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Credit…Ludovic Marin/Agence France-Presse — Getty Images

At the very least, what happened here is a major blunder in geopolitical respect and basic communications to a longstanding important ally. Not to mention the legal or contractual consequences. That’s a hornet’s nest itself. If this happened in a business deal outside the realm of national security or government military arena, there would be millions, perhaps hundreds of millions, of punitive penalties imposed.
I understand the decision to go with nuclear powered subs. There’s no comparison with conventional subs. Certainly not for security purposes when patrolling the Pacific. That’s a simple product comparison. They’re better. Period. How the French and Australia approached their original deal with that choice or conversation in mind is another topic. The issue here is not about that. It is about the multi billion dollar contract between them that got severed. It’s not even about why. It’s about how it happened.
From how this clumsy decision was presented, it’s almost unforgivable behavior from the full trio of Australia, Britain, and U.S. given the size of the preexisting, now cancelled, agreement between Australia and France.
This mishandling will cover Biden’s shoes in excrement for quite some time. It was ultimately his call to handle it this way, and he deserves the pain to fight his way out. But, the equal, if not more accountability, is in the complete failure of multiple military officials and diplomacy advisers to do something, anything, to make sure this incident had a chance, any chance, to be presented in a less damaging light. Instead, what they all collectively let happen, was radioactive fallout.

In Submarine Deal With Australia, U.S. Counters China but Enrages France



Climate Change Hasn’t Changed

Climate Change Hasn’t Changed

Recently, while cleaning out some files, I came across a news story I saved from 2009. It still resonates today with the same common sense logic and awareness that remains elusive among the masses, and frustratingly absent from public policy, political power groups, and corporate accountability. 12-13 years ago. 

Sure, things have improved. But the proportion of outrage and individual virtues in comparison to the broad scale changes needed in oil reliance, automotive design, and all around energy production industries, remains too small to make a difference thus far. 

A related link from 2015 I included at the bottom describes the problem as described by climate scientists, in even more stark terms than Friedman. 

This planet is on the short side of the math, and that’s always been due to the blindness or denial of what the problem to solve actually is. 

The last two Q & As in this interview say it best. >MB

Q&A: Columnist Tom Friedman on Climate Change

In his bestselling book “Hot, Flat, and Crowded,” New York Times columnist Thomas L. Friedman argues that countries that pioneer renewable-energy technologies will increase their national security and prosperity at the expense of those that cling to fossil fuels. He spoke to NEWSWEEK’s Sharon Begley: (Article continued below…)

Begley: A Gallup poll found that 41 percent of Americans—a record high—say concerns about climate change are exaggerated. Why is the public so resistant to the findings of climate science?

Friedman: What’s ironic is that that poll comes out at a time when more and more studies are suggesting that climate change is happening faster, bigger, quicker and with more powerful impacts than we anticipated just a few years ago. For whatever reason, climate change was presented as a political issue, and because [of that] there had to be sides … Also, there is a real aversion among scientists to popularizing things, so sometimes they’ve been a little diffident about making the case strongly. And part of the problem is that the most vocal global advocate on climate change has been Al Gore. For all these reasons it’s not surprising that the average person would be confused.

In the 1970s, the country was making progress toward renewable energy. Then things came to a screeching halt. What happened?

We were too successful. We imposed draconian mileage standards on cars, and it had a very big impact. At the same time, there was a global oil glut, and oil prices collapsed after Jimmy Carter left office [removing the economic pressure to move away from oil]. Ronald Reagan came in and instead of keeping up the initiative to have more solar energy, have more wind power, invest in energy efficiency and continue increasing mileage requirements for cars, he put the brakes on. Reagan proudly stripped the solar panels off the White House roof.

In “Hot, Flat, and Crowded” you use the phrase “dumb as we wanna be” to describe Americans’ attitudes toward energy and climate. What examples did you have in mind?

There are so many. I was trying to convey this idea that we thought we could sit back and delay everything until we got around to it. As a result we fell behind in the renewable-energy industries that are going to be the next great global industry. I believe this industry, which I call ET—energy technology, the search for abundant, cheap, clean, reliable electrons—is going to be the IT of the 21st century. One of the problems with the term “green” is that the definition was imposed by its opponents, by the Rush Limbaugh crowd. They named green [as] liberal, tree-hugging, sissy, girlie-man, unpatriotic, vaguely European. What I’ve been trying to do in this book is to rename green as geopolitical, geostrategic, geo-economic, capitalistic, patriotic. The country that owns green, that dominates that industry, is going to have the most energy security, national security, economic security, competitive companies, healthy population and, most of all, global respect. I want that country to be the United States of America. This isn’t just about electric power. It’s about economic power, it’s about national power.

You’re critical of efforts to get people to make small, symbolic gestures to use less energy. What’s wrong with that?

The danger is you think that if you change your light bulbs [to compact fluorescents], you’ve solved the problem. My motto is, change your leaders, not your light bulbs. Because what leaders do is rewrite the rules. They rewrite the rules of what utilities can burn as energy. They rewrite the car-mileage rules. They rewrite the rules of whether a nuclear plant can be built. These are the only things that give you [change at the scale we need]. Without scale change right now, in terms of climate we’re really cooked. You know, I come out of the world of covering foreign policy, and that trained me to look for where the leverage points are. I don’t think the leverage points now are in more consciousness-raising.

In the past, the public was ahead of politicians on issues such as civil rights. Is that the case with energy and climate?

It’s all about how you frame the issues. We’ve done polling at The New York Times, and if you ask people, would you like a carbon tax or a [higher] gasoline tax, they say no, no. But then you say, would you like a tax that combats climate change over the long term, [and they say,] yeah, I could see that. And would you like a tax that relieves us from living under the thumb of petro-dictators, [and they say,] yeah, I’d like that. I mean, what is it we’re trying to do? [To change things so] that there won’t be such a thing as a “green car,” there will just be a car, and you won’t be able to build it except at the highest levels of efficiency. There won’t be such a thing as a “green home,” there will just be a home, and you will not be able to build it unless it is at the highest standards of green energy, efficiency and sustainability. You’ll know the green revolution has been won when the word “green” disappears.

Original link:

Related from 2015:

Unethical? Unnecessary? The COVID-19 vaccine booster debate intensifies

Unethical? Unnecessary? The COVID-19 vaccine booster debate intensifies

As United States reveals its plan to offer an extra dose of COVID-19 vaccine, equity and scientific questions abound.

A version of this story appeared in Science, Vol 373, Issue 6558.

As the extraordinarily infectious Delta variant of SARS-CoV-2 continues to spread around the world, vaccines’ powers are showing their limits. Although they are still extremely effective at preventing severe COVID-19, the tantalizing hope that the shots could block almost all infections—and squelch transmission—has evaporated. That has upended return to office and school plans, threatened economic recoveries, and spurred fresh political rows over mask and vaccination mandates.

Read full article>>

From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

Useful background and a reality check on the…”reality” of the situation.

The thing about actual history and scholarly text such as this one is they try and paint a picture of current events as accurately juxtaposed to past events. This is what gives perspective. And perspective is what makes true independent decision making happen.

The infernal noise of loudmouths, grandstanders, endless galleries of biased voices, along with all the other assorted hucksters, serves only to hijack our own common sense and deductive reasoning capabilities. There are people who can’t resist trying to “persuade” anyone who listens.

It’s not easy culling out basic data, information, and facts from all the noise around us. But that’s no excuse to embrace a POV just because they’re easily accessed online, and “sound” convincing. If that’s all we do, then we’re surrendering our own powers to others because we don’t want to do the work on our own. That is far worse for all of us. >MB

From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

Syringe being filled from a vial. Vaccine concept illustration.

Cross-posted from COVID-19 and The Law, where it originally appeared on January 14, 2021. 

By Jonathan Iwry

The ongoing fight against COVID-19 has thrown a spotlight on the Food and Drug Administration (FDA) and its power to grant emergency use authorizations (EUAs). EUA authority permits FDA to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety.

Under § 564 of the Food, Drug, and Cosmetic Act (FD&C Act), use of FDA’s EUA authority requires a determination that an emergency exists by secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services (HHS), as well as a declaration by the HHS Secretary that emergency circumstances exist warranting the issuance of EUAs. Each issuance of an EUA requires that FDA conclude that:

  • it is reasonable to believe that a given product “may be effective” as an emergency countermeasure,
  • the known and potential benefits of authorization outweigh the known and potential risks, and
  • no formally approved alternatives are available at the time.

Annie Kapnick’s post on COVID-19 and FDA’s EUA authority provides a helpful overview of FDA’s emergency powers and their use in response to the pandemic. A brief look at the history of FDA’s emergency powers, including key events leading up to their enactment — Thalidomide, swine flu, AIDS, and 9/11 — offers perspective on the situation facing FDA today and its implications for the future. The history of EUA illustrates how its use today against COVID-19 involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.

The pre-history of EUA

The first event to foreshadow the major themes surrounding FDA’s EUA power was the Thalidomide tragedy of the mid-20th century. In the 1950s, a new drug called Thalidomide was put into circulation in West Germany and other countries as a treatment for morning sickness. The next decade would reveal that the drug resulted in severe birth defects, with known cases numbering in the tens of thousands. The drug’s introduction to market is remembered as one of the worst public health disasters in recent times. It underscored the importance of strict standards of clinical review in approving new food and drug products, and remains a key reference point for FDA regulators, emphasizing the importance of the agency’s extensive and thorough formal approval process.

Fast forward to 1976, when reports of cases involving a new strain of influenza A (the same family of flu viruses that caused the flu pandemic of 1918) prompted fears of a possible “swine flu” pandemic. President Gerald Ford pushed for a first-ever national vaccination program — shortly before starting his reelection campaign. After millions had been vaccinated, the public was alarmed by reports that the vaccine might be causing Guillain-Barré syndrome. And ultimately, a pandemic never materialized.

In their post-mortem study, Richard Neustadt and Harvey Fineberg described the swine flu episode as a policymaking disaster; yet they also expressed concern that the American public and policymakers would wrongly oversimplify the event in their memory as a case of government overreaction and overstepping, and that they would thus over-learn the dangers of responding too swiftly to fears of a pandemic. (Some would argue that this concern did not bear out, as nothing was learned at all.)

Next, the AIDS crisis gave rise to an early precursor to EUA authority. In the late 1980s, public health experts suggested that an investigational drug called DDI might prove useful for AIDS patients unable to tolerate other medications. Many objected that DDI lacked formal approval and was not guaranteed to be safe and effective; others countered that the risks of breaking protocol by issuing a drug lacking formal approval paled in comparison to the number of lives that could be saved. Impatient with FDA regulators’ conservative approach, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, proposed a new “parallel track” system to administer DDI to eligible patients while continuing to study the drug. Other measures for circumventing FDA’s formal approval process already existed at the time, but this proposal attracted the attention of President George H.W. Bush, whose support encouraged FDA to adopt the process and administer DDI to those in need.

The enactment and early years of EUA

Ultimately, it was the War on Terror that would give rise to emergency use authorization. After the events of September 11, 2001 and subsequent anthrax mail attacks, Congress enacted the Project Bioshield Act of 2004. The act called for billions of dollars in appropriations for purchasing vaccines in preparation for a bioterror attack, and for stockpiling of emergency countermeasures. To be able to act rapidly in an emergency, Congress allowed FDA to authorize formally unapproved products for emergency use against a threat to public health and safety (subject to a declaration of emergency by HHS). The record indicates that Congress was focused on the threat of bioterror specifically, not on preparing for a naturally-occurring pandemic.

FDA’s newfound EUA authority would be used relatively sparingly for the first 16 years following its enactment. During that time, its most extensive use was in combating the H1N1 swine flu pandemic of 2009 by authorizing medical equipment and existing influenza drugs. Health policy experts would look back on the use of EUA against H1N1 as an overall success. It would also be used (pursuant to an amendment allowing for preemptive EUAs) to authorize occasional countermeasures in anticipation of MERS, Ebola, Zika, and other epidemics, none of which ultimately materialized in the United States.

EUAs against COVID-19

Then came COVID-19. In February 2020, HHS Secretary Alex Azar declared the pandemic a national health emergency warranting emergency use of in vitro diagnostics, followed by subsequent declarations in March warranting emergency use of other countermeasures. Since then, FDA has issued nearly 400 EUAs for personal protective equipment, medical equipment, in vitro diagnostic products, drug products, and, most notably, vaccines (compared to 22 EUAs issued in response to H1N1 in 2009). An EUA had never been granted for a brand-new vaccine before; the only vaccine ever to have received an EUA prior to the current pandemic was AVA, an anthrax vaccine that had already been formally approved for other purposes when it was granted an EUA in 2005. This, combined with the stakes of administering a vaccine to people who are otherwise healthy, led FDA to commit itself to heightened standards of review, or “EUA plus,” in evaluating a COVID-19 vaccine for emergency authorization. Two vaccines have been authorized thus far: one by Pfizer-BioNTech on December 11, 2020, and another by Moderna on December 18, 2020.

FDA’s exercise of discretion in issuing EUAs has not been without controversy, and the politicization of the pandemic by President Donald Trump has added a political dimension to FDA’s decision making as an administrative agency run by a presidential appointee. Many have criticized the White House for encroaching on FDA’s independence and failing to uphold basic standards of respect for scientific evidence and decision-making autonomy by technical experts. Trump notoriously pressured FDA officials into authorizing chloroquine and hydroxychloroquine, anti-malarial drugs that many believed might pose substantial risks for COVID-19 patients. The EUA came only days after Trump publicly endorsed the drugs; FDA revoked it months later. Public health experts were similarly concerned by FDA’s decision to authorize SARS-CoV-2 convalescent plasma on the eve of the Republican National Convention. Even FDA’s decision to grant its first vaccine authorization to Pfizer-BioNTech was somewhat controversial: White House Chief of Staff Mark Meadows allegedly contacted FDA Commissioner Stephen Hahn the day the vaccine would be authorized, demanding his resignation if it was not authorized by end of day.

Yet even when making decisions free of overt political interference, FDA has confronted difficult decisions in exercising its discretion to grant EUAs. In the spring of 2020, for instance, FDA decided to address widespread testing shortages by issuing “umbrella” EUAs for entire categories of diagnostic and antibody tests (as well as masks and other protective equipment) ex ante — allowing those tests to come to market before reviewing them on a case-by-case basis. In doing so, FDA essentially made a value judgment that the risk of allowing unreliable tests to come to market — and thus the risk of contributing to inaccurate data about the pandemic — was outweighed by the value of having more testing data at all.

Historical reflections

Looking back through the history of EUA, two key themes emerge. The first concerns the influence of the President on FDA decision making: sometimes in ways that seem motivated by the public interest, other times by political or personal interest. As the swine flu affair of 1976 demonstrates, President Trump is not the first president to have pressed for a speedy vaccination effort while running for reelection. As long as health regulators are answerable to political officials, there will always be some possibility of political influence. This reflects a deep and fundamental tension between respecting technical expertise and ensuring that technical experts are held accountable to elected officials (and, ultimately, to the public will).

Second, this history points up an inherent ethical dilemma between protecting individuals and benefiting the collective in times of crisis — between cautious restraint and urgent pragmatism. How should FDA weigh the costs to individuals posed by unapproved and potentially harmful products against the benefit to society in addressing a public health emergency quickly? What degree of risk are health regulators justified in imposing on individuals for the sake of a promising but uncertain solution to a pandemic? Even when a drug or vaccine might seem to carry a low risk of serious side effects, the decision to authorize that product takes a stance on this dilemma, rather than finding a way around it. There will always be some tension between those who are willing to depart from ordinary protocol to save lives quickly (as in the case of the AIDS crisis) and those whose primary goal is to avoid authorizing the next Thalidomide.

Beyond COVID-19

Lawmakers and policymakers place great value in precedent, whether written or historical. There is almost no precedent to guide FDA’s use of this relatively new power, let alone during the greatest public health crisis the agency has ever faced. On the contrary, the history of EUAs points up essential dilemmas that aren’t going away, and that will have to be grappled with in emergencies to come.

These questions are not unique to FDA. Much has been written generally about the role of agency norms and institutional dynamics in the administrative state. Others have discussed the myriad violations of norms of democratic governance by the Trump administration (arguably the defining legacy of the Trump years). These issues cannot be resolved by looking to the law; they will inevitably require hard judgments about how to balance deference to scientific expertise with public accountability, how to integrate empirical analysis and value judgments, and how to weigh our competing values in times of crisis.

FDA’s emergency powers underscore the impact these questions have on the public welfare — and demonstrate that the way we answer them can literally be a matter of life and death.