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Oklohama Can’t Break Congress’s Promise That Native American Reservation Would Be ‘Secure Forever,’ Rules Supreme Court

zumaamericastwentyseven978348

“If Congress wishes to withdraw its promises, it must say so.” Per treaties signed in the 1830s, nearly half of Oklahoma, including most of the city of Tulsa, belongs to the Muscogee (Creek) Nation, the U.S. Supreme Court affirmed on Thursday in a 5-4 decision. The ruling could have huge implications for criminal convictions in Oklahoma and other states, Chief Justice John Roberts warned in a dissent.

“In this case, the Muscogee (Creek) Nation had to fight long and hard to protect their homelands,” said John Echohawk, the executive director of the Native American Rights Fund, in a statement. “In holding the federal government to its treaty obligations, the U.S. Supreme Court put to rest what never should have been at question.”

At the micro level, the case—McGirt v. Oklahoma—concerns the state’s prosecution of alleged crimes that took place in this territory.

“Petitioner Jimcy McGirt was convicted by an Oklahoma state court of three serious sexual offenses” and “unsuccessfully argued in state post conviction proceedings that the State lacked jurisdiction to prosecute him because he is an enrolled member of the Seminole Nation and his crimes took place on the Creek Reservation,” explains a Supreme Court synopsis. “He seeks a new trial, which, he contends, must take place in federal court.”

But the case goes way beyond McGirt’s particular situation—as quickly becomes clear in the opening of the Court’s decision, penned by Justice Neil Gorsuch and joined by Justices Ruth Bader Ginsburg, Stephen Breyer, Sonia Sotomayor, and Elena Kagan:

On the far end of the Trail of Tears was a promise. Forced to leave their ancestral lands in Georgia and Alabama, the Creek Nation received assurances that their new lands in the West would be secure forever. In exchange for ceding “all their land, East of the Mississippi river,” the U. S. government agreed by treaty that “the Creek country west of the Mississippi shall be solemnly guarantied to the Creek Indians.”

Both parties settled on boundary lines for a new and “permanent home to the whole Creek nation,” located in what is now Oklahoma. The government further promised that “[no] State or Territory [shall] ever have a right to pass laws for the government of such Indians, but they shall be allowed to govern themselves.”

Today we are asked whether the land these treaties promised remains an Indian reservation for purposes of federal criminal law. Because Congress has not said otherwise, we hold the government to its word.

For the purposes of this case, the key question is “Did he [McGirt] commit his crimes in Indian country?” the opinion states. Answer:

No one disputes that Mr. McGirt’s crimes were committed on lands described as the Creek Reservation in an 1866 treaty and federal statute. But, in seeking to defend the state-court judgment below, Oklahoma has put aside whatever procedural defenses it might have and asked us to confirm that the land once given to the Creeks is no longer a reservation today.

At another level, then, Mr. McGirt’s case winds up as a contest between State and Tribe.

Gorsuch points out that “the scope of their dispute is limited; nothing we might say today could unsettle Oklahoma’s authority to try non-Indians for crimes against non-Indians on the lands in question.” However:

If Mr. McGirt and the Tribe are right, the State has no right to prosecute Indians for crimes committed in a portion of Northeastern Oklahoma that includes most of the city of Tulsa. Responsibility to try these matters would fall instead to the federal government and Tribe. Recently, the question has taken on more salience too. While Oklahoma state courts have rejected any suggestion that the lands in question remain a reservation, the Tenth Circuit has reached the opposite conclusion.

The Supreme Court majority sided with the 10th Circuit, McGirt, and the Creek Tribe, concluding:

The federal government promised the Creek a reservation in perpetuity. Over time, Congress has diminished that reservation. It has sometimes restricted and other times expanded the Tribe’s authority. But Congress has never withdrawn the promised reservation. As a result, many of the arguments before us today follow a sadly familiar pattern. Yes, promises were made, but the price of keeping them has become too great, so now we should just cast a blind eye. We reject that thinking. If Congress wishes to withdraw its promises, it must say so. Unlawful acts, performed long enough and with sufficient vigor, are never enough to amend the law. To hold otherwise would be to elevate the most brazen and longstanding injustices over the law, both rewarding wrong and failing those in the right.

So…what does it all mean?

“The decision puts in doubt hundreds of state convictions of Native Americans and could change the handling of prosecutions across a vast swath of the state,” says The New York Times. “Lawyers were also examining whether it had broader implications for taxing, zoning and other government functions. But many of the specific impacts will be determined by negotiations between state and federal authorities and five Native American tribes in Oklahoma.”

In his dissent, Chief Justice John Roberts predicted dire results:

The state’s ability to prosecute serious crimes will be hobbled and decades of past convictions could well be thrown out. On top of that, the court has profoundly destabilized the governance of eastern Oklahoma.

But “the decision is a stunning reaffirmance of the nation’s obligations to Native Americans,” notes Ronald Mann at SCOTUSblog. “It confirms the existence of the largest tract of reservation land in the country, about 19 million acres encompassing the entire eastern half of Oklahoma.”

“The Supreme Court has affirmed that a promise is a promise: that treaties between the United States and Tribes are the law of the land—no matter how many times the federal government has violated those treaties in the past—and that lands reserved for Tribes remain Indian Country, now and in the future,” said U.S. Sen. Tom Udall (D–N.M.), vice chairman of the Senate Committee on Indian Affairs. “While no court decision can correct centuries of injustice committed against Indigenous people, today’s ruling is a historic step forward to safeguard Tribal sovereignty for decades to come.”

ELECTION 2020

Will (white) women vote for Donald Trump again? “Over the last three years I conducted dozens of focus groups with both college-educated and non-college-educated female Trump voters,” writes Sarah Longwell at The Bulwark.

And the answer given most commonly for why they voted for Donald Trump is “I didn’t vote for Donald Trump. I voted against Hillary Clinton.”

In 2016, Democrats understood that Hillary Clinton was a deeply polarizing candidate. But even they didn’t grasp the full magnitude of it. Right-leaning and Republican female voters had spent more than a decade hating both Clintons, and they didn’t stop just because Hillary’s opponent was an unrepentant misogynist.

In fact, Bill Clinton’s legacy of similarly disgusting behavior with women—and Hillary Clinton’s defense of her husband—had the effect of blunting Trump’s own execrable track record. These women voters decided that either way, there’d be a guy with a long history of sexual malfeasance living in the White House.”

But that was then. Since Trump took office, even women who had voted for him in 2016 “began shifting away from the president,” Longwell writes.

A recent New York Times Upshot/Siena College Poll showed Trump trailing Joe Biden by 22 points with women. That’s 9 points bigger than the gender gap was in 2016.

And while much has been made of college-educated women in the suburbs ditching Trump, a recent ABC/Washington Post survey shows that Trump’s support with white non-college-educated women has fallen by 11 points.

QUICK HITS

• Florida saw its highest single-day death toll from COVID-19 on July 8. The state department of health reported yesterday that 120 people had been killed by COVID-19 in the past 24 hours. South Carolina is also starting to see disturbing coronavirus trends.

• Kazakhstan says it isn’t plagued with a new form of super-deadly pneumonia, contrary to a warning put out by the Chinese Embassy in Kazakhstan that this pneumonia strain had already killed 1,700 people.

• “Unanimity is neither possible nor necessary to fight racism,” writes Conor Friedersdorf in some musings on our cultural moment. “On the contrary, attempts to secure unanimity can undermine the fight: They needlessly divide anti-racists and weaken everyone’s ability to grasp reality.”

from Latest – Reason.com https://ift.tt/2OdEJmc
via IFTTT

Oklohama Can’t Break Congress’s Promise That Native American Reservation Would Be ‘Secure Forever,’ Rules Supreme Court

zumaamericastwentyseven978348

“If Congress wishes to withdraw its promises, it must say so.” Per treaties signed in the 1830s, nearly half of Oklahoma, including most of the city of Tulsa, belongs to the Muscogee (Creek) Nation, the U.S. Supreme Court affirmed on Thursday in a 5-4 decision. The ruling could have huge implications for criminal convictions in Oklahoma and other states, Chief Justice John Roberts warned in a dissent.

“In this case, the Muscogee (Creek) Nation had to fight long and hard to protect their homelands,” said John Echohawk, the executive director of the Native American Rights Fund, in a statement. “In holding the federal government to its treaty obligations, the U.S. Supreme Court put to rest what never should have been at question.”

At the micro level, the case—McGirt v. Oklahoma—concerns the state’s prosecution of alleged crimes that took place in this territory.

“Petitioner Jimcy McGirt was convicted by an Oklahoma state court of three serious sexual offenses” and “unsuccessfully argued in state post conviction proceedings that the State lacked jurisdiction to prosecute him because he is an enrolled member of the Seminole Nation and his crimes took place on the Creek Reservation,” explains a Supreme Court synopsis. “He seeks a new trial, which, he contends, must take place in federal court.”

But the case goes way beyond McGirt’s particular situation—as quickly becomes clear in the opening of the Court’s decision, penned by Justice Neil Gorsuch and joined by Justices Ruth Bader Ginsburg, Stephen Breyer, Sonia Sotomayor, and Elena Kagan:

On the far end of the Trail of Tears was a promise. Forced to leave their ancestral lands in Georgia and Alabama, the Creek Nation received assurances that their new lands in the West would be secure forever. In exchange for ceding “all their land, East of the Mississippi river,” the U. S. government agreed by treaty that “the Creek country west of the Mississippi shall be solemnly guarantied to the Creek Indians.”

Both parties settled on boundary lines for a new and “permanent home to the whole Creek nation,” located in what is now Oklahoma. The government further promised that “[no] State or Territory [shall] ever have a right to pass laws for the government of such Indians, but they shall be allowed to govern themselves.”

Today we are asked whether the land these treaties promised remains an Indian reservation for purposes of federal criminal law. Because Congress has not said otherwise, we hold the government to its word.

For the purposes of this case, the key question is “Did he [McGirt] commit his crimes in Indian country?” the opinion states. Answer:

No one disputes that Mr. McGirt’s crimes were committed on lands described as the Creek Reservation in an 1866 treaty and federal statute. But, in seeking to defend the state-court judgment below, Oklahoma has put aside whatever procedural defenses it might have and asked us to confirm that the land once given to the Creeks is no longer a reservation today.

At another level, then, Mr. McGirt’s case winds up as a contest between State and Tribe.

Gorsuch points out that “the scope of their dispute is limited; nothing we might say today could unsettle Oklahoma’s authority to try non-Indians for crimes against non-Indians on the lands in question.” However:

If Mr. McGirt and the Tribe are right, the State has no right to prosecute Indians for crimes committed in a portion of Northeastern Oklahoma that includes most of the city of Tulsa. Responsibility to try these matters would fall instead to the federal government and Tribe. Recently, the question has taken on more salience too. While Oklahoma state courts have rejected any suggestion that the lands in question remain a reservation, the Tenth Circuit has reached the opposite conclusion.

The Supreme Court majority sided with the 10th Circuit, McGirt, and the Creek Tribe, concluding:

The federal government promised the Creek a reservation in perpetuity. Over time, Congress has diminished that reservation. It has sometimes restricted and other times expanded the Tribe’s authority. But Congress has never withdrawn the promised reservation. As a result, many of the arguments before us today follow a sadly familiar pattern. Yes, promises were made, but the price of keeping them has become too great, so now we should just cast a blind eye. We reject that thinking. If Congress wishes to withdraw its promises, it must say so. Unlawful acts, performed long enough and with sufficient vigor, are never enough to amend the law. To hold otherwise would be to elevate the most brazen and longstanding injustices over the law, both rewarding wrong and failing those in the right.

So…what does it all mean?

“The decision puts in doubt hundreds of state convictions of Native Americans and could change the handling of prosecutions across a vast swath of the state,” says The New York Times. “Lawyers were also examining whether it had broader implications for taxing, zoning and other government functions. But many of the specific impacts will be determined by negotiations between state and federal authorities and five Native American tribes in Oklahoma.”

In his dissent, Chief Justice John Roberts predicted dire results:

The state’s ability to prosecute serious crimes will be hobbled and decades of past convictions could well be thrown out. On top of that, the court has profoundly destabilized the governance of eastern Oklahoma.

But “the decision is a stunning reaffirmance of the nation’s obligations to Native Americans,” notes Ronald Mann at SCOTUSblog. “It confirms the existence of the largest tract of reservation land in the country, about 19 million acres encompassing the entire eastern half of Oklahoma.”

“The Supreme Court has affirmed that a promise is a promise: that treaties between the United States and Tribes are the law of the land—no matter how many times the federal government has violated those treaties in the past—and that lands reserved for Tribes remain Indian Country, now and in the future,” said U.S. Sen. Tom Udall (D–N.M.), vice chairman of the Senate Committee on Indian Affairs. “While no court decision can correct centuries of injustice committed against Indigenous people, today’s ruling is a historic step forward to safeguard Tribal sovereignty for decades to come.”

ELECTION 2020

Will (white) women vote for Donald Trump again? “Over the last three years I conducted dozens of focus groups with both college-educated and non-college-educated female Trump voters,” writes Sarah Longwell at The Bulwark.

And the answer given most commonly for why they voted for Donald Trump is “I didn’t vote for Donald Trump. I voted against Hillary Clinton.”

In 2016, Democrats understood that Hillary Clinton was a deeply polarizing candidate. But even they didn’t grasp the full magnitude of it. Right-leaning and Republican female voters had spent more than a decade hating both Clintons, and they didn’t stop just because Hillary’s opponent was an unrepentant misogynist.

In fact, Bill Clinton’s legacy of similarly disgusting behavior with women—and Hillary Clinton’s defense of her husband—had the effect of blunting Trump’s own execrable track record. These women voters decided that either way, there’d be a guy with a long history of sexual malfeasance living in the White House.”

But that was then. Since Trump took office, even women who had voted for him in 2016 “began shifting away from the president,” Longwell writes.

A recent New York Times Upshot/Siena College Poll showed Trump trailing Joe Biden by 22 points with women. That’s 9 points bigger than the gender gap was in 2016.

And while much has been made of college-educated women in the suburbs ditching Trump, a recent ABC/Washington Post survey shows that Trump’s support with white non-college-educated women has fallen by 11 points.

QUICK HITS

• Florida saw its highest single-day death toll from COVID-19 on July 8. The state department of health reported yesterday that 120 people had been killed by COVID-19 in the past 24 hours. South Carolina is also starting to see disturbing coronavirus trends.

• Kazakhstan says it isn’t plagued with a new form of super-deadly pneumonia, contrary to a warning put out by the Chinese Embassy in Kazakhstan that this pneumonia strain had already killed 1,700 people.

• “Unanimity is neither possible nor necessary to fight racism,” writes Conor Friedersdorf in some musings on our cultural moment. “On the contrary, attempts to secure unanimity can undermine the fight: They needlessly divide anti-racists and weaken everyone’s ability to grasp reality.”

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via IFTTT

The World Shifts

The World Shifts

Tyler Durden

Fri, 07/10/2020 – 09:26

Authored by Bill Blain via MorningPorridge.com,

“Carthago delenda est”

Did you feel the world wobble last night?  

As Washington imposes sanctions on top level Chinese officals over ethnic abuse in Xinjiang, and waits for Trump to sign “autonomy” action over Hong Kong targeting officials over the new security law, we are now even closer to the inevitable showdown between Rome and Carthage.

The implications are going to be enormous… This story is accelerating very quickly… thing are “occurring” faster than we think…

My spidey senses are a-tingle.. 

Trying to fathom out why markets are so strong, ongoing coronavirus and economic breakdowns, how politics are so ineffective, and how fragile and vulnerable sentiment might be to sudden and swift shifts in the narrative, is somewhat exhausting. While the markets are focused on the earnings season (beginning Monday), the ongoing supply chain problems -like car factories being shuttered because they can’t get parts, and the likelihood of further stimulus.. the news out of Asia makes me suspect the real world has just become massively less stable.

At the tactical level, the outbreak of cold-war hostilities and the threat of sanctions on banks in Hong Kong is yet another nail in the decaying corpse of HSBC.  If the former colony is de-dollarised, and banks are stopped from clearing the greenback, it will trigger enormous shifts across Asia. It will raise the prospect of a complete rift between the US and China as banks are forced to make a choice: they can’t serve two masters.. the dollar or Beijing.

At the strategic level.. who knows.. Plus for Europe? After the coronavirus.. a full scale Cold War? Or maybe its going to be a good thing.. a wedge between China and the West driving new innovation and economic growth? Who knows… more on this later… 

I was expecting to see Asia’s financial business shift to Singapore, but talking to chums out there it seems the City State is trying to keep itself neutral. Apparently, it’s making it harder for Western financiers to obtain residency status and discouraging firms from moving Hong Kong operations lock, stock and barrel to the city, demanding they hire locals instead. Perversely, the major beneficiary of Hong Kong’s inevitable decline is likely to be Tokyo.  Which… will be great news for London.. 

*  *  *

However, the main issue for me this morning is… I was in the Pub last night! 

Fantastic, but my head hurts…  

There is nothing quite so wonderful as solving all the problems of the globe over an excellent tomahawk steak, too much red wine, and bantering with mates – despite the landlady’s very best efforts to keep us all socially distanced. So please excuse if this morning’s porridge meanders somewhat. It would be fair to say there is a pink elephant on the balcony in front of me this morning…. 

How stimulating human company is. 

A good friend from the City had joined us for the evening. He’s a chap who has eschewed trying to guess where stocks are headed next, and invested his time, effort and considerable intellect in working out how tech and big data can solve the issue of generating alpha for funds. 

I completely understood everything right up till the third or fourth bottle of most excellent claret mysteriously emptied itself. As I said… Hamble’s King and Queen is a very good pub.. but the glass of Kraken rum for the road was definitely a mistake..  

This morning…. Not so good…

I do remember we tried to solve the problem of the NHS. 

My contention is we can make the NHS so much better through the application of tech. I suggested, and grandly gesticulated my solution.. If we all owned our medical data – stored on our phones, or even a sub-cutaneous chip, and kept that information updated with the results of every test, blood sample and readings from our wearable tech, then medical AI would quickly be able to work out what our symptoms mean and instead of clinicians searching for the needle in haystack of what might be wrong with us…. The AI would be able to suggest immediately the cause. 

Imagine if the same AI was able to learn from the data from all us… we’d very quickly have a focused, targeted, effective NHS. We’d be able to sort the logistical mess the NHS has become as a result of too many layers of bureaucracy, and invest more money in direct medical resources in terms of doctors, nurses and therapists, targeted treatments, and understand more fully the efficacy of drugs and therapies.. 

Edward laughed at me. 

Apparently, we already have the capacity to do most of it. The problem is governments asked/allowed big tech to collate the data. Now Google owns it. They’ve already written the algorithms to predict our health. They expect to be able to monetise it. 

If we want to solve the world by the implementation of big data…. How much are we willing to pay the Tech behemoths to buy our own data back…?

As the wine poured… we went on to solving the issues of supply chains, automation and 3 D printing. Sure, it will be simple to refocus production back to nation states. It would already be cheaper to make widgets locally, but to do so we need more programmers and engineers.. and since most Generation Z’s expect, nay demand, highly paid jobs in cupcake design and applied wokeness… that’s potentially a problem.. 

I could continue… but by the time we concluded our symposium… my brain was pretty full… I might have to have a snooze later this morning… 

via ZeroHedge News https://ift.tt/2C0i2PN Tyler Durden

De Blasio Says BLM Protests Can Continue While Canceling All Other Large Events 

De Blasio Says BLM Protests Can Continue While Canceling All Other Large Events 

Tyler Durden

Fri, 07/10/2020 – 09:09

New York City’s Mayor Bill de Blasio made some stunning remarks on CNN, declaring protests in the streets were perfectly acceptable while canceling other large events through September. 

De Blasio joined CNN’s Wolf Blitzer on Thursday evening, discussing the evolving pandemic and policy response by City Hall to mitigate the spread in the city. He said social justice warriors were too important after months of protests have yet produced an outbreak in cases. 

“This is a historic moment of change. We have to respect that but also say to people the kinds of gatherings we’re used to, the parades, the fairs — we just can’t have that while we’re focusing on health right now,” de Blasio told Blitzer. 

Blitzer then asks: What about protests?

De Blasio responds: “This is a historic moment. We have to respect that.”

The Daily Caller tweeted CNN’s video – here’s how Twitter responded to de Blasio telling Blitzer that the city will ban all large gatherings except for Black Lives Matter protests:

Tweet responses to Daily Caller tweeting de Blasio & Blitzer’s discussion  

So it’s okay to have mass-gatherings, then paint a “Black Lives Matter” mural in front of Trump Tower in New York City – but indoor dining at restaurants has been delayed?

So far, virus cases and deaths have not surged since weeks of demonstrations. 

It’s only a matter of time before residents become angry that restrictions are being politicized. 

via ZeroHedge News https://ift.tt/3ekDSdQ Tyler Durden

Stocks Spike On Yet Another Remdesivir Press Release

Stocks Spike On Yet Another Remdesivir Press Release

Tyler Durden

Fri, 07/10/2020 – 08:54

Shortly after PPI disappointed and Fed’s Kaplan warned of dis-inflation, the markets spiked higher apparently on the heels of yet another press release by Gilead claiming a 62% reduction in mortality rates vs ‘standard care’ with its Remdesivir COVID treatment.  

While the news looks encouraging, Gilead caveats it all further down in the pres release:

“This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” said Susan Olender, MD, Columbia University Irving Medical Center. “While not as vigorous as a randomized controlled trial, this analysis importantly draws from a real-world setting and serves as an important adjunct to clinical trial data, adding to our collective understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic.”

While he welcomed the results as an encouraging development, Dr. Scott Gottlieb noted that we’re not there yet, and that most of these new findings have been gleaned from a “retrospective analysis” of phase III data that had already been released.

So just like Moderna before it, Gilead is learning how to squeeze every last drop of market success from its study data.

And as shares of the pharma giant spike…

…we can’t help but wonder: is it time for Gilead to embark on a secondary offering?

Read the full press release below:

FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) today announced additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir. The data are being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) and include a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials.

Separate subgroup analyses from the Phase 3 SIMPLE-Severe trial, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, found that traditionally marginalized racial or ethnic groups treated with remdesivir in this study experienced similar clinical outcomes as the overall patient population in the study.

Gilead is also presenting new analyses of the company’s compassionate use program, which demonstrated that 83 percent of pediatric patients (n=77) and 92 percent of pregnant and postpartum women (n=86) with a broad spectrum of disease severity recovered by Day 28. No new safety signals were identified with remdesivir across these populations. To further the understanding of these results in individual patient cases, Gilead recently announced the initiation of a global, open-label Phase 2/3 trial to evaluate the safety, tolerability and pharmacokinetics of remdesivir in pediatric patients from birth to less than 18 years of age. Gilead is also collaborating on a study for pregnant women.

Due to the current public health emergency, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for remdesivir for the treatment of hospitalized patients with severe COVID-19; please see below for additional important warnings and information about the authorized use of remdesivir in the United States. In the United States, remdesivir is an investigational drug that has not been approved by the FDA, and the safety and efficacy of remdesivir for the treatment of COVID-19 has not been established.

“We are working to broaden our understanding of the full utility of remdesivir. To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

“These data presented at the Virtual COVID-19 Conference shed additional light on the use of remdesivir in specific patient populations, including those that may be susceptible to higher rates of COVID-19 infection, as well as others that are particularly vulnerable, including children and pregnant and postpartum women.”

Comparative Analysis of Phase 3 SIMPLE-Severe Study and Real-World Retrospective Cohort of Patients Diagnosed with Severe COVID-19

Receiving Standard of Care

This comparative pre-planned analysis included 312 patients treated in the Phase 3 SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity who received standard of care treatment in the same time period as the SIMPLE-Severe study. Patients were primarily located in North America (92 percent, remdesivir cohort vs. 91 percent, standard-of-care cohort), Europe (5 percent vs. 7 percent) and Asia (3 percent vs. 2 percent). The analysis demonstrated that remdesivir treatment was associated with significantly improved clinical recovery and a 62 percent reduction in the risk of mortality compared to standard of care. Findings from the comparative analysis showed that 74.4 percent of remdesivir-treated patients recovered by Day 14 versus 59.0 percent of patients receiving standard of care; recovery was defined as improvement in clinical status based on a 7-point ordinal scale. The mortality rate for patients treated with remdesivir in the analysis was 7.6 percent at Day 14 compared with 12.5 percent among patients not taking remdesivir (adjusted odds ratio 0.38, 95% confidence interval 0.22-0.68, p=0.001).

“This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” said Susan Olender, MD, Columbia University Irving Medical Center. “While not as vigorous as a randomized controlled trial, this analysis importantly draws from a real-world setting and serves as an important adjunct to clinical trial data, adding to our collective understanding of this virus and reflecting the extraordinary pace of the ongoing pandemic.”

The results of this comparative analysis add to the previously presented National Institute of Allergy and Infectious Disease (NIAID) randomized, double-blind, placebo-controlled study in hospitalized patients with COVID-19, which showed that remdesivir shortened time to recovery by an average of four days as compared to placebo (11 vs. 15 days; p<0.001). In the NIAID study, patients taking remdesivir trended toward lower mortality compared with those in the placebo group, but this result did not reach statistical significance (7.1 percent vs. 11.9 percent at Day 14; p=0.07).

Analyses from the Phase 3 SIMPLE-Severe Study

The Phase 3 SIMPLE-Severe trial evaluated the safety and efficacy of 5-day and 10-day dosing durations of remdesivir administered intravenously in hospitalized patients with severe manifestations of COVID-19. The initial phase of the study randomized 397 patients in a 1:1 ratio to receive either a 5-day or a 10-day treatment course of remdesivir in addition to standard of care. The results were published in The New England Journal of Medicine in May. An expansion phase of the study was added to enroll up to 5,600 additional patients, including those on mechanical ventilation; results from the expansion phase are pending.
Additional new data on the safety and efficacy of remdesivir presented at the Virtual COVID-19 Conference feature subgroup analyses, including race and ethnicity of patients treated in the United States, and global baseline characteristics associated with improved clinical status, and concomitant use of hydroxychloroquine.

In this study, 229 patients were enrolled at trial sites in the United States; clinical improvement was defined as a ≥ 2-point improvement on a 7-point ordinal scale. Among these patients, rates of clinical improvement at Day 14 were 84 percent in African American patients (n=43), 76 percent in Hispanic white (HW) patients (n=17), 67 percent in Asian patients (n=18), 67 percent in non-Hispanic white (NHW) patients (n=119) and 63 percent in patients who did not identify with any of these groups (n=32). Key efficacy and safety results with remdesivir treatment across race and ethnicity in the United States are included in the following table.

Among the 397 patients who received remdesivir treatment globally, Black race, age under 65 years, treatment outside of Italy and requirement of only low-flow oxygen support or room air at baseline were factors significantly associated with clinical improvement of at least two points at Day 14.

Following the availability of in vitro data demonstrating chloroquine inhibits the antiviral activity of remdesivir in a dose-dependent manner, Gilead conducted an analysis of clinical outcomes with patients who were treated with both remdesivir and hydroxychloroquine concomitantly, versus patients who were treated with remdesivir and who did not receive concomitant hydroxychloroquine. Through a median follow-up of 14 days, the rates and likelihood of recovery were lower in patients who received concomitant hydroxychloroquine compared with patients treated with remdesivir who did not receive hydroxychloroquine (57 percent vs. 69 percent, covariate-adjusted HR [95% CI] 0.61 [0.45, 0.83], p=0.002). Concomitant hydroxychloroquine use was not associated with increased mortality in the 14-day analysis window. The analysis also showed that patients in the concomitant hydroxychloroquine group experienced overall higher rates of adverse events. After adjusting for baseline variables, this difference was significant for Grade 3-4 adverse events.

Additional Data from Gilead’s Compassionate Use Program for Remdesivir

Gilead has previously reported the safety and efficacy results in 53 patients hospitalized with severe COVID-19 who were receiving remdesivir treatment as part of the company’s compassionate use program. Additional analyses from the compassionate use program are being presented at the conference, including data on the use of remdesivir in pediatric patients and in pregnant and postpartum women. In these analyses, recovery was defined as improvement to room air for patients who required oxygen support at baseline, and discharge for those not requiring oxygen support at baseline.

An analysis of 77 pediatric patients treated with remdesivir in the compassionate use program demonstrated that the vast majority improved in clinical status by Day 28, with 73 percent discharged from the hospital. By Day 28, 12 percent remained hospitalized but on ambient air and four percent had died. Of the 39 pediatric patients who required invasive mechanical ventilation at baseline, 80 percent of these critically ill patients recovered; of the 38 patients not requiring invasive ventilation, 87 percent recovered.

Among the 86 pregnant and postpartum women treated with remdesivir in the compassionate use program (median age of 33), 96 percent of pregnant and 89 percent of postpartum women achieved improvement in oxygen support levels. Pregnant and postpartum women who had more severe illness at baseline achieved similarly high rates of clinical recovery, at 93 percent and 89 percent, respectively. Pregnant women not on invasive oxygen support at baseline had the shortest median time to recovery (5 days), and both pregnant and postpartum women on invasive ventilation at baseline had similar median times to recovery (13 days). No new safety signals were identified; the most common AEs were due to underlying disease and most laboratory abnormalities were Grades 1–2.

About Remdesivir

Remdesivir is an antiviral product that is being studied in multiple ongoing international clinical trials. In recognition of the current public health emergency and based on available clinical data, the approval status of remdesivir varies by country. In countries where remdesivir has not been approved by the regional health authority, remdesivir is an investigational drug, and the safety and efficacy of remdesivir have not been established.

Important Information about Remdesivir in the United States

In the United States, remdesivir (GS-5734™) is authorized for use under an Emergency Use Authorization (EUA) only for the treatment of patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe COVID-19. Severe disease is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO). Remdesivir is authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate, as remdesivir must be administered intravenously.

Remdesivir is an investigational drug that has not been approved by the FDA for any use, and the safety and efficacy of remdesivir for the treatment of COVID-19 have not been established. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of remdesivir and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.

There are limited clinical data available for remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with remdesivir use. Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of remdesivir. The use of remdesivir is contraindicated in patients with known hypersensitivity to remdesivir. Transaminase elevations have been observed in healthy volunteers and patients with COVID-19 in clinical trials who received remdesivir. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy. Do not initiate remdesivir in patients with ALT ≥5x ULN or with an eGFR <30 mL/min. The decision to continue or discontinue remdesivir therapy after development of an adverse event should be made based on the clinical risk/benefit assessment for the individual patient.

Due to a risk of reduced antiviral activity, coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended.

Healthcare providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during remdesivir treatment and considered to be potentially attributable to remdesivir. These events must be reported within 7 calendar days from the onset of the event. MedWatch adverse event reports can be submitted to FDA online at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

* * *

Source: Gilead Sciences

via ZeroHedge News https://ift.tt/2W7CVzh Tyler Durden

Rabobank: “Suddenly, Lots Of Things Might Just Matter All At Once”

Rabobank: “Suddenly, Lots Of Things Might Just Matter All At Once”

Tyler Durden

Fri, 07/10/2020 – 08:45

Submitted by Michael Every of Rabobank

Nothing matters. We (mostly) all know that. Events come and events go, but markets go up regardless. Yet suddenly, lots of things might just matter all at once. And markets actually went down!!

US presidential candidate Biden, who is way ahead in the polls, has outflanked President Trump in the populist stakes with a Build Back Better plan and a USD700bn “Buy American” pledge to create 5m new manufacturing jobs; that while Peter Navarro’s proposal for the same gathers dust on the White House desk. Biden also says he backs unionization and collective bargaining.

Unless Trump comes up with a sweeping new plan he will lose #MAGA ground to a man who spent his career building the neoliberal consensus Trump won by running against. I said Trump would win in 2016 because he said the economy stank: now the economy more than stinks –jobless claims were still around 1.3m yesterday– his message is that everything is Great Again. As such, polls and news show he seems to be shedding both billionaire and working-class supporters simultaneously, which is quite the trick.

Biden also decried that “throughout this crisis, Donald Trump has been almost singularly focused on the stock market, the Dow, the NASDAQ – not you, not your families.” How very dare you, Sir! More audaciously, Biden proposed to raise the corporate tax rate and that for the wealthiest Americans. How very, very dare you, Sir! Forget about toppling George Washington: this is a genuine revolution for markets to contemplate. No more tax cuts to pump into the stock market? Who would that leave to drive markets higher? How else can an economy work? Of course, to underline again, this is a man who spent his career building the neoliberal consensus. One wonders how Biden envisions the Fed operating under his administration: will he allow them to continue to be almost singularly focused on the Dow and NASDAQ, or will he want their support on the fiscal front for actual investment? It’s unclear.

Back to things that suddenly matter. The White House imposed sanctions on four Chinese individuals over human rights abuses of Uighurs, including the head of Xinjiang province, who is a member of the 25-person national Politburo. This is more of a shot across the bows for now given primarily the sanction means they and their families cannot enter the US. However, it shows that sanctions can happen.

Indeed, on that front —and of huge potential significance— Reuters reports that Chinese banks in Hong Kong are “preparing to lose USD access” if the US imposes its toughest sanctions on them and cuts off USD access. What was being blithely dismissed as a nuclear option nobody would ever use is now seeing the same people rush to construct bomb shelters. Several large foreign banks are also so deeply enmeshed in the special autonomous region that they are sweating. FT also reports foreign banks are scouring their client lists to see if they will be impacted should such measures hit. Indeed, all banks are torn between US sanctions law, which demand global compliance, and the new Hong Kong national security law, which demands the same – yet in the opposite directions.

Certainly, the atmosphere is one of schism. Australia just offered asylum to 10,000 Hong Kongers in the country and followed Canada to rip up its extradition treaty, the Aussie PM even saying he would facilitate firms wishing to relocate operations and their staff Down Under. At the same time, Italy has followed France to walk away from Huawei for 5G – leaving just mercantilist Germany, sweating profusely. Even Bloomberg says “A New World Order for the Coronavirus Ear is Emerging”, talking about Potsdam and Yalta and the geopolitical map of the world being redrawn.

Linking these threads is key news, still as far abstract to most people as US sanctions were a year ago, that Iran has signed a 25-year co-operation deal with China encompassing trade, infrastructure, energy, and defence coordination. It means China will be buying huge volumes of Iranian oil – in which currency given Iran can’t use USD? And, if the UN arms embargo collapses, China will be selling Iran huge volumes of weapons – in which currency? (Russia will too of course.) The suggestion last year was even that Chinese troops could be stationed in Iran.

Is the US going to watch its encirclement of Iran (and Russia,…and China) collapse? Or is it going to push back? I don’t have that answer, and Trump or Biden probably don’t either: but it’s going to really matter for markets, as it will risk dragging everyone in. And it’s a decision that’s going to have to be made fairly soon.

Meanwhile, there are also more mundane stories that matter too, and yet which are also linked to this big picture. China may be waiting for the US to light the touch paper on Hong Kong, and the US might be waiting for China to light the touch paper over Iran, but China appears to want to stop the equity fireworks display already. Monday saw stocks soar nearly 6% as the authorities gave their blessing to the latest bubble iteration. Five days and USD1 trillion in capitalisation and “I can’t lose” investor headlines later, Chinese media are telling people to calm down and state pension funds are taking profits. So is that it? Is the bubble over even before the grannies jumped in to help the millennial day-traders? Or is this a pause to refresh? Let’s ask perennial China-bull Shuli Ren of Bloomberg, who argues ”Whereas the 2015 rally was engineered by the central bank which started its rate cut cycle the previous November, this round of trading frenzy is a play on Beijing’s ambitious $1.4 trillion tech infrastructure build-out.”

Basically she argues this time round it is not PBOC easing driving the market, but fiscal easing….into another Chinese mega-project that means an inevitable clash with the US….and where the fiscal spending is backed by the PBOC anyway. In other words, it’s not a rate-cut artificial bull market; it’s not a QE artificial bull-market; it’s an MMT artificial bull-market, predicated on the latest Beijing “build it and they will come” mantra. Joe Biden might approve if it were his plan; it’s odd Trump doesn’t seem to.

So nothing matters again – phew!(?) MMT to the rescue? Hardly.

Don’t forget the geopolitical see-saw of intersecting US vs. Chinese MMT ambitions – and all those caught in the middle.

via ZeroHedge News https://ift.tt/2CiYxlg Tyler Durden

Treasury Yields Tumble As Producer Prices Deflate For 3rd Straight Month

Treasury Yields Tumble As Producer Prices Deflate For 3rd Straight Month

Tyler Durden

Fri, 07/10/2020 – 08:37

For the third straight month, US Producer Prices deflated on a year-over-year basis in June.

Against expectations of a 0.2% decline, PPI Final Demand fell 0.8% YoY…

Source: Bloomberg

The headline PPI print fell 0.2% MoM against expectations of a v-shaped bounce back +0.4% MoM.

Food prices fell 5.2% in June as Energy rose 7.7%.

Core PPI also fell (down 0.1% YoY)

Which helps support the ongoing plunge in Treasury yields…

And completely decouple from stocks…

Trade accordingly.

 

via ZeroHedge News https://ift.tt/2W8bbe1 Tyler Durden

California’s Energy Regulations Hurt the Poor, While ‘Green’ Subsidies Benefit the Rich

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A prominent new study from UCLA researchers about California’s energy policies is fascinating not so much for its Captain Obvious conclusions, but because it points to a growing rift on in the environmental world between those who favor the state’s far-reaching “green” policies—and those who want to hector us to use less energy.

“Wealth is a prominent driver of demand for residential energy,” the authors wrote. “Worldwide, wealthier groups lead more materially and energetically intensive lives than the less affluent, consuming in excess of what they require to meet their essential needs.” That’s stunning for its inanity. Is anyone shocked that those with higher incomes live in bigger houses, and spend more to cool them, than those with lower incomes?

“This level of consumption is clearly beyond what you need to provide for your survival, to allow you to be a functioning member of society,” the study’s lead author, Eric Fournier, told the Los Angeles Times. He and his fellow authors thought long and hard about their descriptions of “excessive” and even “profligate” energy consumption. Apparently, academics should decide how much electricity everyone else should use.

I’ve found a constant theme from the environmental community when it comes to every resource-related policy debate, from electricity production to fossil fuels to water availability. Activists talk about improving efficiencies and battling climate change, but they mainly seem offended that people aren’t conserving enough. I’m going out on a limb here, but it’s an undeniably good thing that we can use more energy than we need for our basic survival.

Nevertheless, the study has raised an interesting—albeit stunningly obvious—point, as California continues its headlong rush toward a green-energy future based on command-and-control edicts, subsidies and quasi-market mechanisms such as cap and trade. It found that incentive programs for electric cars and solar panels and some other costly energy policies, “have been found to disproportionately benefit wealthier individuals.”

Well, poor people generally aren’t installing solar panels or buying $50,000 cars. One need not peruse the study’s charts of Los Angeles County to know that Electric Vehicle adoption is higher in Beverly Hills than Watts. I’m all for the development of alternative energy industries, but using public funds, and hobbling old-line energy industries with excess regulations and taxes, is a wealth transfer from poor to rich. As usual, the state’s progressive policies have unintended consequences.

If the state’s alternative energy policies are successful, they are “likely to greatly increase future electricity demand,” the study laments. So far, those policies mainly are boosting prices, but if they do eventually reduce them, people will indeed use more energy. That’s how supply and demand works. Cheaper energy allows everyone, rich and poor, to live more-enjoyable lives. It lowers the costs for businesses, which can then provide jobs and opportunities.

That brings us back to that above-mentioned tension. Are environmentalists mainly interested in cleaning up the environment or changing the way we live? It often seems to be the latter. As Fournier added, “At some point, you have to get to a place where you’re using less energy.” Why is that so? If energy becomes more abundant and more environmentally friendly, who cares if I use more of it to keep the hot tub toasty? It’s no one’s business but my own if I leave the lights on all day—as long as I pay my utility bill.

California is the world’s fifth-largest economy. It’s a land of unfathomable wealth, yet it also has the nation’s highest poverty rate. That rate is above 20 percent, according to the Census Bureau’s cost-of-living-adjusted model, even though California has the most-generous anti-poverty programs, also. One reason for those dismal numbers is our state’s environmental policies, which increase that cost of living.

California has adopted slow-growth policies that limit housing construction by driving up the cost of developable land. The state imposes regulatory costs that, in some localities, comprise 40 percent of the cost of a new home. The result are median-home prices that are unattainable for low-income and even middle-class people. We all like open space, but every policy choice comes at a price, often a high one.

Similarly, our energy prices are among the highest in the nation. Thanks to California-specific formulations, our gasoline costs more than other states, except for remote Hawaii. Our water and electricity policies boost the costs of those necessary products—and the state adds to our sky-high tax burdens by doling out subsidies. California imposes alternative-energy requirements that force it to import 29 percent of our electricity, raising prices on those who can least afford it.

Then researchers are shocked to discover that California’s energy policies impose disproportionate costs on poor folks. The solution is to promote energy abundance, freer markets and less regulation—rather than to create even more programs or to hector suburbanites who “overconsume” air conditioning to cool their homes.

This column was first published in the Orange County Register.

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