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Sunday, February 19, 2023

The Dangers of a Sentimental Education

 In an elementary school textbook, a math problem is framed by the cryptic question, “How can you understand your feelings?” Another asks students to write “math biographies” to soothe “math anxiety.” Controversy erupted last April when this textbook and 19 others were excluded from the Florida Department of Education’s recommendations. Amid ongoing furor over the role of race and sexuality in America’s classrooms, Florida cited an obscure justification: “the unsolicited addition of Social-Emotional Learning (SEL) in mathematics.”

But what exactly is social-emotional learning? Proponents claim that it is a pedagogical method that fosters social and emotional skills, but finding a real answer requires a Dante-esque descent into an inferno of impenetrable jargon. A leading SEL organization, the Collaborative for Advancing Social and Emotional Learning (CASEL), touts “evidence-based best practices” for making “framework connections” and claims “the story of SEL is as old as the first relationships between teachers and students.” In reality, however, the organized movement pushing for nationwide SEL only emerged after the passage of the 2015 Every Student Succeeds Act, the federal education law that allows states to use one nonacademic measure for accountability alongside the preexisting standardized tests routinely given to students. In contrast to earlier quantitative testing-based reform, SEL calls for the incorporation of nonacademic “soft skills” like empathy and emotional management into traditional classroom instruction.

Today, SEL is emerging as a lightning rod in the culture wars over school curriculum. Progressives uphold it as an unobjectionable method for building emotional self-regulation in students, something not just benign but potentially lifesaving in the face of rising teen suicide rates. But conservatives reject those claims and argue that SEL smuggles ideological indoctrination into classrooms, serving as a gateway to critical race theory or boutique gender ideology.

Conservatives are right to distrust SEL. However, SEL is not indoctrination, but something worse: the nihilism of managerial logic, which finds therapeutic platitudes more convenient and lucrative than ideological fervor. Under the guise of empathy and well-being, SEL enables the endless expansion of a bureaucracy of mental health and big data specialists, who profit off of America’s schoolchildren. Paralleling the recent trend toward the mindful corporate workplace, SEL is the public school equivalent of Amazon’s “data management” of its warehouse employees, who are offered meditation booths to offset the stress of being increasingly monitored and monetized.

SEL’s immediate aim is not to politicize classrooms. While ideologically loaded terms like equity and social justice flit in on occasion, most curricula don’t focus on race or gender. To be sure, as far as its actual educational content, SEL doesn’t focus much on anything. Programs span a panoply of buzzword-rich subjects: safety, teamwork, identity, self-esteem, anti-bullying, anti-harassment, kindness. One curriculum’s video module encourages students to “inhabit a growth mindset” by “drawing angry lines.” A set of digital lessons is both “trauma-informed” and “music-based”; another app claims an “innovative way” to teach children about “appropriate levels of touch.” If teachers are feeling left out, there’s even Adult SEL for educators to practice “self-care.”

For all the diversity of topics, materials largely consist of slideshows, video modules, and activity sheets. If the medium is the message, the message of SEL is not mental well-being, but something akin to mandatory corporate compliance training. The simplest act is often tortured into a litany of tedious technical concepts. A textbook discarded by Florida explains a basic counting exercise: “Students build proficiency with social awareness as they practice empathizing with their classmates.” What isn’t robotic is cloying (children are instructed to say “thank you for filling my bucket”) or obvious (materials trumpet the benefits of cooperative work).

While a basic familiarity with children might lead one to question how any of this helps kids regulate emotions better than story time or recess, SEL advocates insist that their method is backed by science. But the blizzard of efficacy statistics proffered by advocates don’t hold up to scrutiny. CASEL’s most-cited claim of SEL producing an “11 point increase in academic achievement” comes from a meta-analysis that aggregates educational studies conducted from 1970-2007 featuring the words “social,” “emotional,” and “learning,” cherry-picked on the basis of vague criteria; the results aren’t replicated by a later meta-analysis. That “11 point increase,” however, now justifies a profusion of SEL “solutions” that bear no resemblance to the in-school programs analyzed, from mindfulness apps to a 3D printing pen.

Further, far less consensus surrounds SEL than supporters suggest. It has been criticized by education specialists for being unrigorous and rooted in the “faux psychology” of the self-esteem movement. In condemning SEL’s “unexamined rise,” Robert Pondiscio writes that “ideas and techniques borrowed from popular psychology have aggressively inserted themselves into classroom practice.” Additionally, some teachers anonymously complain that SEL asks them to take on the role of provisional therapists for which they have no training. “Every day I had to organize for my SEL advisory class, which I had no qualifications for, and took a lot of time away from my real job teaching math,” one former New York City public school teacher told Tablet. “Wouldn’t it be better if I had put that time into being the best math teacher?”

Perhaps taking time away from core skills like math to focus on emotional learning could be justified if it indeed resulted in happier and more resilient young people. But some teachers believe that, by priming students to be overly conscious of mental health concepts, SEL can in fact worsen emotional well-being and encourage its leverage as an excuse. “If you look at a kid as broken, they will break,” one teacher says. “By constantly talking to kids about anxiety, are we just making them more anxious?”

And yet despite scant evidence that SEL improves academic performance—and indeed some evidence that SEL may make students’ mental health worse—efforts to expand its programs are winning. All 50 states currently have SEL standards in preschool, and more than half have standards in K-12. The challenges of the COVID-19 pandemic, and particularly the harm done to students by extended school shutdowns, have increased demand for mental health resources. From November 2019 to April 2021, SEL spending grew by 45% to $765 million. Today, it is a multi-billion dollar industry, well-poised for future growth.

This recent ascendancy is no coincidence. Disbursement of COVID-19 federal aid has ripened public schools for plunder. Companies scramble for a piece of the $122 billion of the American Rescue Plan that Congress allocated to K-12 education, as well as the $300 million mental health plan unveiled last October. Education management consultant Tyton reports with the refreshing candor of the for-profit sector, “The SEL ecosystem today is flush with dollars from grant funding and federal stimulus programs.” (Tyton warns, however, that “long-term sustainability is far from guaranteed” and recommends “pursuing embedded SEL programs and practices” interwoven with “core curriculum, general professional development, and other staples of school operations.”)

This wave of funding has created an expansive SEL bureaucracy located in a twilight zone between private industry, nonprofit organizations, local school districts, and the federal government. CASEL, for example, is partnered with Allstate’s nonprofit spin-off, the Allstate Foundation (which also partners with the educational DEI nonprofit Facing History and Ourselves, whose board cross-pollinates with Allstate’s corporate PR branch). Though brochures feature stock photos of smiling teachers and students, their real target is administrators and superintendents. CASEL’s promotional materials are written in acronym-studded corporatese: Students become “learners,” friendship becomes “team building,” education a “school career,” and teaching “classroom management.”

For these vested interests, SEL’s vagueness is a convenient feature, not a bug. It makes for a neat label for profiteers to consolidate disparate interests in funding applications. One seemingly benign concept conceals endless appendages: the curriculum providersdata collection and assessment services, technology and telehealth services, training and credentialing programs, and corporate-academic research collaboratives. This dense canopy siphons funding while the intended recipients, the nation’s classrooms, languish on the forest floor.

Since the industry leads its own credentialing and assessments, anything SEL-related easily validates and perpetuates itself. Take restorative justice, a recent trend often intertwined with SEL. Conceived by psychology and criminology academics, it advocates for justice reform through nonpunitive measures like circles, in which offenders meet and speak with their victims and broader community. Through a fuzzy equivalence between “prison” and “suspension,” education reformers have in recent years encouraged schools to adopt restorative practices. Despite their enthusiasm, research on educational restorative justice’s efficacy remains scant. Only one comprehensive study exists, which found that restorative circles led to the Pyrrhic victory of slightly lowered suspensions alongside slightly lowered math scores.

Lack of rigor extends to the credentials that certify new SEL administrators. Restorative Justice Education (RJE), for example, is a nonprofit organization that trains prospective restorative facilitators. Like many similar credentialing programs, RJE’s training, which costs $950, is completely virtual and self-paced. Participants aren’t asked to lead a restorative circle before becoming “Certified Specialists in Creating a Culture of Care in Schools.” RJE’s online FAQ asks, “Where can I find research on the effectiveness of Restorative Practices?” The answer links to a bizarre Google document that recounts not robust statistics but its founder’s various Maori colleagues and conference presentations.

Meanwhile, restorative justice practices have grown dramatically in schools across the nation. Administrators boast of lowered suspension rates while teachers on the front lines are regularly cursed at and assaulted. Bans on punishment tie their hands; some resort to wearing padded bike suits to protect themselves from student beatings. As Jeremy Adams, a California public school teacher and the author of Hollowed Out writes, “Many teachers feel that they are being held hostage to an ideological experiment that harms them and their ability to teach, that harms innocent students who are trying to learn, and that in the end harms the very people it is meant to help by not holding them accountable.”

SEL’s technological emphasis also provides ample opportunity for growing e-learning and digital health industries. Though reports detail the record learning loss that resulted from remote schooling, digital specialists and advocacy groups still push virtual content by engineering false needs. The nonprofit Common Sense Education loftily touts the benefits of “digital citizenship in a connected world” while selling gaudy apps that charge subscription fees. Most top SEL programs now offer entirely virtual options consisting of games and videos, removing any socialization from social-emotional learning. It’s darkly ironic that, after a year of remote or masked instruction, kids are being instructed to recognize facial expressions through online exercises.

The long-term incorporation of virtual content bodes poorly for the future of public education. Peddled to teachers as a sophisticated solution to time-strapped curricular demands and bulging classrooms, digital platforms and classroom management technologies threaten to supplant traditional instruction. As curricula are increasingly automated and parceled out to e-learning providers, teaching will become little more than the pushing of buttons.

And while online exercises are unlikely to improve students’ social or emotional skills, they do feed a secondary market for technological and medical data collection. SEL assessment services like Centervention boast of “high fidelity early intervention data’' gathered through “gamified point systems’' and “daily emotion check-ins.” They even collect “unobtrusive measures,” like the time taken for any action, or the order in which tasks are completed. Educators can “automatically track and monitor progress” to target students who need more “intensive intervention” in the form of more profit-seeking initiatives. More data allows administrators to show off statistics and bolster bureaucrats’ claims of “impact.” Students are not beneficiaries, but the captive base fueling a data economy.

Apart from a therapeutic bureaucracy’s endless push for expansion, at the heart of SEL is a set of false premises about what constitutes emotional well-being and how it is acquired. Contrary to the claims of new specialists, social and emotional skills are not acquired as cognitive concepts. We don’t study for them as we might a test. They are acculturated-modeled by those we love or respect, developed through competition or play with peers. When we recall the sagest advice we’ve been given, we likely think as much of the advice-giver as the advice itself. Calm can be found in contemplating beauty, after vigorous exercise, or through tapping into one’s inner resilience. Such epiphanies make no sense as a technical discipline delivered by PowerPoint, but should naturally flow from a learning process that endows students with the competence that fosters true emotional strength.

SEL’s mindless approach to mindfulness is part of a larger educational trend toward hollow technocratic solutionism. The bipartisan standardized testing movement that preceded SEL, including the Bush-era No Child Left Behind Act and the Obama-era Common Core overhaul of education, imported the business model of management science, which emphasized measurable results. Standardized testing provided a uniform measure of progress across schools, while teachers were analogous to employees, overseen by their manager-administrators. And as Common Core advocate and former Secretary of State Rex Tillerson put it, the student is the “product,” standardized for the efficiency of the eventual modern workplace.

This results-based reform resulted in little more than an empty, nonintuitive curriculum. The much-derided Common Core mathematics standard, replete with “number lines” and “number sentences,” deadened the electric thrill of sudden insight. The humanities fared no better. Prioritized over fiction and history were nonfiction informational texts, tailored to testing for content comprehension. The ideal “product” molded by this education was a worker in a knowledge economy, an “effective relayer of information.”

Small wonder the young people affected by testing-based reform are so depressedaimless, and anxious. Their schooling deprived them of meaningful knowledge while inundating them with pedantic busywork. Neglected by moral authority and cut off from deeper historical awareness, they are extra-dependent on institutional shelter and the certitude afforded by strident narratives of power and privilege.

Indeed, the 2015 Every Student Succeeds Act that precipitated the surge in SEL was meant to amend the failures of standards-based reform. A shift to soft skills was attractive to both teachers beleaguered by punitive testing demands and administrators looking to boost flagging scores. Reformers soon clamored that focusing on social-emotional development, not test scores, would produce “better outcomes.”

But by adopting the unquantifiable as a method of quantification, the very soft skills that were originally not measured by tests became subject to standardization and assessment. Test-based reform’s banal utilitarianism has ceded to something even more hollow and less sensible. What is instinctive or obvious is rebranded into a top-down discipline owned by experts. Everyday concepts like grit are “discovered” by pioneering Ph.D.s. The teacher is divested of her moral authority, transformed from role model into lackey who “delivers” content, standardized for assessment measures. Instead of number lines for math, SEL offers number lines for emotions.

Current conservative attempts to treat SEL as merely an offshoot of the “woke” DEI industry are misguided, and neglect its insidious adaptability. Legislation like Florida’s Stop Woke Act, which prohibits classroom discussion of race or sexuality, is not a solution. It limits free speech, and further evacuates history. Initiatives like SEL are hydras and will reshape themselves to survive. (Coalitions defending SEL against “politicization,” initiated by CASEL, have already formed.) There is simply too much money at stake.

America’s schoolchildren deserve more than corporate simulations of empathy. The solution to a youth mental health crisis cannot be outsourced to experts of dubious quality. But SEL bureaucrats won’t check themselves. Their revenue stream depends on it.

https://www.tabletmag.com/sections/news/articles/dangers-sentimental-education

THE FETTERMAN BLUES

 I was extremely disappointed when Dr. Oz won the 2022 Pennsylvania Senate GOP primary over David McCormick — by 900 hundred votes out of nearly 900,000 cast, with the invaluable support of Donald Trump. I was inspired to express my disgust by adapting the famous translation of one of the Roman poet Martial’s epigrams to fit the occasion when McCormick conceded on June 3. What a farce.

Pennsylvania conducted its statewide primary on May 17. John Fetterman defeated his opponents for the Democratic nomination by a wide margin. Fetterman, however, had suffered a severe stroke only a few days before the primary. That didn’t stop “John Fetterman” from tweeting out his joy over the victory.

NBC News reported: “Minutes after NBC News projected the contest, Fetterman, who is in the hospital recovering from a health scare in the closing days of the race, tweeted his gratitude to voters.” Forgive me for repeating myself — what a farce.

Fetterman was a lunatic leftist to begin with. As the campaign proceeded, however, anyone in his right mind could see that Fetterman had half a mind to be a United States Senator. He is seriously incapacitated. Yet his wife, the party, the mainstream media, and some phony baloney doctor assured voters that all was well. I’m trying not to repeat myself, but hey — what a farce.

Fetterman was hospitalized last week over concerns about his physical well-being. He was reportedly feeling “lightheaded” after sitting through President Biden’s State of the Union Address. I wasn’t feeling too good myself.

Yesterday came word that Fetterman has checked himself into Walter Reed for depression, a common side effect of stroke. The AP reports the story here. Fetterman was evaluated Monday by the attending physician of Congress, Dr. Brian P. Monahan, who recommended inpatient care at Walter Reed, according to the statement released by his chief of staff.

The AP story lets us hear from Mrs. Fetterman:

Fetterman’s wife, Gisele, said she was proud of Fetterman “for asking for help and getting the care he needs.”

“After what he’s been through in the past year, there’s probably no one who wanted to talk about his own health less than John,” she wrote on Twitter.

The AP is running interference for Fetterman. Nothing to see here but heroism:

Dr. Eric Lenze, head of the psychiatry department at Washington University in St. Louis, said it is heroic that a major political figure — Fetterman — admitted to being treated for depression instead of trying to hide it.

“It’s when people admit to it we start to see a reduction in the stigma around mental illness,” Lenze said. “I’m glad he admitted it. I found it a brave thing to do.”

Depression is a terrible ordeal. I wish Fetterman well in his treatment, as I do in his efforts to recover from his stroke. However, Fetterman was not competent to serve in the Senate the day he won the primary. He was not competent to serve in the Senate the day he won the general election. He is not competent to serve now.

But of course no one can say it and the Democrats have reserved their options. Governor Shapiro is in place. Mrs. Fetterman is on standby. Senate Majority Leader Chuck Schumer may even need Fetterman’s vote for some serious business before long. What a disgusting spectacle.

https://www.powerlineblog.com/archives/2023/02/the-fetterman-blues.php

10 Reasons Why U.S. Must Focus More On China Than Ukraine

 As Western officials gathered in Brussels to send even more artillery from depleted weapon stocks and step up the production to help Ukraine, Jens Stoltenberg, the secretary-general of the North Atlantic Treaty Organization, said in opening remarks that the meeting was taking place at "a critical time for our security." His comments pointed to the slow realization that Russia is making gains in Ukraine's east and President Zelenskyy's stated ambition of ejecting Russia from all occupied territories, including Crimea, is becoming increasingly distant.

As we approach the first anniversary of Russia's invasion of Ukraine, Western powers have poured over $115 billion to help in its defense. The justification for committing such large sums to an ‘as long as it takes’ war is to deny Russia any permanent territorial victory under a rules-based international order that respects sovereign borders. Ukraine is fighting the West's war to save "democracy and freedom," this argument goes, so the West's investment is a bargain because it doesn't involve western blood and limbs.

While that may be true to some extent, it would be unwise to lose sight of another nation that poses an equal, if not, bigger threat - China. Democratic missteps in Taiwan (such as Nancy Pelosi's needless visit to Taipei triggering a dangerous escalation in the South China Sea) and the Biden administration's laughable handling of the China balloon episode, it is becoming increasingly clear that America is distracted by and fighting the wrong war. While Russia remains a nuclear-armed superpower with advanced weapons systems and possesses impressive space capabilities, Russia, compared to China, pales as a threat to the United States.

Here are ten reasons that illustrate why China is uniquely positioned to threaten America across multiple dimensions.

  • China is a technology powerhouse. Ford Motor announced recently that it is building a battery plant in Michigan with production and services technology licensed from the Chinese company CATL, the world's largest battery maker. CATL already supplies Tesla and BMW and its batteries power a third of all E.V. cars on the road.
  • It wields wide industrial dominance. China is already the world's leader in numerous industries, including iron, steel, aluminum, textiles, cement, cell phones, personal computers, shoes, chemicals, toys, electronics, rail cars, and ships.
  • It is extending dominance in new industries. China's 'Made in China 2025' (MIC 2025) program, backed by the government, would extend this dominance to ten new industries, including next-generation I.T., robotics, artificial intelligence, aerospace, new energy vehicles, and new materials, biomedicine, and agricultural equipment. China is already the world's largest producer of peaceful nuclear power. If China is successful, there won't be a single advanced sector where the country isn't a key player.
  • China has expanded its regional leadership. Through initiatives such as the One Belt One Road (OBOR) and the Asian Infrastructure Investment Bank, which China essentially controls, China provides low-cost loans on easy terms to smaller countries that the West has ignored.
  • China exploits its 1950-era accommodating foreign policy. As the Asia for Educators page at Columbia University notes, Chinese foreign policy is rooted in the Five Principles of Peaceful Coexistence: mutual respect for sovereignty and territorial integrity, mutual non-aggression, non-interference in each other's internal affairs, equality, and mutual benefit, and peaceful coexistence. The non-interference policy allows China to strike no-questions-asked deals with mineral-rich authoritarian governments like Saudi Arabia and Iran, a luxury the West does not have. It has signed mining contracts for large swathes of land to develop and extract African minerals. Meanwhile, American foreign policy is often based on ideological values such as protecting human rights and freedom.
  • China sports the world's largest standing army. With over 2 million active soldiers, China has the world's largest standing army. It is third behind the U.S. and Russia in its air force strength.
  • China is a nuclear nation. The Federation of American Scientists estimates that China has an arsenal of 260 total warheads as of 2015, the fourth largest nuclear arsenal amongst the five nuclear weapon states.
  • China is a permanent UNSC member. China has been a permanent member of the U.N. Security Council. Working closely with Russia, another permanent member, China has consistently thwarted American attempts to sanction rogue nations.  
  • The Chinese renminbi is part of the SDR. The IMF's Special Drawing Rights basket contains five world currencies - the U.S. dollar, the euro, the Chinese renminbi, the Japanese yen, and the British pound sterling. China first entered the SDR basket with a weight of 10.92% in 2016, which the IMF strengthened to 12.28% in August 2022, reflecting the increasingly important role the Chinese currency plays in world markets. The U.S. dollar also rose in prominence, moving up from 41.73% of the basket in 2016 to 43.38%, a rare instance when Chinese gains came from the weakening influence of other currencies such as the euro, yen, and sterling. Also, China is making more and more deals with other countries to use their own currencies instead of the dollar in international trade. For example, during Xi Jinping's recent visit to Saudi Arabia, the two countries agreed to trade oil, bypassing the dollar. This could severely weaken the US dollar.
  • Chinese consumption could help world economies recover. The world's bourses cheered when China finally opened up its economy after retiring strict Covid-19 restrictions. CEOs began making the pilgrimage to China to renew fractured supply chains, make investment deals, and build relationships. The West can be without Russia, but it relies on China to buy its exports and make its products.

Neocons argue that America is strong enough to fight two concurrent wars in two different theaters. Perhaps, it is. But America has never been tested against two nuclear powers simultaneously. And such a scenario will undoubtedly have adverse, long-lasting effects on the economy and the people. Even as Washington fights Russia to ensure sovereignty for Ukraine, it would be wise to keep an ever watchful eye on China and reserve resources to counter Beijing’s aggression.


https://tippinsights.com/ten-reasons-why-u-s-must-focus-more-on-china-than-ukraine/

AP Takes Sides in the Fight Against Crisis Pregnancy Centers

The Associated Press’ decision to call pregnancy resource centers “anti-abortion centers” in its style guide is just the latest politically motivated shot at pro-lifers. This one is rhetorical, of course, and language isn’t violence.

But in a culture rife with political violence, the language isn’t irrelevant. The AP, of all entities, should know this.

Since the fall of Roe v. Wade last June, more than 80 pregnancy centers have been attacked or vandalized, some of them firebombed or torched, others painted over with death threats. If you include churches that have been attacked, that number is well over 200. Never mind the attempt on a Supreme Court justice’s life.

Calling pregnancy centers, many of which have names that are in no way identified with abortion or the politics surrounding it, “anti-abortion,” jeopardizes the vulnerable women that turn to them for help by dragging them into the political spotlight and straight into the line of sight of violent anti-abortion extremists.

But the AP’s mischaracterization of these centers does more than push incendiary language. It’s flat-out biased and unfair – and that would be true coming from anyone, much less from an enterprise claiming to be the literal vanguard of journalistic integrity.

I know this firsthand, as the overturning of Roe inspired me to get involved with a pregnancy care organization, where I was stunned by the breadth of the services it provides. The first mom I served was an undocumented immigrant escaping domestic violence and caring for several other children as a single parent making minimum wage. She had zero interest in abortion; she was just seeking immediate material support.

We provided her with a stroller, car seat, hundreds of dollars’ worth of groceries and grocery gift cards, winter coats for her children, as well as Christmas gifts for her family, baby clothes, diapers, wipes, and formula. She handed me every single medical bill from her pregnancy and delivery, and we paid them. And I gave her what she perhaps needed more than anything else, a hug, the encouragement that she was a strong enough woman to do this, and the knowledge that someone would be there for her and her family. Contrast that with the findings in a recent study that found that nearly two-thirds of women feel pressure to abort.

And yet, the word “abortion” never even came up. Nor has it come up with subsequent client moms I am helping, one who is a young teen and has no immediate family in this country. Instead, we go through their list of needs and find a way to meet every single one of them. Soon I am going to her apartment with a team of men to install a crib. Many pro-life pregnancy centers go so far as to offer moms job training and even a home to live in as they transition through the postpartum stage. They exist to offer women who are seeking a refuge from the pervasive cultural pressure to abort and the support they need to thrive as the moms they want to be, no matter how challenging the circumstances of their pregnancy. This is not first and foremost “anti-abortion.” This is authentically and comprehensively pro-woman.

No doubt this is why a recent Marist poll found that 90% of Americans support these centers and the work they do. Americans know that their work is about far more than opposing abortion. And even those Americans who self-identify as pro-choice increasingly don’t recognize the modern-day abortion lobby that wears its bona fides loudly and proudly. The abortion heart pin look that Sen. Ed Markey sported to the State of the Union is not the look Americans are going for; it’s the provide-women-in-crisis-with-true-loving-support they want more of.

Which is why these centers find themselves quite literally in the crosshairs of abortion activists. As Jane’s Revenge, one of the leaders of the attacks on pregnancy centers, said in a statement:

“For the allies of ours who doubt the authenticity of the communiqués and actions: there is a way you can get irrefutable proof that these actions are real. Go do one of your own. Everyone with the urge to paint, to burn, to cut, to jam: now is the time.”

Now they have the Associated Press to help them make a list of targets.

'Extreme' Story of How Two Game-Changing Cancer Drugs Came to Market

 In his new book, For Blood and Money

opens in a new tab or window, Nathan Vardi provides deep insights into how blockbuster drugs are developed -- particularly, how strongly the investment community and the science are intertwined.

Vardi tells the "extreme" story, as he calls it, of the development of two Bruton's tyrosine kinase (BTK) inhibitors that changed the way doctors treat chronic lymphocytic leukemia (CLL). Part of what makes the story extreme is its wild cast of characters, which includes two hard-charging investors, Bob Duggan and Wayne Rothbaum.

That story ends with the sale of Duggan's company, Pharmacyclics, to AbbVie for $21 billion, and Rothbaum's company, Acerta Pharma, to AstraZeneca, for almost $7 billion.

MedPage Today spoke with Vardi in a video chat about the book. An edited transcript of the conversation follows.

What's your background, and how did you come to this story?

Vardi: For many years, I was a senior editor at Forbes where I was responsible for big investors – billionaires, hedge funds, private equity. People making big investments. So, my world was not siloed.

Between 2010 and 2020, which is the era when this book takes place -- and I view that as a golden age for biotechopens in a new tab or window -- I found that, of all the industries I was looking at through an investment lens, biotech was the most interesting.

I didn't see any other industry that was having as big an impact on human beings. You have to remember what was going on during this period. There was Facebook, and there was a big social media revolution. There was Netflix. Those were the big stocks. As much as those were revolutionary, I just didn't think they were having as big an impact for human beings as what was going on in biotech.

Then I stumbled onto this specific story, which I really thought was extreme in nature and epitomized this era. Also, I thought it was just a good story, which I think you need to write a book.

Right, ibrutinib (Imbruvica) and acalabrutinib (Calquence) extended survival in CLL. Netflix wasn't saving lives.

Vardi: When Facebook went public -- and Facebook was the big IPO of that era -- people really looked at it as this world-changing technology that was bringing people together. That's what the company and the people who worked for it would espouse. Now we look at Facebook as this socially divisive and problematic technology.

At the time, people in Silicon Valley really talked this talk about how they were in it to change the world, which I always thought was kind of hollow. Now, money plays a huge role in biotech. But I think that the biotech people could much more credibly say that they were really making a difference.

Let's talk about the role of the investment community in biotech. There was a scene in the book from the American Society of Clinical Oncology meeting in 2010, where doctors and investors were together at a private dinner meeting. It was an investor who really pushed finding the maximum tolerated dose for ibrutinib at that gathering. Throughout the book, there are many examples of how the investment community drives the science. Can you talk about that relationship?

Vardi: I think that we need to be honest about the role that money plays in drug development, and not be afraid of it, or somehow gloss over it. That's what I tried to do in this book.

Wayne Rothbaum is a stock trader and an investor. And he was the chief financial backer of Acerta, which is the company that developed Calquence. If you look at the key clinical trials that have been published for acalabrutinib, you will see that Wayne Rothbaum is a co-author on those peer reviewed trials. He has no scientific training whatsoever.

I think that he contributed a lot to the development of acalabrutinib. So I'm not saying that that is some kind of a corruption of the process ... What I was trying to do with this book is to reverse-engineer what is an unambiguously good outcome. No one can look at these two drugs and say, "This is bad." These drugs have made a huge difference for patients. How did that happen?

I think that for your readers, maybe they can grapple a little bit with this idea that Wayne's name is on the papers. He helped write them and played a role in the direction of the science. He contributed a lot to that process.

There are interesting questions about that, and I tried to share that as much as I could in the book.

The other main investor character is Bob Duggan. He was a bit quirkier than Rothbaum, and perhaps it was more unexpected for him to have kind of the influence that he had on the science.

Vardi: Again, this an extreme story, which is why I thought it was interesting. There are a lot of extreme characters, and I think that Bob Duggan is one of them.

There's a scene in the book where I say when he was CEO of Pharmacyclics, which was the biotechnology company that developed Imbruvica, he was literally reading children's books to better understand human biology.

And yet, again, it's not debatable -- he navigated that company and that drug through clinical trials to approval in a very, very fast time. And he didn't screw it up, which, I think, is another really important thing to think about. Because often you only get one shot at these things.

So again, here's a guy who is not a scientist. He was a Scientologist. He had no experience in the industry and never graduated from college. But he had a track record of success in business and was able to apply some of that to the development of Imbruvica.

I mean, luck played a big role as I show in the book, and circumstance played a big role. But I think that sometimes having an outsider like him in the mix can be helpful.

In the end, Bob Duggan made $3.5 billion selling Pharmacyclics to AbbVie, and Wayne Rothbaum made $3 billion selling Acerta to AstraZeneca. Is that really the incentive we need to develop new cancer drugs?

Vardi: So, the Economist wrote a very generous review of my book. And the reviewer at the end of the review asked a really good question, which was, There's all this money floating around, and [all this] testosterone, and all the science seems soaked with cash. Is there not a better way? There's gotta be a better way. There must be, right?

And the answer is, I don't know if there's a better way or not.

This way we know produces certain outcomes. We saw that over the last decade. About 400 new drugs were approved in the United States, many of them were oncology medicines. Some of them were great; some were not so great. But there was a lot of really cool innovation that went on in this system that we have. There is no other system that has ever produced 400 drugs like that over the course of 10 years.

Cancer drug development is very expensive. And part of it is because of the regulatory requirements that exist. And we all agree that they should exist, at least I do. So it's really unclear to me. I mean that truthfully, but I really don't know if there's another way to do this.

These are public policy issues that people are wrestling with, and we're going to find out because the landscape that existed in the last decade has changed. We'll see if we get the same amount, or, if not, what the impact on innovation is going to be.

I'll tell you one thing that I find troubling is that some people profess that they do know, they're very sure that they know that this is not going to impact innovation. I don't know how anyone could say that, because there's so much going on here. It's so complex, and it's so hard. I can't understand how someone could categorically just say that if you change the rules and the factors, that it's not going to have an impact. I'm not saying that it will, but I just will see. I don't, I really don't know.

The current system is obviously responsible for a lot of innovation, but is it also leaving out a lot of innovation? When you look at the rare disease community, families try to do drug development and often have to raise so much money to try to get just the basic science going. Are we preventing some treatments from being developed because we're pulling others up to this bar where the rest of biotech is at?

Vardi: I don't know. I think these are really, really good questions. My only argument is that they're really hard. Like, this is really hard. I certainly don't know what the answers to those questions are.

They're really complex. Let's take the example of the Inflation Reduction Actopens in a new tab or window (IRA). Now, Medicare is going to negotiate the prices of its most expensive drugs. If you look at the IRA, the clock on that starts ticking the moment a drug is approved.

So what does that mean? Let's look at the drugs in my book, Calquence and Imbruvica. Both of those drugs were approved, initially, in mantle cell lymphoma, which is a very small indication with not a lot of patients. It's not lucrative compared to CLL, which is arguably the biggest indication in blood cancer.

Would those companies have pursued a mantle cell approval if they knew the clock was going to start ticking when the mantle cell approval came in?

These are the questions that I think drug companies are carefully wrestling with right now. The motivations are good: let's lower drug prices. We all agree that's a good thing. But you don't know when you start mucking around with the rules, how that's going to play out.

I look at the IRA and I say, I just don't know. Maybe by trying to reduce drug prices, we'll get less innovation for rare cancers or rare diseases. It seems like it's possible. To me that just shows how complex and difficult this all is. And I certainly don't know what the answer is.

https://www.medpagetoday.com/special-reports/exclusives/103079

China warns U.S. to suffer 'consequences' if it escalates balloon incident

 China warned the United States on Sunday it would "bear all the consequences" if it escalated the controversy over a Chinese balloon that the U.S. military shot down this month.

Beijing will "follow through to the end" in the event "the U.S. insists on taking advantage of the issue", the foreign ministry said in a statement.

A U.S. military jet on Feb. 4 shot down what Washington calls a Chinese spy balloon after it had crossed North America. Beijing says it was an errant weather-monitoring craft.

China's statement followed a meeting between top diplomat Wang Yi and U.S. Secretary of State Antony Blinken on the sidelines of the Munich Security Conference.

https://www.yahoo.com/news/china-warns-u-suffer-consequences-095015384.html