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Sunday, September 3, 2023

Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging

 A federal appeals court ruled Friday that a lawsuit against the Food and Drug Administration (FDA) over its campaign against the use of ivermectin to treat COVID-19 can continue, reversing a lower court decision.

Three doctors sued the FDA last year claiming that the agency’s anti-ivermectin campaign went too far, overstepping its authority and acting more as a medical body than a regulator.

A district court ruled that the suit could not continue, but the 5th Circuit Appeals Court revived the doctors’ hope in its Friday ruling, sending the case back to lower court where it will be reconsidered.

“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise,” Judge Don Willett wrote for the appeals court. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

The FDA’s campaign, which included viral signs reading “You are not a horse,” emphasized agency recommendations that ivermectin — an anti-parasite medication often used for horses but sometimes prescribed to humans — should not be used to treat COVID-19.

“Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use,” the agency’s recommendations stated.

Some fringe conservative circles hailed the drug as a miracle cure, while others were hospitalized and some died from its side effects.

review of 14 studies on ivermectin use in 2021 found little significant evidence supporting its use, noting that among the studies, “few are considered high quality.”

“It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings,” researchers wrote.

The World Health Organization and the National Institutes of Health are among the bodies which have also recommended against ivermectin use for COVID treatment. The drug’s manufacturer, Merck, said there is “no meaningful evidence” that is is effective at treating the disease.

The three doctors said their reputations were harmed by the FDA campaign because they promoted ivermectin use. One doctor was suspended from a hospital, while another was fired from a medical school.“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” the doctors’ attorney Jared Kelson said in a statement. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”

Mary Talley Bowen, one of the plaintiffs, celebrated the ruling Friday.

“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny,” she said. “ONWARD!”

https://thehill.com/regulation/court-battles/4184259-federal-appeals-court-revives-lawsuit-against-fda-over-covid-19-ivermectin-messaging/

Yes, late-term abortions are real, and they happen every day

 There is a concerted effort from the abortion lobby and its allies in media to convince Americans that there is no such thing as late term abortion. It isn’t true.

Just recently, Planned Parenthood President Alexis McGill claimed that: “Like Nessie and Bigfoot, the term ‘late-term abortion’ is completely made up. It’s anti-abortion propaganda with no basis in medicine, intended to confuse people.” 

Likewise, former White House Press Secretary Jen Psaki echoed that “no one supports abortion up until birth,” and then later defended this claim on her MSNBC show: “This claim that Democrats support abortion up until the moment of birth is entirely misleading,” she said.

But the truth is that 10,000 babies’ lives are lost every year to late-term abortions, the majority of which take place for elective reasons.     

These denials of the harsh reality reveal one positive thing — the deniers at least recognize that support for limitless abortion is unpopular. One poll shows that 70 percent of Americans believe that abortion should be limited at least after 12 to 15 weeks into pregnancy, and other polls demonstrate the same consensus on the issue.

Throughout my time as a leader in the pro-life movement, I have worked to educate pro-abortion rights leaders about the beauty of life and the truth about abortion so that we can overcome the differences dividing us.   

Psaki’s claim, that “no one supports abortion up until birth,” has also been roundly debunked by the many members of her own party who refuse to name a single limit on abortion they would support. This includes Sens. Ben Cardin (D-Md.), Mark Kelly (D-Ariz.) and John Fetterman (D-Pa.); former gubernatorial candidate Stacey Abrams (D-Ga.); and former Reps. Beto O’Rourke (D-Tex.) and Tim Ryan (D-Ohio), among many others.  

As a Virginia resident, I will never forget the day when our former Governor Ralph Northam (D) admitted publicly that he believed it permissible, both as a physician and as governor, to allow survivors of botched abortions to be left to die even after they were born alive.  

Such heartlessness is not merely rhetorical. That same year, U.S. Senate Democratic leaders killed a bill that would have required medical care for babies who survive abortions. 

I could barely believe it then, and I also can’t believe that today, seven states and Washington D.C. have no limits on abortion whatsoever. The result of such policies was on display about a year ago when pro-life advocates discovered the mutilated remains of five fully formed babies, including possible victims of illegal partial birth abortions, originating from a Washington D.C. abortion clinic.

Some in Congress and the White House have also been fighting to pass the deceptively named “Women’s Health Protection Act (WHPA),” which would allow abortion on demand, up until birth, for any reason at any time. Supporters often claim that the WHPA’s mention of “viability” constitutes a limit on late-term abortion. But “viability” can be, and in the past has been, interpreted to mean just about anything. According to the late-term abortionist Warren Hern, “the viability of a fetus is determined not by gestational age but by a woman’s willingness to carry it.”

One of Planned Parenthood’s chief medical officers, Colleen McNicholas, similarly admitted during sworn testimony before Congress that “there is no particular gestational age” for viability. “There are some pregnancies in which the fetus will never be viable,” she added. “My practice includes (abortion) through the point of viability, and as we previously discussed, that could be at any point.”  

So late-term abortion is far from a myth. Statistically, it occurs dozens of times each day. This brings me enormous grief, especially since I have spent the past decade leading an organization that works and marches to ring in a new era where Psaki’s words ring true — when “no one supports abortion up until birth.” Unfortunately, we are not there yet, even though a large majority of Americans believe that second- and third-trimester abortions should be illegal.  

The 10,000 lives lost each year to late term abortions should compel even those who do not call themselves pro-life to join us as we work to end the violence and provide women and children with the resources, love and support they need to thrive.

Jeanne Mancini is president of the March for Life

https://thehill.com/opinion/healthcare/4182865-yes-late-term-abortions-are-real-and-they-happen-every-day/

France to ban disposable e-cigarettes, PM says

 France plans to ban disposable electronic cigarettes, French Prime Minister Elisabeth Borne said on radio station RTL on Sunday.

“It’s an important public health issue,” said Borne, adding that the government is drawing up plans for a national programme to fight tobacco use that she said was responsible for 75,000 deaths a year in France.

So-called "puff" devices generate habits among young people that can lead to tobacco addiction, she added.

However, the government does not plan to raise taxes on tobacco next year after an increase this year, the prime minister said.

French President Emmanuel Macron in 2021 set out ambitious plans to tackle tobacco and alcohol, pledging more smoking-free areas and aiming to make all 20-year-olds tobacco-free by 2030.

https://news.yahoo.com/france-ban-disposable-e-cigarettes-101239047.html

Canada shut its land border to asylum seekers. More refugees came anyway

 A deal Canada struck this year to stem the flow of asylum seekers entering from the U.S. was, at first glance, a quick success: Within days, the number of people caught at unofficial crossings along the border dwindled to a trickle.

But five months later, the overall number of people filing refugee claims in Canada has risen instead of falling. Many now come by air, while others sneak across the border and hide until they can apply for asylum without fear of being sent back, people working with migrants told Reuters.

The numbers show how hard it is for countries to shut the door on desperate people and the challenge unexpected numbers of asylum seekers can pose: In Toronto, hundreds slept on the streets this summer as they struggled to find beds.

"The basic reality is that closing a border doesn’t do anything to solve the need for protection," said Shauna Labman, an associate professor and acting director of the Human Rights Program at the University of Winnipeg.

"It only increases the desperation."

Canada prides itself on welcoming immigrants and aims to bring in a record half a million new permanent residents in 2025 to deal with an acute labor shortage. But it has sought to discourage those applying for asylum, chiefly through an agreement with the U.S. under which each country turns back asylum seekers.

Still, last year alone, more than 39,000 asylum seekers entered Canada via unofficial crossings - mostly into Quebec via a dirt path off Roxham Road in New York, prompting the province to complain it could not handle the arrivals. Asylum seekers are drawn by Canada's reputation for swifter processing and greater acceptance of asylum applications compared to the U.S.

In response, Canada and the United States in March amended their two-decade-old asylum-seeker pact, the Safe Third Country Agreement. The agreement now applies to the length of the countries' 4,000-mile land border, rather than just at ports of entry.

The expanded pact led to a dramatic drop in the number of people intercepted at informal crossings - down to double digits in April through July from 4,173 in March.

But overall, the number of asylum seekers entering Canada has surged. The total number of refugee claims made in Canada rose in July to 12,010 - the highest monthly total since at least January 2017 - and up from 10,120 in March, according to data from the immigration, refugees and citizenship department.

DEMAND FOR SAFETY

Some of the higher numbers are being driven by more people filing refugee claims at airports or local immigration department offices - often days, weeks or months after arriving in the country, government data shows.

People applying at airports comprised about a third of all refugee claims made in July, up from about 16% in March. Those filing claims at immigration offices accounted for about 54% of July's total, up from about a third in March. The top five countries that claimants came from in the first half of the year were Mexico, Haiti, Turkey, Colombia and India - though the numbers include those who applied before the expanded U.S. pact.

At least part of the reason for the latest influx is that Canada is among a shrinking group of countries seen as offering safe harbor while pressures of war, climate change and human rights violations force a greater number to flee, some migrant experts say.

The European Union, for example, recently introduced an asylum seeker pact allowing nations to more quickly send back some migrants. Britain's government is pushing forward on a law making it easier to send asylum seekers to Rwanda, while U.S. President Joe Biden's administration has introduced a rule making it harder for migrants to receive asylum if they cross U.S. borders illegally.

"If you’re a person who’s trying to make this set of decisions, then Canada becomes a more likely option," said Craig Damian Smith, a research affiliate at the Centre for Refugee Studies at York University.

Canada's immigration minister was not available for an interview.

"The world is facing unprecedented flows of migrants and refugees, and Canada is not immune to these trends," Remi Lariviere, a spokesperson for the department, said in a statement.

Lariviere said Canada amended the deal with the U.S. to address "irregular" crossings and that the expansion "does not mean that claims for asylum will not be made in Canada at all."

'BAD ACTORS'

People working with migrants say some of the people filing claims days or weeks after they arrive in Canada are hoping to skirt a clause in the expanded agreement with the U.S. that says any asylum seeker apprehended within two weeks of crossing the border will be turned back unless they meet a narrow exemption.

That has prompted some to cross over undetected, sometimes with a smuggler's help, and hide until the two-week period elapses.

The Refugee Centre in Montreal says it helped four families in one day last week who had been in hiding for a fortnight after crossing overland into the country.

"Unfortunately this is not a very safe avenue for them," Executive Director Abdulla Daoud told Reuters. "It promotes bad actors who take advantage of these individuals."

At the FCJ Refugee Centre in Toronto, about 20% to 30% of recent arrivals say they crossed into Canada undetected and hid with a smuggler's help, Executive Director Loly Rico said.

Reuters spoke with 10 people seeking refugee status who recently arrived in Toronto, Canada's largest city. They came from Sudan, Uganda and Mexico, among other places. All arrived by plane, with valid visas in hand. Some filed refugee claims days or weeks after their arrival.

Though they left for reasons ranging from domestic violence to war, the common draw for all was Canada's reputation for protecting human rights and providing refuge.

"It is the first country that I thought about," said Hana Bakhit. The 35-year-old from war-torn Sudan says she applied for a visitor’s visa in May, flew to Canada in July and filed a refugee claim two weeks later.

She has been sleeping in a mosque and a church, calling Toronto’s central shelter daily for a bed, only to be told there are none available. Still, she considers herself lucky to be in Canada.

With Canada's land border largely closed off, the asylum system now favors people like Bakhit who can get a visa and plane ticket, refugee lawyer Maureen Silcoff said.

"Some of the most vulnerable people remain barred from accessing Canada’s system and I think we have to reflect on the inequity of that development," Silcoff said.

Grace Nanziri, 42, was among those with the comparative privilege of being able to get a visa and flight ticket: she applied for a Canadian visitor's visa when her LGBTQ advocacy made her a target in her home country, Uganda.

After waiting a year for the visa, she flew to Toronto in August - drawn by Canada's reputation of protecting human rights, she said.

"They wanted to kill me," she said. "That’s why I came to Canada."

https://news.yahoo.com/canada-shut-land-border-asylum-100632402.html

Pentagon Extends Troop Deployment At US-Mexico Border Through September

 by Aldgra Fredly via The Epoch Times,

The U.S. Defense Department said Thursday that it will extend the deployment of up to 400 active-duty American troops at the U.S. southern border with Mexico until at least the end of September.

The Pentagon had pulled 1,100 troops from the border last month but extended the deployment of the remaining 400 soldiers.

"On Aug. 24, 2023, the secretary of defense approved an extension of up to 400 personnel providing support to Customs and Border Protection on the southwest border through Sept. 30, 2023," Pentagon spokesman Lt. Col. Devin Robinson told NBC News on Sept. 1.

Secretary of Defense Lloyd Austin approved in May the deployment of 1,500 active-duty troops to the southern border for 90 days to assist border officials with a possible influx of illegal immigration at the border.

The Pentagon said the troops will "fill critical capability gaps, such as ground-based detection and monitoring, data entry, and warehouse support" but will not directly participate in law enforcement activities.

The troops were intended to help back up border officials dealing with the end of Title 42, which allowed U.S. authorities to quickly expel tens of thousands of migrants from the country in the name of protecting Americans from COVID-19.

Spike in Illegal Border Crossings

Data released by Customs and Border Protection (CBP) on Aug. 18 showed that the U.S. Border Patrol recorded 132,652 encounters between ports of entry along the southwest border in July, up from 99,545 in June.

Migrants seeking asylum wait for U.S. Customs and Border Protection agents to allow them enter the United States at the San Ysidro crossing port on the US-Mexico border, as seen from Tijuana, Baja California state, Mexico on May 31, 2023. (Guillermo Arias/AFP via Getty Images)

According to CBP data, the U.S. Border Patrol encountered an average of 2,016 single adults per day in July alone, marking a 66 percent decrease from the 6,164 they encountered per day in the first 11 days of May.

"CBP's message for anyone who is thinking of entering the United States without authorization or illegally along the southwest border is simple: don't do it. When noncitizens cross the border unlawfully, they put their lives in peril," it stated.

CBP One App

The latest numbers also reflect a sharp increase in use of the CBP One mobile app through which up to 1,450 migrants can get appointments at land crossings with Mexico to seek asylum. CBP processed more than 44,700 individuals with CBP One appointments at ports of entry in July.

CBP One is for people of any nationality in central and northern Mexico entering the United States by land and seeking asylum or humanitarian parole.

Migrants must book an appointment through the app and show up to the appointment at U.S. ports of entry. If they don't have an appointment, they would be turned away.

Rep. Tom McClintock (R-Calif.) said on July 26 at the House Judiciary Committee hearing that the influx of people at the border has not decreased, noting that the CBP One app "allows migrants to bypass the southern border and enter directly in the United States’ ports of entry."

"Instead of bringing them to the southern border, you’re bringing them directly to ports of entry,” Mr. McClintock said.

Texas Attorney General Ken Paxton makes a statement at his office in Austin, Texas, on May 26, 2023. (Eric Gay/AP Photo)

Texas Attorney General Ken Paxton filed a lawsuit against the Biden Administration on May 23 to challenge a rule that encourages illegal immigrants to use CBP One app to seek entry into the United States.

Mr. Paxton said the app encourages illegal immigration to the United States because it "cannot verify that an illegal immigrant would qualify for an exception, which would prevent them from being deported."

"The Biden Administration deliberately conceived of this phone app with the goal of illegally pre-approving more foreign aliens to enter the country and go where they please once they arrive," he said in a press release.

Saturday, September 2, 2023

Highest-Earning Creators Of The Internet Content Machine

 At the 2023 Streamy Awards which aired Sunday night on YouTube, content creator MrBeast aka Jimmy Donaldson won the main category Creator of the Year as well as the award for Best Collaboration (with Dwayne "The Rock" Johnson). The 25-year-old who grew up in North Carolina was the only winner taking home multiple awards, showing the resounding success he has had with his YouTube channel focused on over-the-top challenges (and the occasional grand gesture).

As Statista's Katharina Buchholz reportsthe latest release of Forbes' list of the most successful internet creators lists Donaldson as the highest-earning of them all - at a yearly gross of $54 million. The MrBeast channel was also the second-most followed on YouTube as of August 2023 - up from rank 4 at the beginning of the year. In this time span, Donaldson has attracted attention for paying for operations making 1,000 blind people see and 1,000 deaf people hear.

Infographic: The Highest-Earning Creators of the Internet Content Machine | Statista

SF Records More Than A Dozen Suspected Overdose Deaths In One Day

 by Travis Gillmore via The Epoch Times,

Videos from San Francisco posted on social media Aug. 30 show morgue vans loading bodies amid scenes of widespread addiction, with people folded up and contorted in unnatural positions in what many describe as dystopian settings on the streets of downtown.

Posts on X, formerly known as Twitter, repeatedly shared by locals indicated that as many as 18 overdose deaths took place in San Francisco throughout the day, but a spokesperson for the chief medical examiner’s office told The Epoch Times by email Aug. 31 that 13 deaths occurred and are currently under investigation.

“Today, the Office of the Chief Medical Examiner initiated examinations on 13 cases received within the past twenty-four hours,” the spokesperson wrote.

“The case and manner of death for these decedents remain under review.”

No toxicology results are yet available, and the examiner’s office had no further comment.

Approximately 2,500 people have died from overdose in San Francisco since 2020, according to medical examiner statistics (pdf) including the first seven months of 2023.

More than 81 percent of such cases revealed fentanyl during toxicology testing.

While deaths dipped slightly last year, numbers are now on the rise and on pace to set a record, as more than 500 have occurred in the city so far, with 71 accidental overdose deaths in July alone, according to the medical examiner’s data.

Overdose locations are spread throughout the city and concentrated in certain areas, based on medical examiner records.

Known for high crime and open-air drug markets, the Tenderloin accounts for approximately 18 percent of deaths, with the SOMA area, which is short for South of Market located blocks from Union Square, and Polk/Russian Hill—known for curvy, picturesque Lombard Street—each accounting for 20 percent.

Homeless people gather near drug dealers in the Tenderloin District of San Francisco on Feb. 22, 2023. (John Fredricks/The Epoch Times)

Fentanyl is responsible for the majority of deaths this year, according to testing results released by the medical examiner.

Odorless, tasteless, and highly toxic, the insidious nature by which fentanyl poisonings occur in unsuspecting victims is leading to rising numbers of overdose deaths, according to experts.

New synthetic analogs—drugs that are similar chemically but not identical to fentanyl— and other tranquilizers including Xylazine and Isotonitazine further complicate matters, as they are resistant to opioid reversal medications like naloxone, better known as Narcan. Xylazine is responsible for at least 16 deaths in San Francisco in 2023, according to the report, and isotonitazine is reportedly 20 times stronger than fentanyl, according to the Drug Enforcement Agency.

Victim advocates and family members of those lost to addiction wrote thousands of names in chalk on the sidewalk outside City Hall that night, as the deaths occurred one day before San Francisco Supervisor Dean Preston held a gathering to bring attention to International Overdose Awareness Day on Aug. 31.

“Overdoses are at crisis levels,” Mr. Preston wrote on X the same day.

“Today & every day, I’ll continue to work to ensure our city is using every evidence-based tool at our disposal—including overdose prevention, treatment on demand, recovery resources—to reduce overdoses [and] save lives.”

Supervisors have faced scrutiny on social media, as concerned residents express disappointment in the public safety issues plaguing the city, and many questioned Mr. Preston’s post with comments about perceived policy failures.

A drug user displays fentanyl in the Tenderloin District of San Francisco on Feb. 23, 2023. (John Fredricks/The Epoch Times)

At the drug awareness gathering, one advocate for harm reduction—which focuses on education and overdose prevention as opposed to prosecution—was pictured at the event waving a sign declaring “Downtown is for drug users,” and another wore a “police are terrorists” shirt.

Responsible for nearly 6,000 deaths a year in California, as of the latest statistics from the Department of Public Health covering 2021, fentanyl is drawing attention from lawmakers on both sides of the aisle.

Bipartisan bills seeking to increase penalties for fentanyl distribution were met with resistance in the Legislature, with members of public safety committees in both houses voicing preference for rehabilitation and overdose prevention.

Some lawmakers voiced reluctance to advance any proposals that include punitive measures, including incarceration, arguing that doing so would be extending the “failed War on Drugs.” Subsequently, eight of nine such bills were killed earlier this year.

California Gov. Gavin Newsom announced in May a joint operation between California Highway Patrol and the National Guard to disrupt fentanyl distribution in San Francisco.

Since then, hundreds of arrests have been made and enough fentanyl seized in two neighborhoods—56 kilograms—to kill nearly the state’s entire population, according to San Francisco Mayor London Breed’s office released Sept. 1.