It helps them hide the tyranny they are inflicting upon us all:
"Coronavirus Safety Runs Into a Stubborn Barrier: Masculinity" by Daniel Victor New York Times, Oct. 10, 2020
(Blog author pauses as he ponders the usefulness of continuing with this inane and absurd garbage that is to be found in my pre$$. They have really reached the limit)
On Tuesday, and not for the first time, Joseph R. Biden Jr. described President Trump’s reluctant attitude toward wearing masks as “macho.”
Tomi Lahren, a conservative commentator and Fox Nation host, countered that Mr. Biden “might as well carry a purse with that mask.”
They were among the most direct comments yet that have tied stereotypes about acting and appearing manly to the basic precautions that doctors, epidemiologists and other health experts recommend to prevent infection by the highly contagious and deadly coronavirus.
The theme has been there since the beginning of the pandemic. Some experts who study masculinity and public health say the perception that wearing masks and following social distancing guidelines are unmanly has carried a destructive cost. The virus has infected more men than women and killed far more of them.
The experts say the best public health practices have collided with several of the social demands men in many cultures are pressured to follow to assert their masculinity: displaying strength instead of weakness, showing a willingness to take risks, hiding their fear, appearing to be in control.
Yeah, kill off the stronger defenders of humanity so that the lesser females will be easy prey.
I say that with no insult meant, simply a recognition of biological reality as I extoll women to celebrate their unique child-birthing skills instead of the false god of equality pushed by world-destroying globalists.
Men’s resistance to showing weakness — and their tendency to take risks — was demonstrated by scientists long before Covid-19. Studies have shown men are less likely than women to wear seatbelts and helmets, or to get flu shots. They’re more likely to speed or drive drunk. They are less likely to seek out medical care.
Who trusts the medical system these days, and speaking of WHO, they just accidentally(?) admitted that the fatality rate from COVID is actually the same as seasonal flu so how risky can it be?
The entire lockdown strategy to advance other goals is woefully apparent now, and it's all based on flawed and faulty tests that are now a crime against humanity.
Some initial research indicates a similar pattern is playing out with the coronavirus. Surveys have found that women are more likely than men to wear masks in the United States, and recent polls have found men give higher marks to President Trump than women on his handling of the pandemic.
I have anecdotally noticed that.
“To admit you’re threatened is to appear weak, so you have to have this bravado,” said Peter Glick, a professor of social sciences at Lawrence University. If you wear a mask, he said, “the underlying message is: ‘I’m afraid of catching this disease.’”
Mr. Trump tends to reject anything that can be read as a sign of weakness or lack of control. His behavior and comments after his own hospitalization, amid a widening outbreak within his circle, have also exposed a White House that flouted the basic precautions endorsed by its own health experts, and many American men who look up to Mr. Trump are taking his cues, choosing to forgo protective measures that health officials say are crucial to slowing the spread of the virus.
I view it as a sign of unreasonable submission for no good reason and an unhealthful thing to do that is ripped off as soon as I get out of the store, and I see those that don it outside as weak.
Meanwhile, the New York Times says the White House blocked the CDC from requiring masks on public transportation while the Globe says that people trained in public health — who are not necessarily physicians — should handle public health crises (they don't answer why it is a military operation).
They carry a heavy burden because just when we need it most, when it’s time to renew the compact between science and society, science is in danger and the pandemic isolation is destroying our social skills, with everyone touchy about everything so we can’t even make small talk anymore, and "even cheerful people are getting grouchy, finding themselves saying “I hate people.”
The most reliable subject of conversation, she said sadly, is alcohol, “if I had a dollar for everyone who told me they drink a bottle of wine every day, I could retire,” but seriously, folks.....
This is not a new problem for those who work in public health messaging. Stacey Hust, an associate professor of communication at Washington State University, said prevention campaigns around sexual assault often try to appeal to masculine ideals, making better behaviors “worthy of the alpha male.”
It tends to be more difficult to reach those who identify strongly with traditional masculine characteristics. As an example, the more someone identifies with those masculine traits, the less likely that person will be to use condoms during sex, she said.
“I think that translates really clearly into why some men choose not to wear masks,” she said. “It’s really about not wanting to show weakness or fear, not wanting to show any vulnerability.”
Now they are tying the refusal to wear a mask into sexual assault and abuse and being unwilling to wear a condom.
Have they NO SHAME!?
Mr. Biden, who has modeled wearing masks and adhering to social distancing guidelines, has consistently criticized Mr. Trump for his approach to his personal coronavirus precautions. In May, he called Mr. Trump “falsely masculine” for his refusal to wear a mask, and said the precaution connoted leadership, not weakness.
Another New York Times distortion or outright falsehood.
At first, Mr. Trump would not wear a mask in public. On very rare occasions he has been photographed in one, but has continued to play down their effectiveness.
He has mocked Mr. Biden for his mask use, and made a show of removing his mask while on a White House balcony when he returned from Walter Reed National Military Medical Center on Monday. He has also continued to host large campaign rallies and other events that don’t follow recommended social distancing guidelines.
Theresa Vescio, a professor of psychology and women’s, gender and sexuality studies at Penn State University, said Mr. Trump has frequently engaged in “masculinity contests” as a president and candidate.
He has demeaned male rivals — repeatedly referring to former Mayor Michael R. Bloomberg as “Mini Mike,” for one — and in the 2016 Republican primary defended the size of his penis after an attack by Senator Marco Rubio, and Republicans have successfully staked ground as the party for men who take their masculinity seriously. In research with Nathaniel Schermerhorn, a graduate student at Penn State, Professor Vescio has found that the degree to which someone endorses traditional masculine ideals — including women who value traditionally masculine men — very strongly correlates with identifying as a Republican. Polls show Mr. Trump attracts more support from men than from women.
“Republicans have been doing this since 2016, effectively feminizing or suggesting Democrats have masculine shortcomings,” she said.
It seems to be working.
Many of Mr. Trump’s supporters admire his aggressive style, Professor Glick said, and see him as a model of male dominance.
It was a lost opportunity early in the pandemic. The president could have used that authority to change the perception of masks and other precautions among those who value traditional masculine traits, he said.
“It certainly would have helped,” Professor Glick said, “but at this point, it’s hard to go back.”
--more--"
His brother-in-arms:
"For Boris Johnson, and maybe Trump, COVID as metaphor is hard to shake" by Mark Landler New York Times, October 10, 2020
LONDON — President Donald Trump got a well-wishing phone call this past week from one of the few foreign leaders who knows what he’s been going through: Prime Minister Boris Johnson of Britain, a survivor of a serious brush with the coronavirus this spring.
Trump seized on the call as another opportunity to boast of a swift recovery from COVID-19, but he should take little comfort from Johnson’s experience — six months after Johnson was released from the hospital, he has yet to shake off questions about the effects of the disease on his energy, focus and spirit. His health is a source of whispered speculation in the hallways of Parliament, questions from reporters and ominous musings by columnists, for whom Johnson’s illness has become a symptom of his broader political decline.
That's why Pelosi formed a 25th Amendment committee. Trump really fell into their trap.
“It’s a metaphor for his government, and that’s affecting him personally,” said Jonathan Powell, who was chief of staff to Tony Blair when he was prime minister. “He looks like the wrong man for the job at this time.”
Look at who the New York Times turns to for analysis. An aide to Iraqi war criminal Bliar.
Related:
"Iraqi militias backed by Iran have agreed to temporarily halt attacks targeting the American presence in Iraq, on the condition that US-led coalition troops withdraw from the country in line with a parliamentary resolution, three militia officials said Sunday. Roadside bombs and in particular rocket attacks targeting the U.S. Embassy in Baghdad — located inside the heavily fortified Green Zone — have become a frequent occurrence and have strained ties between Washington and Baghdad. The militia factions offered a truce and will refrain from targeting the U.S. in Iraq, including the embassy, on the condition that all American-led forces withdraw within an “acceptable timeframe,” said Mohammed Mohie, a spokesman for the powerful Iran-backed Kataib Hezbollah. “If it does not withdraw, the resistance factions will resume their military activities with all the capabilities available to them,” he said....."
After all these years, the Iraqis are going to finally DRIVE US OUT!
Parallels between Johnson and Trump are often overblown, and there is little in the prime minister’s convalescence that compares to the daily spectacle of a president pronouncing himself back to normal and scheduling campaign rallies a week after being airlifted to the hospital with trouble breathing.
Still, both initially played down the threat of the virus — Johnson, most notoriously, when he bragged about shaking the hands of coronavirus patients while visiting them in the hospital.
Despite his efforts, Johnson has never recaptured the public buoyancy that propelled him to a landslide election victory in December. On Tuesday, speaking to his Conservative Party’s annual conference, he tried again to put to rest questions about lingering effects of COVID-19, the disease caused by the virus.
“I have read a lot of nonsense recently about how my own bout of COVID has somehow robbed me of my mojo,” the prime minister said in a tone of theatrical umbrage, “and of course, this is self-evident drivel, the kind of seditious propaganda that you would expect from people who don’t want this government to succeed.”
I am for giving him the Charles the First treatment, but that is up to the British people not me.
Far from being a political Austin Powers, sapped of his vitality by an invisible enemy, Johnson said he had lost 26 pounds since his recovery. Having long struggled with his weight, he has declared himself as “fit as a butcher’s dog” and challenged the people of Britain to join him in getting into shape.
Both leaders sought to make political points after being discharged from the hospital: Trump about the miracle-cure qualities of the drugs he was treated with, which he promised to distribute free to all Americans; and Johnson about the miracle workers who treated him — the doctors and nurses of the National Health Service, perhaps Britain’s most revered institution, but Johnson, unlike Trump, emerged from his illness with a new appreciation for the virus’s deadliness and his own vulnerability. He spoke movingly about how the nurses in the ICU took turns giving him oxygen, something that Trump, who also received supplemental oxygen, has not mentioned.
That as predicted back in 2012 (the "fun" starts 20 minutes in after the royalty arrives, and note the Masonic compasses encircling the top of the stadium).
Johnson also became a reluctant proponent of protective measures, a stance that has put him at odds not only with Trump but also with members of his own party who worry about the damage that lockdowns do to the economy.
Those are the ones who get "infected," and have you noticed that Democrats are immune from COVID?
The prime minister’s speech to the Conservative conference was a concession to the times. Whereas he would typically deliver the speech in a giant hall with the party faithful arrayed before him, Johnson instead faced a camera in an empty room.
“There is no one to clap or heckle,” he lamented.
He did his best to turn the page, sketching out his vision of a post-COVID future for Britain: ambitious investments in wind turbines and windmills, under the slogan “Build Back Better,” which happens to also be the slogan of the jobs and recovery plan of former Vice President Joe Biden, the Democratic candidate for president.
That is where the print copy ended, and they are not the only ones commandeering the phrase:
The Trump campaign accused Biden of plagiarizing Johnson, but “Build Back Better” has been used recently by the United Nations, the World Economic Forum and Prime Minister Justin Trudeau of Canada, suggesting a lack of imagination more than a theft of intellectual property.
OMG, they have been UNMASKED as the New York Times sees Nazis everywhere where the Great Re$et is opposed, with the vanguards being Germany and the UK.
It would make one laugh were it not so deadly serious.
In any event, the British news media largely ignored “Build Back Better” and kept the focus on Johnson’s misplaced mojo. The state of his health is hard to judge, given that his office provided sketchy, uninformative updates while he was sick and has not offered a medical briefing since then. He looked energetic Tuesday but has seemed occasionally lethargic during debates in Parliament.
Still, it is not just Johnson’s polarizing personality that has caused his problems. His government’s botched response to the pandemic — from its tardy lockdown and trouble-prone test-and-trace system to its serial reversals on lockdown measures — has cemented the perception that it is ill-equipped to deal with the challenge.
Johnson’s approval rating, which peaked at 66% when he left the ICU, has sagged to 35%, according to the research group YouGov. Early polls suggest that Trump may not even get that transitory a sympathy bump from his illness, and unlike Johnson, he is due to face voters in less than a month.
When Johnson and several of his top advisers got sick in late March, it was eerily similar to the contagion now sweeping through the White House. Like the president’s aides in the West Wing, Johnson and his staff huddled in the cramped offices of 10 Downing Street, not observing adequate social distancing.
What it revealed, people who know him said, was Johnson’s blithe disregard for health issues — another trait he once shared with Trump. Before his illness, he boasted of his appetite for cheese and argued against regulating fast-food advertising or taxing companies that use unhealthy ingredients.....
COVID has turned him into a new man, huh?
--more--"
Time to take off the mask and speak up:
"Battered by Trump, the CDC’s director faces pressure to speak out" by Sheryl Gay Stolberg New York Times, October 10, 2020,
WASHINGTON — Pressure is mounting on the leaders of the Centers for Disease Control and Prevention — from inside and outside the agency — to speak publicly against the White House’s manhandling of CDC research and public health decisions, with career scientists so demoralized they are talking of quitting if President Donald Trump wins reelection.
Good!
Get your Deep $tate a$$e$ out the door!
The situation came to a boiling point this week when William Foege, a giant in public health who led the CDC under Democratic and Republican presidents, called for its current director, Dr. Robert R. Redfield, to “stand up to a bully” — he meant Trump — even at the risk of being fired.
“Silence becomes complicity,” he said in an interview after a private letter he wrote to Redfield leaked to the news media.
Related: The Redfield Letter
The pre$$ has been silent about that, just as they are silent about so many things.
Redfield further infuriated public health experts by issuing a memo, released by the White House, that cleared Vice President Mike Pence to participate in the vice presidential debate Wednesday, even as the White House became a coronavirus hot spot. Nearly a dozen current and former CDC officials — including six who still work there — called the letter highly inappropriate, and Sen. Patty Murray of Washington, the ranking Democrat on the Senate health committee, said she told Redfield in a private telephone conversation before he testified on Capitol Hill last month that he had to take a stand.
“What I said to him was that my concern was about the agency’s credibility today — and the agency’s credibility that we need as a country in the future,” Murray said in an interview. “This isn’t just about right now. If we lose all the really good scientists there, if people don’t believe the CDC when they put out guidance, what happens in the next flu outbreak? What happens in the next public health crisis?”
We will survive as always given our blessed immune systems, and they have no credibility even with the "good scientists(?)."
No federal health agency has been beaten up quite like the CDC, which is based in Atlanta and prides itself on avoiding Washington partisanship. The Food and Drug Administration did buckle to White House demands to grant emergency approvals for two unproven COVID-19 therapies, but more recently, the FDA withstood enormous pressure — including from Trump — and issued tough new guidelines for emergency approval of a coronavirus vaccine that almost certainly pushes any vaccine release past the election.
The National Institutes of Health has remained above the political fray, and one of its top officials, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has become a symbol of scientific defiance to Trump. On Friday, Fauci called the White House ceremony announcing Judge Amy Coney Barrett’s nomination to the Supreme Court a “superspreader event,” but the CDC leadership has proved far more malleable to the president’s will. The White House successfully pressured the agency to revise guidelines on matters like school reopenings, church gatherings and whether cruise ships can sail.
There is no masking the NYT propaganda.
The CDC was forced, over the serious objections of its own scientists, to post coronavirus testing guidelines that suggested asymptomatic people should not be tested (Redfield later walked that back after the resulting uproar, and it was ultimately reversed), and the White House thwarted a plan, laid out in a directive drafted last month by Redfield, to require individuals to wear masks on all commercial transportation in the United States.
Supporters of the agency fear the CDC’s reputation will be irrevocably damaged if Redfield does not start more vigorously defending its science.
Too late.
“What has happened at CDC has been horrifying to see,” said Dr. Mark Rosenberg, who pioneered public health research into gun violence at the CDC but was pushed out after Republicans in Congress effectively cut off funding for his work. “It’s been terribly demoralizing to people who have been working 16- and 17-hour days for weeks or months at a time while taking on COVID-19.”
That qualifies him as an expert in COVID?
Redfield declined to comment. Murray said he had given her his assent in their conversation, acknowledging without saying much that he agreed with what she said. A spokesperson for the Department of Health and Human Services, the CDC’s parent agency, said, “The American people are fortunate to have Dr. Redfield leading the CDC.”
The agency’s scientists know that their work will invariably collide with politics; they make decisions and do research on hot-button issues like abortion, teenage pregnancy and gun violence, but they have never seen anything quite like what is happening under Trump.
“We’ve all learned a terrible lesson,” said one CDC official who spoke on the condition of anonymity for fear of being fired. “As much as we want to believe we can operate independently of politics and it’s all about the science, it took just a few months to hobble our ability to steer the course of this pandemic. So we can pretend that the politics don’t matter, but we have been kneecapped.”
Political appointees of the president meddled in the agency’s Morbidity and Mortality Weekly Reports, regarded as the “holiest of the holy” in medical literature. Equally troubling, agency officials say, is that the White House has muzzled the CDC, refusing to allow the nation’s leading public health experts to talk directly and regularly to the American people — a critical component of any successful infectious disease response.
One longtime CDC scientist said it was time not only for Redfield to speak out but also for senior career scientists in the agency to do so.
Before the election is over.
Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, has hardly been seen since late February, when she enraged Trump by presciently telling reporters that day-to-day life in the United States was about to change drastically: “It’s not so much of a question of if this will happen anymore but rather more of a question of exactly when this will happen.”
Because of the "live exercise" and plannedemic!
Another CDC veteran scientist said he and colleagues were planning to look for new jobs if Trump wins reelection.
Redfield’s memo about Pence — addressed to Marc Short, the vice president’s chief of staff — is a particular sore spot because Redfield has not examined Pence, and the CDC is not involved in contact tracing to track the extent of the White House outbreak. In addition, federal law bars most executive branch employees from engaging in political activities, and some say Redfield crossed a red line.
“It sounds very manipulative,” said Foege, who served as CDC director under Presidents Jimmy Carter and Ronald Reagan, adding that while he sometimes had to fend off pressure from Washington, he “was never faced with having to do something like that.”
The CDC has made its own missteps. Sloppy laboratory practices caused the botched introduction of coronavirus tests early in the pandemic. More recently, the agency withdrew a notice on its website acknowledging for the first time that the coronavirus spreads mainly by air, saying that it had been “posted in error” on the agency’s website. The weaker version was later published.
The tests actually infected people with the virus, folks!
Redfield has at times offered lukewarm statements in defense of the CDC, like when he told the Senate health committee that suggestions that the agency was a “deep state” were “offensive.” In an internal email last month summing up his testimony, he told agency employees that he had “shared my sadness over misperceptions regarding the scientific integrity” of the reports and pledged that they would “not be compromised under my watch.”
Hey, I believe the report stating that 94% of COVID deaths had 2-3 co-morbidities that were the likely cause of death. It feels like the CDC is engaged in some CYOA movements.
The agency’s scientists say that is not enough. Current CDC employees contacted would not speak on the record for fear of reprisal, but the sense of despair is clear. Many view public health as a calling and remain at the agency knowing that they could earn much higher salaries working in industry.
Then go!
Most current and former CDC officials acknowledge that Redfield is in a terrible position, working for a president who has declared all-out war on his agency and who regards its scientists as members of a so-called “deep state” out to get him. Unlike Fauci, he is a political appointee and lacks civil service protections, and unlike the FDA commissioner, he cannot turn to a powerful industry constituency like pharmaceuticals to back him up.
The fact that the Times brings up the "deep state" and the pre$$ has been hollering conspiracy theories is a sign that the people of the world are indeed getting wise to this.
Some say it would be unwise for him to step down, for fear of his successor.
“What happens if 50 of the top scientists at CDC say, ‘We’ve had it, we’re leaving?’ Does that leave the country better off or worse off?” asked Dr. Jeffrey Koplan, who served as the CDC director under Presidents Bill Clinton and George W. Bush and regularly met Redfield for lunch before the pandemic. “I suspect that Dr. Redfield is asking himself the same question.”
Foege’s letter to Redfield, dated Sept. 23 and first published by USA Today, made clear that he and Redfield had talked about the prospect of resignation. Foege helped lead the effort to eradicate smallpox in the 1970s and is a giant in the world of public health.
“As I have indicated to you before, resigning is a one-day story and you will be replaced,” he wrote. Instead, he urged Redfield to describe the administration’s failures and his own in a letter to the agency’s employees. Then, he concluded, “when they fire you, this will be a multiweek story and you can hold your head high.”
Yeah, but DON'T LET POLITICS enter into the equation at all!
As pressure on him intensified this spring and summer, Redfield did not tell top aides that he was considering resigning, a former federal health official said. Instead, he would make versions of the same comment: “As long as I’m here, with the time I have left, which may not be long, we’re going to try to do x, y and z,” the official recalled.
Known as “R3” by his staff — a reference to his initials — Redfield has rarely been in Atlanta during the pandemic, with top aides seeing him only a dozen or so times. Often summoned to coronavirus task force meetings and congressional hearings, he instead has stayed at his home in Baltimore, where he helped found and run a virology institute at the University of Maryland before becoming CDC director in 2018.
He was named to the job by Trump’s health secretary, Alex Azar, replacing Dr. Brenda Fitzgerald, who resigned after six months on the job amid disclosures that she had bought tobacco stocks.
$moke 'em if you got 'em!
When he arrived at the CDC, one scientist there said, many in the agency were relieved. They had feared Trump might appoint someone openly hostile to science or an opponent of vaccines, but Redfield had no experience in public health or in running a large government agency like the CDC, with 11,000 employees. Nor is he an especially good communicator.
“I don’t think he was the leader for this agency at this point in time,” said Dr. Georges Benjamin, executive director of the American Public Health Association, who has known Redfield since they served together in the Army decades ago. “I don’t know if anybody could have been.”
Now, less than a month from the election, the question is whether the CDC can recover. Foege refused to allow the possibility that it could not.
“They have to recover,” he said. “The world needs a gold standard in public health.”
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The gold standard is he of the golden toilets:
"Can Trump Really Speed Approval of Covid Treatments?" by Robert P. Baird New York Times, Oct. 10, 2020
In a five-minute video posted to his Twitter account on Wednesday, President Trump stood in front of the White House and offered a lavish endorsement for a treatment he had received while hospitalized at Walter Reed National Military Medical Center.
“They gave me Regeneron, and it was like, unbelievable, I felt good immediately,” the president said, referring to an experimental cocktail of monoclonal antibodies produced by the pharmaceutical company Regeneron. “I want everybody to be given the same treatment as your president.”
The president’s video raised many questions, including whether it was likely that the antibody cocktail had such a dramatic effect in such a short time (some physicians were skeptical), but for one question, at least — how the president planned to ensure that a therapy not yet approved by the Food and Drug Administration would soon be available to “everybody” — he had a ready answer: “I have emergency-use authorization all set,” the president said in his video, “and we’ve got to get it signed now.”
The president’s mention of the emergency-use authorization, or E.U.A., is the latest stage of a transformation that has seen a formerly obscure corner of regulatory law become a centerpiece of the federal government’s response to the coronavirus pandemic. Vaccines, drugs and medical devices sold in the United States generally require F.D.A. approval, a rigorous process that is meant to demonstrate their safety and effectiveness. For more than 15 years, however, the F.D.A. has had the authority, when certain conditions are met, to grant E.U.A.s, which allow the sale of unapproved medical products.
The F.D.A. has granted such authorizations during several previous disease outbreaks, including H1N1 flu in 2009 and Zika in 2016, but the coronavirus pandemic has seen the deployment of E.U.A.s on a new scale.
Since February, the agency has granted more than 300 Covid-related emergency-use authorizations. Most were for diagnostic tests, but they were also granted for personal protective equipment, blood-purification devices, ventilators and therapies. (Some of these E.U.A.s were the subjects of considerable controversy, most notably one that authorized the use of chloroquine and hydroxychloroquine to treat Covid-19, which was later revoked, in June.) Many observers expect that Covid vaccines will first be made available in the United States under an E.U.A.
The regulations that govern E.U.A.s were originally enacted as part of the Bioshield Act, a 2004 law designed to help the nation prepare for chemical, biological, radiological and nuclear terror attacks. F.D.A. approval has long been recognized as the gold standard for medical products, but the requirements to obtain that approval, which often include clinical trials, inspections of manufacturing facilities and detailed statistical analyses, can be time-consuming. In the wake of the Sept. 11 terrorist attacks, and especially the anthrax mailings later that year, it was widely acknowledged that even the agency’s fastest approval mechanisms were too slow and inflexible to handle a true emergency.
To address these concerns, President George W. Bush proposed Project Bioshield during his 2003 State of the Union address. The project established incentives for companies that were developing medical countermeasures, allowed the federal government to stockpile unapproved products and permitted the F.D.A. to authorize the emergency use of those products.
The Bioshield Act, along with the laws that later modified it, was not intended as a carte blanche. For instance, an E.U.A. can only be granted during a declared public health or national security emergency, and is supposed to be used only for products that have no adequate, approved or available alternatives, but the F.D.A. was granted wide discretion to decide whether a product ought to be made available to the public. By law, the agency can grant E.U.A.s to products that “may be effective,” whose “known and potential benefits” outweigh “the known and potential risks.” It is up to the agency, however, to determine what those criteria mean.
“It was deliberately a quite flexible kind of standard,” said Dr. Jesse Goodman, the director of the Center on Medical Product Access, Safety and Stewardship at Georgetown, and the F.D.A.’s chief scientist from 2009 to 2014. E.U.A.s are intended to be evaluated on a case-by-case basis; the F.D.A. might tolerate more risk for a drug designed to treat a disease with a high mortality rate, such as Ebola, than for a vaccine that would be given to healthy people to stop a disease like Covid-19, Mr. Goodman said, but, he added, E.U.A.s were not meant as a substitute for traditional approvals: “The intent originally was that ultimately you should be collecting data and moving these products toward approval,” even after the emergency authorization was granted; however, it can be difficult to fully enroll a product in clinical trials after it has received an E.U.A., Dr. Goodman said, because clinical trials typically impose more stringent requirements on patients than an E.U.A. would. “Now we have tens of thousands of people getting convalescent plasma” — a Covid-19 treatment that was granted an E.U.A. in August — “and we still don’t know whether it works,” he said.
Another potential hazard of emergency authorization became apparent not long after the Bioshield Act was signed into law, when the F.D.A. granted its first E.U.A., at the request of the Defense Department, for the use of an anthrax vaccine, in 2005. That authorization suggested to some people, including Chris Shays, then a Republican congressman from Connecticut, that the E.U.A. process provided an avenue for political interference. The apparent urgency “appears to be the product of preventable legal and regulatory failures,” Mr. Shays wrote in a letter to the Secretary of Health and Human Services, “rather than any validated external threat.”
The actions of the Trump administration during the Covid pandemic have renewed these concerns. In May, Rick Bright, the former head of the Biomedical Advanced Research and Development Authority, alleged in a whistle-blower complaint that he had arranged an E.U.A. request for hydroxychloroquine and chloroquine as a “compromise position” to head off pressure by administration officials to make the drugs available under a less-restrictive protocol known as “expanded access.”
See: Bloom is Off Bright Winter
In late September, Mr. Trump said that he was considering blocking the F.D.A.’s vaccine E.U.A. guidelines, which made it unlikely that a vaccine would be authorized before the presidential election, because he saw them as “a political move more than anything else,” and Mr. Trump’s insistence, in the video he posted on Wednesday, that “we’ve got to get” an E.U.A. for the Regeneron antibodies “signed now” was an extraordinary intervention into a process that is usually left to career scientists at the F.D.A. (A few hours after Mr. Trump tweeted the video, Regeneron announced that it had officially applied for an E.U.A., although the company had previously suggested its intention to seek one.)
F.D.A. officials, for their part, have asserted their determination throughout the pandemic to keep E.U.A.s free from political interference. Dr. Peter Marks, the head of the F.D.A.’s Center for Biologics Evaluation and Research, said in an interview with the Journal of the American Medical Association on Monday that meetings of the F.D.A.’s vaccine-advisory committee would be broadcast online for maximum transparency.
“We want to make sure that the American public knows that what they’re getting is not pressure to do something, but what comes from looking at the data,” Dr. Marks said, and an F.D.A. spokesman pointed to a speech given by the F.D.A. commissioner, Dr. Stephen Hahn, on Tuesday to the Food and Drug Law Institute in which he emphasized that the agency’s decisions have been and will be “based on science and data, not politics.”
BULL!
Dr. Eric Topol, a professor of molecular medicine at Scripps Research, said that Mr. Trump had not made it easy for the agency to maintain its appearance of independence. Dr. Topol believed that the Regeneron antibodies would have been granted an E.U.A. without Mr. Trump’s endorsement, and possibly before Election Day, but he was concerned that the president planned to “use this as a political lever just as he was planning on using the vaccine.”
Even though they are basically controlled by the pharmaceutical companies.
Even so, Dr. Topol said he was heartened that the F.D.A. had released its vaccine E.U.A. guidance, on Tuesday, despite Mr. Trump’s initial reluctance. The guidelines call for safety and efficacy data that Dr. Marks has described as “E.U.A.-plus,” and include a requirement that manufacturers follow participants in late-stage clinical trials for a median of two months, to ensure the long-term safety of a vaccine.
“I’ve been very hard on Hahn and the F.D.A., but I was relieved and absolutely delighted to see him standing up,” Dr. Topol said.
Now if only Redfield would, huh?
It will be up to vaccine manufacturers to decide whether to request E.U.A.s for their Covid-19 vaccine candidates. Many public health experts say that there are conditions under which an E.U.A. for a coronavirus vaccine would be appropriate. An application for formal approval of a vaccine can require tens of thousands of pages of documentation, and even a priority review of a new vaccine typically takes eight months after clinical trials are completed.
“There’s a lot of I’s you have to dot and a lot of T’s you have to cross” to get a vaccine approved, said Susan Ellenberg, a former F.D.A. official and a professor of biostatistics at the University of Pennsylvania. After a clinical trial was completed, she said, she could imagine that, absent any safety issues, agency officials “might issue an E.U.A. before they tied up everything for the formal approval.”
Still, Dr. Ellenberg noted, “We’ve seen an unprecedented involvement of the high-level administration in some of these issues.”
Because it is unclear how much political pressure is being put on the scientists at the F.D.A., she said, she would want to see the data from clinical trials before deciding whether to trust a vaccine authorized under an E.U.A.
“If it looked to me like it was very effective, and I didn’t see any safety problems, then definitely,” Dr. Ellenberg said. “I think I would recommend people getting it. I would get it myself.”
Her tube would be filled with harmless saline.
--more--"
Related:
"Protesters from Republican Texas Gov. Greg Abbott’s own party have gathered outside his home to criticize his coronavirus orders as overbearing and unlawful. State party chairman Allen West, Texas Agriculture Commissioner Sid Miller and some GOP lawmakers were among an estimated 200 people gathered outside the governor’s mansion to protest Abbott’s executive orders including a continued statewide mask mandate and lockdowns. Abbott was scheduled for a Saturday morning campaign event in Dallas and shortly after noon tweeted a photo of himself at the Texas-Oklahoma football game in Dallas. COVID-19 has killed more than 16,500 people in Texas, according to the state’s official count, and is closing in on 800,000 confirmed cases since the pandemic started....."
The Lone Star state is not alone:
"Rome was the site of two anti-mask protests on Saturday, even as Italy undergoes a resurgence of coronavirus infections. The Health Ministry reported another 5,724 cases in the last 24 hours and 29 deaths. Most cases were asymptomatic and determined through increased testing — more than 133,000 in the period. Protesters at one of the demonstrations complained about measures they call harsh, including a new order for all Italians to wear masks outdoors or face fines of up to 1,000 euros ($1,200). In front of the Duomo Cathedral In Milan, entertainment workers protested against the government’s economic policies to combat the spread of the coronavirus. Italy has reached totals of nearly 350,000 confirmed cases and 36,140 deaths."
Also see:
"India’s confirmed coronavirus cases are nearing 7 million with another 73,272 reported in the past 24 hours. The Health Ministry on Saturday also reported 926 additional deaths, taking total fatalities to 107,416. The deaths have remained below 1,000 for the seventh straight day. India is seeing a slower pace of coronavirus spread since mid-September when the daily infections touched a record of 97,894 cases. It’s averaging more than 70,000 cases daily so far this month, while the recovery rate has exceeded 85%, but health experts have warned that congregations during major festivals later this month and in November have the potential for the virus to spread. “We have to work aggressively to make sure that during winter months and during the festive season coronavirus cases don’t rise dramatically,” said Dr. Randeep Guleria, a government health expert. Experts say India’s fragile health system has been bolstered in recent months but could still be overwhelmed by an exponential rise in cases. Consumer activity is gradually rebounding and millions of factory workers who had fled cities when India imposed a 2-month-long rigorous lockdown on March 25 are returning."
I, for one, am sick of their never-ending spew.
"India’s confirmed coronavirus toll crossed 7 million on Sunday with a number of new cases dipping in recent weeks, even as health experts warn of mask and distancing fatigue setting in. The Health Ministry registered another 74,383 infections in the past 24 hours. India is expected to become the pandemic’s worst-hit country in coming weeks, surpassing the U.S., where more than 7.7 million infections have been reported. The number of people who have died of COVID-19 has remained relatively low in South and Southeast Asia — from India to Vietnam and Taiwan — compared to European countries and the United States, said Dr. Randeep Guleria, a government health expert. “We have been able to keep the curve rise slow, but I do agree that we have not been able to get it to move aggressively down. That’s related to our population density, diversity of our country and socioeconomic challenges in our country,” said Guleria, referring to India’s burgeoning population of nearly 1.4 billion. Some experts say though that India’s death toll may not be reliable because of poor reporting and health infrastructure and inadequate testing. India aims to provide vaccines to 250 million people by July 2021, Health Minister Harsh Vardhan said last week. He said that the government was planning to receive 450 million to 500 million vaccine doses and would ensure “equitable access”. India saw a steep rise in cases in July and added more than 2 million in August and another 3 million in September, but it is seeing a slower pace of coronavirus spread since mid-September, when the daily infections touched a record high of 97,894. It’s averaging more than 70,000 cases daily so far this month. India has a high recovery rate of 85% with active cases below 1 million, according to the Health Ministry. Health officials have warned about the potential for the virus to spread during the upcoming religious festival season, which is marked by huge gatherings in temples and shopping districts. A crucial factor will be people wearing masks and maintaining a safe distance. Dr. S.P. Kalantri, a hospital director in the village of Sevagram in India’s worst-hit western Maharashtra state, said that people in his village had stopped wearing masks, maintaining distance or washing their hands regularly. He added that the sick were still being brought in to his hospital. India’s meager health resources are poorly divided across the country. Nearly 600 million Indians live in rural areas, and with the virus hitting India’s vast hinterlands, experts worry that hospitals could be overwhelmed. “If we are able to have good behavior in terms of physical distancing and masks, maybe by early next year we should be able to come to a new normal. COVID-19 will not finish but it will be under reasonable control with travel and other things becoming much more easier and people relatively safer,” said Guleria.
It's sad to read this given India's previous experience with Gates.
Retired virologist Dr. T. Jacob John said there was increasing tendency among Indians not to wear masks or maintain distancing. Social media have compounded the problem by propagating misinformation and fake cures, “and the result of this is that people have gotten fed up and have started making their own conclusions,” John said. Nationwide, India is testing more than 1 million samples per day, exceeding the World Health Organization’s benchmark of 140 tests per 1 million people, but many of these are antigen tests, which look for virus proteins and are faster but less accurate than RT-PCR, which confirm the coronavirus by its genetic code. With the economy contracting by a record 23.9% in the April-June quarter, leaving millions jobless, the Indian government is continuing to relax lockdown restrictions that were imposed in late March. The government in May announced a $266 billion stimulus package, but consumer demand and manufacturing are yet to recover. A large number of offices, shops, businesses, liquor stores, bars and restaurants have reopened. Restricted domestic and international evacuation flights are being operated along with train services....."
The CDC admits they have never isolated the virus, and the majority of Covid misinformation is conveyed by the media without question or correction.
Someone permanently mask this guy:
"Dr. Anthony Fauci, the government’s top infectious-disease expert, is again cautioning against large-scale gatherings of people without masks. President Donald Trump is planning to convene another large crowd outside the White House on Saturday. Trump’s Rose Garden event announcing Judge Amy Coney Barrett as his Supreme Court nominee on Sept. 26 has been labeled a “super-spreader” for the coronavirus. Fauci said of the Rose Garden event in an interview with The Associated Press on Friday: “I was not surprised to see a super-spreader event given the circumstances. Crowded, congregate setting, not wearing masks. It is not surprising to see an outbreak.” Fauci says the CDC guideline for getting people back into society generally “is 10 days from the onset of your symptoms.”
{@@##$$%%^^&&}
Trump insists he’s ready for campaign trail
He declares he’s now “immune” from the virus, amid series of outstanding questions about his health.
Related: Trump Back on the Campaign Trail
So is Biden:
"In the homestretch of the 2020 campaign, there has been little good news for the incumbent, and that is showing up as an ominous turn for him in the polls as Joe Biden consolidates support. What had been a steady national lead for Biden in the high single digits during the late summer has expanded to 12 points in early October, according to a Washington Post polling average. A Washington Post-ABC News poll released Sunday fits with the trend, putting Biden at 54 percent nationally and President Trump at 42 percent, a 12-point lead that is similar to the 10-point advantage Biden held in a September survey. While key battleground-state polls have shown a somewhat closer contest, the trajectory has been clear....."
Trump is going to get fried and you can postpone the war on Iran.
If Trump somehow miraculously prevails and is not some sort of deepfake with the capacity to fool the eyes with a dangerous form of unanswerable speech:
"Police used tear gas on demonstrators and arrested 28 people during a third straight night of protests over the lack of charges against a suburban Milwaukee police officer who fatally shot a Black teen, authorities said, as they took to Twitter on Saturday to outline what they called an “escalation in force by the protesters.” About 100 people gathered outside City Hall on Friday past Wauwatosa’s 7 p.m. curfew and refused multiple orders to disperse, according to police. Police said they used tear gas on the crowd, after bottles were thrown at officers. On Saturday, the Wauwatosa Police Department posted on Twitter that people have been asking valid questions about the police response over three nights of protests. Police posted a picture of bottles they said were found in a backpack, including a bottle of lighter fluid, noting that the materials can be used to start fires. “Over the past three nights, we have seen an escalation in force by the protesters. Our law enforcement response is in reaction to this escalation,” police tweeted. They said that on Friday night, protestors had Molotov cocktails and other fire starting supplies and guns were spotted in the crowd. Protesters have gathered every day since prosecutors announced Wednesday that they would not charge Officer Joseph Mensah in 17-year-old Alvin Cole’s death. Mensah, who is Black, shot Cole after a foot chase outside a Wauwatosa mall in February."
Finally, BLM upset about Blacks killing Blacks.
"The police department’s tweets come as some have chastised authorities for the way they have handled the protests. During Thursday night’s demonstration, police arrested Alvin Cole’s mother, Tracy Cole, and his sisters. Family attorney Kimberly Motley criticized the way police treated the family, noting Tracy Cole had to be treated for injuries. In a tweet addressing the police chief and mayor on Friday, Motley said “due to your failed leadership you have turned Wauwatosa into a war zone!′ About an hour after Friday’s curfew went into effect, law enforcement began advancing toward the crowd. Police said they used chemical irritants, which they described as tear gas, as well as pepper balls and paint balls after bottles and rocks were thrown at them. Video posted to Twitter by local reporters showed heavy smoke in the air as police advanced, and multiple people taken into custody. Windows were broken at a Snap Fitness center, police said. Police said two of Friday’s 28 arrests were for felonies, one was for a misdemeanor and 25 were for municipal citations. Police noted that some of the people arrested were blocking traffic, others had tried to start fires, and one person had materials to start a fire. Another person in the group posted a picture of himself with a handgun, authorities added, though it was not clear if he was among those arrested. Two people arrested were evaluated for minor injuries, police said. One of the arrestees was driving in one of three vehicles that had come to the Wauwatosa Police Department early Saturday. The vehicle almost hit an officer, according to police. The driver got into a second vehicle, and police arrested the person after a short chase, authorities said. “We can appreciate the anger and frustration that exists among those closely affected by recent events,” police said in a statement Saturday. They asked people to continue to comply with the 7 p.m. curfew, which was to be in effect again on Saturday and Sunday nights. The National Guard is assisting local police. The protests in Wauwatosa are just the latest in a series of demonstrations against police racism and brutality that have erupted across the country since George Floyd’s death. Floyd, who was Black, died in May after a white police officer in Minneapolis pressed his knee into his neck as Floyd gasped that he couldn’t breathe. The co-founder and publisher of The Daily Caller said two of his reporters were beaten and detained by police in Wauwatosa on Thursday as they were videotaping Tracy Cole’s arrest. Numerous journalists have been injured or arrested while covering protests nationwide in recent months. Neil Patel, who founded the conservative news outlet with Tucker Carlson, said in a statement that reporters Shelby Talcott and Richie McGinniss “were brutally beaten with clubs for no reason,” the Milwaukee Journal Sentinel reported. A message seeking comment from the Wauwatosa Police Department was not immediately returned to The Associated Press."
Wisconsin will soon look like France:
"Dozens of people attacked a police station outside Paris early Sunday with blasts of fireworks and metal bars, damaging several police cars, officials said. No one was injured. It was the latest action among numerous attacks against police officers, and sometimes firefighters, that Interior Minister Gerald Darmanin says are a sign that France is growing “savage.” Last week, two police officers in civilian clothes were pulled from their vehicle in a Paris suburb and shot multiple times with their own guns....."
Related:
"A significant number of [French nurses responding to a poll say they are] tired and fed up, with 37% saying the coronavirus pandemic is making them want to change jobs, a consultation by the National Order of Nurses published Sunday suggested, as national health authorities reported on Saturday nearly 26,900 new daily infections in 24 hours and soaring infections and increased hospitalizations put four other cities on the maximum alert list on Saturday. Two more French cities on Sunday joined Paris and Marseille and four others in maximum alert status to fight back the coronavirus, surgical strikes with strict new measures to stop the spread of infections. As of Sunday, there were 32,730 COVID-19 deaths, but the actual number is likely higher due to deaths at home and incomplete reporting from hospitals or rest homes. Nearly 59,400 nurses responded to the Oct. 2-7 internal survey on the impact of the health crisis on their working conditions, out of 350,000 in the Order of Nurses. The numbers suggested that French medical facilities may not be keeping pace with the growing need, despite lessons from the height of the virus crisis last spring....."
The solution is to bring in the military to detain the protesters despite the cease-fire, and it didn't stop them from demonstrating even as they were forcibly evicted from their homes.
Nothing to see there after the hurricane came and went, and maybe the criminal mayor of Bo$ton should be evicted for what he has done.
Also see:
"The Israeli military on Sunday opened a new coronavirus unit in a converted parking garage at a hospital in northern Israel, in a first-of-its-kind effort by the army to assist the country’s overloaded health care system. The unit, set up at Haifa’s Rambam Health Care Campus, will utilize some 100 military doctors, nurses and other medical personnel working alongside hospital staff. It is the first time the army has deployed its medical personnel to treat Israeli civilians in the country’s history. Dr. Noam Fink, the deputy chief medical officer of the military, said the army would operate two wards capable of supporting several dozen “intermediate to severe” cases. It accepted its first two patients on Sunday.
As Israel goes, so goes the West!
The COVID CAMPS are REAL, folks!
“The purpose of the operation is to support the hospitals in the north and efforts to treat COVID-19 patients,” said Fink, who holds the rank of colonel. Rambam set up the underground hospital unit in the wake of Israel’s 2006 war against the Lebanese militant group Hezbollah. Operating primarily as a parking garage, the facility can quickly be converted into an emergency hospital insulated from rocket fire. Dr. Avi Weissman, Rambam’s deputy director, said bringing on the military personnel would ease the work load on staff and also allow the hospital to resume elective surgeries that have been delayed because of the overload. After appearing to contain its coronavirus outbreak early this year, Israel reopened its economy too fast and the virus quickly returned. Israel, a country of 9 million people, is now grappling with one of the world’s highest infection rates with over 290,000 cases reported so far. It currently has over 850 serious cases, straining the nation’s health care system, and nearly 2,000 deaths. The new coronavirus unit marks a new partnership between the hospital, the military and the national Health Ministry. In recent months, the army has taken on an increasingly prominent role in managing the crisis and is now in charge of the country’s contract-tracing efforts. Defense Minister Benny Gantz, a former military chief of staff, visited the hospital Sunday to see the new coronavirus unit. “I am proud of the IDF, which is working within the Health Ministry for the first time,” he said. “We are working on closing the gaps that have formed within a good public health-care system that has been neglected for a decade.”
I dare you to do the math and see if the lockdowns are justified.
Say Thank You before it is too late:
"Canadian Thanksgiving comes earlier than the American version — families will gather to eat turkey and avoid discussing politics on Monday, but in this pandemic year, the timing is unfortunate. As a second wave of the coronavirus prompts new restrictions in several provinces, authorities across the country are urging Canadians to curtail their holiday plans. Some suggest celebrating only with others who are already living under the same roof. Others advise moving the party outdoors or online. In a rare nationally televised address last month, Prime Minister Justin Trudeau said it might be necessary to cancel Thanksgiving to “have a shot at Christmas.” Whether Canadians obey those pleas remains to be seen. Forty percent of Canadians surveyed by the Montreal polling firm Leger this month said they haven’t or won’t change their Thanksgiving plans because of the pandemic. Canada’s experience Monday might offer a preview of what Americans can expect next month — and a warning about what to avoid. The United States has recorded nearly five times as many cases of coronavirus per capita than Canada and more than twice as many deaths, but Canada’s numbers are moving in the wrong direction, reversing gains made in the late spring and early summer. Officials worry the worst is yet to come as winter approaches, bringing with it flu season and temperatures that force more people indoors. The country reported an average of 2,052 new daily cases over the previous seven days on Thursday, up 30 percent from the week before, according to Theresa Tam, Canada’s chief public health officer. Daily case counts in some provinces have eclipsed the records set in the spring, when tougher restrictions were in place. Hospitalizations are up."
I'm so sick of the lies and the evil promoting them to kill joy and love, and if you want to know what is going on in Canada go here and here and here and here.
Thank you.
"Canada’s coronavirus performance hasn’t been perfect, but it’s done far better than the U.S. Infectious-diseases specialists see several reasons for the surge: Large social gatherings; the reopening of bars and restaurants; the failure of officials to take advantage of a summer of comparatively few cases to prepare for a fall wave; and pandemic fatigue. “My fear here is that we’re going to have a really dark fall and winter if we don’t act,” said University of Toronto professor Andrew Morris, an infectious-diseases specialist at the Mount Sinai Hospital and University Health Network. In Ontario, testing centers are so overwhelmed that officials have tightened the criteria for who can get a test. A backlog of tens of thousands of samples has left officials flying blind on the source of infections and the scope of the problem.
PFFFFFT!
Toronto, Canada’s largest city, has scaled back contact tracing. Ontario Premier Doug Ford, of the Progressive Conservative party, has responded with harsh words for rule breakers. The organizers of large social gatherings, he said, are “a few fries short of a Happy Meal.” The hundreds who attended a car rally in a parking lot in Hamilton last month should get their brains scanned, he said. He had for several weeks resisted calls, including from Toronto’s top doctor, to do more. He said early last week that he needed to see more evidence before taking “someone’s livelihood away” and that the province was “flattening the curve,” but on Friday, Ford’s tone changed, and he warned that Ontario was at risk of the “worst-case scenarios” seen in northern Italy. He announced restrictions in hard-hit areas, including a ban on indoor dining at bars and restaurants, and the closing of indoor gyms, theaters and casinos for at least 28 days. Infectious-diseases specialists say the response has been hampered by muddled messaging. Ford described his own holiday plans, then appeared to change them after it was pointed out that they contradicted his own government’s advice to celebrate only with those in one’s immediate household.
If you look in the dictionary, there is a picture of Ford's face next to the definition of asshole!
Morris, the University of Toronto professor, said the messaging mishaps risk damaging public trust in officials when it’s most needed. “There’s been a failure to recognize the inconsistent messaging . . . and an almost delusion that if you implore people to behave differently, then they will behave differently,” he said. Canadians observe Thanksgiving each year on the second Monday of October. As in the United States, many celebrate with turkey, stuffing and pumpkin pie. College students return home. The Canadian Football League typically plays a game or two — the Thanksgiving Day Classic — but the league canceled the season this year after failing to secure financial aid from the federal government....."
I wouldn't keep your fingers crossed for a more normal Christmas.
Now put on the game:
"Postponing the Patriots-Broncos game that was supposed to take place Monday evening was not ideal for the NFL. It takes a wrecking ball to the league’s schedule. The domino effect of having to move just one game is maddening — a total of eight games had to be moved around, affecting six other teams, yet postponing Patriots-Broncos to next Sunday was the only decision for the NFL to make if it wanted to avoid a player revolt. A noticeable whiff of rebellion has been in the air this past week, and it’s not just the NFL league office drawing raised eyebrows. The NFL Players Association, which has had equal say in developing the league’s protocols, isn’t inspiring confidence from the players, either....."
Who cares about basketball (I watched absolutely none of it) and the Globe doesn't know how the the NFL continues its season as postponements and positive COVID-19 cases pile up and that they have only themselves to blame because the “the next six months could be excruciatingly challenging, with the winter definitely being a belt-tightening time” and gut check because the cases are out of control.
Better get in your bets before it is too late!
