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Senate panel backs Biden’s FDA selection Robert Califf

Robert Califf has cleared another stage on his return journey to the top job at the FDA, after
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Robert Califf has cleared another stage on his return journey to the top job at the FDA, after the influential Senate committee on Health, Education, Labour and Pensions (HELP) voted by 13 to eight to support his nomination by President Joe Biden.

Califf was nominated by Biden as FDA commissioner last November, ending a search for a permanent replacement for current acting commissioner Janet Woodcock after almost a full year of the new administration.

He led the FDA under the Obama administration in 2016 and garnered a reputation for cracking down on manufacturing and safety, and pushed for the modernisation of the regulator before Donald Trump’s election win saw his time come to an end just 11 months later.

If he makes it over the line, Califf will lead an agency having to make difficult decisions over the future handling of the pandemic, affected by a lack of permanent leadership and facing scrutiny over its handling of the opioid epidemic.

The dissenting votes – from Vermont independent Bernie Saunders, Democrats Maggie Hassan and Edward Markey, and a clutch of Republican senators – suggest that the full Senate vote on Califf’s appointment may not be a foregone conclusion.

Sanders reiterated his concerns about Califf’s consultancy work with pharma companies and the “revolving door” between the FDA and industry, while Hassan and Markey are both from US states (New Hampshire and Massachusetts, respectively) that have been hard hit by the opioid crisis.

Hassan said in a statement that she did not believe Califf would take the action needed to address the FDA’s “inaction…to address opioid misuse and the failure to address issues of labelling guidance for prescriptions.”

Califf has said he will review FDA decision-making on opioid drugs, and he will face other challenges as well.

An advocate of reform of the clinical trial framework, Califf will have to tackle the issue of approving drugs based on preliminary data while a confirmatory trial is carried out – brought to the fore last year when the FDA approved Biogen and Eisai’s Alzheimer’s drug Aduhelm (aducanumab). It’s now facing an investigation into that by the Office of the Inspector General (OIG).

There have been concerns that for many years the industry dragged its heels on those follow-up studies, and the DA failed to take a tough stance on tardy companies. There are signs of change with various cancer drugs losing indications last year, but pressure from within and outside the agency to do more.

After so long without a permanent commissioner, however, market observers think that the odds are in favour of Califf returning to the role.

“As a former FDA commissioner, Dr Califf is an experienced pick to lead this important agency, and today the committee advanced his nomination in a bipartisan manner,” said HELP chair, Washington Democrat Patty Murray.

“As our nation continues to fight the COVID-19 pandemic, the scientists and experts at the Food and Drug Administration who are working diligently to ensure we have safe and effective vaccines, tests, treatments, and more, deserve a strong leader who will make sure science always comes first,” she added.

A date for the full Senate vote has not yet been set.

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The Grinch Who Stole Freedom

The Grinch Who Stole Freedom

Authored by Jeffrey A. Tucker via The Epoch Times (emphasis ours),

Before President Joe Biden’s State of the…

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The Grinch Who Stole Freedom

Authored by Jeffrey A. Tucker via The Epoch Times (emphasis ours),

Before President Joe Biden’s State of the Union address, the pundit class was predicting that he would deliver a message of unity and calm, if only to attract undecided voters to his side.

President Joe Biden delivers the State of the Union address in the House Chamber of the U.S. Capitol in Washington, D.C., on March 7, 2024. (Mandel Ngan/AFP/Getty Images)

He did the opposite. The speech revealed a loud, cranky, angry, bitter side of the man that people don’t usually see. It seemed like the real Joe Biden I remember from the old days, full of venom, sarcasm, disdain, threats, and extreme partisanship.

The base might have loved it except that he made reference to an “illegal” alien, which is apparently a trigger word for the left. He failed their purity test.

The speech was stunning in its bile and bitterness. It’s beyond belief that he began with a pitch for more funds for the Ukraine war, which has killed 10,000 civilians and some 200,000 troops on both sides. It’s a bloody mess that could have been resolved early on but for U.S. tax funding of the conflict.

Despite the push from the higher ends of conservative commentary, average Republicans have turned hard against this war. The United States is in a fiscal crisis and every manner of domestic crisis, and the U.S. president opens his speech with a pitch to protect the border in Ukraine? It was completely bizarre, and lent some weight to the darkest conspiracies about why the Biden administration cares so much about this issue.

From there, he pivoted to wildly overblown rhetoric about the most hysterically exaggerated event of our times: the legendary Jan. 6 protests on Capitol Hill. Arrests for daring to protest the government on that day are growing.

The media and the Biden administration continue to describe it as the worst crisis since the War of the Roses, or something. It’s all a wild stretch, but it set the tone of the whole speech, complete with unrelenting attacks on former President Donald Trump. He would use the speech not to unite or make a pitch that he is president of the entire country but rather intensify his fundamental attack on everything America is supposed to be.

Hard to isolate the most alarming part, but one aspect really stood out to me. He glared directly at the Supreme Court Justices sitting there and threatened them with political power. He said that they were awful for getting rid of nationwide abortion rights and returning the issue to the states where it belongs, very obviously. But President Biden whipped up his base to exact some kind of retribution against the court.

Looking this up, we have a few historical examples of presidents criticizing the court but none to their faces in a State of the Union address. This comes two weeks after President Biden directly bragged about defying the Supreme Court over the issue of student loan forgiveness. The court said he could not do this on his own, but President Biden did it anyway.

Here we have an issue of civic decorum that you cannot legislate or legally codify. Essentially, under the U.S. system, the president has to agree to defer to the highest court in its rulings even if he doesn’t like them. President Biden is now aggressively defying the court and adding direct threats on top of that. In other words, this president is plunging us straight into lawlessness and dictatorship.

In the background here, you must understand, is the most important free speech case in U.S. history. The Supreme Court on March 18 will hear arguments over an injunction against President Biden’s administrative agencies as issued by the Fifth Circuit. The injunction would forbid government agencies from imposing themselves on media and social media companies to curate content and censor contrary opinions, either directly or indirectly through so-called “switchboarding.”

A ruling for the plaintiffs in the case would force the dismantling of a growing and massive industry that has come to be called the censorship-industrial complex. It involves dozens or even more than 100 government agencies, including quasi-intelligence agencies such as the Cybersecurity and Infrastructure Security Agency (CISA), which was set up only in 2018 but managed information flow, labor force designations, and absentee voting during the COVID-19 response.

A good ruling here will protect free speech or at least intend to. But, of course, the Biden administration could directly defy it. That seems to be where this administration is headed. It’s extremely dangerous.

A ruling for the defense and against the injunction would be a catastrophe. It would invite every government agency to exercise direct control over all media and social media in the country, effectively abolishing the First Amendment.

Close watchers of the court have no clear idea of how this will turn out. But watching President Biden glare at court members at the address, one does wonder. Did they sense the threats he was making against them? Will they stand up for the independence of the judicial branch?

Maybe his intimidation tactics will end up backfiring. After all, does the Supreme Court really think it is wise to license this administration with the power to control all information flows in the United States?

The deeper issue here is a pressing battle that is roiling American life today. It concerns the future and power of the administrative state versus the elected one. The Constitution contains no reference to a fourth branch of government, but that is what has been allowed to form and entrench itself, in complete violation of the Founders’ intentions. Only the Supreme Court can stop it, if they are brave enough to take it on.

If you haven’t figured it out yet, and surely you have, President Biden is nothing but a marionette of deep-state interests. He is there to pretend to be the people’s representative, but everything that he does is about entrenching the fourth branch of government, the permanent bureaucracy that goes on its merry way without any real civilian oversight.

We know this for a fact by virtue of one of his first acts as president, to repeal an executive order by President Trump that would have reclassified some (or many) federal employees as directly under the control of the elected president rather than have independent power. The elites in Washington absolutely panicked about President Trump’s executive order. They plotted to make sure that he didn’t get a second term, and quickly scratched that brilliant act by President Trump from the historical record.

This epic battle is the subtext behind nearly everything taking place in Washington today.

Aside from the vicious moment of directly attacking the Supreme Court, President Biden set himself up as some kind of economic central planner, promising to abolish hidden fees and bags of chips that weren’t full enough, as if he has the power to do this, which he does not. He was up there just muttering gibberish. If he is serious, he believes that the U.S. president has the power to dictate the prices of every candy bar and hotel room in the United States—an absolutely terrifying exercise of power that compares only to Stalin and Mao. And yet there he was promising to do just that.

Aside from demonizing the opposition, wildly exaggerating about Jan. 6, whipping up war frenzy, swearing to end climate change, which will make the “green energy” industry rich, threatening more taxes on business enterprise, promising to cure cancer (again!), and parading as the master of candy bar prices, what else did he do? Well, he took credit for the supposedly growing economy even as a vast number of Americans are deeply suffering from his awful policies.

It’s hard to imagine that this speech could be considered a success. The optics alone made him look like the Grinch who stole freedom, except the Grinch was far more articulate and clever. He’s a mean one, Mr. Biden.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Mon, 03/11/2024 - 12:00

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International

Chinese migration to US is nothing new – but the reasons for recent surge at Southern border are

A gloomier economic outlook in China and tightening state control have combined with the influence of social media in encouraging migration.

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Chinese migrants wait for a boat after having walked across the Darien Gap from Colombia to Panama. AP Photo/Natacha Pisarenko

The brief closure of the Darien Gap – a perilous 66-mile jungle journey linking South American and Central America – in February 2024 temporarily halted one of the Western Hemisphere’s busiest migration routes. It also highlighted its importance to a small but growing group of people that depend on that pass to make it to the U.S.: Chinese migrants.

While a record 2.5 million migrants were detained at the United States’ southwestern land border in 2023, only about 37,000 were from China.

I’m a scholar of migration and China. What I find most remarkable in these figures is the speed with which the number of Chinese migrants is growing. Nearly 10 times as many Chinese migrants crossed the southern border in 2023 as in 2022. In December 2023 alone, U.S. Border Patrol officials reported encounters with about 6,000 Chinese migrants, in contrast to the 900 they reported a year earlier in December 2022.

The dramatic uptick is the result of a confluence of factors that range from a slowing Chinese economy and tightening political control by President Xi Jinping to the easy access to online information on Chinese social media about how to make the trip.

Middle-class migrants

Journalists reporting from the border have generalized that Chinese migrants come largely from the self-employed middle class. They are not rich enough to use education or work opportunities as a means of entry, but they can afford to fly across the world.

According to a report from Reuters, in many cases those attempting to make the crossing are small-business owners who saw irreparable damage to their primary or sole source of income due to China’s “zero COVID” policies. The migrants are women, men and, in some cases, children accompanying parents from all over China.

Chinese nationals have long made the journey to the United States seeking economic opportunity or political freedom. Based on recent media interviews with migrants coming by way of South America and the U.S.’s southern border, the increase in numbers seems driven by two factors.

First, the most common path for immigration for Chinese nationals is through a student visa or H1-B visa for skilled workers. But travel restrictions during the early months of the pandemic temporarily stalled migration from China. Immigrant visas are out of reach for many Chinese nationals without family or vocation-based preferences, and tourist visas require a personal interview with a U.S. consulate to gauge the likelihood of the traveler returning to China.

Social media tutorials

Second, with the legal routes for immigration difficult to follow, social media accounts have outlined alternatives for Chinese who feel an urgent need to emigrate. Accounts on Douyin, the TikTok clone available in mainland China, document locations open for visa-free travel by Chinese passport holders. On TikTok itself, migrants could find information on where to cross the border, as well as information about transportation and smugglers, commonly known as “snakeheads,” who are experienced with bringing migrants on the journey north.

With virtual private networks, immigrants can also gather information from U.S. apps such as X, YouTube, Facebook and other sites that are otherwise blocked by Chinese censors.

Inspired by social media posts that both offer practical guides and celebrate the journey, thousands of Chinese migrants have been flying to Ecuador, which allows visa-free travel for Chinese citizens, and then making their way over land to the U.S.-Mexican border.

This journey involves trekking through the Darien Gap, which despite its notoriety as a dangerous crossing has become an increasingly common route for migrants from Venezuela, Colombia and all over the world.

In addition to information about crossing the Darien Gap, these social media posts highlight the best places to cross the border. This has led to a large share of Chinese asylum seekers following the same path to Mexico’s Baja California to cross the border near San Diego.

Chinese migration to US is nothing new

The rapid increase in numbers and the ease of accessing information via social media on their smartphones are new innovations. But there is a longer history of Chinese migration to the U.S. over the southern border – and at the hands of smugglers.

From 1882 to 1943, the United States banned all immigration by male Chinese laborers and most Chinese women. A combination of economic competition and racist concerns about Chinese culture and assimilability ensured that the Chinese would be the first ethnic group to enter the United States illegally.

With legal options for arrival eliminated, some Chinese migrants took advantage of the relative ease of movement between the U.S. and Mexico during those years. While some migrants adopted Mexican names and spoke enough Spanish to pass as migrant workers, others used borrowed identities or paperwork from Chinese people with a right of entry, like U.S.-born citizens. Similarly to what we are seeing today, it was middle- and working-class Chinese who more frequently turned to illegal means. Those with money and education were able to circumvent the law by arriving as students or members of the merchant class, both exceptions to the exclusion law.

Though these Chinese exclusion laws officially ended in 1943, restrictions on migration from Asia continued until Congress revised U.S. immigration law in the Hart-Celler Act in 1965. New priorities for immigrant visas that stressed vocational skills as well as family reunification, alongside then Chinese leader Deng Xiaoping’s policies of “reform and opening,” helped many Chinese migrants make their way legally to the U.S. in the 1980s and 1990s.

Even after the restrictive immigration laws ended, Chinese migrants without the education or family connections often needed for U.S. visas continued to take dangerous routes with the help of “snakeheads.”

One notorious incident occurred in 1993, when a ship called the Golden Venture ran aground near New York, resulting in the drowning deaths of 10 Chinese migrants and the arrest and conviction of the snakeheads attempting to smuggle hundreds of Chinese migrants into the United States.

Existing tensions

Though there is plenty of precedent for Chinese migrants arriving without documentation, Chinese asylum seekers have better odds of success than many of the other migrants making the dangerous journey north.

An estimated 55% of Chinese asylum seekers are successful in making their claims, often citing political oppression and lack of religious freedom in China as motivations. By contrast, only 29% of Venezuelans seeking asylum in the U.S. have their claim granted, and the number is even lower for Colombians, at 19%.

The new halt on the migratory highway from the south has affected thousands of new migrants seeking refuge in the U.S. But the mix of push factors from their home country and encouragement on social media means that Chinese migrants will continue to seek routes to America.

And with both migration and the perceived threat from China likely to be features of the upcoming U.S. election, there is a risk that increased Chinese migration could become politicized, leaning further into existing tensions between Washington and Beijing.

Meredith Oyen does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Vaccine-skeptical mothers say bad health care experiences made them distrust the medical system

Vaccine skepticism, and the broader medical mistrust and far-reaching anxieties it reflects, is not just a fringe position in the 21st century.

Women's own negative medical experiences influence their vaccine decisions for their kids. AP Photo/Ted S. Warren

Why would a mother reject safe, potentially lifesaving vaccines for her child?

Popular writing on vaccine skepticism often denigrates white and middle-class mothers who reject some or all recommended vaccines as hysterical, misinformed, zealous or ignorant. Mainstream media and medical providers increasingly dismiss vaccine refusal as a hallmark of American fringe ideology, far-right radicalization or anti-intellectualism.

But vaccine skepticism, and the broader medical mistrust and far-reaching anxieties it reflects, is not just a fringe position.

Pediatric vaccination rates had already fallen sharply before the COVID-19 pandemic, ushering in the return of measles, mumps and chickenpox to the U.S. in 2019. Four years after the pandemic’s onset, a growing number of Americans doubt the safety, efficacy and necessity of routine vaccines. Childhood vaccination rates have declined substantially across the U.S., which public health officials attribute to a “spillover” effect from pandemic-related vaccine skepticism and blame for the recent measles outbreak. Almost half of American mothers rated the risk of side effects from the MMR vaccine as medium or high in a 2023 survey by Pew Research.

Recommended vaccines go through rigorous testing and evaluation, and the most infamous charges of vaccine-induced injury have been thoroughly debunked. How do so many mothers – primary caregivers and health care decision-makers for their families – become wary of U.S. health care and one of its most proven preventive technologies?

I’m a cultural anthropologist who studies the ways feelings and beliefs circulate in American society. To investigate what’s behind mothers’ vaccine skepticism, I interviewed vaccine-skeptical mothers about their perceptions of existing and novel vaccines. What they told me complicates sweeping and overly simplified portrayals of their misgivings by pointing to the U.S. health care system itself. The medical system’s failures and harms against women gave rise to their pervasive vaccine skepticism and generalized medical mistrust.

The seeds of women’s skepticism

I conducted this ethnographic research in Oregon from 2020 to 2021 with predominantly white mothers between the ages of 25 and 60. My findings reveal new insights about the origins of vaccine skepticism among this demographic. These women traced their distrust of vaccines, and of U.S. health care more generally, to ongoing and repeated instances of medical harm they experienced from childhood through childbirth.

girl sitting on exam table faces a doctor viewer can see from behind
A woman’s own childhood mistreatment by a doctor can shape her health care decisions for the next generation. FatCamera/E+ via Getty Images

As young girls in medical offices, they were touched without consent, yelled at, disbelieved or threatened. One mother, Susan, recalled her pediatrician abruptly lying her down and performing a rectal exam without her consent at the age of 12. Another mother, Luna, shared how a pediatrician once threatened to have her institutionalized when she voiced anxiety at a routine physical.

As women giving birth, they often felt managed, pressured or discounted. One mother, Meryl, told me, “I felt like I was coerced under distress into Pitocin and induction” during labor. Another mother, Hallie, shared, “I really battled with my provider” throughout the childbirth experience.

Together with the convoluted bureaucracy of for-profit health care, experiences of medical harm contributed to “one million little touch points of information,” in one mother’s phrase, that underscored the untrustworthiness and harmful effects of U.S. health care writ large.

A system that doesn’t serve them

Many mothers I interviewed rejected the premise that public health entities such as the Centers for Disease Control and Prevention and the Food and Drug Administration had their children’s best interests at heart. Instead, they tied childhood vaccination and the more recent development of COVID-19 vaccines to a bloated pharmaceutical industry and for-profit health care model. As one mother explained, “The FDA is not looking out for our health. They’re looking out for their wealth.”

After ongoing negative medical encounters, the women I interviewed lost trust not only in providers but the medical system. Frustrating experiences prompted them to “do their own research” in the name of bodily autonomy. Such research often included books, articles and podcasts deeply critical of vaccines, public health care and drug companies.

These materials, which have proliferated since 2020, cast light on past vaccine trials gone awry, broader histories of medical harm and abuse, the rapid growth of the recommended vaccine schedule in the late 20th century and the massive profits reaped from drug development and for-profit health care. They confirmed and hardened women’s suspicions about U.S. health care.

hands point to a handwritten vaccination record
The number of recommended childhood vaccines has increased over time. Mike Adaskaveg/MediaNews Group/Boston Herald via Getty Images

The stories these women told me add nuance to existing academic research into vaccine skepticism. Most studies have considered vaccine skepticism among primarily white and middle-class parents to be an outgrowth of today’s neoliberal parenting and intensive mothering. Researchers have theorized vaccine skepticism among white and well-off mothers to be an outcome of consumer health care and its emphasis on individual choice and risk reduction. Other researchers highlight vaccine skepticism as a collective identity that can provide mothers with a sense of belonging.

Seeing medical care as a threat to health

The perceptions mothers shared are far from isolated or fringe, and they are not unreasonable. Rather, they represent a growing population of Americans who hold the pervasive belief that U.S. health care harms more than it helps.

Data suggests that the number of Americans harmed in the course of treatment remains high, with incidents of medical error in the U.S. outnumbering those in peer countries, despite more money being spent per capita on health care. One 2023 study found that diagnostic error, one kind of medical error, accounted for 371,000 deaths and 424,000 permanent disabilities among Americans every year.

Studies reveal particularly high rates of medical error in the treatment of vulnerable communities, including women, people of color, disabled, poor, LGBTQ+ and gender-nonconforming individuals and the elderly. The number of U.S. women who have died because of pregnancy-related causes has increased substantially in recent years, with maternal death rates doubling between 1999 and 2019.

The prevalence of medical harm points to the relevance of philosopher Ivan Illich’s manifesto against the “disease of medical progress.” In his 1982 book “Medical Nemesis,” he insisted that rather than being incidental, harm flows inevitably from the structure of institutionalized and for-profit health care itself. Illich wrote, “The medical establishment has become a major threat to health,” and has created its own “epidemic” of iatrogenic illness – that is, illness caused by a physician or the health care system itself.

Four decades later, medical mistrust among Americans remains alarmingly high. Only 23% of Americans express high confidence in the medical system. The United States ranks 24th out of 29 peer high-income countries for the level of public trust in medical providers.

For people like the mothers I interviewed, who have experienced real or perceived harm at the hands of medical providers; have felt belittled, dismissed or disbelieved in a doctor’s office; or spent countless hours fighting to pay for, understand or use health benefits, skepticism and distrust are rational responses to lived experience. These attitudes do not emerge solely from ignorance, conspiracy thinking, far-right extremism or hysteria, but rather the historical and ongoing harms endemic to the U.S. health care system itself.

Johanna Richlin does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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