We need to begin to reclaim control over the institutions which have such oversized roles in our lives. As you read this people work tirelessly to see to it that you are dumb and docile. Let's stop them.
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"According to the plan, per the Epoch Times, the organization will implement several strategies, including “racial and social justice” throughout the culture, systems, policies and practices; expanding medical education to include critical race theory; and pushing toward “racial healing, reconciliation, and transformation.”
The AMA also indicated that it now rejects the concepts of “equality” and “meritocracy,” which have long been goals in the field of medical science and care.
“Equality as a process means providing the same amounts and types of resources across populations,” the association said. “Seeking to treat everyone the ‘same’ ignores the historical legacy of disinvestment and deprivation through historical policy and practice of marginalizing and minoritizing communities.”
“The commonly held narrative of meritocracy is the idea that people are successful purely because of their individual effort,” it said. “Medical education has largely been based on such flawed meritocratic ideals, and it will take intentional focus and effort to recognize, review and revise this deeply flawed interpretation.”"
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"A student at a public high school in Connecticut was arrested following a racist social media post targeting an African-American classmate. The arrest has sparked free speech debates because, under the protection of the First Amendment, it’s odd for a person to be arrested for speech in the US, even though it’s common in regions such as Europe where protection of speech is sparse.
A 16-year-old student at Fairfield Warde High School posted a photo of an African-American classmate, Jamar Medor, and posted it on Snapchat, alongside a caption containing a racial slur. According to the black student’s mother, the student who made the Snapchat post is white.
The student was later arrested and charged with a hate crime of ridicule on account of religion, color, denomination, creed, nationality, or race. The misdemeanor has existed in Connecticut’s state laws since 1917.
According to free speech group American Civil Liberties Union (ACLU) and some law experts, the law is not only an infringement of the First Amendment free speech rights but also unconstitutional. The student, who cannot be identified due to juvenile offender laws, is also facing a breach of peace charge.
But the National Alliance for the Advancement of Colored People (NAACP) had called on authorities to criminally charge the student behind the Snapchat post. The NAACP Greater Bridgeport chapter is also demanding the arrest of a student involved in another incident where Jamar’s brother was on the receiving end of racial slurs during a phone call.
“It was shocking,” president of the NAACP chapter Rev. D. Stanley Lord said of the posting. “We have to send a strong message that behavior like this won’t be tolerated in any school system.”
...
“Having racist ideas or sharing racist ideas is something that we actually protect,” said Emerson Sykes, a senior staff attorney with the ACLU’s national chapter. “Even if that viewpoint is offensive, even if it’s deplorable, we don’t want the government making the call about what’s OK to say and think and what is not. But we have limitations on that right.”
According to Sykes, the school has every right to discipline the student, especially because his post caused disruption. The school’s administrators refused to say whether or not the student was punished, citing student privacy rights. However, Judith Medor, Jamar’s mother, said that the school told her that the student was expelled."
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"While imagining breakneck progress, we’ve been backing off a cliff. This is no surprise to those whose historic knowledge is not limited to the stifling propaganda dispensaries called American History class, mainstream news and Hollywood blockbusters that animate the anodyne story lines of comic books. The loudly heralded “Great Reset” to a “New Normal” and “Fourth Industrial Revolution” embracing artificial intelligence is not new at all, just a reification of every tyrant’s dream. It’s a vision of global technocratic feudalism.
About a century ago as John D. Rockefeller envisioned agriculture and medicine wrenched away from nature and replaced with oil derivatives, artists and writers saw the prospective horror ahead.
...
One such film was Fritz Lang’s 1927 silent expressionist classic, Metropolis, which leaves indelible visual memory imprints. Lang’s images ominously anticipated the vast economic stratification and dehumanizing technocracy we see taking shape rapidly nearly a century later. Lang showed us the cartoon society we have become – the rulers living far above in towering penthouses with private “pleasure gardens” (think Jeffrey Epstein) while workers labor underground in coordinated robotic motion obliterating individuality. The film can be seen online with meticulously restored footage completed in 2010.
The written word has been similarly prescient. George Orwell’s 1949 novel, 1984, describing a totalitarian society of inescapable mass surveillance and suffocating repression, echoes clearly today. And even earlier, Aldous Huxley’s 1932 novel, Brave New World, envisioned a dehumanized technocratic society where government and citizen political participation had become superfluous and natural interpersonal sources of pleasure and comfort had been replaced by an ever-available drug, soma. And even earlier yet, Franz Kafka’s unfinished 1926 novel, The Castle, provides a deeply disturbing metaphoric vision of society operating under arbitrary rules administered by impersonal bureaucrats on behalf of unknown and unseen rulers above. In a striking parallel with covid-19 today, oppressed and ignored villagers invent endless justifications for their own oppression.
...
Now, a century later, the Castle is called the Deep State. With a massive society to control, an illusion of democracy maintained by smothering, multi-level propaganda is necessary. One vilified figure after another is accused of “threatening our democracy” but in fact the US has no democracy. Late Princeton political theorist Sheldon Wolin identified our system as not a democracy but a system of “inverted totalitarianism” wherein finance and industry control government in upside-down comparison with 1930s Nazi and fascist regimes wherein government dictated the conduct of finance and agendas of industry.
...
...We must examine, deconstruct and dismember the “Great Reset,” “Fourth Industrial Revolution” and “New Normal” toward which this is leading, ominously preached and pronounced inevitable by Bill Gates, Klaus Schwab of the World Economic Forum, Joe Biden, and their automaton acolytes.
They follow a long line of ideological predecessors from John D. Rockefeller through Zbigniew Brzezinski’s Trilateral Commission and the Council on Foreign Relations before which, confident of his patrician impunity, Biden proudly described his shakedown of Ukrainian President Poroshenko to fire the prosecutor investigating an energy company where his son enjoyed an obscenely generous sinecure. Such is their unbridled arrogance and contempt for laws and rules of conduct that govern commoners.
We commoners increasingly face suffocating surveillance, censorship and police state control – key characteristics of fascism – including informal deputizing of citizens to police each other to enforce senseless, degrading, identity-obliterating rules of mask wearing, touch avoidance and “social distancing” within an arbitrary 6-foot spacing – for none of which is there remotely persuasive scientific evidence for pathogen protection even were covid-19 the dreaded plague it has been cast to occupy in the public imagination.
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Dogs, cats, monkeys and humans, inter alia, all seek and need comforting touch for ongoing autonomic regulation and normal socialization. Psychologist Harry Harlow demonstrated how young monkeys are able to progressively reduce anxiety in response to unfamiliar and unsettling stimuli by retreating to an ever-available mother figure providing tactile comfort. Food provision alone was not enough. With unavailability of anxiety modulation, monkeys raised without comforting touch fail to mature socially and sexually.
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Humans begin life snuggled with their mothers and gazing into her smiling face. No mother should be masked at this moment, or later for many years as young children take cues from their parents in public and other uncertain situations. Children are closely attentive to both the facial expressions and voice intonations of their caretakers and surrounding adults. Deprivation or attenuation of these psychologically essential cues constitutes child neglect, which can affect brain development and be more psychologically damaging than overt abuse. Every new developmental challenge from our first step to our first date to our first job application involves some degree of apprehension that must be soothed first by a parents hands, later a parent’s words and voice, and eventually the internalized experience of that support buried in our psyche. Without that, human psychological growth is truncated, often irreversibly.
Psychologist James Prescott examined 49 of 400 pre-industrial societies comparing violence among cultures at the high and low end of a scale measuring physical affection to infants. He found that this and another developmental variable – permissiveness around adolescent sexuality – differentiated more from less violent societies. Both involve generosity of touch during developmentally crucial periods and were the only cultural variables associated with prediction of societal violence. His paper, published in the Bulletin of Atomic Scientists – a profession deeply concerned with human aggression following our bombings of Hiroshima and Nagasaki – was titled “Body Pleasure and the Origin of Violence.”
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“Social distancing” and promotion of touch phobia is beyond absurd. This is a targeted attack on our innate human sensibilities. Our psychological warfare developers cannot be unaware of this and have been free to secretly cultivate methods prohibited to ethical behavioral scientists due to our careful protection of human subjects in recent decades following the Milgram and Zimbardo research that exposed participants to unsettling truths about their predispositions to abuse authority or passively comply with abuse by others.
Application of other familiar psychological control mechanisms from behaviorism are obvious, however insidiously disguised, in this manufactured program of fear induction joined with fear relief prohibition including self-isolation. Virus-terrorized citizens have been manipulated into administering punishment-by-shaming to other citizens who resist or refuse compliance with their own dehumanization.
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To maintain cohesion, stable groups become self-reinforcing echo chambers, exchanging transactional “strokes” (units of social recognition) in mutually familiar formats with predictable payoffs. Two fundamental environments with differing stroke contingencies are work and family. Both involve structured interactive agendas with self-imposed limitations to protect valued relationships.
A third environment is the informal, less structured and less stratified public space – cafes, taverns, and recreational settings – called “The Great Good Place” by sociologist Ray Oldenburg. These provide a safety valve for the other two, both of which include duties, performance expectations, and responsibilities that must be met for positive recognition. Oldenburg writes, “daily life, in order to be relaxed and fulfilling, must find its balance in (those) three realms of experience.” Already weaker in the US than elsewhere, this third, freer, less conditional area of life with less influence of institutional hierarchy has been deeply attacked and damaged by the covid-19 psyops agenda. Restoring and expanding that vital sector of our society is essential to recover from fraud-induced psychological conditions of fear and passive intimidation. We must unmask, undistance, and uncensor ourselves. We must dethrone the high priests of Science-by-Fiat who have lied and manipulated us out of our humanity.
Most importantly, the phobias induced within children must be undone. It is appalling how our young citizens are being trained to fear rather than understand our microbial environment, to fear infecting their families and teachers and peers, and to fear normal play with each other. This is an unspeakable crime for which the perpetrators should be stripped of rank and riches and quarantined from human company until they make full confession and apology to the children of the world.
The remedy will require, at the very least, a thorough and carefully designed curriculum. The Year of Covid-19 provides a focused educational opportunity, first realistically addressing the ubiquity and functional importance of microbes. We must give due credit to our resident microbes evolved over countless millenia to protect us, their host organisms. Children must learn that our 30 trillion cells are outnumbered and protected by some 39 trillion microbes located throughout each human body, highly concentrated at the entry points of skin, mouth and gut. Vaccines injected directly into the bloodstream recklessly bypass these natural defenses that are vastly more competent than our Frankenstein bioscientists. Almost all ambient microbes are benign protectors or simply bystanders minding their own business.
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Our fellow citizens who self-righteously clamor for dehumanization to save humanity claim the sacred ground of “Science.” To correct this, our children must learn that “science” is functionally not a noun but a verb – empirically based methods of thinking, investigation and evidence evaluation. The entire lockdown/masking/touch-me-not/self-isolation ritual has no basis in scientific findings, as I and many others have widely documented elsewhere. The word “science” has been hijacked into the realm of metaphysics, no longer a widely applicable method of rigorous inquiry and hypothesis-testing, but a word deformed and sanctified into a secular religion.
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This plays – not accidentally I suspect – into a deep, irrational force in the collective human psyche that anthropologist Mary Douglas explored in her book, Purity and Danger. Impurity or pollution represents dangerous power outside our control, existentially threatening both society and its individual members, who must conform in purification rituals (e.g., masking, 6-foot distancing and obsessive-compulsive disinfectant wiping) for group survival. Those of us outside the faith are shunned and shamed as heretics, apostates, archetypical infectious lepers. Thus, a “pandemic virus” is not unlike “communism” or “Islamic terrorism” to be identified and rooted out for individual and group survival. PCR testing – however meaningless and unreliable – becomes a magical unmasking instrument, and vaccines – however experimental, woefully untested, unapproved, unnecessary, and already producing alarming harms while immunized from ordinary legal liability – become an exorcism ritual and its growing list of victims ritual sacrifices to the new 3-letter gods CDC, WHO and NIH.
We are a primitive society that needs to grow up, and quickly before the power-insulated priesthood including Klaus Schwab, Bill Gates and the technocratic clergy takes over everything. Once better choices are recognized, opportunities emerge for revolution of political consciousness and systemic transformation. But we have no time to waste.
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Democracy is for psychologically mature adults. Citizen responsibility for self-governance must involve knowledge acquisition, sober reflection, evidence examination and reasoned discussion built into everyday public life. It must require sound collective judgment and moral responsibility for all local, regional and national decisions. To create a grown-up nation retrieved from the grip of ruling-class psychopaths who have long disempowered, neglected, exploited and abused us along with much of the world, we must mature into political grown-ups."
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"On May 12, 2021, the United States Advisory Committee on Immunization Practices (ACIP) voted to recommend the investigational Emergency Use Authorization (EUA) Pfizer shot to children ages 12 to 15.
The ACIP also voted to end restrictions around co-administration with other vaccines even though there has not been a single clinical trial administering any of the shots with any other vaccine....
...
For this most recent EUA, Pfizer’s claim, repeated by the CDC, that the shot is “100%” effective in 12-15 year olds might accurate for the study outcome (although the term “efficacy” is more appropriate), but it’s also very deceptive. 100% is the RRR — the Relative Risk Reduction. That’s how many kids showed “evidence of infection” in the Pfizer shot group verses the saline placebo group, from 7 days post the second shot until the cutoff date (length of time varied per participant, depending on when they got the shot).
But the risk of getting COVID-19 at all was already very small. How much did the shot reduce the risk of getting sick? That’s the ARR–the Absolute Risk Reduction. While the FDA advises ARR to always be reported with RRR so that individual and public policy decisions can be soundly made, ARR is rarely every mentioned.
In this case, between 7 days post the second dose and the cutoff date, the control group had 16 cases out of 978 kids, which is 0.016 of the kids. The shot group had no cases, so 0.00 of the kids. To get ARR you subtract the shot number from the control number and you get 0.016. Expressed as a percent that’s 1.6%.
So the shot–in this short, limited study–reduced the risk of getting COVID by 1.6%.
If we can trust the data. The general public has no idea that all of the studies are conducted by the manufacturers who stand to profit, and they turn in their data to the FDA. It is an honor-system among entities that have a history of criminal fraud.
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As unethical as it is to expose children who are not at high risk of severe outcomes to infection to investigational liability-free products that have seen unprecedented level of adverse reactions and deaths reported, when the ACIP opened up the shots to be co-administered with other vaccines, including those with adjuvants, they stepped fully into crimes against humanity.
Not a single clinical trial has been done administering the COVID-19 shots with any other vaccine. There is zero safety data....
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After the 14-0 vote with one abstention to recommend the Pfizer EUA shot to 12-15 year olds, with no restriction on co-administration with other shots, some ACIP members gave their reason.
They only had one.
They don’t want to miss an opportunity to vaccinate.
That’s it. Science be hanged, safety unknown, by gosh, they didn’t want doctors to miss an opportunity to give other vaccines."
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"The 11-year-old was playing alone at a bus stop in West Pensacola, Florida, when the terrifying attempted abduction occurred. Surveillance footage released by law enforcement shows a car circling the area before abruptly stopping on the side of the road. A man, reportedly armed with a knife, then exits the vehicle and runs towards the girl, lunging at her. Seeing him approaching, the child gets up from the ground and attempts to run away, before being grabbed. The suspect then tries to carry her to his car, but falls to the ground. After a brief struggle, the girl is able to free herself. She then picks up her bag that she dropped on the ground and runs away, as the kidnapper hurries back to his car and flees the scene.
The local sheriff’s department mobilized its entire force of 50 deputies in an effort to catch the perpetrator. Using surveillance footage, officers were able to track him down in less than eight hours. He was found at his home and reportedly surrendered to authorities without incident. In an attempt to evade authorities, the man had repainted his car."
Two important things to keep in mind here.
1. Most instances of abduction aren't like this.
2. Incidents like these are used to normalize & provide support for more pervasive surveillance. Without all these cameras he may have gone uncaught and gone on to do this to others. We have to find a way to be OK with that.
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"For much of the past month national media has been replete with headlines decrying “vaccine hesitancy” as coronavirus infection rates continue on the decline. Amid dire “warnings” this may “hinder” herd immunity goals, local and federal health agencies are busy pouring vast resources into vaccine-promoting ad campaigns. “The United States has a surplus of coronavirus vaccine doses on its hands, and long gone are the days when people waited hours to get jabbed. Dwindling demand has forced governors and mayors to get creative,” The Washington Post observed this week.
But one initiative in Dallas County in Texas is going far beyond anything we’ve seen thus far, and as many on social media have observed, it is downright creepy and bizarre in its brazenly coercive optics. Texas has long been fully opened and bars and restaurants are now packed, but vaccine sites are not, apparently. So naturally Dallas County Health and Human Services (DCHHS) thought it would be a good idea to go to the bars with the vaccines… along with uniformed US Army National Guard soldiers.
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“So right now we are going to give a COVID vaccine to someone inside a 7-Eleven – this is what community service looks like and getting the community vaccinated,” a video narrator states.
The Dallas County HHS featured its efforts in a short social media clip showing a couple of US Army solders in full camouflage fatigues flanking a top Dallas health official.
“We’re going out tonight too administering the COVID-19 to bar goers in Deep Ellum,” the Twitter post said.
“By getting vaccinated you’ll be able to enjoy going out again knowing that you’re safe & protected” – except of course the people in the popular nightlife area this past weekend were already clearly quite comfortable “going out again” to have a good time. A local CBS-DFW news clip said of the new Dallas HHS-National Guard campaign that Dallas County is hoping to attract the “younger crowd”.
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One 7-11 clerk who agreed to receive the shot was asked by the troops: “How do you feel that you got the vaccine right here, at work, by US soldiers?”
The man then extolls the benefits of being a US citizen – which given the weird optics of the whole encounter between the jab-proffering Army personnel and an apparently somewhat recent immigrant to the US, brings up some serious questions…
For starters, when a “vaccine crew” of literal uniformed soldiers randomly walks up to citizens saying they “need to get vaxxed”… do the individuals understand it’s entirely an option and not an authoritative mandate? And would (in the example of the video) a recent immigrant to the country or even new American citizen understand the nature of the encounter?
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With vaccine hesitancy on the rise, and with President Biden’s new bizarre announcement that “Those who are not vaccinated will end up paying the price” – is the new “creative” strategy all about putting “muscle” in terms of serious federal authority in the room (or on busy nightlife venue streets) for added pressure?"
Well I must admit I never considered they'd start attempting to get possibly drunk people to "consent" to their experimental gene therapies.
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"US coronavirus czar Anthony Fauci appeared to shift his response as to why he was masking up while vaccinated. Suggesting earlier that it was due to many variants of the coronavirus, he now says it was to avoid public confusion.
“I am now much more comfortable [with] people seeing me indoors without a mask. Before the CDC made the recommendation change, I didn’t want to look like I was giving mixed signals,” Fauci told the hosts of Good Morning America on Tuesday, referring to CDC guidance issued last week which states that the fully vaccinated no longer need to wear face coverings or socially distance.
The health official’s explanation appears to be at odds with previous comments Fauci made during a contentious exchange with Senator Rand Paul (R-Kentucky) in March. At the time, Paul argued that those who had been vaccinated did not need to wear masks, suggesting that anyone doing otherwise was engaged in “theater.”
Fauci shot back that even those who have been immunized would be wise to mask up – and even to wear two masks – given that the coronavirus had mutated into several dangerous variants.
“When you talk about reinfection and you don’t keep in mind the concept of variants, that’s an entirely different ball game. That’s a good reason for a mask,” Fauci said. He cited a South African study, claiming it showed that the people who had been infected with the wild-type strain and then were exposed to a mutant variant lacked any immune protection."
We've all been guilty of this at one point or another: providing contradictory rationalizations for our behavior. It's certainly human. The problem is when we allow certain humans' opinions to have too much weight.
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"Google announced on Tuesday, during its I/O developer conference, that editing capabilities of Google Docs have been expanded to police text and monitor a writer’s level of inclusivity.
Thus an update to the app means that Google Docs will start suggesting changing words like “mailman” to “mail carrier” and “chairman” to “chairperson,” it has been revealed.
Users will also be prompted to avoid using passive voice or what Google determines to be offensive language. It’s unclear from reports if the new feature will be opt-in or out, or hard-coded in the app, that is, impossible to avoid using.
This user-facing change comes after Google’s style guide for developers already seeking to “tidy up” language according to the sensitivities the giant is pandering to. For example, developers are instructed to replace “crazy” with “baffling,” “dummy variable” with “placeholder variable,” and “final sanity-check” with “final check for completeness and clarity.”"
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"Israel could not commit its crimes without the overwhelming support of the U.S. government. U.S. officials are aiding and abetting Israel’s crimes with massive military aid and scotching any criticism of Israel in the UN Security Council.
President Joe Biden said he didn’t think Israel’s attack on Gaza has been a “significant overreaction.” He expressed his “unwavering support” for Israel’s“right to defend itself” from rocket attacks from Gaza, but he did not condemn Israel’s airstrikes that are killing Palestinian civilians and destroying residential buildings, or the Israeli attacks on worshippers at the Al Aqsa Mosque.
...
Secretary of State Antony Blinken declared that there is a “fundamental difference between a terrorist organization in Hamas that is indiscriminately targeting civilians and Israel, which is defending itself.” But as Raji Sourani, director of the Palestinian Centre for Human Rights, wrote in an email to this writer, claims like Blinken’s obscure the fact that nearly all of Israel’s targets have been civilians. And the vast majority of those killed have been Palestinians. Moreover, as an occupying power, Israel cannot use military force against the occupied Palestinian people because under international law, the occupier has a duty to protect the territory it occupies.
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Hamas has fired rockets into Israel in response to the Israeli attack on worshipers at the holy Al Aqsa Mosque in occupied East Jerusalem. Seven Israelis have been killed. But 120 Palestinians have been killed and 900 people wounded, according to Palestinian health officials.
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On March 3, 2021, Fatou Bensouda, chief prosecutor of the International Criminal Court (ICC), announced that her office was launching a formal investigation into war crimes committed in the West Bank, including East Jerusalem and the Gaza Strip since Israel’s 2014 “Operation Protective Edge,” in which Israeli forces killed 2,251 Palestinians.
Bensouda found a reasonable basis to believe that Israeli forces committed the war crimes of willful killing, willfully causing serious injury, disproportionate use of force, and the transfer of Israelis into Palestinian territory. She also found a reasonable basis to investigate possible war crimes by Palestinians, including intentional attacks against civilians, using civilians as human shields, and torture and willful killing.
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Under international law, the Palestinians have a lawful right to resist Israel’s occupation of their lands, including through armed struggle. In 1982, the UN General Assembly “reaffirmed the legitimacy of the struggle of peoples for independence, territorial integrity, national unity and liberation from colonial and foreign domination and foreign occupation by all available means, including armed struggle.”
The Biden administration is claiming that Israel is acting in self-defense against the Hamas rockets, but under international law, Israel, as an occupying force, does not have the right to use military force in self-defense against its occupied territory.
Noura Erakat, a human rights attorney and associate professor at Rutgers University, wrote in Jadaliyya, “A state cannot simultaneously exercise control over territory it occupies and militarily attack that territory on the claim that it is ‘foreign’ and poses an exogenous national security threat. In doing precisely that, Israel is asserting rights that may be consistent with colonial domination but simply do not exist under international law.”
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The U.S. government gives Israel $3.8 billion in military aid annually. Israel could not maintain its occupation of Palestinian lands and persecution of the Palestinian people without U.S. assistance.
Moreover, the United States regularly prevents the UN Security Council from issuing resolutions or statements that criticize Israel. The U.S. was the only country on the Security Council to oppose a statement urging Israel to prevent the evictions of Palestinian families from the Sheikh Jarrah neighborhood in East Jerusalem. The proposed statement, endorsed by 14 of the 15 Council members, called on Israel “to cease settlement activities, demolitions and evictions, including in east Jerusalem in line with its obligations under international humanitarian law” and refrain from taking unilateral actions “that exacerbate tensions and undermine the viability of the two-state solution.”
Between 1967 and 2017, the United States used its veto in the Security Council 43 times to protect Israel from international accountability.
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The National Lawyers Guild issued a statement in solidarity with the Palestinian people. It notes that May 15 is the 73–year anniversary of the Nakba, the Arabic word for catastrophe.“In 1948, the Zionist settler colonial movement with the support of imperialist powers established the state of Israel through the expulsion of hundreds of thousands of Palestinians, waged through massacres and the destruction of over 500 Palestinian villages,” the statement reads. “This colonial project continues today as we are witnessing the forced expulsion of Palestinians in the Sheikh Jarrah neighborhood of Jerusalem by armed settlers, indiscriminate violence against Palestinian protestors, attacks on Palestinian holy sites, and the ongoing devastating closure and indiscriminate bombing of Gaza.”
As Israel continues its assault on Gaza, congressional disapproval and international opposition will increase. Those who oppose Israeli war crimes should pressure their congressmembers and the White House to halt U.S. military assistance to Israel and stop blocking UN Security Council action to end Israel’s human rights violations."
As the author highlights, actors on both sides are likely guilty of war crimes. But when considering this seemingly never-ending conflict I always try to remember that countless Americans would behave similarly if placed in a comparable situation. And that applies whether that means they're the Palestinians or the Israelis. It's also good to remember only one side is inflicting violence with an assortment of high-tech weaponry and backed by immense resources, both monetary & military.
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"Giving in to the demands of the blackmailers was “a highly controversial decision,” Blount told the Wall Street Journal in his first interview since the devastating cyberattack on May 7, which saw Colonial Pipeline losing access to its computer systems.
He said he authorized the payment of the ransom by nightfall that same day because it was unclear how bad the breach had been and how long it would require to make the pipeline operational again.
...
“I didn’t make it lightly,” he said of his decision to pay. “I will admit that I wasn’t comfortable seeing money go out the door to people like this.”
“But it was the right thing to do for the country,” Blount, who leads the company since 2017, added.
...
The move by Colonial Pipeline contradicted the recommendation from the FBI, which says that companies that are hit with ransomware shouldn’t pay the perpetrators to regain access to their systems as it could lead to a spike in such crimes.
However, the swift payment couldn’t prevent the shutdown of the 8,850-km-long Colonial Pipeline after all. The hack had already done its damage and the pipeline remained inoperable for another six days, provoking a gasoline crisis on the East Coast, with many gas stations running empty and fuel prices reaching their highest levels in almost seven years.
Despite the flow of fuel being restored now, it would require tens of millions of dollars to fully restore some of the company’s business systems to their full capacity, Blount said. Colonial Pipeline is still unable to bill its customers since the hack, he confessed."
I'm sure all that automation which allowed consolidation & cost savings while increasing vulnerability were done "for the country" too.
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"The US military operates a vast network of soldiers, civilians, and contractors that it uses for clandestine missions both at home and abroad, Newsweek has claimed, adding that the force also manipulates social media.
After a two-year investigation, the outlet reported that the undercover army consists of around 60,000 people, many of whom use fake identities to carry out their assignments. The Pentagon’s agents operate in real life and online, with some even embedded in private businesses and well-known companies.
The massive program, unofficially known as “signature reduction,” is reportedly 10 times the size of the CIA’s clandestine service, making it the “largest undercover force the world has ever known,” Newsweek claimed. But the true scale and scope of the shadow army remains a closely guarded secret. No one knows the program’s total size, and Congress has never held a hearing on the military’s increasing reliance on signature reduction. There appears to be very little or no transparency regarding the massive clandestine military force, even as its continued development “challenges US laws, the Geneva Conventions, the code of military conduct, and basic accountability,” the outlet said.
Around half of the signature reduction force is said to consist of special operations personnel who hunt down terrorists in war zones and work in “unacknowledged hot spots” such as North Korea and Iran. Military intelligence specialists reportedly make up the second-largest part of the secret army.
However, the fastest-growing group within the Pentagon’s clandestine force operates exclusively online. These “cyber fighters” assume fake identities to gather intelligence and search for “publicly accessible information” on the internet. They even reportedly take part in “campaigns to influence and manipulate social media.” Hundreds of these shadowy keyboard warriors are employees of the National Security Agency, Newsweek reported.
According to the outlet, the network relies on 130 private companies and dozens of little-known and secret government agencies to support its operations. The businesses, which do everything from forging documents to creating disguises, collectively make over $900 million annually to help fund the secret army."
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"Since the beginning of the pandemic, Big Tech platforms, including Facebook, have used information from the WHO, which is often favorable to China, and fact-checkers, such as Politifact, to censor COVID-19 content on their platforms.
The WHO claimed to have conducted investigations that concluded that the virus did not escape from the Wuhan Institute of Virology. As a result, anyone who dared link the disease’s origins to Wuhan or China was silenced and punished by Big Tech platforms.
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One of Facebook’s fact-checkers might have had a conflict of interest with the issue, as they worked at the lab in Wuhan.
...
Last September, Politifact, one of Facebook’s fact-checkers, blasted Tucker Carlson for interviewing a guest who said COVID-19 was created in a lab, in an article on their website. The headline of the article read:
“Tucker Carlson guest airs debunked conspiracy theory that COVID-19 was created in a lab.”
...
On May 17, the fact-checker silently walked back on their bold statement that the link between the virus and the Wuhan lab was a debunked conspiracy theory. Politifact archived the “fact-check, and wrote:
“When this fact check was first published in September 2020, PolitiFact’s sources included researchers who asserted the SARS-CoV-2 virus could not have been manipulated. That assertion is now more widely disputed.”
While some may argue that Politifact is being responsible and holding itself accountable, it is worth noting that while they debunked the obvious origin of the virus as a conspiracy theory, there were multiple experts who were saying otherwise."
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"Just over ten years ago, on July 25, 2010, Wikileaks released 75,000 secret U.S. military reports involving the war in Afghanistan. The New York Times, The Guardian, and Der Spiegel helped release the documents, which were devastating to America’s intelligence community and military, revealing systemic abuses that included civilian massacres and an assassination squad, TF 373, whose existence the United States kept “protected” even from its allies.
The Afghan War logs came out at the beginning of a historic stretch of true oppositional journalism, when outlets like Le Monde, El Pais, Der Spiegel, The Guardian, The New York Times, and others partnered with sites like Wikileaks. Official secrets were exposed on a scale not seen since the Church Committee hearings of the seventies, as reporters pored through 250,000 American diplomatic cables, secret files about every detainee at Guantanamo Bay, and hundreds of thousands of additional documents about everything from the Iraq war to coverups of environmental catastrophes, among other things helping trigger the “Arab Spring.”
There was an attempt at a response — companies like Amazon, Master Card, Visa, and Paypal shut Wikileaks off, and the Pentagon flooded the site with a “denial of service” attack — but leaks continued. One person inspired by the revelations was former NSA contractor Edward Snowden, who came forward to unveil an illegal domestic surveillance program, a story that won an Oscar and a Pulitzer Prize for documentarian Laura Poitras and reporters Glenn Greenwald and Jeremy Scahill. By 2014, members of Congress in both parties were calling for the resignations of CIA chief John Brennan and Director of National Intelligence James Clapper, both of whom had been caught lying to congress.
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Fast forward seven years. Julian Assange is behind bars, and may die there. Snowden is in exile in Russia. Brennan, Clapper, and Hayden have been rehabilitated and are all paid contributors to either MSNBC or CNN, part of a wave of intelligence officers who’ve flooded the airwaves and op-ed pages in recent years, including the FBI’s Asha Rangappa, Clint Watts, Josh Campbell, former counterintelligence chief Frank Figliuzzi and former deputy director Andrew McCabe, the CIA’s John Sipher, Phil Mudd, Ned Price, and many others.
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After the Capitol riots of January 6th, the War on Terror came home, and “domestic extremists” stepped into the role enemy combatants played before. George Bush once launched an all-out campaign to pacify any safe haven for trrrsts, promising to “smoke ‘em out of their holes.” The new campaign is aimed at stamping out areas for surveillance-proof communication, which CNN security analyst and former DHS official Juliette Kayyem described as any online network “that lets [domestic extremists] talk amongst themselves.”
Reporters pledged assistance, snooping for evidence of wrongness in digital rather than geographical “hidey holes.” We’ve seen The Guardian warning about the perils of podcasts, ProPublica arguing that Apple’s lax speech environment contributed to the January 6th riot, and reporters from The Verge and Vice and The New York Times listening in to Clubhouse chats in search of evidence of dangerous thought. In an inspired homage to the lunacy of the War on Terror years, a GQ writer even went on Twitter last week to chat with the author of George Bush’s “Axis of Evil” speech about imploring the “authorities” to use the “Fire in a Crowded Theater” argument to shut down Fox News.
Multiple outlets announced plans to track “extremists” in either open or implied cooperation with authorities. Frontline, ProPublica, and Berkley Journalism’s Investigative Reporting Program used “high-precision digital forensics” to uncover “evidence” about the Boogaloo Bois, and the Huffington Post worked with the “sedition hunters” at the Twitter activist group “Deep State Dogs” to help identify a suspect later arrested for tasering a Capitol police officer. One of the Huffington Post stories, from February, not only spoke to a willingness of the press to work with law enforcement, but impatience with the slowness of official procedure compared to “sleuthing communities”
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Here The Intercept is announcing it considers QAnon devotee Marjorie Taylor Greene and Alex Jones “violent white supremacists” — they’re a lot of things, but “violent white supremacists”? In the first piece about “extremists” on Gab, reporter Micah Lee claimed to have found an account belonging to a little-known conservative youth figure; the man’s attorney later reached out to deny the account was his, leading to a correction. When asked about his process, Lee responded, sarcastically, that he “certainly wouldn't want to accidentally do investigative journalism about white supremacist domestic terrorists.” When asked how he defined a terrorist, and if he’d be naming public figures only, the sarcastic answer this time was, “Of course I won't be naming anyone. Racist white people must be defended at all costs.”
Greenwald left the organization among other things after an editor asked that he address the “disinformation issue” in a piece about Hunter Biden’s laptop, a reference to a claim made by 50 intelligence officers that the story had “the classic earmarks of a Russian disinformation campaign.” He found it inappropriate then for a publication with The Intercept’s history to be pushing an intelligence narrative, and the Gab project struck him in a similar way.
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In a separate mailer, the Intercept — owned by Omidyar, whose net worth has risen from $11 billion just a few years ago to $22 billion now — complained that “while the right wing’s culture warriors will always be able to turn to the super-rich for financial resources, progressive organizations and independent news outlets are struggling for support.” As The Columbia Journalism Review reported a few years ago, the company has long struggled to attract enough outside funding to maintain its 501(c)3 status as a public charity, which may explain why an outlet owned by the world’s 81st richest person complains about a lack of access to “the super-rich” as it solicits donations from individuals.
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It hasn’t escaped the notice of some current and former Intercept staffers that combing through the hacked private communications of ordinary people in an FBI-like hunt for “extremists” is more or less the exact opposite of the company’s original mission, which focused on the institutional abuses of the very counterintelligence and law enforcement bureaucracies they now seem anxious to aid.
“What a turnaround,” one former Intercept employee, who was there for the company’s early years, said last week. “The answer to white supremacy is not to bring the War on Terror home.”
“That a media outlet founded in order to battle mass surveillance of ordinary citizens and to safeguard privacy rights is now trolling through stolen digital data of private citizens in order to expose and punish them for thought crimes and ideological dissent is as grotesque as it is ironic,” says Greenwald.
The giveaway that these deviance hunts have little to do with holding the powerful to account is that they’re taking place as news outlets have given up even the pretense of interest in spy agency abuses.
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News that the government is considering using private citizens to help it conduct what amount to vigilante intelligence operations for the DHS, FBI, CIA, and NSA — an end-run around once-cherished liberal values like the exclusionary rule — inspired almost no reaction in the op-ed pages of ostensibly liberal outlets. The perceived targets are white supremacists, as unsympathetic as al-Qaeda once was. Who cares?
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All of this is taking place as a slew of War on Terror programs are being retooled for domestic use. A month ago, the New York Times casually reported that “The White House is also discussing… executive orders to update the criteria of terrorism watch lists to potentially include more homegrown extremists.”
Politico also reported the DHS was considering “analyzing the travel patterns” of right-wing suspects, expanding the No Fly List to include “domestic extremists,” and stopping such targets at customs, where officials may “search their phones and laptops” before allowing them back in-country (I know of at least one not-at-all-conservative African-American to whom this has already happened).
Vigilante press efforts at outing “domestic extremists” will function as an auxiliary watch list. Do we need help remembering how the last version worked out? Over 1.1 million names were entered on a list that was shared with 1,400 private groups, from hospitals to universities to prospective employers, resulting in people losing jobs, being denied banking services, having travel restricted, and experiencing all sorts of other difficulties.
The related No-Fly List, Kill List, and other suspect databases were fraught with similar problems, all stemming from the same issue: a lack of procedural oversight, combined with the absence of any requirement that targets commit a crime or be reasonably suspected of planning a crime before they were put on lists.
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Buzzwords cooked up by security agencies have for years now become media talking points instantaneously. Whether it’s “an attack on our democracy” or the “sowing of discord,” media outlets are happy to re-transmit propaganda constructions verbatim.
Two more recent security-agency talking points are now gospel. First, the greatest threat to America is no longer al-Qaeda but homegrown extremists, whom the FBI defined as being almost, but not quite, foreign, i.e. “inspired by, but not receiving individualized direction from, foreign terrorist organizations (FTOs).” Second, the security agencies are held back in their ability to combat such folks by “weak laws” and encryption. As FBI Director Christopher Wray told Congress last year, the FBI has “a decline in its ability to gain access to the content of both domestic and international terrorist communications.”
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A portion of blue-state voters, and a larger percentage of people working in media, are likely to be fine with media projects undertaken to track and identify dangerous elements. What could be wrong with “hunting sedition”? Are journalists not citizens? Why shouldn’t news outlets help plug the investigatory gaps for law enforcement officials held back by outdated civil rights laws?
If you have to ask, you missed the last War on Terror, where we learned the hard way that even the most unsympathetic surveillance targets will never come close to posing as big of a threat to democracy as the security agencies themselves can be, especially when they’re encouraged to operate without meaningful oversight.
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In the first War on Terror, at the exact moment when the public was at its most fearful, politicians convinced Americans to accept sweeping changes to how they understood citizenship. People stopped demanding presidents ask permission to go to war, gave up the expectation that everything from library records to medical histories remain private, were gradually disabused of the idea the state needed warrants to wiretap them, and came to accept the idea that the U.S. had the right to assassinate or detain without trial anyone from any country.
In the domestic sequel, the aim will be getting Americans to lose attachment to concepts like legal guilt or innocence. It won’t matter if you’ve actually committed or planned to commit a crime: if you check enough boxes, you may not be able to post on Internet platforms, fly a plane, use credit services, buy advertising, go on dating apps, work in your chosen profession (or at all), or do any of a dozen other things. A person’s quality of life might hang on whether or not someone — perhaps in the press — decides to publicly attach a name to a term like “white supremacist” or “domestic terrorist.” This is Hayden’s wet dream: “We ruin based on metadata.” There are dangerous racially-motivated extremists in America to be sure, but all of them combined don’t approach the threat of making the entire population subject to the logic of the Watch List."
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"Continuing his world tour doling out righteous lectures to the world, U.S. Secretary of State Antony Blinken on Thursday proclaimed — in a sermon you have to hear to believe — that few things are more sacred in a democracy than “independent journalism.” Speaking to Radio Free Europe, Blinken paid homage to "World Press Freedom Day”; claimed that “the United States stands strongly with independent journalism”; explained that "the foundation of any democratic system” entails "holding leaders accountable” and “informing citizens"; and warned that “countries that deny freedom of the press are countries that don't have a lot of confidence in themselves or in their systems.”
The rhetorical cherry on top of that cake came when he posed this question: "What is to be afraid of in informing the people and holding leaders accountable?” The Secretary of State then issued this vow: “Everywhere journalism and freedom of the press is challenged, we will stand with journalists and with that freedom.”...
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That the Biden administration is such a stalwart believer in the sanctity of independent journalism and is devoted to defending it wherever it is threatened would come as a great surprise to many, many people. Among them would be Julian Assange, the founder of WikiLeaks and the person responsible for breaking more major stories about the actions of top U.S. officials than virtually all U.S. journalists employed in the corporate press combined.
Currently, Assange is sitting in a cell in the British high-security Belmarsh prison because the Biden administration is not only trying to extradite him to stand trial on espionage charges for having published documents embarrassing to the U.S. Government and the Democratic Party but also has appealed a British judge's January ruling rejecting that extradition request. The Biden administration is doing all of this, noted The New York Times, despite the fact that “human rights and civil liberties groups had asked the [administration] to abandon the effort to prosecute Mr. Assange, arguing that the case . . . could establish a precedent posing a grave threat to press freedoms” — press freedoms, exactly the value which Blinken just righteously spent the week celebrating and vowing to uphold.
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...like so many other Trump policies concerning press freedoms — from defending the Trump DOJ's use of warrants to obtain journalists’ telephone records, to demanding Edward Snowden be kept in exile, to keeping Reality Winner and Daniel Hale imprisoned — top Biden officials have long been fully on board with Assange's persecution. Indeed, they have been at the forefront of the effort to destroy basic press freedoms not just for WikiLeaks but journalists generally.
It was Joe Biden who called Assange a "high-tech terrorist” in 2010. It was the Obama administration that convened a years-long grand jury to try to prosecute Assange. It was Sen. Dianne Feinstein (D-CA) who urged Assange's prosecution under the Espionage Act years before Trump was in office. And it was Blinken's colleague on the Obama national security team, Hillary Clinton, who praised the DOJ for its prosecution of Assange. All of this was intended as punishment for Assange's revelations of rampant wrongdoing by the U.S. Government and its allies and adversary governments around the world.
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In 2013, while Blinken was serving as a high-level official in the State Department, the Committee to Protect Journalists did something very rare — issued a report warning of an epidemic of press freedom attacks by the U.S. Government — and said: “In the Obama administration’s Washington, government officials are increasingly afraid to talk to the press.” The New Yorker's Jane Mayer said of the Obama administration's press freedom attacks: "It's a huge impediment to reporting, and so chilling isn't quite strong enough, it's more like freezing the whole process into a standstill." James Goodale, the New York Times’ General Counsel during the paper's battle in the 1970s to publish the Pentagon Papers, warned that “President Obama will surely pass President Richard Nixon as the worst president ever on issues of national security and press freedom."
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It is always easy — and cheap — to condemn the human rights abuses of your enemies. It is much harder — and more meaningful — to uphold those principles for your own dissidents. Blinken, like so many who preceded him in that Foggy Bottom office, theatrically excels at the former while failing miserably at the latter."
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"The move means officials at county level, in cities, school districts, public health authorities and government will not be able to require people to cover their face, Abbott's office announced in a statement.
From May 21, local governments or officials who try to enforce mask-wearing in Texas could be slapped with fines of up to $1,000.
Schools may follow existing guidelines until June 4, and state-run hospitals and detention facilities will be exempt from Abbott's executive order.
"Texans, not government, should decide their best health practices, which is why masks will not be mandated by public school districts or government entities," Abbott said in a statement."
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"Scientists on a committee that encouraged the use of fear to control people’s behaviour during the Covid pandemic have admitted its work was “unethical” and “totalitarian”.
Members of the Scientific Pandemic Influenza Group on Behaviour (SPI-B) expressed regret about the tactics in a new book about the role of psychology in the Government’s Covid-19 response.
SPI-B warned in March last year that ministers needed to increase “the perceived level of personal threat” from Covid-19 because “a substantial number of people still do not feel sufficiently personally threatened”.
Gavin Morgan, a psychologist on the team, said: “Clearly, using fear as a means of control is not ethical. Using fear smacks of totalitarianism. It’s not an ethical stance for any modern government. By nature I am an optimistic person, but all this has given me a more pessimistic view of people.”
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One SPI-B scientist told Ms Dodsworth: “In March [2020] the Government was very worried about compliance and they thought people wouldn’t want to be locked down. There were discussions about fear being needed to encourage compliance, and decisions were made about how to ramp up the fear. The way we have used fear is dystopian.
“The use of fear has definitely been ethically questionable. It’s been like a weird experiment. Ultimately, it backfired because people became too scared.”
Another SPI-B member said: “You could call psychology ‘mind control’. That’s what we do… clearly we try and go about it in a positive way, but it has been used nefariously in the past.”
One warned that “people use the pandemic to grab power and drive through things that wouldn’t happen otherwise… We have to be very careful about the authoritarianism that is creeping in”.
Another said: “Without a vaccine, psychology is your main weapon… Psychology has had a really good epidemic, actually.”
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Another member of SPI-B said they were "stunned by the weaponisation of behavioural psychology" during the pandemic, and that “psychologists didn’t seem to notice when it stopped being altruistic and became manipulative. They have too much power and it intoxicates them”.
Steve Baker, the deputy chairman of the Covid Recovery Group of Tory MPs, said: “If it is true that the state took the decision to terrify the public to get compliance with rules, that raises extremely serious questions about the type of society we want to become.
“If we’re being really honest, do I fear that Government policy today is playing into the roots of totalitarianism? Yes, of course it is.”"
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"Thanks to global labor arbitrage and the outright purchase of our pay-to-play political system, capital has skimmed $50 trillion from labor over the past 45 years. It's all quantified in the RAND Corporation's 2020 report Trends in Income From 1975 to 2018 that documents the $50 trillion that's been transferred to the Financial Aristocracy from the bottom 90% of American households in the past 45 years.
Time magazine's article The Top 1% of Americans Have Taken $50 Trillion From the Bottom 90% -- And That's Made the U.S. Less Secure lays out the key role played by our political leadership:
"No, this upward redistribution of income, wealth, and power wasn't inevitable; it was a choice-- a direct result of the trickle-down policies we chose to implement since 1975.
We chose to cut taxes on billionaires and to deregulate the financial industry. We chose to allow CEOs to manipulate share prices through stock buybacks, and to lavishly reward themselves with the proceeds. We chose to permit giant corporations, through mergers and acquisitions, to accumulate the vast monopoly power necessary to dictate both prices charged and wages paid. We chose to erode the minimum wage and the overtime threshold and the bargaining power of labor. For four decades, we chose to elect political leaders who put the material interests of the rich and powerful above those of the American people."
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...Consider the minimum wage as a reflection of the structural stripmining of labor. According to the BLS inflation calculator, the $1.65 per hour minimum wage I earned in 1970 on Dole's pineapple plantation now equals $11.66 per hour--hence the calls for $12 per hour minimum wage.
But we all know the Consumer Price Index (CPI) has been gamed for decades to understate inflation, and in terms of the goods and services that could be bought with $1.65 in 1970, it would take at least $18 in today's money to buy the same basket of goods and services--if you include real-world prices for healthcare, childcare, higher education, rent, etc.
In terms of competition, the worm has turned, as the number of people who are competent, reliable and willing to work for lousy pay has dwindled. While our educational system was busy trying to make every student into an engineer, coder or at least a college graduate, all the real-world skills needed to keep the real world functioning were given short shrift and denigrated in the media as unworthy compared to the fantasy of coding something and selling it to Facebook, Apple or Google for millions.
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...a consequential percentage of the workforce is re-thinking trading their lives for Neofeudal Debt-Serfdom....
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There are two other dynamics in play in wages ratcheting higher: one is that wages, like taxes, ratchet higher but resist dropping back to previous levels. Once someone earns $15 an hour, they're less inclined to accept $12 an hour, just as local governments are never inclined to lower property taxes, excise taxes, etc. to previous levels.
Another is that when you have to pay one warehouse worker more money to fill the position, word gets out and every other worker in the warehouse will demand the same wage as the new hire. This is how pricing on the margins of the labor market ends up increasing the wages of the entire workforce.
Corporations love to demand everyone keep their salary secret to avoid this ratcheting up from the margins (and mask various biases in pay scales), but the political winds protecting corporations at all costs are finally shifting, and it's going to be more difficult to retain workers at $12 an hour after they heard the new employee is getting $15 an hour for the same work.
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All of these dynamics will accelerate wage "inflation," Corporate Media-Speak for a long overdue shift back from capital to labor. The Fed has created trillions out of thin air to boost the speculative wealth of Wall Street, but it can't print experienced workers willing to work for low wages.
Now that McMansions are unaffordable, people are giving up their McMansion Dreams. And once people give up McMansion Dreams of debt-funded overconsumption, they also give up debt-serfdom and wage slavery."
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"As hundreds of millions of people around the world get vaccinated, it may seem like wordsmithing to highlight the fact that none of the COVID-19 vaccines in use are actually “approved.” Through an emergency access mechanism known as Emergency Use Authorisation (EUA), the products being rolled out still technically remain “investigational.” Factsheets distributed to vaccinees are clear: “There is no FDA approved vaccine to prevent COVID-19.”
The approval-authorisation distinction is often misunderstood by the media, even in the scientific press. But it was the focus of much discussion back in September 2020. With large phase III trials by Pfizer and Moderna well under way, and the November U.S. presidential election looming, many worried about political pressure resulting in the rollout of an unsafe or ineffective vaccine.
The FDA had already come under fire, accused of bending to the White House in granting EUAs for two COVID-19 treatments, hydroxychloroquine and convalescent plasma. But those fears largely dissipated when the FDA published a guidance document in early October outlining its expectations for the EUA. According to the document, at least half of a trial’s participants would need to be followed for at least two months. This alone made it all but certain no vaccine could cross the line before the election.
The FDA also said it would want a vaccine at least 50% effective (with a confidence interval reaching no lower than 30%) against a primary endpoint of preventing SARS-CoV-2 infection or COVID-19 disease of any severity — parameters it had previously defined as necessary for approval. Even for non-clinical parameters, like manufacturing quality, the FDA characterised its expectations for the EUA as “very similar” to those for approval.
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One key difference between EUA and approval (also called “licensure,” and which for vaccines is known as a BLA (Biologics License Application) was the expected length of follow-up of trial participants. Unlike its clear articulation of two months for an EUA, the FDA has not committed to a clear minimum for approval.
Cody Meissner, a professor of paediatrics at Tufts University and member of the FDA’s advisory committee, was curious. “Is it possible to predict or estimate when conditions of safety and efficacy might be satisfied for BLA?” Meissner asked at the agency’s December 10 meeting which had been convened to consider the FDA’s first emergency authorisation for the Pfizer vaccine.
The FDA’s Doran Fink responded: “I couldn’t predict, but I will say that we typically ask for at least six months of follow-up in a substantial number of clinical trial participants to constitute a safety database that would support licensure.”
An approval based on six months of data would represent one of the fastest for a novel vaccine in FDA history. Among the six “first in disease” vaccines approved by the FDA since 2006, pre-licensure pivotal trials were a median of 23 months in duration, according to a recent analysis.
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Duration of protection is not the only question that longer, placebo controlled trials can address. They also address vaccine safety.
“Very often, it’s the fact that we have that placebo controlled follow-up over time, that gives us the ability to say that the vaccine didn’t cause something at a longer period of time after vaccination,” the FDA’s Philip Krause explained last December.
Yet there is a gap — currently of unknown size but growing — between any expectation of blinded placebo controlled data, and the reality that within weeks of the vaccines receiving an EUA the unblinding of trials commenced as placebo recipients were offered the chance to get vaccinated.
Steven Goodman, associate dean of clinical and translational research at Stanford University, told the FDA in an invited presentation last December, “Once a vaccine is made widely available and encouraged, maintaining a double blinded control group for more than a nominal period is no longer in the investigator’s (or regulator’s) control and undue pressure to do so may undermine the entire vaccine testing enterprise.”
Goodman’s recommendation was to rapidly convert the trials into crossover studies, enabling those on placebo to get vaccinated (and vice versa), while maintaining the blind. The companies challenged the feasibility, calling it “onerous,” and a crossover never occurred.
The BMJ asked Moderna, Pfizer, and Janssen (Johnson and Johnson) what proportion of trial participants were now formally unblinded, and how many originally allocated to placebo have now received a vaccine. Pfizer declined to say, but Moderna announced that “as of April 13, all placebo participants have been offered the Moderna COVID-19 vaccine and 98% of those have received the vaccine.” In other words, the trial is unblinded, and the placebo group no longer exists.
Janssen told The BMJ: “We do not have specific figures on how many of our study participants have received a vaccine at this time.” But the company confirmed it was implementing an amended protocol across all countries to unblind all participants in its two phase III trials, the earlier of which passed the median of two month follow-up mark in January.
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The BMJ asked the manufacturers why they were seeking a BLA. Moderna did not respond and Janssen only confirmed it intended to apply for a BLA “later in 2021.” Pfizer likewise did not answer but instead quoted an FDA webpage on medical devices, which stated: “Sponsors of EUA products are encouraged to follow up the EUA with a pre-market submission so that it can remain on the market once the EUA is no longer in effect.” But EUAs have no built-in expiry date — in fact, 14 EUAs for Zika diagnostic tests remain active despite the public health emergency expiring in 2017.
Cody Meissner told The BMJ he saw some distinct advantages of a BLA over EUA. An approved vaccine, for one, would provide “an element of assurance,” increasing public trust in the vaccines, particularly for those currently sitting on the fence. It would also pave the way for claims of vaccine injury to be routed through a more established compensation programme, and for adding the vaccine to government funded schemes to reach children in financial need.
Finally, it may affect the potential for vaccine mandates: “It is unlikely these vaccines will be mandated while an EUA is in place. Remember that currently these vaccines are still considered experimental.”
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Officials have consistently emphasised that despite shaving years off traditional timelines for producing vaccines, no compromises in the process were taken. However one type of study, tracking the distribution of a vaccine once injected in the body, was not conducted using any of the three vaccines currently authorised in the U.S.
Such biodistribution studies are a standard element of drug safety testing but “are usually not required for vaccines,” according to European Medicines Agency policy, which adds, “However, such studies might be applicable when new delivery systems are employed or when the vaccine contains novel adjuvants or excipients.”
In the case of COVID-19 vaccines, regulators accepted biodistribution data from past studies performed with related, mostly unapproved compounds that use the same platform technology."