Blinken Says ‘No Fatigue’ Among NATO In Supporting Ukraine As Russia Amasses Missiles Ahead Of Winter

Blinken Says ‘No Fatigue’ Among NATO In Supporting Ukraine As Russia Amasses Missiles Ahead Of Winter

US Secretary of State Antony Blinken came a away from a NATO meeting of foreign ministers on Wednesday with the conclusion that the alliance is holding strong on supporting Ukraine, despite the avalanche of negative reports on how Ukrainian forces are fairing on the battlefield.

He told a press briefing there is “no sense of fatigue” among NATO allies and they are remaining firm. “We must and we will continue to support Ukraine,” he said following the NATO meeting in Brussels. 

His words seemed by design a flat rejection of the avalanche of headlines which go to back to at least the summer which warned of increasing ‘war fatigue’ among Western publics and among political leadership.

But more specifically there have been echoes of fatigue voiced by NATO countries’ top leadership:

In particular, Giorgia Meloni, the Italian prime minister, fell victim to a prank call from a pair of Russian comedians where she acknowledged international “fatigue” over the war in Ukraine.

“There is a lot of fatigue, I have to say the truth, from all the sides,” she said. 

“The problem is to find a way out which can be acceptable for both, without destroying the international law.”

Ms Meloni since said she regretted the comments and that Italy will continue to back Ukraine

The fact that Blinken now has to address the question of alliance members’ fatigue head on is itself very telling. It also comes after the Israel-Gaza conflict has for the past eight weeks dominated the globe’s attention. Gone are the days of Zelensky addressing packed out parliaments and Western audiences greeting him as if he’s a rock star. 

Winter is coming, and the already stalemated front line situation will likely get a lot worse. NATO Secretary Jens Stoltenberg warned of precisely this in Brussels, saying Russia amassed a large missile stockpile ahead of winter, as cited in Reuters. Other sources have also pointed to Russia’s amassing more missiles…

“It is important that our solidarity with Ukraine is not only demonstrated in words but also in deeds,” Stoltenberg continued, arguing that the Western allies must do more. “These are concrete actions, we need more of them and we need sustained and stepped up support.”

Both the US and Kiev have meanwhile denied recent and growing reports that Washington is pressuring the Zelensky government behind the scenes to negotiate for ceasefire, which would necessitate territorial concessions. Yet, the US government’s own social media accounts strongly suggest otherwise…

Ukraine is still vowing it “won’t back down” and has consistently refused to so much as consider or discuss the prospect of direct peace negotiations so long as President Vladimir Putin is in power.

Tyler Durden
Thu, 11/30/2023 – 02:45

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UK Govt Staff Asked To Check Pronouns Of Co-Workers Before Assuming Gender Identity

UK Govt Staff Asked To Check Pronouns Of Co-Workers Before Assuming Gender Identity

Authored by Steve Watson via Modernity.news,

People working for the government in the UK have been told that they should check what pronouns their colleagues prefer and not assume they know the gender their co-workers identify as.

The Telegraph reports that civil servants were advised to take the measures in an internal memo that asked staff to mark Transgender Day of Remembrance, one of several calendar days earmarked for LGBTQ+ themed activities.

The report further notes that the director general of trade negotiations in the Department for Business and Trade told staff that the event “encourages us to pause to commemorate those whose lives have been lost due to intolerance”.

The memo also contained a diatribe from a non-binary staff member who expressed a desire for “actions that I’d like to see colleagues take to work towards removing stigma and build [sic] a culture where we are open and inclusive of our trans colleagues.”

The memo continues, “Checking people’s email signatures for their pronouns and not assuming colleagues’ pronouns, are both simple things that I know can make acknowledging gender diversity part of our daily discourse.”

It adds, “Joining DBTs LGBTQ+ Network is also a way to support your LGBTQ+ colleagues and keep up to date with current issues the community is facing.”

In response to the revelation, Helen Joyce, director of advocacy for the campaign group Sex Matters, told The Telegraph: “Telling civil servants to check each other’s emails for pronouns is downright nasty, and it’s very worrying that a senior official endorsed a memo suggesting such uncollegial and bigoted behaviour.”

Joyce also argues that the Transgender Day of Remembrance amplifies false claims that “trans people in the UK are at elevated risk of murder or other violence – a claim that is unsupported by the evidence.”

She noted “The day is supposed to feature the deaths of trans-identified people caused by ‘transphobia’, and is used to circulate baseless claims that trans people face outsize risk of violence. These are in turn used to suggest that doctors must give cross-sex hormones and genital surgery to trans-identified people on demand, and everyone else must pretend that trans people are the sex they claim to be, not the sex they actually are.”

“If these demands are rejected, trans lobby groups engage in emotional blackmail, claiming that the result will be trans people dying by violence or suicide,” Joyce further asserts.

She concludes that “All employers, including DBT, should think carefully about the risk of claims against them for discrimination and harassment of gender-critical employees if they allow themselves to be used as mouthpieces for evidence-free and inflammatory lobbying.”

As we previously highlighted, U.S. government departments have also attempted to force workers into using preferred pronouns and marking Transgender calendar days at work:

Whoops! State Department Says It ‘Unintentionally’ Added MANDATORY Pronouns Onto Emails

Biden State Dept. Blasted For Celebrating ‘Intersex Day’

Biden Health Department Forces ALL Employees To Use ‘Preferred Pronouns’

Video: Biden Department of Education ‘Pride’ Seminar Advocates Puberty Blockers For Kids

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Tyler Durden
Thu, 11/30/2023 – 02:00

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Yes, Heavy Regulation Hurts the Economy. Just Look at France.


A man protests in France during a yellow vest demonstration | Telmo Pinto/ZUMAPRESS/Newscom

It’s fashionable to claim that the free market ideas of Nobel laureate economist Milton Friedman have failed the country, and that it’s time for new policies. Campaigning in 2020, Joe Biden declared that “Milton Friedman isn’t running the show anymore.” More recently, New York Times columnist David Leonhardt noted that people like Friedman promised that the free market “would bring prosperity for all. It has not.”

This is nonsense. For one thing, I wish we lived in a world fashioned more fully by Friedman’s ideas. Sadly, while his insights have indeed influenced some U.S. economic policies, particularly during former President Ronald Reagan’s administration, the extent of their implementation has been quite limited.

Friedman, for example, would be appalled that federal debt is now roughly the size of annual gross domestic product (GDP), having grown like a kudzu vine since registering at around 25 percent in the early 1980s. Taxes remain lower since the Reagan revolution took place, but our incomes are often taxed multiple times. Nearly every aspect of our lives is regulated by various agencies—local, state, and national. And—no surprise—cronyism is alive and well.

Still, Friedman’s critics are right to treat him as a monumental figure. His ideas helped make trade freer and school choice mainstream. His clarity in contrasting markets with government opened many eyes to the benefits of capitalism. We are immeasurably better off for it. If you don’t believe me, look at my native France, where Friedman has had almost no influence.

The French economy is weighed down by one of the heaviest tax levels among wealthy democratic nations, with regressive taxes and social security contributions representing a significant portion of GDP. This tax haul funds France’s extensive web of social welfare programs, including health care, education, and pensions.

French regulation is also comprehensive, covering many aspects of employment, business operations, and environmental protection. The labor code is particularly onerous. Additionally, its government plays a direct role in the economy, with a significant number of partially state-owned enterprises and interventionist policies intended to safeguard employment and prioritize equality and social cohesion.

Let’s see how they’re doing.

U.S. GDP per capita is now $76,398; France’s is $40,964. The U.S. unemployment rate is 3.9 percent. As of the second quarter of 2023, France’s was 7.2 percent—a relatively low figure for a country that often faces double-digit rates even outside of recession periods. We shouldn’t be surprised at any of this, considering France’s stringent rules on working hours, dismissals, and employee benefits, which make it difficult for businesses to respond to market conditions. The country is slathered with reasons not to hire people.

Youth unemployment is a significant indicator of how well an economy integrates its young population into the job market. As of May 2023, France’s youth unemployment rate was 17.2 percent, with historical data showing an average of 20.6 percent from 1983 until 2023. In November of 2012, it peaked at a Great Depression–like level of 28.20 percent. This is the result of well-documented structural issues distorting France’s labor market. Rigid labor laws dissuade employers especially from hiring young, inexperienced workers.

In contrast, in October 2023, the U.S. youth unemployment rate was 8.9 percent. These are not just numbers; they have real implications for young individuals’ economic prospects, skills development, and long-term career trajectories. As such, American youth, for all its complaints, is much better off than its French peers are.

Some claim that this is a fair price to pay for France’s social cohesion and equity. I don’t see it. Over the last decade, France has experienced significant social unrest rooted in economic, political, and social issues. One of the most notable periods of unrest was the “Yellow Vest” movement that began in 2018. It was sparked by the announcement of another increase in the fuel tax on top of hundreds of other taxes. It quickly morphed into a broader movement against economic inequality and the cost of living. The protests were marked by widespread demonstrations, some of which turned violent.

France is also renowned for its labor strikes, which often bring millions of protesters onto the streets. The frequency and intensity of these protests underscore the challenges that France faces in balancing economic reforms with social cohesion.

The U.S. isn’t perfect. Its social cohesion could certainly be better. But given a choice between an economic system that has been somewhat influenced by Friedman and one that’s barely been influenced by him at all, my choice is clear. I made it when I left France and became an American.

COPYRIGHT 2023 CREATORS.COM.

The post Yes, Heavy Regulation Hurts the Economy. Just Look at France. appeared first on Reason.com.

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The White House Goes Rogue: Secret Surveillance Program Breaks All The Laws

The White House Goes Rogue: Secret Surveillance Program Breaks All The Laws

Authored by John & Nisha Whitehead via The Rutherford Institute,

“We are rapidly entering the age of no privacy, where everyone is open to surveillance at all times; where there are no secrets from government.”

 – William O. Douglas, dissenting in Osborn v. United States (1966)

The government wants us to believe that we have nothing to fear from its mass spying programs as long as we’ve done nothing wrong.

Don’t believe it.

It doesn’t matter whether you obey every law. The government’s definition of a “bad” guy is extraordinarily broad, and it results in the warrantless surveillance of innocent, law-abiding Americans on a staggering scale.

For instance, it was recently revealed that the White House, relying on a set of privacy loopholes, has been sidestepping the Fourth Amendment by paying AT&T to allow federal, state, and local law enforcement to access—without a warrant—the phone records of Americans who are not suspected of a crime.

This goes way beyond the NSA’s metadata collection program.

Operated during the Obama, Trump and now the Biden presidencies, this secret dragnet surveillance program (formerly known as Hemisphere and now dubbed Data Analytical Services) uses its association with the White House to sidestep a vast array of privacy and transparency laws.

According to Senator Ron Wyden, Hemisphere has been operating without any oversight for more than a decade under the guise of cracking down on drug traffickers.

This is how the government routinely breaks the law and gets away with it: in the so-called name of national security.

More than a trillion domestic phone records are mined through this mass surveillance program every year, warrantlessly targeting not only those suspected of criminal activity but anyone with whom they might have contact, including spouses, children, parents, and friends.

It’s not just law enforcement agencies investigating drug crimes who are using Hemisphere to sidestep the Fourth Amendment, either. Those who have received training on the program reportedly include postal workers, prison officials, highway patrol officers, border cops, and the National Guard.

It’s a program ripe for abuse, and you can bet it’s getting abused.

Surveillance, digital stalking and the data mining of the American people—weapons of compliance and control in the government’s hands—haven’t made America any safer, and they certainly aren’t helping to preserve our freedoms.

Indeed, America will never be safe as long as the U.S. government is allowed to shred the Constitution.

The Fourth Amendment was intended to serve as a protective forcefield around our persons, our property, our activities, our communications and our movements. It keeps the government out of our private business except in certain, extenuating circumstances.

Those extenuating circumstances are spelled out clearly: government officials must have probable cause that criminal activity is afoot (a higher legal standard than “reasonable suspicion”), which is required by the Constitution before any government official can search an individual or his property.

Unfortunately, all three branches of government—the legislatures, courts and executive offices—have given the police state all kinds of leeway when it comes to sidestepping the Fourth Amendment.

As a result, on a daily basis, Americans are already being made to relinquish the most intimate details of who we are—our biological makeup, our genetic blueprints, and our biometrics (facial characteristics and structure, fingerprints, iris scans, etc.)—in order to clear the nearly insurmountable hurdle that increasingly defines life in the United States: we are now guilty until proven innocent.

Warrantless, dragnet surveillance is the manifestation of a lawless government that has gone rogue in its determination to do whatever it wants, whenever it wants, the Constitution be damned.

Dragnet surveillance. Geofencing. Fusion centers. Smart devices. Behavioral threat assessments. Terror watch lists. Facial recognition. Snitch tip lines. Biometric scanners. Pre-crime. DNA databases. Data mining. Precognitive technology. Contact tracing apps.

What these add up to is a world in which, on any given day, the average person is now monitored, surveilled, spied on and tracked in more than 20 different ways by both government and corporate eyes and ears.

This creepy new era of government/corporate spying—in which we’re being listened to, watched, tracked, followed, mapped, bought, sold and targeted every second of every day—has been made possible by a global army of techno-tyrants, electronic eavesdroppers, robotic snoops and digital Peeping Toms.

The government has a veritable arsenal of surveillance tools to track our movements, monitor our spending, and sniff out all the ways in which our thoughts, actions and social circles might land us on the government’s naughty list, whether or not you’ve done anything wrong.

Rounding out the list of ways in which the Techno-Corporate State and the U.S. government are colluding to nullify the privacy rights of the individual is the Biden Administration’s latest drive to harness the power of artificial intelligence technologies while claiming to protect the citizenry from harm.

In his executive order on artificial intelligence, President Biden is calling for guidelines on how the government will use AI while simultaneously insisting that corporations protect consumer privacy.

Talk about ironic that the very government that has been covertly invading our privacy rights wants to appoint itself the guardian of those rights.

Tell me this: how do you trust a government that continuously sidesteps the Constitution and undermines our rights? You can’t.

A government that repeatedly lies, cheats, steals, spies, kills, maims, enslaves, breaks the laws, overreaches its authority, and abuses its power at almost every turn can’t be trusted.

At a minimum, you shouldn’t trust the government with your privacy, property or freedoms.

Whatever else it may be—a danger, a menace, a threat—the U.S. government is certainly not looking out for our best interests.

Remember the purpose of a good government is to protect the lives and liberties of its people.

Unfortunately, what we have been saddled with is, in almost every regard, the exact opposite of an institution dedicated to protecting the lives and liberties of its people.

Indeed, the government has a history of shamelessly exploiting national emergencies for its own nefarious purposes.

Terrorist attacks, mass shootings, civil unrest, economic instability, pandemics, natural disasters: the government has been taking advantage of such crises for years now in order to gain greater power over an unsuspecting and largely gullible populace.

That’s exactly where we find ourselves now: caught in the crosshairs of a showdown between the rights of the individual and the so-called “emergency” state.

All of those freedoms we cherish—the ones enshrined in the Constitution, the ones that affirm our right to free speech and assembly, due process, privacy, bodily integrity, the right to not have police seize our property without a warrant, or search and detain us without probable cause—amount to nothing when the government and its agents are allowed to disregard those prohibitions on government overreach at will. 

This is the grim reality of life in the American police state: our so-called rights have been reduced to technicalities in the face of the government’s ongoing power grabs.

While surveillance may span a broad spectrum of methods and scenarios, the common denominator remains the same: a complete disregard for the rights of the citizenry. 

With every court ruling that allows the government to operate above the rule of law, every piece of legislation that limits our freedoms, and every act of government wrongdoing that goes unpunished, we’re slowly being conditioned to a society in which the Constitution means nothing.

Any attempt by the government to encroach upon the citizenry’s privacy rights or establish a system by which the populace can be targeted, tracked, monitored and singled out must be met with extreme caution.

Dragnet surveillance in an age of pre-crime policing and overcriminalization is basically a fishing expedition carried out without a warrant, a blatant attempt to circumvent the Fourth Amendment’s warrant requirement and prohibition on unreasonable searches and seizures.

What we need is a digital “No Trespassing” sign that protects our privacy rights and affirms our right to be left alone.

Then again, as I make clear in my book Battlefield America: The War on the American People and in its fictional counterpart The Erik Blair Diaries, what we really need is a government that respects the rights of the citizenry and obeys the law.

Tyler Durden
Wed, 11/29/2023 – 23:40

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Texas Judge With Ties To Biden, Obama, Clinton Under Investigation For COVID Bid-Rigging Scheme

Texas Judge With Ties To Biden, Obama, Clinton Under Investigation For COVID Bid-Rigging Scheme

Authored by Alice Giordano via The Epoch Times,

A Texas judge is under investigation by the Texas Rangers for allegedly rigging an $11 million pandemic outreach contract so it would be awarded to one of her political allies, a former campaigner for Hillary Clinton, Barack Obama, and data director for the Democratic National Committee (DNC).

On Nov. 9, 2023, the Texas Rangers Public Corruption Investigation Unit announced it had obtained search warrants for documents relative to an investigation it has launched in conjunction with the Harris County District Attorney’s Office into Harris County Judge Lina Hidalgo. The corruption investigation unit accuses Ms. Hidalgo of witness tampering, intent to conceal evidence, and the misuse of emergency authorization powers to bypass the county’s contract voting process. They are planning to take their findings to a grand jury.

“Whether it’s the White House or the Harris County Judge’s office, there appears to be an epidemic of corruption among high-level Democrat officials,” Harris County GOP Chairman Cindy Siegel said in a statement about the recently announced investigation into Judge Hidalgo.

According to a Nov. 14 story by Fox 26 in Texas, invoices from the Harris County auditor show that the companies paid out from the $11 million COVID outreach money paid to Elevate Strategies, were all Democratic campaign organizations that focused on outreach to Democratic voters, and had no history of engaging in pandemic-related activity.

Rice University political analyst Mark Jones told the television network that the evidence overwhelmingly shows that the public money was being used as a “camouflage” to maximize Democratic voter turnout by buying voter lists and funding data mining operations.

Ms. Hidalgo already boasts an influential list of Democrats who have stumped for her in the past, including First Lady Jill Biden and “Hamilton” creator and liberal activist Lin Manuel-Miranda.

Prior to the bid-rigging scandal, Ms. Hidalgo was under scrutiny by state Republicans for creating a controversial “threat policy” at the height of the pandemic that included a $1,000 fine and jail time for not wearing a mask. Some of the $11 million in pandemic funds was intended to be used to enforce her policies.

The search warrants, which were obtained by The Epoch Times, show that Ms. Hidalgo is accused of using her position to direct $11 million worth of pandemic outreach money to Elevate Strategies, which is owned by her political ally Felicity Pereyra.

Ms. Pereyra and Elevate Strategies did not respond to inquiries from The Epoch Times.

According to her resume posted on LinkedIn, Ms. Pereyra has worked on a variety of other Democratic campaigns including as the analytics director for Ms. Clinton’s Hillary for America campaign in 2016. Her resume shows she was also DNC’s director of data between 2017 and 2018, and served as deputy data director for Obama for America campaign in 2012.

Mrs. Hidalgo held a press conference on Nov. 10, the day after the search warrants were served, to deny any wrongdoing. She said she is a victim of “dirty politics” and accused Harris County District Attorney Kim Ogg of abusing her office for political reason. Mrs. Hidalgo pointed out that her staffers were indicted during her reelection bid in 2022 and that the search warrants were obtained during Mrs. Ogg’s campaign for reelection.

Ms. Hidalgo, who won her reelection bid, has publicly endorsed Mrs. Ogg’s Democrat challenger Sean Teare.

“This is the same politics she’s been playing for years,” Ms. Hidalgo said about Mrs. Ogg. “She’s abused the power of her office the way that a bully abuses size on the playground.”

Harris County is located in Houston, a liberal stronghold in otherwise heavily Republican Texas. It has voted Democrat for more than a decade.

Mrs. Ogg told KHOU-11 that Judge Hidalgo was using her status to “taint the investigative process and confuse the public.”

“County Judge Hidalgo’s outburst today was nothing more than an attempted deflection from the facts and evidence that led to the initial indictment of her staffers,” Mrs. Ogg said.

Three of Ms. Hidalgo’s senior staffers, including her chief of staff, have already been indicted on felony charges that include record tampering and misuse of official information.

Following their indictment in April 2022, Ms. Hidalgo took a leave of absence, citing “mental health reasons.” She returned to the bench last month. Three weeks later, the Texas Rangers announced their investigation.

According to the search warrants, the Texas Rangers believe Ms. Hidalgo edited and/or erased documents relative to the COVID contract and that she failed to turn over correspondence she was initially asked for in the criminal investigation into her staffers.

The search warrants also claim that Ms. Hidalgo sometimes uses encrypted messaging to communicate with her senior-level staff members and that show her staffers used their personal phones to communicate about the vaccine outreach money with Ms. Pereyra.

They also showed that Ms. Hidalgo communicated with Ms. Pereyra about the availability of the $11 million contract before it was publicly announced and that when she believed the county commissioner might not approve the allocation of funds, she used her emergency authorization powers to bypass the voting process and award it to Ms. Pereyra’s Elevate Strategies.

As uncovered by Houston blogger Aubrey Taylor, county real estate records show Ms. Pereyra and her husband bought a new home two months after her company was awarded the contract.

Prior to the bid rigging scandal, Ms. Hidalgo also came under public scrutiny for her behavior at the funeral of slain Harris County police officer Cpl. Charles Galloway, who was shot to death during a routine traffic stop on Jan. 23, 2022.

A video taken of Officer Galloway’s funeral shows Ms. Hidalgo arguing with several law enforcement officials.

According to Sgt. Roy Guinn of the Harris County Constable’s Office, when he and the other officers asked her to take her seat with all the other elected officials in attendance, she refused, saying, “Do you know who I am, I’m the county judge.”

Mr. Guinn made a YouTube video of the incident and was interviewed by both TV and radio media about it.

Sgt. Guinn, who accused Judge Hidalgo of deliberately positioning herself in front of media cameras during the entire service “to be seen,” said she even refused to move when she was told she was in the way of the honor guard.

A spokesperson for Judge Hidalgo said she would not be commenting on the incident.

Tyler Durden
Wed, 11/29/2023 – 23:00

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Man ‘Orally Raped’ On Flight To Moscow By Sex-Crazed Woman: Reports

Man ‘Orally Raped’ On Flight To Moscow By Sex-Crazed Woman: Reports

A male passenger on a five-hour flight to Russia was allegedly the victim of oral rape, after a sex-crazed 29-year-old blonde woman named Valeria insisted on blowing him after departing from Antalya, Turkey.

“On a flight from Antalya to Moscow, a female passenger went on a rampage and [orally] raped her [male] neighbour,” according to Russian new outlet Gazeta.ru (and via the Daily Mail ), which added that there were children on board.

The man, sitting next to her in economy class of the Pobeda Airlines flight, allegedly rebuffed Valeria’s advances – only to ‘stop resisting’ a short time later.

According to the report, flight attendants let him finish before moving the possibly intoxicated woman away – who then tried to bribe them.

Valeria with the bank note she allegedly used to bribe the flight crew. A stewardess put the bank note in the rubbish bin and Valeria was then seen emptying the trash onto the floor of the plane and retrieving the money (BAZA/East2west News via the Daily Mail)

More via the Daily Mail:

‘She pulled down his trousers and committed violent acts of a sexual nature.

‘Later the neighbour stopped resisting.

‘All this happened in front of the flight attendants and other passengers.’

Shot media reported: ‘Surprisingly, the flight attendants waited until the end of the action and only then moved Valeria further away.

The woman fought back and did not want to leave her newly-made companion.’

Another male passenger was deputed to guard her during the rest of the flight.

During the flight Valeria ‘scratched the flight crew’ and smoked an e-cigarette despite repeated demands to stop doing so, according to reports citing eyewitnesses.

The woman was detained in Moscow following the incident, however she told BAZA media that she has no regrets, and was able to pay a fine of 500 roubles ($5.62) and move on with her day.

“Everything was fine,” she said. “I had a good time on the plane. Well, that’s a little more than that.”

So, two people got off in this story. All’s well that ends well?

Tyler Durden
Wed, 11/29/2023 – 22:40

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FDA Investigating “Serious Risk” Of New Cancers Arising From Gene Therapy Cancer Treatments

FDA Investigating “Serious Risk” Of New Cancers Arising From Gene Therapy Cancer Treatments

Authored by Naveen Athrappully via The Epoch Times,

A gene therapy treatment used in cancer patients is under scrutiny by the U.S. Food and Drug Administration (FDA) after the agency received reports of new blood cancers among treated individuals.

The treatment, CAR-T, was first approved by the FDA in 2017 and is used in the treatment of blood cancers. However, the agency has received “reports of T-cell malignancies”—a group of blood disorders—among some of the patients who received CAR-T treatments, according to a Nov. 28 announcement.

The reported malignancies include lymphoma, a cancer of the lymphatic system which includes lymph nodes, the thymus gland, bone marrow, and the spleen.

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action,” the agency said.

In CAR-T treatments, a type of white blood cells called T cells are removed from the blood of a patient. These cells are then genetically engineered to make proteins called chimeric antigen receptors (CAR).

The receptors allow T cells to attach to cancer cells and kill them. Once the genetic engineering is completed, the modified cells are then infused back into the patient’s blood, The New York Times reported.

The FDA pointed out that “patients and clinical trial participants receiving treatment with these products should be monitored life-long for new malignancies.”

“In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the Chimeric Antigen Receptor (CAR) transgene,” the agency said.

At present, the FDA has approved six CAR-T products:

  • Kymriah from Novartis

  • Yescarta from Gilead

  • Carvykti from J&J and Legend

  • Breyanzi from Bristol Myers Squibb

  • Abecma from Bristol Myers Squibb

  • Tecartus from Gilead

The risk for developing malignancies applies to all six products, the FDA said.

Surprising Announcement

Medical experts did not expect the FDA’s recent announcement.

“In informal emails among many scientists and physicians in the field, we are all surprised by this announcement,” Marcela Maus, a researcher at Mass General Cancer Center, told health outlet STAT.

Ms. Maus said that the only cases of CAR-T lymphoma or leukemia she heard of were from Australia where the products used a genetic element which was not present in the six CAR-T treatments approved by the FDA.

Bruce Levine, a professor at the University of Pennsylvania Health System, said in a Nov. 29 X post that the FDA report leaves “many questions unanswered,” adding that “colleagues I’ve consulted with are very surprised” by the announcement.

“What was the clinical status of the patients in terms of immunosuppression, prior therapy, conditioning chemotherapy, evidence of prior clonal hematopoiesis?” he asked.

“It’s important to put into context the remote though real risk when compared to conventional chemotherapy that has significant long and short term side effects, including genotoxicity and predisposition to secondary cancers.”

Dr. Mikkael Sekeres, chief of the Division of Hematology at Florida’s Sylvester Comprehensive Cancer Center said in a social media post that he “would love to see absolute risk and some details on likelihood of causality here,” regarding the FDA announcement.

In an interview with The New York Times, Dr. John DiPersio, director of the Center for Genetic and Cellular Immunotherapy at Washington University School of Medicine in St. Louis, said he hasn’t seen “a single one” of his 500 to 700 patients who received CAR-T treatments develop a new T cell cancer.

CAR-T treatments are reserved for patients who would otherwise die without it, he noted.

“They are all going to die and they are all going to die quickly without this treatment. It saves their life … It works in a substantial portion of patients. The benefit is enormous.”

When a patient’s T cells are genetically modified in the CAR-T treatment, a virus is used to slip new genes into the DNA of these cells. As such, when the modified T cells are inserted back into the blood of the patient, it could potentially disrupt other genes and lead to cancer, The New York Times explained.

However, blood cancers among CAR-T treated patients could also be explained by the fact that individuals who receive such treatments have already undergone other treatments like chemotherapy and radiation, which can give rise to cancers.

Company Responses

Based on an analysis by medical news outlet FiercePharma, 12 total cases of T-cell lymphoma have been reported, with Kymriah accounting for seven cases, Yescarta three, and one each from Breyanzi and Carvykti.

The Epoch Times reached out to the respective companies for comment.

A Gilead spokesperson told FiercePharma that the company is “confident in the overall safety profile of both Tecartus and Yescarta.” Both treatments have been applied on 17,700 patients, with no evidence linking them with development of new malignancies, the spokesperson stated.

“We have a rigorous process in place to continuously monitor for and report adverse events to regulatory authorities. … We have fully cooperated with the FDA’s request for an analysis of our data related to this inquiry.”

Novartis pointed out that over 10,000 patients have been treated with Kymriah and that the company has not identified its link to any secondary malignancies. Bristol Myers Squibb told the outlet that Abecma and Breyanzi have been used among 4,700 patients, with none of them developing T-cell malignancy.

Data from the FDA Adverse Event Reporting System (FAERS) show that the six products have reported the following adverse events:

  • Kymriah—2,470 adverse events, including 2,303 serious cases, 662 deaths, and 504 blood and lymphatic system disorders.

  • Yescarta—3,729 adverse events, including 3,551 serious cases, 746 deaths, and 567 blood and lymphatic system disorders.

  • Carvykti—408 adverse events, including 251 serious cases, 28 deaths, and 18 blood and lymphatic system disorders.

  • Breyanzi—202 adverse events, 172 serious cases, 38 deaths, and 18 blood and lymphatic system disorders.

  • Abecma—528 adverse events, 454 serious cases, 60 deaths, and 87 blood and lymphatic system disorders.

  • Tecartus—609 adverse events, 570 serious cases, 136 deaths, and 58 blood and lymphatic system disorders.

Tyler Durden
Wed, 11/29/2023 – 22:20

via ZeroHedge News https://ift.tt/4AicpBL Tyler Durden

‘They Are An Evil Terrorist Organization’ – Newsom Blasts Hamas-Defenders At Oakland City Council Meeting

‘They Are An Evil Terrorist Organization’ – Newsom Blasts Hamas-Defenders At Oakland City Council Meeting

Several members of the public voiced support for Hamas during a six-hour Oakland City Council meeting Nov. 27 before the board unanimously passed a resolution calling for a permanent ceasefire between Israel and the terrorist organization.

The comments sparked indignant responses from California Gov. Gavin Newsom and other state officials.

As Jill McLaughlin reports, via The Epoch Times, The resolution calls for congressional and worldwide support for an immediate ceasefire in Gaza, which has been under attack by Israeli forces following Hamas’s murderous rampage in Israel Oct. 7.

The resolution also condemned the recent rise of anti-Semitic, Islamophobic, racist, homophobic, and xenophobic attacks in the city and across the world, including the “doxing,” or public reveal, of information about officials and others who comment about the issue.

Councilman Dan Kalb called for an amendment to the resolution that would have added a statement condemning the mass murder of 1,200—mostly Israeli citizens—by Hamas, but it did not pass.

“I don’t ask a lot of you, but I do ask you to consider and support [the amendment],” Mr. Kalb told councilors.

“Not even clearly mentioning the Hamas mass murder on Oct. 7 is sending the wrong message and an embarrassing message.”

Councilwoman Carroll Fife, who introduced the resolution, did not support adding the amendment. She told other councilors during the meeting that she worked with Jewish and Muslim community members to craft the resolution.

“That was the fourth draft of a resolution created that was intentionally drafted to center on peace,” Ms. Fife said.

“It didn’t name condemnation of Hamas or Israel because they wanted to focus on love, life, and lifting up what we support and not what we condemn.”

One Arab community member called the amendment “racist.”

“As an Arab, asking with this context to condemn Hamas is very anti-Arab racist,” one woman told councilors.

Residents voicing support for both sides of the ongoing battle between Israel and Hamas spoke out during the lengthy public comment period.

“Allowing Hamas to continue and regroup is a threat to all,” one man said.

A number of others spoke in support of Hamas and Palestinians, saying they believed much of the news about Hamas was false or propaganda.

“There have not been beheadings of babies and rapings. Israel murdered their own people on Oct. 7th,” one woman said.

In an incredulous statement, another young woman said:

“Calling Hamas a terrorist organization is ridiculous, racist, and plays into genocidal propaganda that is flooding our media and that we should be doing everything possible to combat,” said

Another resident commented:

“I support the right of Palestinians to resist occupation, including through Hamas, the armed wing of the unified Palestinian resistance.”

One woman, who was cut off by a city council member, said news of the massacre was false.

“The notion that this was a massacre of Jews is a fabricated narrative,” she said.

“Many of those killed on Oct. 7, including children, were killed by the [Israel Defense Forces].”

An elderly man commented, saying,

“Listening to them complain about Hamas violence is like listening to a wife beater complain when his wife finally stands up and fights back.”

Another woman asked the crowd:

“Did anyone else notice that those who oppose this resolution are old white supremacists?”

State officials have since spoken out about the controversial public comments at the meeting.

On Wednesday, Mr. Newsom shared a video on X, formerly Twitter, of those who supported Hamas during the council meeting, disagreeing with their statements.

“Hamas is a terrorist organization,” Mr. Newsom posted.

“They must be called out for what they are: evil.”

State Sen. Scott Wiener called the comments “awful.”

“Oakland City Council passed a [resolution] calling for [a] Gaza ceasefire,” Mr. Wiener posted on X Tuesday.

“When a council member asked to add language condemning Hamas, a stream of public comment praising and supporting Hamas ensued. The council then rejected the request to condemn Hamas. Just awful.”

“Tonight’s meeting was a complete disgrace and will bring nothing constructive to actual Palestinians and Israelis on the ground. What it instead has achieved is the fanning of flames of antisemitism in Oakland,” SFJCRC CEO Gregory said.

The Oakland city clerk said they had more than 1,200 comments online.

The resolution will be forwarded to the governor, President Joe Biden, and Vice President Kamala Harris.

Tyler Durden
Wed, 11/29/2023 – 22:00

via ZeroHedge News https://ift.tt/0ntMrJR Tyler Durden

Medicare’s Private Contractors Are Gaslighting Transplant Patients: Newt Gingrich

Medicare’s Private Contractors Are Gaslighting Transplant Patients: Newt Gingrich

Authored by Newt Gingrich via RealClear Wire,

Once again, the government is getting between patients and their doctors to ration care – and it’s endangering my own family.

Due to rare a lung disease that runs in the McPherson side of my family, two of my siblings have had lung transplants. Further, my sister-in-law has had a liver transplant. When my brother Randy received his transplant four years ago at our local hospital, INOVA, he stayed at our house for months while he recovered. I have personally witnessed the physical and emotional journey of a loved one who needs a transplant – and the relief and joy of being given a second chance through the gift of a donated organ.

Randy’s lung transplant was successful, but we quickly learned it was just the beginning of his journey as a transplant recipient. The complexity and precision needed to keep his newly transplanted organ healthy was intense. Estimates indicate that more than 40% of lung transplants will fail within five years. This is most often due to organ rejection by the recipient’s immune system. Doctors must find a precise balance of immunosuppressive drugs to keep the body from attacking itself.

Fortunately, there are advances in molecular diagnostics that give doctors the ability to monitor the health of organs more effectively. This largely replaced the previous surveillance method, which includes costly, painful biopsies. Biopsies are invasive procedures that require recovery time and have complication risks. Before the non-invasive molecular tests were available, Randy might have had to endure eight to 16 invasive biopsies in his first year post-transplant. Now, he just has his blood drawn. Access to these non-invasive surveillance tests is vital for identifying organ injury or rejection. Rejection can occur without signs or symptoms, and detecting it early can help prevent irreversible damage. So, when I heard that coverage for these tests was being dramatically curtailed, I suspected a faceless, unaccountable bureaucracy was the culprit. I was right.

Earlier this year, one of Medicare’s private contractors dramatically limited coverage for these tests without any opportunity for public comment, which violated the Medicare statute. The decision was made by Palmetto, a private contractor that operates Medicare’s Molecular Diagnostic Services Program (MolDX), with opaque accountability and oversight from the Centers for Medicare and Medicaid Services (CMS).

Doctors were given 30 days’ notice that they would be left without this critical surveillance tool to help manage organ rejection. Patients, such as my brother Randy, are left wondering if they will be able to protect their transplanted organ.

The Honor the Gift coalition, comprising 13 patient organizations such as the Lung Transplant Foundation, Transplant Life Foundation, and Transplant Recipients International Organization, alongside physician organizations like the American Society of Transplant Surgeons, American Society of Transplantation, International Society for Heart and Lung Transplantation, have written to the government to advocate for this cause. Regrettably, their appeals have been met with silence. They have had to turn to the public and Congress for assistance.

My friend, Congressman Michael Burgess (who is a medical doctor), along with 14 other members of Congress, sent CMS Administrator Chiquita Brooks-LaSure a letter asking for an explanation and calling into the question the process. They wrote, “This approach effectively silenced the voices of the transplant community, including patients, healthcare providers, and experts in the field.” Importantly, they noted that MolDX’s policy may especially harm poor communities that have “less access to specialized transplant centers, making non-invasive diagnostic tests even more critical for their ongoing post-transplant care.” Additionally, this decision disproportionally impacts black and Hispanic patients who represent 40% of transplants in the U.S., despite being only 32% of the population.

Rather than question its private contractor, review evidence, or listen to the front-line doctors using the tests, CMS doubled down on its decision. CMS issued a statement denying there was a coverage change and claimed it was just a clarification of coverage, asserting “… neither CMS nor the MACs have made changes that affect patient’s ability to have blood tests used to monitor organ transplantation.”

CMS’s private contractor is gaslighting Medicare transplant patients, their loved ones, and the physicians who care for them. It is using its private contractors and sub-regulatory policymaking to do so. Despite claiming that there was no change, now MolDX is attempting to promulgate these changes in coverage through a new proposed “Local Coverage Determination” (LCD). It is doing so while it continues to claim that substantial coverage changes are mere “clarifications.” CMS is also inappropriately limiting the comments it will consider to those related to clarity, not the decision itself. This is pure bureaucratic doublespeak and misdirection.

Dr. Burgess and Congresswoman Anna Eshoo sent a follow-up letter to CMS writing, “Your response letter dated September 26, 2023 did not answer our questions. Your letter also asserts beneficiary access to noninvasive post-transplant blood testing remains unchanged. This is in stark contrast to what transplant patients and physician associations nationwide have shared with us.”

The Wall Street Journal editorial board has published three brilliant editorials in the last several months on this issue. The board described the nonsensical actions CMS and Palmetto have taken and the economic short-sidedness of the decision. Ultimately, the editorial board called out this overreach for what it is: “MolDX and CMS may not admit it, but this looks like a classic case of government denying coverage to save money, though it isn’t clear it really will save money or lives if more transplants are rejected. This rule by bureaucratic diktat is the future of medicine as government dominates payments.”

The change in Medicare coverage puts patients’ health in jeopardy. It goes against medical evidence. And it is irrational economics. The surveillance blood test costs an estimated $3,000 each time, but lung and heart biopsies – which are invasive, painful, and damage the transplanted organ each time – can be triple the cost (if there are not complications).

All of this is happening under the watch of President Joe Biden, the Cancer Moonshot President, who claims he supports health innovation and signed a bill trying to make transplant organs more available. What is he doing to protect the gifted organs already in transplant patients while CMS is running amuck?

As we await the final decision from CMS, we will soon discover if government-led health care that dictates and rations medical care has been the president’s real agenda all along.

Newt Gingrich is a former speaker of the U.S. House of Representatives. Gingrich 360 advises the Honor the Gift coalition and consults with various companies in the health care industry.

Tyler Durden
Wed, 11/29/2023 – 21:40

via ZeroHedge News https://ift.tt/VcJTSKk Tyler Durden