Just Stirring the Pot – Updated
Regeneron Seeks Emergency Approval per trump’s miracle recovery and subsequent endorsement.
Biotech company Regeneron moved Wednesday to apply for emergency approval for an experimental antibody treatment praised by President Trump.
“Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for our REGN-COV2 investigational antibody combination for COVID-19.”
And trump? President Donald Trump received the antibody cocktail last Friday along with other drugs under a compassionate use program after becoming sick(?) with the coronavirus. Trump hailed Regeneron’s treatment in a video posted on Twitter Wednesday, saying he would authorize its emergency use and make it available to Americans for free.
Who knew this was a clinical trial of the real drug? What if it was a placebo and he cured himself? If they approve this after all the hoopla over other drugs . . .
Just more deflection from the real issues, the pandemic, himself, etc.
Maybe, we should just follow the money???
A 4–3 party-line vote and Republican judges on the Michigan Supreme Court invalidated a law that had empowered a historically popular Democratic chief executive to take emergency actions to combat COVID-19. The basis for the decision was an antiquated doctrine that conservatives on the United States Supreme Court have signaled they want to revive.
The Michigan Supreme Court was following the lead of the U.S. Supreme Court. In an opinion last year, Justice Neil Gorsuch wrote a dissent calling for the revival of the nondelegation doctrine. Gorsuch premised his argument on the originalist claim the Framers believed “such delegation of power, in the case emergency powers, would frustrate ‘the system of government ordained by the Constitution’ if Congress could merely announce vague aspirations and then assign others the responsibility of adopting legislation to realize its goals.”
Legislatures aren’t equipped to resolve every question for themselves. Nor are they nimble enough to confront every new challenge as it arises. Sometimes, they need to draw on the executive branch’s expertise and dispatch. And in this case, the Michigan legislature through Gerrymandering has had control of the legislature since 1990. They have the ability to overrule the governor.
Courts Are Taking Away One of Americans’ Best Options for Fixing Voting
“In 2019, writing the decision for Common Cause v. Rucho, Chief Justice John Roberts closed off the federal courts as an avenue for addressing partisan gerrymandering. But, Roberts insisted, the Supreme Court’s decision did not condone these excesses. Rather, another path for addressing structural electoral reform existed. Noting the success of several citizen-driven state-constitutional amendments passed by ballot in Colorado, Michigan, and Missouri the previous November, Roberts said that citizens still had the tools to make change.”
Just over a year later; however, Citizens having the tools to create change has not proved to be able to change the law as Roberts stated. State redistricting, voting, and other initiatives have been closed off to citizens through both state and federal courts
“Voters in Arkansas, North Dakota, and Idaho took Roberts up on his suggestion to drive reform via citizen-led initiative or by amending their state constitution. In Arkansas, with two different amendments, citizens worked to establish an independent redistricting commission and also open primaries and institute ranked-choice voting. In North Dakota, they looked to strengthen overseas-military voting and election audits, open primaries to all voters, and enact instant runoffs. Idaho voters, meanwhile, sought to expand funding for public education. One by one, these initiatives have been knocked off the ballots this summer by state and federal courts, and for the most tendentious and technical reasons.”
May 14, 2020; “On Thursday, Michigan closed down its capitol building and canceled its legislative session after online death threats made against Governor Gretchen Whitmer.
The threats were made by protesters who planned to attend a “Judgement Day” protest at the capitol. The protesters ostensibly oppose Whitmer’s statewide shutdown orders meant to slow the spread of coronavirus.”
One man was arrested. There has been displays of latent violence toward the Governor within protests at the Capitol with protestors armed with bullet – spewing – weapon, displayed effigies such as dolls with hangman’s nooses around their necks, etc. It was only a matter of time before the boundary was crossed from almost peaceful protests to potentially more violent actions. Our president, who could have a calming impact, is not a man of calming words in the face of angry crowds. Quite the opposite, he has egged them on with his comments to white supremist groups, “stand back and stand by” supposedly to the Proud Boys?
October 8, 2020; “NBC: More than a dozen men were arrested on federal and state charges in connection with an alleged foiled plot to kidnap Michigan’s Democratic governor, Gretchen Whitmer, authorities said Thursday.
Six were apprehended and charged with federal crimes, while another seven were picked up on state charges, officials in Michigan said.
Governor Gretchen Whitmer: All are members of two militia groups “who were preparing to kidnap and possibly kill me,” in an address from Lansing late Thursday afternoon following the arrests.”
Since the protests started in May and went on over the course of a few months, some of the protestors have felt the need to protect themselves against angry legislators and have brought their toy bullet – spewing – weapons to the Capitol. At the May protests were two of the protesters who were arrested in the last 24 hours for plotting to kidnap Governor Whitmer and blow up a bridge as a distraction. There has been a Senate bill stuck in committee banning the carrying of bullet – spewing – weapons on Capitol building grounds. Sounds sensible to me, except it is still stuck in committee and Republican controlled legislatures have left the decision up to the appointed Capitol Commissioners to decide on a ban or not. Time to act before someone gets hurt.
Sell before May
then walk away
. go short before September
, but if you can remember
go long before Columbus Day
for a Santa December
don’t forget to remember
to raise cash before May
Has Trump been cured? Listen to his two coughing episodes during last night’s interview with Sean Hannity.
I do not believe we will even know if he had Covid or not. It appears he did but then there is the caution shown by doctors and others in talking about his illness. Nobody is cured that quickly regardless of what you take or what you have. This man is a liar.
For his sake, I hope it’s COVID, because otherwise the treatment regime he is receiving (note that the Regeneron CEO is a Mar-a-Lago member; no idea if he joined before 2016) is going to be a strain on his body. (There is good reason he hasn’t been seen live since Monday and that tape was clearly edited together.)
CDC says quarantine until “ten days after symptoms.” Even if you don’t count last night–as with pgl, I do–letting him out and about is, at best, a murder/suicide arrangement.
Since Ruby Ridge and Waco, the question has been whether to do something or wait for them to self-destruct. The mugs of the idiots can’t be good for recruiting, can it?
Ethicists say Trump special treatment raises fairness issues
AP via @BostonGlobe – October 7
The special treatment President Donald Trump received to access an experimental COVID-19 drug raises fairness issues that start with the flawed health care system many Americans endure and end with the public’s right to know more about his condition, ethics and medical experts say.
Regeneron Pharmaceuticals Inc. revealed on Tuesday how rare it was for anyone to get the drug it gave Trump outside of studies testing its safety and effectiveness. The drug, which supplies antibodies to help the immune system clear the coronavirus, is widely viewed as very promising.
Trump also received the antiviral remdesivir and the steroid dexamethasone, and it’s impossible to know whether any of these drugs did him any good.
“He deserves special treatment by virtue of his office,” said George Annas, who heads Boston University’s center for law and health ethics. “The question is whether it’s good treatment.”
These drugs are unproven for mild illness and have not been tested in combination. The steroid seems at odds with medical guidelines based on what doctors have said about the severity of his illness.
“The public is getting mixed messages about his condition and that’s a problem,” Annas said, adding that there’s a right to know anything that could affect Trump’s ability to do his job.
HOW HE GOT THE DRUG
Trump’s doctors asked for the Regeneron drug under “compassionate use” rules, which allow a patient with a life-threatening disease to get an experimental medicine if they can’t enroll in a study testing it and there’s no good alternative.
Trump was given the drug at the White House on Friday before he was taken to Walter Reed National Military Medical Center. Walter Reed is not a site where the drug is being tested, so he may have met that criterion on technical grounds. Had he enrolled in a study, he would have risked being randomly assigned to a comparison group getting usual care rather than getting the drug.
Compassionate use requests are decided on a case-by-case basis, and both the drug company and the U.S. Food and Drug Administration must agree. An FDA spokeswoman refused comment on the FDA’s decision or to say how many others have asked for the drug.
HOW SPECIAL WAS THIS?
Fewer than 10 of these requests have been granted, said Regeneron spokeswoman Alexandra Bowie. The drug is in limited supply, the priority is using it for the ongoing studies, and emergency access is granted “only in rare and exceptional circumstances,” she wrote in an email.
Regeneron also contacted Democratic presidential nominee Joe Biden’s campaign “to make them aware of the compassionate use mechanism, should they need to apply” if Biden becomes infected, Bowie wrote. “There was no promise of access to the medicine,” she added.
Alison Bateman-House, an ethicist at NYU Langone Health, said Regeneron’s overture to Biden raises concern.
“That crosses lines of appearing to promote a potentially unapproved product” in violation of FDA rules, she said. Rather than directing people to enroll in studies, it suggests “just call us up and we’ll cut the line for you,” she said.
As for Trump, “it’s not clear to me that this was an emergency situation,” said Dr. Steven Joffe, medical ethics chief at the University of Pennsylvania.
“I think there is something wrong with the privileged, the president, getting special treatment that’s not available to the rest of us,” he said. “There’s so much injustice in our health care system, with so many people not even having access to the basics,” that the favoritism shown Trump is “a symptom of a much larger problem.” …