Saturday, March 28, 2020

TRO [Mostly] Granted -- On A Saturday Night. Victory For... Humanity, From Judge Gee -- In Flores.


I honestly don't know how these people sleep at night.

Some of these kids have been in custody for more than seven months -- without any articulated justification -- in the face of a prior order requiring very prompt release -- and in no event more than 30 days without detailed written explanations. And. . . none were so provided. What on Earth is wrong with these people?

Here it is in full [a 13 page PDF order and opinion]. Next date is April 10, for preliminary injunction hearings:

. . . .For the reasons stated below, the Court finds that Plaintiffs have shown serious questions as to the merits of their claim that ICE has breached the FSA with regard to the provision of safe and sanitary conditions and appropriate medical care and living accommodations in the context of the COVID-19 outbreak. The Court further finds that Plaintiffs have a strong likelihood of succeeding on their claim that both ICE and ORR have breached the FSA in their failure to release minors to suitable custodians in a prompt manner and to record their continuous efforts towards minors’ release. . . .

Because COVID-19 poses unprecedented threats to the safety of Class Members and all who come in contact with them, including ORR and ICE staff, healthcare providers, and local populations, the Court finds that any unexplained delay in releasing a child in ORR and ICE custody violates of Paragraphs 14 and 18 of the FSA, which require the agencies to release Class Members in their custody without unnecessary delay and make and record efforts to release the Class Members. This finding is bolstered by the Court’s longstanding orders construing and mandating compliance with paragraphs 14 and 18 due to past violations. See July 24, 2015 Order [Doc. # 177]; June 27, 2017 Order [Doc. # 363]; July 30, 2018 Order [Doc. # 470]. Accordingly, Plaintiffs have established a strong likelihood of success as to the merits of this part of their claim. . . .

Defendants are hereby ORDERED to SHOW CAUSE by April 10, 2020 at 10:00 a.m. why a preliminary injunction should not issue (1) requiring Defendants to make and record continuous efforts to release class members; (2) enjoining Defendants from keeping minors who have suitable custodians in congregate custody due to ORR’s unexplained failure to promptly release these minors to suitable sponsors under the TVPRA; and (3) enjoining Defendants from keeping minors who have suitable custodians in congregate custody due to ICE’s unexplained failure to release these minors within 20 days, especially given the emergent circumstances and the Court’s prior orders requiring the same (see, e.g., July 24, 2015 Order [Doc. # 177], June 27, 2017 Order [Doc. # 363], July 9, 2018 Order [Doc. # 455], July 30, 2018 Order [Doc. # 470]). . . .

ORR and ICE shall make every effort to promptly and safely release Class Members in accordance with Paragraphs 14 and 18 of the FSA and the Court’s prior orders (see, e.g., July 24, 2015 Order [Doc. # 177], June 27, 2017 Order [Doc. # 363], July 9, 2018 Order [Doc. # 455], July 30, 2018 Order [Doc. # 470]). . . .


We must vote this lawless dictator, and his henchmen out. Vote vote vote. This is posted on a night after Trump said he would withold federal COVID related emergency aid from Michigan -- to spite the Democratic woman Governor there. Insane. We the people must not allow this to persist.

Vote.

नमस्ते

Friday, March 27, 2020

LA Flores TRO Hearing Today (At 5 PM EST): For "Seven Day" Order -- Releasing Minors In ICE Custody To Families Or Sponsors


More, of the ACLU's ongoing heroism, in vindicating human rights -- in the face of Trump's lawless opposition.

Do read the full 33 pages -- but here's a bit -- detailing health risk abuses in the time of COVID-19:

. . . .The spread of COVID-19 into Defendants’ facilities is not speculative. It has already infected ORR’s MercyFirst and Abbott House congregate facilities in New York and facilities housing ICE detainees. At least one child is now in quarantine awaiting test results in the ICE family detention center in Berks, Pennsylvania. Declaration of Bridget Cambria. The Agreement “sets out nationwide policy for the detention, release, and treatment of minors in the custody of the [Defendants] …” Agreement at ¶ 9. The certified class includes “[a]ll minors who are detained in the legal custody of the [Defendants].” Id. ¶ 10. It requires that Defendants “treats[ ] and shall continue to treat, all minors in its custody with dignity, respect and special concern for their particular vulnerability as minors.” Id. ¶ 11.5 It requires that except for class members who are flight risks or a danger, class members shall be released without unnecessary delay to listed sponsors, id. ¶¶ 14 and 18, and if not promptly released, must “as expeditiously as possible,” id. ¶ 12.A.3, be transferred to a “non-secure” program licensed by a state for the care of dependent children. Id. ¶¶ 6 and 19, and Exhibit 1. The obvious ways to comply with the Agreement and protect class members’ safety are to (1) expedite children’s release to sponsors identified in Paragraph 14, and (2) not detain children in congregate unlicensed facilities where their risk of exposure to COVID-19 is high. . . .

Seven days should be more than enough for ORR to manage post-release risk. See e.g., Declaration of James Owens, Feb. 7, 2018, Exhibit K, ¶ 6 (state dependency courts determine cause to detain children within three days); Exhibit M (ORR Manual of Procedures, at § 2.2.2 (care providers generally expected to complete custodian evaluations within 10-21 days), § 2.7.2 (case coordinators expected to make recommendation within 1 business day), and § 2.7.3 (Federal Field Specialists expected to make release decisions within 1-2 business days of receiving case coordinator recommendations)). Class counsel recently secured the release of a class member in ORR custody to his undocumented father in about five days. Schey 3. Any marginal gains to that ORR may claim for child safety from their prolonged investigations of sponsors for more than 30 days cannot outweigh the harm congregate detention will inevitably cause to the health and safety of children in ORR and ICE custody. . . .

A preliminary review of data provided by Defendants to class counsel on a monthly basis shows that during February 2020 ICE detained about 3,359 class members in ICE family detention facilities. Schey ¶ 4. Of these class members it appears two (2) were apprehended in 2014. Id. Four (4) were apprehended in 2018 and have been detained for over fourteen months. Id. About ten (10) have been detained for about one year and another ten (10) have been detained for about eleven months. Id. About twenty-six (26) have been detained for about ten months, fifteen (15) for about nine (9) months, eleven (11) for about eight months, fifty-eight (58) for about seven (7) months, ninety six (96) for about six (6) months, two hundred and five (205) five (5) months, one hundred and fifty-one (151) for about four (4) months, two hundred and ninety-three (293) for three (3) months, and nine hundred and eighty (980) have been detained for two months. Id. In short, about 1,861 class members appear now in ICE custody have been detained for three months or longer with no efforts made by Defendants to release them under the terms of the Agreement. . . .

When the alternative is to leave children on the tracks with the COVID-19 train fast approaching, Defendants’ not releasing minors without unnecessary delay and ICE’s blatant violation of the Agreement and this Court’s Orders, are unconscionable. The temporary procedural relief Plaintiffs seek is a minimal step to protect children’s substantive rights under the Agreement and the Court’s prior Orders requiring the prompt release of minors who are neither a flight risk nor a danger. The children’s right to Defendants’ compliance with the Agreement they reached with Plaintiffs has now become critically important to avoid unnecessarily keeping children in congregate detention endangering their health and well-being during a global pandemic. . . . This Court should require Defendants to articulate good cause for exposing children to the clear dangers of congregate detention in lieu of release to their families or transfer to non-congregate settings. . . .


The papers also insist that ICE facilities provide for sanitary needs: soaps, baths and clean bedding mong other things. It is simply insane, that a court would have to tell our government this is. . . needed. I N S A N E.

नमस्ते

Thursday, March 26, 2020

Surprising No One, The 3.2 Million [All Time Record!] Jobless Claims... Were Partially Avoidable -- As Were Many Of The Deaths.


It must be said: most of this morning's economic carnage -- and at least some of these COVID-19 fatalities -- were. . . avoidable.

Trump simply refused. He refused -- for a month or more -- solely because he knew it would hurt his chances. . . in the fall. Now I think he has fallen, in truth -- he is doubly-damned. He's reaping the whirlwind of his delays, and fecklessness. And sadly, so are we all. From The Hill / Politico:

. . . .The 69-page document, obtained by Politico, lays out step-by-step responses to a pandemic, such as implementing directives on workplace safety and procurement of safety equipment.

The Trump administration has failed to follow multiple recommendations, Politico noted, and is only just now taking some steps directed for the early days of the coronavirus's spread. . . .

Under the NSC timeline, the Trump administration in late January should have begun issuing directives aimed at "coordination of workforce protection activities including. . . [personal protective equipment] determination, procurement and deployment," according to the report. Such actions have only been recently implemented.

A request for congressional funding to combat the pandemic, the timeline further dictates, should have taken place a month before it happened. . . .


Disgusting, indeed. Onward. That said, please donate blood -- if you are able.

नमस्ते

Tuesday, March 24, 2020

Courtesy Of Our Commenters, We Learn Generic Daraprim Is Now Selling In US, At A 60% "Discount"... Still Outrageous.


The press in India is [now finally] reporting that Cerovene has struck a US distribution deal with stalwart high price generic manufacturer Dr. Reddy's Labs -- and the generic is now selling here stateside. Of course, this is still. . . deeply obscene.

The price, pre-Martin's mark-up, per pill, was only $13.50. His 2015 markup kicked it to $750. At 60 per cent off the Martin markup, it is to be sold in the US at $300, give or take. That is still over 22 times its prior price -- before Martin gouged the nation's vulnerable AIDS patients. [Backgrounder, here.]

So there is still much work to be done -- yet 22X is better than 50X -- even as Phoenixus presumbly fades away, into. . . a dead, dry dust. According to the local Indian papers, Phoenixus only sold about $10 million of the branded version of the drug, in all of 2019:

. . . .The Daraprim (pyrimethamine) brand had US sales of about $10 million for the most recent 12 months ending in January 2020, according to IQVIA Health. . . .


Immensely. . . frustrating. Thanks, again Marty. Sheesh.

Onward -- I resolve to smile, anyway.



नमस्ते

In Which Trump (Again!) Has Deep And Abiding Trouble... With All Real Science.


Tonight, The New York Times makes plain what we’ve known for a decade, ever since the passage of Obamacare: Donald Trump hates it when pesky, actual facts get in the way of his generally ill-informed. . . superstitions. He’s simply incapable of believing he could be wrong. About anything. Ever.

And tragically, that has already cost us many additional American lives (as he dithered about taking decisive action when it would have mattered most), and caused incalculable damage to our economy (by being late) — once-again now increasing the probability he will cost us many more American lives.

Trump long denied a crisis was brewing; he delayed and hamstrung the response efforts, and now threatens to call off the very measures real scientists say will stave off hundreds of thousands of unneeded deaths. And he’ll do it while taking a bailout for his precious resorts businesses. Dr. Fauci may soon get the General Kelly treatment, for having the temerity to tell him he is, in fact, clueless on almost every sub-topic that matters as to COVID-19, and the science based methods for blunting its mortality rate. Consider this (from the paper, tonight):

. . . . Dr. Fauci and the president have publicly disagreed on how long it will take for a coronavirus vaccine to become available and whether an anti-malaria drug, chloroquine, could help those with an acute form of the virus. Dr. Fauci has made clear that he does not think the drug necessarily holds the potential that Mr. Trump says it does.

In an interview with Science Magazine, Dr. Fauci responded to a question about how he had managed to not get fired by saying that. . .“[Trump] goes his own way. He has his own style. . . on substantive issues, he does listen to what I say.”

But Dr. Fauci also said there was a limit to what he could do when Mr. Trump made false statements, as he often does during the briefings.

I can’t jump in front of the microphone and push him down,” Dr. Fauci said. “OK, he said it. Let’s try and get it corrected for the next time. . . .”


I often wish he. . . would. I am fairly concerned that Team Trump is about to make all of it worse than it needs to be (again). Economy plainly. . . included. G’night. . . .

नमस्ते

Sunday, March 22, 2020

Like The New Crewed Moon Mission, Now James Webb Space Telescope Is On A COVID "Hold"...


We have followed this mission's construction and ground assembly -- for over five long years now, right here. So this comes as difficult news, as the project has encountered numerous prior delays. Perhaps we won't now see a launch before. . . 2024. [I assume that if 45 is no longer at 1600 Penn, after January 2021, there will be less urgency for crewed missions -- to the Moon or ultimately, Mars. There simply is a decreased need to take the added risks, with the increased maturation of our autonomous technology.]

Webb is as strong a case for pure space science as NASA has ever articulated. It is a sorely-needed successor to Hubble. We must see it through. Here's a bit:

. . . .NASA is suspending integration and testing operations on the Hubble Space Telescope’s successor to ensure the safety of the agency’s workforce. NASA didn’t say when work on the project would resume but noted that decisions could be adjusted as the situation unfolds over the weekend and into next week. . . .

The James Webb Space Telescope (sometimes called JWST or Webb) will be a large infrared telescope with a 6.5-meter primary mirror. The telescope will be launched on an Ariane 5 rocket from French Guiana in [late 2023?] 2021.

The Webb telescope will be the premier observatory of the next decade, serving thousands of astronomers worldwide. It will study every phase in the history of our Universe, ranging from the first luminous glows after the Big Bang, to the formation of solar systems capable of supporting life on planets like Earth, to the evolution of our own Solar System.

The Webb telescope was formerly known as the "Next Generation Space Telescope" (NGST); it was renamed in September 2002 after a former NASA administrator, James Webb.

Webb is an international collaboration between NASA, ESA (the European Space Agency), and the Canadian Space Agency (CSA). NASA's Goddard Space Flight Center in Greenbelt, Maryland, is managing the development effort. The main industrial partner is Northrop Grumman; the Space Telescope Science Institute will operate Webb after launch.

Several innovative technologies have been developed for Webb. These include a primary mirror made of 18 separate segments that unfold and adjust to shape after launch. The mirrors are made of ultra-lightweight beryllium. Webb's biggest feature is a tennis court sized five-layer sunshield that attenuates heat from the Sun more than a million times. . . .




So we will have to wait at least a few more trips around the sun, to see the collected wonders of our Universe with these "better eyes". . . so it goes. . . grinnin' -- ever grinning.

नमस्ते

Friday, March 20, 2020

Papers ≠ No Virus; Conversely, No Papers ≠ Virus -- Simply No... Common Sense.


It is time to speak out. The virus is present in every North American nation. The virus cannot be contained by closed borders. People, with or without papers should limit non-essential risk taking, and that includes. . . non-essential travel.

But if a human without papers takes the monumental risk of fleeing an oppressive state, and arrives to take the additional risk of seeking an entirely uncertain asylum, there is no reason to assume that human is more likely carrying the virus, than any other human.

And it is plain beyond peradventure that that travel is. . . essential, to their very survival. So Canada, Mexico and the US shutting their asylum doors. . . Is unwise, from a human rights policy perspective — and unwarranted, on the biological science front. From the Washington Post, of moments ago then, bit:

. . . .At a news conference in Washington, acting U.S. secretary of homeland security Chad Wolf said the agreement will go into effect at midnight Friday night.

The Centers for Disease Control and Prevention order “directs the department to suspend the introduction of all individuals seeking to enter the U.S. without proper travel documentation — that’s for both the northern and southern border,” he said. “Tonight at midnight, we will immediately execute the CDC order by immediately returning individuals arriving without documentation to Canada, Mexico, as well as a number of other countries.”

The agreements with Canada and Mexico suspend all nonessential travel at the U.S.-Canada and U.S.-Mexico borders. . . .


In sum, no virus declares a nation state; no one afflicted is more likely to jump a border than anyone not so afflicted, and perhaps less physically up to the rigors of such travel. So we demonize our fellow humans. . . to achieve no discernible rational policy goal. I dissent from this descent — into little more than. . . jingoism. End, rant.

नमस्ते

[U, on Monday Night] Friday -- Smiling...


Well. . . that was quick.

Gratifying, too. . . see this:

. . . .Ultra-thinly traded micro cap Humanigen (OTCQB:HGEN +156%) rockets up on a 16x surge in volume, a scant 67K shares, in response to its proposed plan to conduct a Phase 3 clinical trial evaluating lead drug lenzilumab for the prevention and treatment of cytokine storm (potentially life-threatening out-of-control immune response) that could lead to acute respiratory distress syndrome associated with SARS-CoV-2 infection, the coronavirus responsible for the COVID-19 outbreak. . . .

Lenzilumab is a monoclonal antibody that neutralizes (binds to) a pro-inflammatory protein called granulocyte-macrophage colony stimulating factor (GM-CSF) that is over-expressed in COVID-19 patients. The company is developing it for the potential treatment of CART-T toxicity, graft versus host disease, certain blood cancers and eosinophilic asthma. . . .


Yep -- it may all not ultimately pan out, but I am grinning, this afternoon. UPDATE: Here for the record, is the full prospectus, as of Monday night. Onward.

नमस्ते

Thursday, March 19, 2020

[U -- Friday Stock Pop 150%!] In 2016, Dr. Cameron Durrant [As The Polar Opposite Of Mr. Shkreli] Took Over At KaloBios -- Now Called Humanigen...


. . .And Dr. Durrant may well (if rather suddenly) have on his deft hands. . . a viable COVID-19 "radical intervention" treatment candidate -- for the wracking lung destruction the most severe form of the viral infection occasionally inflicts.

UPDATE -- Humanigen stock is now up over 155%, on Friday morning -- on the OTC / NASDAQ board, on about 30 times normal volume. Delicious. End update.

[What a sweet irony it would work, should all of this play out in the favor of those investors burned by Martin, since long ago he was required to divest all his holdings in what became Humanigen. But back to the story, proper, then:]

One of the programs Dr. Durrant has pursued since the company was freed of Martin via a bankruptcy reorganization, involved. . . Lenzilumab.

Here is a bit from the top of page 78 of the just filed Humanigen SEC Form 10-K, related to the at least animal model studies of Lenzilumab:

. . . .Recent data from China and the subject of a pre-publication titled “Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus”, supports the hypothesis that cytokine storm-induced immune mechanisms have contributed to patient mortality with the current pandemic strain of coronavirus.

The severe clinical features associated with some COVID-19 infections result from an inflammation-induced lung injury requiring Intensive Care Unit (ICU) care and mechanical ventilation. This lung injury is a result of a cytokine storm resulting from a hyper-reactive immune response. The lung injury that leads to death is not directly related to the virus, but appears to be a result of a hyper-reactive immune response to the virus triggering a cytokine storm that can continue even after viral titers begin to fall.

The authors of the study assessed samples from patients with severe pneumonia resulting from COVID-19 infection to identify whether inflammatory factors such as GM-CSF, G-CSF, IL-6, MCP-1, MIP 1 alpha, IFN-gamma and TNF-alpha were implicated.

The authors noted that steroid treatment in such cases has been disappointing in terms of outcome, but suggested that a monoclonal antibody that targets GM-CSF may prevent or curb the hyper-active immune response caused by COVID-19 in this setting. Humanigen believes that the authors’ findings are worthy of further investigation, suggesting that to reduce or eradicate ICU care and prevent deaths from COVID-19 infection, an intervention may be needed to prevent cytokine storm.

Separate publications confirm that cytokine storm is characterized by surge of high levels of circulating inflammatory cytokines, and is an overreaction of the immune system under the conditions, such as CAR-T therapy and patients infected with SARS-CoV-2. These recent studies revealed that high levels of GM-CSF, along with a few other cytokines, are critically associated with severe clinical complications in COVID-19 patients. High concentration of GM-CSF was found in the plasma of severe and critically ill patients, which account for approximately 20% of all patients, especially in those requiring intensive care.

Lenzilumab has been shown to prevent cytokine storm in animal models and this work has been published in peer reviewed journals. Patients are expected to be enrolled soon in a clinical study to determine lenzilumab’s effect on cytokine storm associated with the hyper-active immune response associated with CAR-T therapy, in collaboration with Kite Pharma. . .


Clearly, these are only early green shoots -- but promising, just the same.

And no matter how the Lenz- program turns out, I am abidingly convinced Martin didn't really spend his talent very wisely, or well -- in the first half of his life.

Even so, I'll remain hopeful that was "the life he learned with". . . and, now [starting in 2024] -- perhaps he may yet do something wonderful with the "life after" -- his now hard-learned BoP lessons. . . . just maybe.

Onward -- smiling. Ever. . . smiling.



नमस्ते

Tuesday, March 17, 2020

NIH Funded Clinical Trial Now Underway -- Moderna COVID-19 Vaccine Candidate...


Looking for hopeful news here, on the Saint's day -- and this clearly qualifies.

Moderna -- and its candidate -- are both widely well regarded [Merck maintains a separate, immuno onoclogy-focused venture with the company, which we covered both three, and two years ago, here]. This same "encapsulated container" tech was the winner, in the ebola vaccine efforts. It has been over 99.9 per cent effective. So. . . there is good reason to be highly hopeful.

Here's The Beeb on it:

. . . .Experts say it will still take many months to know if this vaccine, or others also in research, will work.

The first person to get the jab on Monday was a 43-year-old mother-of-two from Seattle.

"This is an amazing opportunity for me to do something," Jennifer Haller told AP.

Scientists around the world are fast-tracking research.

And this first human trial, funded by the National Institutes of Health, side-steps a check that would normally be conducted -- making sure the vaccine can trigger an immune response in animals. . . .


Skipping an animal model is a very reasonable risk to take, given the immensely vast stakes.

Onward -- to go vote, now. . . grinning.

नमस्ते

Saturday, March 14, 2020

[U] We Must Ever Keep Charity In Mind -- Even In Tough Times... Donate Blood.


Our blood supply, in the US, is almost all derived from volunteer donors.

Plese consider donating -- if you are healthy. See here:

. . . .Many states, including Washington, California, Kansas, Pennsylvania, the Carolinas, Massachusetts and Rhode Island, are now calling for blood donations. At the same time, some states are closing schools and other sites that typically host mobile blood drives; even prior to the coronavirus, some events had been canceled. In Massachusetts, the Red Cross announced last September it would no longer be hosting blood drives in the central and western parts of the state. Obviously, this makes it even harder for people to donate.

Even in the best of times, less than 10% of the U.S. population donates blood in a given year, although 38% are eligible. And these are not the best of times. Other than donations, there is no way to maintain a sufficient supply of blood. It cannot be manufactured, and no substitute for it has yet been invented. What's more, it's perishable. Red blood cells last 42 days, and platelets only five. Regular replenishment of the supply is imperative. On top of that, the blood banking industry was already facing major challenges before COVID-19; the U.S. supply chain is now undergoing major economic transformations. This includes increased competition among blood service organizations.

Our blood supply chain is stunningly complex. It requires altruistic donations, collection, testing, processing and distribution to hospitals and medical centers. All along the way, the coronavirus can disrupt any of these essential steps. If donors are ill, they cannot donate; if the staff is ill, they cannot collect, test and process. If our health care workers are compromised, they cannot transfuse. . . . To avoid shortages, the American Red Cross is encouraging healthy, eligible individuals to schedule a blood or platelet donation at Redcrossblood.org. Donating blood is safe, and there is no evidence that COVID-19 can be transmitted by blood transfusion. This was also the case for other major coronaviruses, SARS and MERS-CoV. . . .


Do be excellent to one another -- even those you've not yet met. . . consider donating -- I will this coming week. Update: Nationwide, the Red Cross won't hold large blood drives -- until at least next week, on a wise flattening strategy. But it is at least one concrete thing you can do, in the coming weeks.

नमस्ते

Friday, March 13, 2020

Fast FDA OK -- For Roche's COVID-19 Diagnostic Assay. As Ever, The Trick Will Be... Logistics.


To be certain, this is. . . good news.

But as is ever true in truly far-flung, global health emergencies -- getting these kit-supplies delivered, in vast bulk -- essentailly immediately. . . and then ferried [also immediately] back to one of the latest-model machines [to make the result actionble, from a clinical perspective]. . . that is a feat of logistical wizardry. Here's the bit:

. . . .The first high-speed coronavirus test was approved by the U.S. Food and Drug Administration, said Roche Holding today. The Swiss medical giant’s new test works in its high-volume cobas 6800/8800 systems—widely used diagnostic machines that will be able to process up to 4,000 of the Covid-19 tests per day. That’s 10 times faster than currently used tests.

There are more than 800 of the automated Roche systems around the world, the company has said, including about 110 in the U.S. More have been placed in recent weeks. . . .


The relatively paltry number of machines [800] will be a serious bottleneck.

And as ever, Trump is days late -- and weak, with his Friday declaration. Not surprising -- just frustrating. Onward.

नमस्ते

Tweeted Good News -- From Mars -- InSight Is Again "Making Some Depth"...


We were in need of some good news, on this very hard scrabble week.

Ironic, that it comes in the form of a tweet, from. . . Mars.

Yes. . . it seems that NASA's hammer is boring its way into Barsoom, again -- or at least, so it seems. Do go read it all -- but I'll offer a bit here:

. . . ."Yes, I have been to Barsoom again. . . ." begins John Carter in Edgar Rice Burroughs' 1913 science fiction classic The Gods of Mars. In Burroughs' novels of Carter's adventures, "Barsoom" is the local name for Mars. The red planet continues to capture the imagination of science fiction writers and scientists alike and serves as an impetus for exploration. . . .

“There was one slight, desperate chance, and that I decided I must take -- it was for Dejah Thoris, and no man has lived who would not risk a thousand deaths for such as she. . . .”

“I have ever been prone to seek adventure and to investigate and experiment where wiser men would have left well enough alone. . . .”

“[Many] years have intervened; for ten of them I lived and fought for Dejah Thoris and her people, and for ten I have lived upon her memory. . . .”

― Edgar Rice Burroughs, A Princess of Mars

~~~~~~~~~~~~~~~~


. . .A bit of good news from #Mars: our new approach of using the robotic arm to push the mole appears to be working! The teams @NASA JPL/@DLR_en are excited to see the images and plan to continue this approach over the next few weeks. . . .


Onward indeed. Smile.

नमस्ते

Wednesday, March 11, 2020

[U] Time To Be Careful, True — But Do Take A Breath...


Okay. I’m unconvinced that flights from Europe were the single most important problem. But... whatever.

That said, if it encourages the elderly and people who are immune compromised to be extra cautious, I think that’s marginally... helpful. Unlike Trump though, I think common sense ought to rule the moment, not the fact that futures are off another 600 for tomorrow because there is no clear... plan.

The plan has to be... we adapt. Life is evolving — Tom Hanks has it; so we must recognize that our responses whatever those may be... will not “mistake proof” things.

We — as American taxpayers — can fund good therapies, and good vaccines -- right now; and we can agree to give them to all in need. That ought to be our goal — it will be expensive, and there will be more down Dow Jones days than up ones, at least until summer. But we must be more... flexible than just a payroll tax cut, or delaying income tax filings. We must fund... bio-science. Right now. [UPDATED: In our commitment to funding a safe vaccine, we need not and should not expect a need to give it to every person in the US, as the outbreak does not remotely warrant it. It should only be used in "ring" fashion -- as was deployed in the successful approach in the DRC, Sierra Leone, and Guinea for Ebola -- just to be clear.]

This is a developing, fluid bio-science situation, and suspending NBA games — or playing March Madness without a live audience... should not be criticized — as perhaps it will save some lives. But it will not be “enough”; not hardly.

If you are able to telecommute — again... that makes sense — at least for a couple of weeks. Then we reassess. But this is not Ebola.

So... it is a tough virus, but also harder to catch than this year’s flu. So buckle up, drink OJ... stay well-rested and above all... don’t be paralyzed into a panic. Do your grocery shopping — no need to hug everyone you see when you do, though. Be... sensible. And... be excellent to one another.

नमस्ते

Tuesday, March 10, 2020

[U @ Noon Wed.: Silver Now "Gone" From His Site] Televangelist Better Hope His "God" Isn't The Vengeful, Old Tesss'ment Kind...


So very many things to say. . . but I'll hold my tongue, save this: if I indeed still believed in the horrors of. . . the River Styx -- this guy would have to row his own boat, all the way down. . . the length of it.

It seems FDA and FTC have repeatedly warned Bakker about this sort of chicanery, on other product claims -- it's mostly just sugar water -- but to hawk it to the unsophisticated, bioscience-illiterate "faithful", as a COVID-19 cure. . . is reprehensible, well beyond words.

What an ass. See below, but felonies may well be made of this [since the repeated pattern conduct establishes "willfulness"]. . . .

TO: partner.services@jimbakkershow.com, website@jimbakkershow.com

James Bakker,
The Jim Bakker Show
180 Grace Chapel Rd.
Blue Eye, MO 65611


RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)1

This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address www.jimbakkershow.com on February 21, 2020 and February 13, 2020, respectively. We have also reviewed your social media page at https://www.facebook.com/jimbakkershow/, where you provide a link to your website www.store.jimbakkershow.com to purchase your products. The FDA has determined that your website offers products labeled to contain silver, such as “Silver Sol Liquid,” for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. FDA has determined that these products are unapproved new drugs sold in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide as a result of confirmed cases of COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose or cure COVID 19 in people. We request that you take prompt action to cease the sale of such unapproved and unauthorized products for mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

Some examples of the claims on your website that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:

• “But this influenza [sic] that is now circling the globe, you’re saying that Silver Solution would be effective? Well let’s say it hasn’t been tested on this strain of the coronavirus, but it’s been tested on other strains of the coronavirus, and has been able to eliminate it within 12 hours, totally eliminate it, kills it, deactivates it” [from your video entitled “A Close Look At What’s Not Being Said About the Coronavirus (Day 1)” at [44:48], https://jimbakkershow.com/watch/?guid=3861]

• “Silver Solution has been proven … to kill every pathogen it has ever been tested on … and it can kill any of these known viruses …”

• “So the virus, like the coronavirus that we’re talking about … affects the lung tissue so what you can do … put it straight … in a nebulizer which then creates a steam and you breathe it in and it will go directly into your lungs where that virus is and any other infection”

“You should take immediate action to correct the violations cited in this letter. The violations cited in this letter are not meant to be an all-inclusive list. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not representing your products for a COVID-19 related use for which they have not been approved by FDA, and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to COVID-19-Task-Force-CFSAN@fda.hhs.gov describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.

FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken corrective actions and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.

If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) listed above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States. Please direct any inquiries to FDA at COVID-19-Task-Force-CFSAN@fda.hhs.gov.

In addition, it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. To make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act.

There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure coronavirus disease 2019 (COVID-19). Thus, the claims cited above are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims. In addition, you are advised to review all claims for your products and immediately cease making claims that are not supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction and an order may require that you pay back money to consumers. Within 48 hours, please send an email to Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov describing the specific actions you have taken to address the FTC’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088.

Sincerely,



William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition

Sincerely,




Richard A. Quaresima
Acting Associate Director Division of Advertising Practices
Federal Trade Commission


_____________________________

1 COVID-19 is the official name for the disease that is causing the 2019 novel coronavirus outbreak, first identified in Wuhan, China. . . .


U G L Y. Let these people's karma. . . soon come a' callin'. . . .

नमस्ते

Team Trump Capitulates -- Drops At Least One Ninth Circuit Appeal...


Overnight, Team Trump withdrew at least one of its manifold appeals -- from losses it has suffered at the the trial court levels, in the border detainee cases.

That is imaged at left right.

Separately, the able USDC Judge Sabraw also overnight formally ordered the sides to keep working, in "meet and confer" sessions, to achieve practical effect -- for his order of very prompt DNA testing in all circumstances where border agents may want to separate families on mere suspicion of not actually being. . . biological. . . families.

That's clearly the right result.

Onward, with markets staging at least smallish rebound now. Grin. . . ever. . . grinning.

नमस्ते

Sunday, March 8, 2020

A Decidedly-Serious Sunday Question: What Might FDA Do -- About Brazenly Lawless... Monopolists?


Many know I’ve long followed Mr. Shkreli’s crime spree, at another property of mine. About ten days ago, Daraprim was approved by FDA, as a generic for Cerovene. That closed one of Martin’s remaining open loops. Here’s a bit, over several days, on that.

The opinion piece we mentioned on Saturday morning -- from NDSU Asst. Prof. March -- set me to thinking overnight:

Given that Martin Shkreli didn't even bother to offer a facially plausible [and by that I mean an arguably lawful] reason — for (among other things) prohibiting sales of reference products, for testing, to would-be generic manufacturers... the FDA has very little in the way of remedies — to punish the wrong-doer, and release the drug for generic equivalency testing.

It seems, for five decades, the FDA in the main has been able to rely on the good faith of the industry. But with characters like Martin on the scene, that makes FDA’s job nearly impossible — without DoJ’s intervention. And bringing an action against monopolists takes a minimum of five years, in federal court — meaning generics are slow to reach market.

While Martin’s spree was perhaps an outlier, in its audacity — there are many big pharma companies smart enough, or well-lawyered enough, to cleverly articulate “safety” and/or purity arguments — and then (just the same!) discourage and delay reference drug supply deliveries... to the generic manufacturers for testing and ultimate approvals. But not outright ban the practice by contract.

This is a new world, then — with at least some larger pharma players no longer willing to play strictly by the rules, if only pricing/cost (as opposed to multiple patient deaths) hangs in the balance. [Should a chemical entity (generic) just be presumed equivalent, to speed generic approvals? I think that’s a dangerous idea — but without cooperative bulk supplies — from the branded company... adequate testing is well nigh... impossible.]

In those cases — by far the more prevalent version of the problem... it would seem new legislation will be needed.

But with both Rs and Ds largely in big pharma’s pocket... don’t hold your breath.

Moreover, all of 45’s bluster about getting generics to market, or reimportation from Canada... is just that: empty claptrap.

He has no intention of doing... any of it.

~~~~~~~~~~~ Earlier ~~~~~~~~~~~




Yesterday, I saw a purported expert on US drug pricing reform offer yet another poorly thought out opinion on Daraprim and Mr. Shkreli. He claims that since Martin was gone by late 2015, from what was called Turing, and then Vyera... and then became Phoenixus, the price was no longer his fault.

Poppy-cock.

Of course we now well know from the federal court filings that Martin left his minions behind to run the company and was still calling the shots even from prison [via his very substantial holdings of Phoenixus common voting stock] as late as mid 2019 via an illicit cell phone. We also know that he set up all the contractual pacts that prevented generic companies from getting the needed data to get FDA approval packets together. Oh -- and he, until last week [and the generic arrival], saw his Phoenixus stockholdings profit from his own monopolistic moves -- ones he didn't even bother to give a facially neutral rational explanation for. Both of these facts this "expert" seems completely... cluefree about.

Martin is 100 per cent culpable [in my more well-thought-out opinion]... for the lawless machinery he created despite what this man says:
. . . .[R]ather than emphasizing the benefit to patients, many people [use the] news of [generic Daraprim and] the FDA’s [slow] approval as an opportunity to continue chastising Shkreli. MedCity News, a leading news source for healthcare markets, recently published an article entitled, “Sorry, Martin Shkreli: FDA approves first generic version of Daraprim.”

We might protest Shkreli’s actions as shameful. Many of his critics, however, seem to forget that Shkreli stepped down as CEO in late 2015. [Ed. Note: he had been indicted by then -- and he left behind his minions Mulleady, et al., to do his bidding.] Daraprim still costs $750. If his successors haven’t lowered the price, how much blame can be placed on Shkreli? [Editor: all of it.]

...Daraprim’s story teaches us two lessons about pharmaceutical markets. First, when competition is stifled, producers raise their prices. Second, although there are many obstacles to making prescription drugs more affordable, the easiest way is to increase competition between drug producers. Most often, that involves generics. . . .


So the author cluelessly ignores the fact that it was Martin's willingness to engage in conduct that violates the Clayton and Sherman Acts at multiple companies [locking down the needed Daraprim samples -- to CREATE the generic data package for FDA approval of a generic]... that prevented FDA from approving a generic until now.

That is just... a very poor excuse for... actual critical thinking.

Onward to a workout, and fun — with baby girl, this afternoon, at the park!

नमस्ते

Saturday, March 7, 2020

Yet Another Loss For Trump -- In The Court Of Appeals: 100 Page Opinion


While we await the able USDC Judge Sabraw's order, from yesterday's San Diego status hearing, we will post on new one here. Again, in yet another case, involving refugees and migrants approaching our borders, Trump's lawlessness at the border is enjoined -- and confirmed, on appeal. He's now like three for forty, overall.

Here is the 100 page opinion -- with a turgid and voluminous dissent -- but a dissent that mis-states the facts, and is wrong on the law.

. . . .[T]his motion stems from the impact of a separate regulation, promulgated while this litigation was pending, on a subgroup of metered asylum seekers. That regulation, known variously as the “Third Country Transit Rule,” “transit rule,” and “asylum ban,” (“the Rule”), provides, subject to narrow exceptions, that a noncitizen who “enters, attempts to enter, or arrives in the United States” at the southern border on or after July 16, 2019 is not eligible for asylum in the United States unless they applied for asylum in another country, such as Mexico, that they passed through on their way to the southern border. 8 C.F.R. § 208.13(c)(4).

The district court granted a preliminary injunction enjoining enforcement of the Rule against a provisionally certified class of plaintiffs who arrived at the southern border seeking asylum before July 16, 2019 but were denied entry and prevented from making an asylum claim under the metering policy. The government appealed and moved this court for a stay of the injunction pending appeal. Because the government has not carried its burden of showing that a stay is warranted, we deny the motion. . . .


Now you know. Onward, to Daylight Savings, come dawn. . . smile.

नमस्ते

Thursday, March 5, 2020

Psst. Confidential To Trump: Court-Ordered DNA Parentage Tests... Mean Exactly... That.


So. . . Trump's team thinks federal court orders are mere. . . suggestions. Options, ideas -- to be employed only if it feels [in its own discretion] the cost is. . . worth it. Who are these people? They propose to take children from their parents, without conducting a DNA test -- based on the agents' mere "suspicion" of fraud?! What. The. Actual. Hell?

This is more lunacy -- from the Trumpians.

Read the middle ten pages, from the bottom of page twelve, onward of the status report just filed.

I won't spoil the below good karma / mood off-world with a pull quote, until Friday morning -- but the parties are due back before the able UDSC Judge Sabraw tomorrow afternoon. I. Don't. Think. He'll. Like. This. One. Damn. Bit.

Onward. Pissed.

नमस्ते

Perseverance, It Is... Smile.




नमस्ते