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Tuesday, February 28, 2023

Corporations Embracing ESG Must Lose Their Legal Protection

 by Bruce Abramson via RealClear Wire,

ESG, an acronym for Environmental, Social, and Governance, is everywhere. If you work for, advise, invest in, regulate, study, or otherwise care about one or more corporations, you’ve likely encountered the term. Consultancies, banks, investment funds, managers, governments, and international organizations trip over themselves touting their ESG scores and credentials.

So what is ESG, and why should we care?

Though the term calls for incorporating concern with global warming (“E”), systemic racism (“S”), and other “woke” priorities into corporate governance (“G”), specifics can be elusive. The basic effect, however, is clear. ESG’s redefinition of “the corporation” threatens to undermine the stock market, the global economy, and large swathes of American law.

Its radicalism is hardly coincidental. ESG is an outgrowth of “stakeholder capitalism,” a theory first forwarded decades ago as an alternative to “shareholder capitalism.” Its earliest advocates thought that corporations whose sole purpose is to serve their owners—or shareholders—are cold and uncaring. Shouldn’t corporations also care about their employees, customers, neighbors, and all others whose lives they touch?

Under stakeholder capitalism, those people would gain a say over corporate decision-making. Under ESG, if all human activity affects problems like climate change and systemic racism, then all corporate decisions should incorporate such concerns. Corporations operating under this stakeholder model are thus a different species from the familiar shareholder corporation.

But corporations don’t exist in nature, and they don’t evolve. They’re legal constructs, subject to certain assumptions and constraints. Their legal and financial treatment is designed to make sense given the consequent model of corporate behavior. Alter the conceptual model of the corporation, and the bases of both corporate law and corporate finance collapse.

Shareholder corporations answer to a single moral imperative: maximize shareholder value. Whether you like the implicit morality or not, the behavior of entities following a single rule is predictable. Every existing element of both corporate law and corporate finance assumes that corporations are predictable profit-maximizers.

Stakeholder corporations undermine that assumption. Though stakeholder corporations can return value to shareholders, any corporation claiming proudly to consider multiple potentially conflicting tradeoffs cannot be assumed to work toward maximizing shareholder value. Stakeholder corporations are more complex entities than shareholder corporations—requiring corresponding complexity in their legal and financial treatment.

The World Economic Forum’s Klaus Schwab, arguably the most influential and prominent advocate of the ESG movement, was an early champion of stakeholder capitalism. In his recent Great Reset and Great Narrative books, Schwab shows how the stakeholder model, filtered through ESG, will centralize decision-making authority among a small cadre of corporate leaders and government bureaucrats—who, unencumbered by annoying shareholders or voters, will be free to focus on the common good.

For those of us who wish to prevent ESG’s takeover of the corporate landscape, corporate law offers a promising avenue of counterattack. The predictability of shareholder corporations earned them a simplified legal treatment subject to many helpful presumptions. Proud of their “evolved” ethical codes, stakeholder corporations have announced that such presumptions are misplaced.

Fair enough. Let the law take them at their word. Litigation and legislation must sever the legal treatment of stakeholder corporations from that of shareholder corporations.

Perhaps the cleanest—and potentially the most consequential—place to start is the Business Judgment Rule. This legal presumption allows every corporate defendant to arrive in the courtroom asserting that its decisions—including those that prove disastrous for shareholders—were made in the service of maximizing shareholder value. Plaintiffs—whether employees, shareholders, or business partners—complaining about corporate actions that failed to deliver bear the burden of proving bad faith, rather than mere errors in judgment.

The Business Judgment Rule makes sense when applied to shareholder corporations—but not to stakeholder corporations. Any corporation with an ESG statement has explicitly proclaimed that it will subvert some shareholder interests in favor of pressing environmental or social concerns.

The campaign to restore shareholder capitalism would snowball from there. Stakeholder corporations shorn of such legal benefits would sue the lawyers and consultants who guided them away from the legally beneficial shareholder model towards ESG—assuming only that even the most woke American corporations still value their own corporate interests. The legal and consulting classes will get the message.

ESG will persist as long as corporate leaders view it as cheap virtue signaling, would-be overlords see it as a path to power, and lawyers and consultants can milk it for revenues. The best way to defeat ESG is to rely on the same self-interest driving its current embrace: if the costs of ESG become exorbitant and obvious, the entire edifice will fall.

Like all utopian schemes, ESG is an attack on global freedom and prosperity. If you’re really dedicated to improving the lives of all stakeholders, you should work for an end to ESG.

Bruce Abramson, PhD, JD, is the author of five books, most recently “The New Civil War: Exposing Elites, Fighting Utopian Leftism, and Restoring America” (RealClear Publishing, 2021). He is president of the strategic consultancy Informationism, Inc. and a director of the American Center for Education and Knowledge.

https://www.zerohedge.com/political/corporations-embracing-esg-must-lose-their-legal-protection

FDA to 'restrict unlawful import' of veterinary tranquilizer Xylazine

 U.S. health regulators on Tuesday issued an import alert for drug ingredients and products related to Xylazine, used largely as a veterinary tranquilizer but has been a drug of abuse, to restrict its unlawful entry into the United States.

The Food and Drug Administration (FDA) said its move aims to prevent the drug from entering the U.S. market for illicit purposes, while maintaining availability for its legitimate uses in animals.

Under the alert, the FDA will do an entry review of evidence offered by importers if incoming Xylazine is properly labeled, not adulterated, and for legitimate use.

Xylazine is approved by the FDA only for veterinary use and German drugmaker Bayer's animal sedative drug Rompun is among the drugs which are based on Xylazine.

Xylazine has increasingly been found in illicit drugs and detected in overdose deaths, the agency said in its statement, adding that its staff may detain shipments found in violation of the law during the review.

The drug can depress breathing, blood pressure, heart rate and body temperature to critical levels and when taken by people through injections may result in severe skin wounds that could lead to amputation and become life-threatening.

"The FDA remains concerned about the increasing prevalence of Xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue," FDA Commissioner Robert Califf said in the statement.

https://finance.yahoo.com/news/u-fda-restrict-unlawful-import-165916852.html

Ghislaine Maxwell to ask appeals court to throw out sex trafficking conviction

 Ghislaine Maxwell is expected on Tuesday to ask a U.S. appeals court to throw out her conviction for helping Jeffrey Epstein sexually abuse teenage girls, saying a slew of errors marred the case as prosecutors made her a scapegoat because the financier was dead.

"The government prosecuted Ms. Maxwell as a proxy for Jeffrey Epstein" to satisfy "public outrage" over the case, and worked with his accusers "to develop new allegations out of faded, distorted, and motivated memories," Maxwell lawyer Arthur Aidala said in a statement obtained by Reuters.

A spokesman for U.S. Attorney Damian Williams in Manhattan declined to comment.

Maxwell, 61, is expected to present her legal arguments in a filing with the 2nd U.S. Circuit Court of Appeals in Manhattan.

She is serving a 20-year prison sentence after a Manhattan jury convicted her in December 2021 on five charges for recruiting and grooming four girls for abuse by Epstein between 1994 and 2004.

The daughter of deceased British media mogul Robert Maxwell is imprisoned in Tallahassee, Florida, and could be freed in July 2037 with credit for good behavior and two years she previously spent in jail.

Maxwell's lawyers had tried to discredit her accusers and claimed that prosecutors turned the socialite's case into a legal reckoning that Epstein, a registered sex offender, never had.

Epstein killed himself at age 66 in a Manhattan jail cell in August 2019, one month after being charged with sex trafficking.

Hundreds of women claimed to be victims of Epstein's abuse, and famous people, most notably Britain's Prince Andrew, who were friendly with him have seen their reputations tarred or destroyed.

Many arguments in Maxwell's appeal are expected to mirror those she made unsuccessfully before, during and after the trial.

She has claimed that Epstein's 2007 nonprosecution agreement with federal prosecutors in southern Florida, arising from alleged abuse at his Palm Beach mansion, also immunized her.

Epstein, in exchange for immunity, pleaded guilty the next year to a Florida state prostitution charge and served 13 months in jail. That arrangement is now widely considered too lenient.

Maxwell is expected to claim that prosecutors charged her long after a five-year statute of limitations expired.

She is also expected to challenge the trial judge's refusal to toss her conviction after a juror admitted having failed to disclose before trial that he had been sexually abused as a child. Maxwell has claimed that the juror, identified as Scotty David or Juror 50, used his experience to convince other jurors that she was guilty.

Lawyers for Maxwell have also said she was unable to prepare meaningfully for trial at her Brooklyn jail because of raw sewage, sleep and water deprivation, as well as surveillance resembling Hannibal Lecter's in the movie "The Silence of the Lambs."

At Maxwell's trial, the four accusers said Maxwell and Epstein at first made them feel welcome in their orbit before subjecting them into giving Epstein sexualized massages.

Prosecutors are expected to respond to Maxwell's filing before the appeals court hears oral arguments.

https://www.yahoo.com/now/ghislaine-maxwell-ask-appeals-court-155524305.html

Wave of poison attacks on schoolgirls alarms Iranians

 Hundreds of Iranian girls in different schools have suffered "mild poison" attacks over recent months, the health minister said, with some politicians suggesting they could have been targeted by religious groups opposed to girls' education.

The attacks come at a critical time for Iran's clerical rulers, who faced months of anti-government protests sparked by the death of a young Iranian woman in the custody of the morality police who enforce strict dress codes.

The poison attacks at more than 30 schools in at least four cities started in November in Iran's Shi'ite Muslim holy city of Qom, prompting some parents to take their children out of school, state media reported.

Social media posts showed some hospitalised schoolgirls, who said they had felt nauseous and suffered heart palpitations.

"Investigating where this mild poison comes from ... and whether it is an intentional move are not within the scope of my ministry," Health Minister Bahram Einollahi was quoted as saying by state media.

His deputy, Younes Panahi, said on Sunday "it was found that some people wanted schools, especially girls’ schools, to be closed", according to IRNA state news agency.

One boys' school has been targeted in the city of Boroujerd, state media reported.

Lawmaker Alireza Monadi said the existence of "the devil's will" to stop girls from going to school was a "serious threat", according to IRNA.

He did not elaborate, but suspicions have fallen on hardline groups that operate as the self-declared guardians of their interpretation of Islam.

In 2014, people took to the streets of the city of Isfahan after a wave of acid attacks, which appeared to be aimed at terrorising women who violated the country's strict Islamic dress code.

"If operatives of the acid attacks had been identified and punished then, today a group of reactionaries would not have ganged up on our innocent girls in the schools," reformist politician Azar Mansoori tweeted.

Visa, Mastercard pause crypto push in wake of industry meltdown

 U.S. payment giants Visa and Mastercard are slamming the brakes on plans to forge new partnerships with crypto firms after a string of high-profile collapses shook faith in the industry, people familiar with the matter told Reuters.

The crypto industry saw a stunning reversal of fortunes in 2022 as bankruptcies of industry majors FTX and BlockFi rattled investors and increased regulatory scrutiny on the sector.

Both Visa and Mastercard have decided to push back the launch of certain products and services related to crypto until market conditions and the regulatory environment improve, said the people, who asked not to be named as talks were confidential.

"Recent high-profile failures in the crypto sector are an important reminder that we have a long way to go before crypto becomes a part of mainstream payments and financial services," a spokesperson for Visa, the world's largest payment processor, said.

That does not change the company's crypto strategy and focus, however, the spokesperson added.

A spokesperson for Mastercard said: "Our efforts continue to focus on the underlying blockchain technology and how that can be applied to help address current pain points and build more efficient systems."

CRYPTO RETREAT

Over the past couple of years, major card firms had warmed up to crypto as the popularity of the asset class exploded, with some touting it as the next big thing in finance.

Card companies, which pocket a small percentage of the dollar value of transactions they process, had announced multiple partnerships with crypto firms and put in place dedicated teams to explore blockchain technology.

Mastercard teamed up with crypto lender Nexo in April to launch what it called the world's first "crypto-backed" payment card.

In November, Visa severed its global credit card agreements with FTX, just a month after announcing an expanded partnership with the exchange.


Aptinyx, reeling from setbacks, dumps dementia drug, stops PTSD trial after phase 2 flop

 Serial clinical trial train wreck Aptinyx is at it again. After seeing a pain prospect flunk three clinical trials, the biotech has added Parkinson's disease and dementia to its list of failed indications—prompting it to stop work on its two clinical candidates, cut costs and seek strategic alternatives.

Last year, the third midphase failure of NYX-2925 prompted Aptinyx to drop the pain program and switch its attention to a pair of other NMDA receptor positive allosteric modulators, NYX-458 and NYX-783. The delivery of data from a phase 2 clinical trial of NYX-458 has prompted the company to rethink its plans once again and sent its stock down 54% to 27 cents in premarket trading.

The midphase study randomized 99 patients with mild cognitive impairment or mild dementia caused by Parkinson’s or Lewy body dementia to receive NYX-458 or placebo for 12 weeks. Aptinyx began the trial on the basis of evidence that the molecule boosts cognition by addressing glutamatergic dysregulation. 

Across a slate of efficacy endpoints, NYX-458 failed to deliver on the preclinical promise. Aptinyx is yet to share data from the trial but revealed the absence of clinically meaningful improvements. The efficacy endpoints included two evaluations of the patients’ everyday functions and a battery of computerized neurocognitive tests designed to assess cognition.

The comprehensive failure led Aptinyx to drop plans for further development of NYX-458. The fallout has hit the rest of the business, with the biotech terminating an ongoing study of NYX-783 in post-traumatic stress disorder (PTSD) early. Aptinyx had expected to report phase 2b data in PTSD in the second half of the year.

Now, the biotech will review the data generated on NYX-783 to date to inform the next steps while trying to conserve its cash and identify a way out of its current predicament. Aptinyx is yet to publicly disclose layoffs but said it will “undertake cost-cutting measures.” The biotech ended September with $67 million to its name. 

https://www.fiercebiotech.com/biotech/aptinyx-reeling-series-setbacks-dumps-dementia-drug-stops-ptsd-trial-after-phase-2-flop

FDA flags Guillain-Barré risks for GSK, Pfizer RSV shots, but just one will need safety trial

 Both Pfizer and GSK’s upcoming respiratory syncytial virus (RSV) vaccines had instances of Guillain-Barré syndrome in clinical trials. And yet the FDA is only recommending that one of them conduct a new post-marketing study to assess the risk.

Just Pfizer—which is seeking approval for RSVpreF, to be known as Abrysvo if approved—has been asked to submit a plan for a follow-up trial, which the company has offered to do in briefing documents (PDF) released ahead of an FDA advisory committee meeting. GSK has for the time being avoided the after-approval work and detailed the risk in its pharmacovigilance plan, which the FDA is assessing.

The companies will spend the next two days at the FDA’s Vaccines and Related Biological Products Advisory Committee meeting. Pfizer is in the hot seat first and GSK will present tomorrow. Ahead of the meeting, the FDA released its briefing documents that details what both pharmas will have to defend to secure an approval recommendation. Both are seeking approval for RSV vaccines in a tight race to market.

Guillain-Barré syndrome (GBS) is a rare neurological disorder that causes your immune system to attack part of the peripheral nervous system, which is located outside the brain and spinal cord. Most people eventually recover, but the condition can lead to paralysis and even the inability to breathe independently in severe cases. The condition can happen to anyone but vaccinations can increase the risk. 

In Pfizer’s phase 3 study 1013, one 66-year-old male recipient with a history of high blood pressure was hospitalized on day seven post-vaccination for a heart attack and underwent angioplasty. On day eight, the patient began experiencing lower back pain and later lower extremity weakness, which is a hallmark of GBS. The condition was later confirmed with tests, but the diagnosis was eventually updated to chronic inflammatory demyelinating polyneuropathy. Symptoms were resolving as of the data cutoff, about six months after emerging. Pfizer referred to this as a “life-threatening event” in its briefing documents.

The investigator determined the case of GBS was possibly related to the study after conferring with the patient’s neurologist. Pfizer, however, noted that the event occurred just a day after the heart attack and angioplasty, calling that timing a “confounding factor.”

There was also a severe case of Miller Fisher syndrome, a variant of GBS, where a 66-year-old woman with type 2 diabetes had to be hospitalized after symptoms emerged eight days post-vaccination. The woman experienced severe fatigue, unstable movements, poor muscle control and other symptoms. The case had resolved by three months without treatment.

Since Miller Fisher syndrome is so rare, the investigator concluded with the other clinical evidence that there was a reasonable possibility that the event was related to the study participation. Pfizer noted there was some evidence missing to make this determination and said the condition was preceded by upper respiratory infection symptoms.

The FDA, however, agreed with the investigators that the GBS cases were likely related to the study and called GBS an important potential risk in the briefing docs.

The FDA noted (PDF) that non-fatal serious adverse events were balanced between the placebo group and vaccine recipients at 2.3%, even with the instances of GBS. There were two total cases of GBS including the Miller Fisher syndrome event in 19,942 people who were vaccinated.

The normal rate of GBS is about 1.5 to three cases per 100,000, according to the FDA. So Pfizer will be asked to include it and other immune-mediated demyelinating conditions in a pharmacovigilance plan to warn of an important potential risk. The company will have to submit a proposal for a study to assess the risk of GBS. Pfizer will also have to report all instances of GBS regardless of how serious and will need to submit an analysis of the cases.

Pfizer detailed plans for that study in its pharmacovigilance plan, promising to conduct a trial in the older adult population. The company will also examine the risk of Abrysvo vaccination in immunocompromised older adults.

In the case of GSK’s RSVPreF3-AS01, to be known as Arexvy if approved, a 78-year-old woman in the phase 3 study 004 began exhibiting symptoms of GBS nine days after receiving the vaccine. She experienced lower and upper limb weakness, difficulty walking and respiratory weakness. She was hospitalized and treated for the condition, leaving the hospital six months after vaccination. Testing was not conducted to confirm the GBS diagnosis but GSK noted that the occurrence was "within the risk window for [GBS] as a vaccine-related reaction."

There were no cases of GBS in GSK’s study 006 or any other studies conducted with RSVPreF3-AS01 to date, meaning the incidence was one in 15,000 vaccines.

This event was considered to be related to vaccination by the investigators and the FDA (PDF). GSK included a warning of potential immune-mediated disease in its pharmacovigilance plan, noting that GBS is an important potential risk. The rate of these events was balanced at 0.3% for the vaccine group and the placebo arm of the trial. GSK will also conduct routine pharmacovigilance activities, including reporting adverse events and examining postmarketing safety data.

The FDA is reviewing the pharmacovigilance plan at the moment and will provide further guidance on any actions needed at a later time, but a post-marketing study was not requested. 

https://www.fiercebiotech.com/biotech/fda-flags-guillain-barre-syndrome-risks-gsk-pfizer-rsk-vaccines-just-one-will-need-post