. President!

September 5, 2017 - Leave a Response

As he promised he would if 45 made a move to end DACA, our 44th President now breaks his self-imposed silence — and weighs in, via Facebook.

I will say almost nothing more — other than to say he is unquestionably in the right. And Mr. Trump is both unquestionably wrong here, from a moral perspective — and engaging in a cowardly act of political Kabuki theater. But I’ve said that before, just yesterday. Here is what a real leader sounds like:

. . . .Immigration can be a controversial topic. We all want safe, secure borders and a dynamic economy, and people of goodwill can have legitimate disagreements about how to fix our immigration system so that everybody plays by the rules.

But that’s not what the action that the White House took today is about. This is about young people who grew up in America – kids who study in our schools, young adults who are starting careers, patriots who pledge allegiance to our flag. These Dreamers are Americans in their hearts, in their minds, in every single way but one: on paper. They were brought to this country by their parents, sometimes even as infants. They may not know a country besides ours. They may not even know a language besides English. They often have no idea they’re undocumented until they apply for a job, or college, or a driver’s license.

Over the years, politicians of both parties have worked together to write legislation that would have told these young people – our young people – that if your parents brought you here as a child, if you’ve been here a certain number of years, and if you’re willing to go to college or serve in our military, then you’ll get a chance to stay and earn your citizenship. And for years while I was President, I asked Congress to send me such a bill.

That bill never came. And because it made no sense to expel talented, driven, patriotic young people from the only country they know solely because of the actions of their parents, my administration acted to lift the shadow of deportation from these young people, so that they could continue to contribute to our communities and our country. We did so based on the well-established legal principle of prosecutorial discretion, deployed by Democratic and Republican presidents alike, because our immigration enforcement agencies have limited resources, and it makes sense to focus those resources on those who come illegally to this country to do us harm. Deportations of criminals went up. Some 800,000 young people stepped forward, met rigorous requirements, and went through background checks. And America grew stronger as a result.

But today, that shadow has been cast over some of our best and brightest young people once again. To target these young people is wrong – because they have done nothing wrong. It is self-defeating – because they want to start new businesses, staff our labs, serve in our military, and otherwise contribute to the country we love. And it is cruel. What if our kid’s science teacher, or our friendly neighbor turns out to be a Dreamer? Where are we supposed to send her? To a country she doesn’t know or remember, with a language she may not even speak?

Let’s be clear: the action taken today isn’t required legally. It’s a political decision, and a moral question. Whatever concerns or complaints Americans may have about immigration in general, we shouldn’t threaten the future of this group of young people who are here through no fault of their own, who pose no threat, who are not taking away anything from the rest of us. They are that pitcher on our kid’s softball team, that first responder who helps out his community after a disaster, that cadet in ROTC who wants nothing more than to wear the uniform of the country that gave him a chance. Kicking them out won’t lower the unemployment rate, or lighten anyone’s taxes, or raise anybody’s wages.

It is precisely because this action is contrary to our spirit, and to common sense, that business leaders, faith leaders, economists, and Americans of all political stripes called on the administration not to do what it did today. And now that the White House has shifted its responsibility for these young people to Congress, it’s up to Members of Congress to protect these young people and our future. I’m heartened by those who’ve suggested that they should. And I join my voice with the majority of Americans who hope they step up and do it with a sense of moral urgency that matches the urgency these young people feel.

Ultimately, this is about basic decency. This is about whether we are a people who kick hopeful young strivers out of America, or whether we treat them the way we’d want our own kids to be treated. It’s about who we are as a people – and who we want to be.

What makes us American is not a question of what we look like, or where our names come from, or the way we pray. What makes us American is our fidelity to a set of ideals – that all of us are created equal; that all of us deserve the chance to make of our lives what we will; that all of us share an obligation to stand up, speak out, and secure our most cherished values for the next generation. That’s how America has traveled this far. That’s how, if we keep at it, we will ultimately reach that more perfect union. . . .

And, once again — we (the collective ACLU “we“) will see Mr. Trump’s lawyers in court, and answer them there — on all these topics. And just like Ban 2.0, they will. . . lose. Onward — and Forward — as one.



Merck Scores New EU Approval For Keytruda® — In Certain Bladder Cancers

September 5, 2017 - Leave a Response

I’ll use a throwback graphic, from a time when the candidate was known by its chemical name — and not yet branded. To be certain, this is decidedly good news.

While both Kenilworth and BMS expect important new US FDA indication approvals in the last few days of September of this year (for Opdivo® and Keytruda®), the entrance of additional immuno-oncology agents (from two other competitors) has dampened the significance of any one approval out of FDA. Each of BMS and Merck will make perhaps $5.8 billion in revenue next year on their immuno offerings alone. Here’s a bit of the latest EU nod — for Merck:

. . . .[T]he European Commission has approved KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Specifically, KEYTRUDA is approved for use as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for cisplatin-containing chemotherapy.

The approval in patients previously treated with platinum-containing chemotherapy was based on superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002), as demonstrated in the randomized, phase 3 KEYNOTE-045 trial.

The approval in patients ineligible for cisplatin-containing chemotherapy was based on phase 2 data from the KEYNOTE-052 trial, which demonstrated an overall response rate (ORR) of 29 percent (95% CI, 25-34).

The approval allows for the marketing of KEYTRUDA in these two new indications in all 28 EU member states plus Iceland, Lichtenstein and Norway at a dose of 200 mg every three weeks until disease progression or unacceptable toxicity. . . .

Now you know — as a shortened office week begins. Onward, after a wondrously languid and long holiday weekend. . . . now a quite busy day ahead, as it is high time to get after Trump (on his unlawful DACA detainers), over at the federal courthouse on Dearborn.


No Matter What 45 Does On DACA Tomorrow, There Will Be Legal/Constitutional Challenges — Nationwide.

September 4, 2017 - Leave a Response

I find myself (once again!) looking at 1600 Pennsylvania as an insular place — a place that knows just about nothing of our way of governing. Our 240 year experiment in real and tangible freedoms. In boisterous, but ultimately vibrant democracy.

So some time tomorrow, apparently, 45 will declare that he is (in some delayed form) ending the Obama era policy that came to be known as DACA. And he will simply kick it over to Congress to save these fine young Americans’ futures.

And in a transparently silly prevarication, Trump will then say he did his part to end “illegal” immigration — and “blame” Congress for keeping about 800,000 now solid Americans on a path to becoming. . . citizens. This Kabuki theater session, over a series of months, now is simply nauseating, because real people — and real families — are at real risk, of being torn apart by it.

I certainly wish we had a real leader, instead of a clownish cartoon. Here is a bit, from today’s NYT editorial page:

. . . .Dreamers divulged information to the government, expecting that their information would not be shared. The information includes not only potentially incriminating information like date of initial entry and length of stay in the United States, but also details like their names, addresses, school information and Social Security numbers — precisely what the government needs to locate and detain them quickly.

As Zachary Price of the University of California Hastings College of the Law has argued, using such information would constitute entrapment. Courts have thrown out convictions of defendants who were prosecuted based on actions, statements or information they provided when they were assured that their conduct would not lead to adverse action. Dreamers facing deportation could apply the same logic here. Absent that information, it would be much harder, though not impossible, to deport them. Allowing the government to use their information would be, to quote the Supreme Court in a leading entrapment case, “shocking to the universal sense of justice”. . . .

I will file — in Chicago — on behalf of any Dreamer whose fundamental rights are threatened with an “entrapment” style abridgement. And that suit will prevail, almost without a doubt. So. . . bring it on, 45 — just like Muslim Bans 1.0 and 2.0 — we will run the table on your lunacy (if Congress doesn’t legislatively neuter you, first). Read this as ardent. . . motivation, walking.

G’night, one and all.


Editorials: A “New, New Deal” On Unions — And Creative Organizing — Needed In America

September 4, 2017 - Leave a Response

With each passing Labor Day, I am torn anew, by the criminal tragedies that befell my family of origin on this day, 32 years ago. . . . I have long ago forgiven — but I do not. . . ever. . . forget.

And in truth, more and more, from that time — I am also reminded of how much the presence of organized labor, in the hard rock mines of my youth, almost singularly allowed me to be where I am today — purely by a stroke of great good luck. [I am also put in mind of our brothers and sisters at West Point, PA here, as well.] And so, I do agree with the Wa Po and NYT editors of late, we do need another “new deal” with organized labor. The gig economy, while vibrant, does take more than it gives to many many individual participants. Largely gone are the auto-line, and coal mine struggles, of yesteryear — now unions need to focus on making the fluid, often virtual, work spaces more economically friendly to the individual worker. Here’s a bit, from the Wa Po:

. . . .The central issue in American politics is the economic security of the middle class and their sense of opportunity for their children. As long as a substantial majority of American adults believe that their children will not live as well as they did, our politics will remain bitter and divisive. . . .

Surely related to middle-class anxiety is the slow growth of wages even in the ninth year of economic recovery. The Phillips curve — which postulates that tighter labor markets lead to an acceleration of wage growth — appears to have broken down. Unemployment is at historically low levels, but the Bureau of Labor Statistics reported Friday that average hourly earnings last month rose by all of 3 cents — little more than a 0.1 percent bump. For the past year, they rose by only 2.5 percent. In contrast, profits of the S&P 500 are rising at a 16 percent annual rate. . . .

On this Labor Day, we would do well to remember that unions have long played a crucial role in the American economy in evening out the bargaining power between employers and employees. They win higher wages, better working conditions and more protection from unjust employer treatment for their members. More broadly, they provide crucial support in the political process for programs such as Social Security and Medicare that benefit members and nonmembers alike. (Both were passionately opposed by major corporations at their inception.). . . .

In an era when the most valuable companies are the Apples and the Amazons rather than the General Motors and the General Electrics, the role of unions cannot go back to being what it was. But on this Labor Day, any leader concerned with the American middle class needs to consider that the basic function of unions, balancing the power of employers and employees, is as important to our economy as it has ever been. . . .

Indeed. And be well, but beware — for I fear this will all close out quite. . . icily, now. On, to the cooking, then. . . .


We Last Looked In On This Individual NuvaRing® Opt-Out In September 2014… DISMISSED.

September 3, 2017 - Leave a Response

We have been remiss — but someone just a few moments ago searched for the outcome of this case: Castro.

So here is the final update: In July of 2105, a year after we last looked in, and now two full years ago — the able US District Judge Rodney Sippel, in Kansas City, Missouri, had dismissed this individual case permanently — due to the plaintiffs’ failure to provide information supporting the earlier motion to remand it, into state court — in a “questionable” state court venue (in far southwestern Texas). Here’s what I last wrote, end of summer — in 2014:

. . . .As the MDL winds down, a handful of plaintiffs have elected to reject the settlement, and press on individually, in the same ways they started. In one of those cases, the plaintiff’s lawyer seeks remand — out of federal court, and back into the the state court system of Texas. But not just any state court in Texas, no. That plaintiff seeks a remand order to Cameron County, Texas.

I mention this bit of detail only because that is a local court system with a documented, published history of corruption — and a national reputation for being an overly plaintiff-friendly “hellhole” — among pharma defense lawyers. I have no reason to believe that Merck will not draw an impartial lot in these local courts (should the able Judge Sippel grant remand), but I suspect some of its defense counsel do. So they are opposing a return to the very bottom of Texas, for this case. . . .

I’ll close with some coverage of the problems in this local court system — from a local paper, in Southwest Texas. . . .

So — Castro is. . . no more. That’s another clean up, of sorts, as we are doing much of that. . . this long weekend. Closing out my city place as well, at least until next summer, later today. Smile.


More Post Trial Subsequent Authority — In Gilead/Merck Hep C Patent Fight — In Delaware Federal Court…

September 3, 2017 - Leave a Response

As we discussed last week, on Tuesday — the post trial wrangling is now well-underway, here.

At stake is as much as a series of payments totaling perhaps $2.54 billion — to Merck. I suspect that amount (and the ongoing royalty, if any) will be substantially reduced, as the appeals process proper takes its course. However, as of Friday night, Merck’s lawyers were citing a newly decided appellate case, for the notion that Merck’s win ought to stand undisturbed in Delaware. [Recall though that Merck lost in a similar patent spat in California, involving these same patents (and w as ordered to pay Gilead’s legal fees), due to Kenilworth’s “unclean hands“.] Here’s a bit — from the latest six pager — but we will have to wait a tic. for rulings, now:

. . . .Gilead says that Wyeth stands for the principle that, if extensive screening is required, a patent claim “lacks enablement as a matter of law.” (D.I. 536 at 6.) As Judge Bryson explained, that is an incorrect understanding of Wyeth. Rather, the inquiry turns on the specific facts of each case. Quoting Wyeth, Judge Bryson reiterated that “‘[u]ndue experimentation is a matter of degree. Even a considerable amount of experimentation is permissible as long as it is merely routine or the specification provides a reasonable amount of guidance regarding the direction of experimentation.’” UroPep at 45 (quoting Wyeth v. Abbott Labs., 720 F.3d 1380, 1385-86 (Fed. Cir. 2013)).

For extensive experimentation to be “undue,” the defendant must provide clear and convincing evidence such as “a disclosure and a field that provides no guidance, [and requires] aimless plodding through systematic experimentation of a single compound that would take weeks.” Id. Those facts were present — and undisputed — in Wyeth. But such facts were not present in UroPep, and they are not present here, either: The jury heard copious evidence that contradicted Gilead’s “undue experimentation” claim, including that Pharmasset scientists read and understood the value of the ’597 patent disclosure and that Mr. Clark, with the ʼ597 disclosure in hand, was able to practice the invention with ease. This case, like UroPep, has a rich trial record on enablement that is far removed from the undisputed record in Wyeth. . . .

Now you know. . . and with sweet Cassini now only one full orbit away from its final plunge, and obliteration — in the thickening, burning and toxic atmosphere of Saturn. . . I find myself reflecting — in the now cold, clear dawn glow — on the passing of the last five years, with some wonderment. . . Smile.


I Assume A Redacted Settlement Agreement Will Be Available By Mid-Week Next Week…

September 2, 2017 - Leave a Response

As expected, the trial court level New York federal settlement in Darweesh, et al. v. Trump, 1:17-cv-00480-CBA-LB (NY ED) was filed in open court at the end of the week.

It seems likely that it may name individual names — of plaintiffs who sought redress, from their earlier denial of entry — under 45’s Muslim Bans 1.0, and 2.0. Which means the public is, at present, not permitted to view the actual as signed settlement — in full.

In short order, the press will file a simple motion to have a redacted for names version made public. If they don’t — I will. There can scarcely be a more important matter of public interest and concern than closely monitoring 45’s attempts to abridge the free exercise clause of Amendment One. And the free press clause of that same amendment gives us all the nearly plenary right to the records of our court proceedings, at the federal level. So stay tuned into next week: we will post it then, as redacted.

. . . .SETTLEMENT AGREEMENT , Signed by All Parties, by John Kelly, Jamea T. Madden, Kevin K. McAleenan, Donald J Trump, U.S. Customs and Border Protection (“CBP”), U.S. Department of Homeland Security (“DHS”) (Attachments: # (1) Settlement Agreement) (Platt, Steven). . . .

Onward. And, approp of Labor Day — and Hamilton: “Immigrants, we get the job done!”


Update On Status Of Federal NuvaRing® MDL — In Mizzou…

September 2, 2017 - Leave a Response

Here is the smallish update:

. . . .ORDER

IT IS HEREBY ORDERED that a teleconference is set in this matter on August 31, 2017 is continued and will now be held on October 12, 2017 at 2:00 p.m. Central Time. The parties shall file a proposed agenda no later than October 10, 2017.

IT IS FURTHER ORDERED that Counsel who wish to participate in the status conference are directed to call the conference toll free at 1-888-684-XXXX from the United States (for callers outside the United States the caller paid international number is 215-446-XXXX). The access code to enter the telephone conference for all participants is: XXXXXXXXX. Counsel will then be prompted to enter the participant security code: XXXXX followed by the # (pound) key. This conference will be activated at 1:45 p.m. so the conference may start promptly at 2:00 p.m. Counsel who are not participating and are just monitoring the conference must mute their phones so the proceeding is not interrupted by background noise. . . . /s/ August 30, 2017.

Now you know. . . g’night one and all.


Busy Planetary Science Long Weekend: Juno’s Seventh Jupiter Dive Now Underway — Closest Dip, At 5:49 PM EDT

September 1, 2017 - Leave a Response

I can barely keep up with all that is happening over a billion miles from here, these days. . . .

In addition to the second to last Cassini Saturn loop, this weekend, and the 40th year of Voyager, now in interstellar space. . . (the first human-made object to reach the interstellar winded “shipping lanes” to the stars) we are reminded of Juno’s seventh dip to the cloud tops of mighty Jupiter.

Do see it all in near real time, this evening — via NASA/JPL’s tweets — but here is the press release, of a few hours ago:

. . . .NASA’s Juno spacecraft will make its seventh science flyby over Jupiter’s mysterious cloud tops on Friday, Sept. 1, at 2:49 p.m. PDT (5:49 p.m. EDT and 21:49 UTC). At the time of perijove (defined as the point in Juno’s orbit when it is closest to the planet’s center), the spacecraft will be about 2,200 miles (3,500 kilometers) above the planet’s cloud tops.

Juno launched on Aug. 5, 2011, from Cape Canaveral, Florida, and arrived in orbit around Jupiter on July 4, 2016. During its mission of exploration, Juno soars low over the planet’s cloud tops — as close as about 2,100 miles (3,400 kilometers). During these flybys, Juno is probing beneath the obscuring cloud cover of Jupiter and studying its auroras to learn more about the planet’s origins, structure, atmosphere and magnetosphere.

NASA’s Jet Propulsion Laboratory, Pasadena, California, manages the Juno mission for the principal investigator, Scott Bolton, of Southwest Research Institute in San Antonio. The Juno mission is part of the New Frontiers Program managed by NASA’s Marshall Space Flight Center in Huntsville, Alabama, for the Science Mission Directorate. Lockheed Martin Space Systems, Denver, built the spacecraft. JPL is a division of Caltech in Pasadena, California. . . .

I feel so fortunate — to be alive in an age of near-daily planetary science discovery and wonders. . . not that the suffering engendered by Harvey is small, but it should help us to realize we are only tenants here — and the Universe regularly reminds us that we survive here, and occupy — under her rules, exclusively. It may take millennia for some of us (45 cough!) to see that, but it is true.

All of us here — we have so much more in common, as inhabitants of this tiny sphere, than we claim as differences, to keep us apart. In truth, we are all but very temporary guests here, on this incredibly waifish pale blue dot — floating now, in Milton’s nearly endless powdered night blanket — in front of the stars, stretching to near infinity. . . . Whoosh. Do rest up over the long weekend, and do stay dry and safe with the rains now moving into middle Tennessee. Smile.


If Don Draper Had Been Hired To Do The NASA/JPL Cassini Account Pitch…

September 1, 2017 - Leave a Response

This made me smile. Though in truth, I see her as infinitely more graceful than the last few paragraphs of his would-be ad copy. She is a gossamer thing — twisting and soaring high above the wet black background pavement of space, now powered with Milton’s stars. . . . at least in my eyes, she is. Smile.

. . .Cassini can dive between Saturn and its rings at a blazing-fast 75,000 mph, and yet her delicate thrusters can change her velocity by mere millimeters per second. . . . It was written as loving tribute by JPL and NASA staffers, and loaded to the Cassini Grand Finale twitter feed, overnight.

Spot-on. Have a good one, one and all. I’m out.