Brownstone Institute
Sorry Seems to Be the Hardest Word
From the Brownstone Institute
It’s been more than obvious since April 2020 that lockdowns were far too costly for individuals and society and could never earn a rational public-health defense. And the evidence was rolling in from one year later that the vaccine mandates were similarly indefensible.
Both tactics had in common the enormous use of state coercion that flew in the face of every principle of civilized government.
As we are constantly told, both people and government were panicked, and needlessly so. As it turns out, the infection fatality rate was not 2-3 percent, as the WHO had said early on, or 1 percent as Fauci told the Senate in March 2020, but rather 0.035 percent for anyone under the age of 60 (which is 94 percent of the population).
Covid has been highly transmissible and with it the resulting protection of natural immunity. The correct policy should have been to maintain all social and market functioning while the actual vulnerable population protected itself as it awaited widespread immunity. That’s how every generation for 100 years has handled infectious disease: as a medical and not political matter.
In other words, politicians and officials the world over made enormous and obvious errors, just not later but from the outset. This is not really worth arguing any more. The evidence is now 2.5 years deep. Insisting on 85 percent coverage of an ineffective vaccine was also an egregious error becaus people are not stupid and knew that they did not need this vaccine, especially since it protects not against infection or transmission and its approval bypassed all normal standards of clinical trials.
Where are the apologies? Sorry seems to be the hardest word. Faced with enormous failure, the machinery that did this to us has generally refused to say the simple word. It’s the hardest thing for people with power to admit their fallibility. Even though the whole world knows what they did and vast and increasing numbers are aware of the utter failure, the political class still insists on living in a fantasy land of its own creation.
There are exceptions.
Prime Minister Imran Khan apologized for lockdowns in April 2020.
Ron DeSantis of Florida has repeatedly said that the lockdowns were an enormous mistake and will never happen again so long as he is in charge. That’s very close to being an apology, though many residents are still awaiting the magic word.
Also in 2020, Norway’s prime minister Erna Solberg went on Norwegian television to say that she and others panicked and “took many of the decisions out of fear.”
That’s close to being an apology.
So far as I know, that’s about it. Until yesterday. The new Premier of Alberta Canada Danielle Smith has offered an apology to Albertans who were discriminated against because of their COVID-19 vaccination status. “I am deeply sorry for any government employee that lost their job and I welcome them back if they want to come back.”
Glory be! That’s precisely what we are looking for. Not just from a few but from all. The near absence of such apologies is driving the massive political realignment the world over, as furious voters demand admission of wrongdoing and justice for the victims.
They are not forthcoming and therefore the anger is only rising. The storm clouds are gathering around the impossibly arrogant Anthony Fauci, with a new hit movie making the rounds and a judge demanding that he be deposed in a powerful lawsuit filed against his hypercritical collusion with social media companies to censor truth.
Now nearly three years into this disaster, the worry that humanity would just accept the outrage and move on is proving unwarranted. People are discovering that there is plenty of dissent out there, and it stretches across the partisan divide. The resulting cultural and political realignments will echo long into the future, like other major upheavals of the past.
Think of the big historical events that echoed for generations in American politics. The struggle over slavery. World War I. Prohibition. The New Deal. World War II. The Cold War. The last one I know well, having come of age in the latter years. In retrospect, the long episode of the Cold War was packed with mythology. Still, the struggle was expressed in ideological terms of freedom vs. communism. The alliances that lined up remained for decades and impacted cycle after cycle of political controversy at home and abroad.
For strange reasons of timing and loss of principle, the “woke” left found itself mixed up in lockdown politics and then the vaccine mandate. Many of them lined up with policies that violate the very rights they had spent decades defending. So much for the Bill of Rights, the freedom of movement, the appreciation for the classless society, bodily autonomy, and so on. The left lost its soul during these years, and thereby alienated multitudes of sane lefties who watched in horror as their own tribe abandoned them in favor of the authoritarianism they had long decried.
Lockdown/mandate vs not: this has the capacity to be a theme that will resonate far into the future. It also unites people on the political “right” again with small business, genuine civil libertarians, and champions of religious liberty. It permits the “left” to again find its voice for human rights and freedoms. For that matter, they do not have to be activists; they only need to be people who do not want their houses of worship padlocked, their business closed and bankrupted, their speech curtailed, or their bodily autonomy violated.
It also put the emphasis on the correct point: the protection of American liberties not from some shadowy foreign enemy but from our own governments. It also draws in the left that has long been suspicious of the place of big business, and, in this case, rightfully so. The largest corporations such as Google, Amazon, and Meta (Facebook), for all the good that they achieve in this world, have leaned decisively in favor of lockdowns.
Same with Big Media. The reason is not just that they are harmed less by lockdowns and, in many cases, actually benefited from them. It’s because the people ruling these companies enjoy ruling-class lives, and they see the world through them. Lockdowns were the favored policy for cultural and political reasons, which is itself a scandal.
There is another group of powerful people in a position to dedicate themselves to the anti-lockdown/anti-mandate cause: parents. In an astonishing act of despotic ignorance, governors closed schools down all over the country, with zero medical benefit and grotesque levels of abuse for children and parents.
These are schools for which people pay heavily in property taxes, while parents using private schools pay twice. Governments shut them down, robbing parents of their money and smashing their settled lives. Many children in this country lost two years of education. Many families with two incomes had to drop one of them in order to babysit their children at home as they pretended to learn on Zoom while being denied access to peers.
Then once schools were operating normally, the CDC approved without evidence the Covid vaccine as an addition to the childhood schedule. Parents are not this dumb. They will never go for it. They will pull the kids out of public school and into private and homeschooling, causing a real crisis for one of the most settled institutions in American life.
Then you have the problem of colleges and universities. Rightly or wrongly, parents and students make extreme financial sacrifices to pay for college in the hopes that the right education and degree sets people up for a lifetime of success. Whether this is true or not, parents are risk-averse with their children’s future so that they do whatever is necessary to make it happen.
Then one day, the kids were locked out of the universities that they pay to attend. No parties. No study sessions. No going to other people’s rooms. No in-person instructions. Many thousands of students in this country have been fined and harassed for noncompliance. They’ve had masks forced on them even though their risk from the virus approaches zero, and the memory of this humiliation will last a full lifetime. Then came the vaccines, forced on college students who did not need them and are most vulnerable to adverse events.
Why have the people put up with this? Under normal conditions, they never would have. None of this would have been possible. The one reason they did this time: fear. Fear of getting sick and dying or, if not dying, experiencing permanent health effects. This emotion can last far longer than one might think. But eventually emotions do catch up with facts, among which is that the danger of severe outcomes was wildly exaggerated and the lockdowns and mandates achieved nothing in terms of disease mitigation.
You mean all this suffering and horror was for naught? Once that realization dawns, fear turns to anger, and anger to action. If you understand that dynamic, you can see why the architects of lockdowns from Dr. Fauci to the CDC are doing their best to delay that dawning, with daily doses of alarmism designed to keep people languishing in fear and ignorance.
The fear however is breaking. We will reflect on all the incredible health theater to which we’ve been subjected for two and a half years, the hopping around people to stay 6 feet away, the silly ban on restaurant menus, the on-again-off-again mandatory masking of the people, the curfews and capacity limits, and we’ll realize that the people who passed on all these emergency measures were just making things up in order to appear decisive and precise.
We will look back and feel mortified at how we treated each other so brutally, how so many turned into rats hungry to get our friends and neighbors in trouble with the compliance police, how we willingly believed so many untrue things and practiced such preposterous rituals out of a belief that we were avoiding and thus controlling the enemy pathogen we couldn’t see.
None of this will soon be forgotten. It’s the trauma of our lives. They stole our freedom, our happiness, our way of life, and attempted to replace them all with a stern regime with puritan sensibilities that rivaled the Taliban, forcing the whole population to hide their faces and live in fear of the American Mandarins who then came after the whole population with needles and woefully vetted shots.
Karma is already turning on the whole gang of coercive totalitarians here and abroad. While the virus is invisible, the people who dreamed up and enforced lockdowns and mandates who wrecked the country are highly visible. They have names and careers, and they are right to be very worried about their futures.
The sociological basis of the Catholic institution of auricular confession is to habituate people into the psychologically most difficult practice of admitting error, asking forgiveness, and pledging not to do it again. Saying it out loud within earshot of others is harder still. Every religion has some version of this because doing so is part of becoming a responsible human being.
The best approach is a simple word: sorry. So rare but so powerful. Why won’t more follow the lead of Danielle Smith and just say it?
Author
From the Brownstone Institute
The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.
That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee, published by The Lever.
Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.
One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”
A System Built on Weak Evidence
The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.
Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.
Yet only 28% of drugs met all four criteria—40 drugs met none.
These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.
But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility.”
Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.
In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before proving that they work, with the promise of follow-up trials later.
But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”
“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.
More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively.
And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.
The result: a regulatory system where the FDA no longer acts as a gatekeeper—but as a passive observer.
Cancer Drugs: High Stakes, Low Standards
Nowhere is this failure more visible than in oncology.
Only 3 out of 123 cancer drugs approved between 2013 and 2022 met all four of the FDA’s basic scientific standards.
Most—81%—were approved based on surrogate endpoints like tumour shrinkage, without any evidence that they improved survival or quality of life.
Take Copiktra, for example—a drug approved in 2018 for blood cancers. The FDA gave it the green light based on improved “progression-free survival,” a measure of how long a tumour stays stable.
But a review of post-marketing data showed that patients taking Copiktra died 11 months earlier than those on a comparator drug.
It took six years after those studies showed the drug reduced patients’ survival for the FDA to warn the public that Copiktra should not be used as a first- or second-line treatment for certain types of leukaemia and lymphoma, citing “an increased risk of treatment-related mortality.”
Elmiron: Ineffective, Dangerous—And Still on the Market
Another striking case is Elmiron, approved in 1996 for interstitial cystitis—a painful bladder condition.
The FDA authorized it based on “close to zero data,” on the condition that the company conduct a follow-up study to determine whether it actually worked.
That study wasn’t completed for 18 years—and when it was, it showed Elmiron was no better than placebo.
In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalized with colitis. Some died.
Yet Elmiron is still on the market today. Doctors continue to prescribe it.
“Hundreds of thousands of patients have been exposed to the drug, and the American Urological Association lists it as the only FDA-approved medication for interstitial cystitis,” Lenzer and Brownlee reported.
“Dangling Approvals” and Regulatory Paralysis
The FDA even has a term—”dangling approvals”—for drugs that remain on the market despite failed or missing follow-up trials.
One notorious case is Avastin, approved in 2008 for metastatic breast cancer.
It was fast-tracked, again, based on ‘progression-free survival.’ But after five clinical trials showed no improvement in overall survival—and raised serious safety concerns—the FDA moved to revoke its approval for metastatic breast cancer.
The backlash was intense.
Drug companies and patient advocacy groups launched a campaign to keep Avastin on the market. FDA staff received violent threats. Police were posted outside the agency’s building.
The fallout was so severe that for more than two decades afterwards, the FDA did not initiate another involuntary drug withdrawal in the face of industry opposition.
Billions Wasted, Thousands Harmed
Between 2018 and 2021, US taxpayers—through Medicare and Medicaid—paid $18 billion for drugs approved under the condition that follow-up studies would be conducted. Many never were.
The cost in lives is even higher.
A 2015 study found that 86% of cancer drugs approved between 2008 and 2012 based on surrogate outcomes showed no evidence that they helped patients live longer.
An estimated 128,000 Americans die each year from the effects of properly prescribed medications—excluding opioid overdoses. That’s more than all deaths from illegal drugs combined.
A 2024 analysis by Danish physician Peter Gøtzsche found that adverse effects from prescription medicines now rank among the top three causes of death globally.
Doctors Misled by the Drug Labels
Despite the scale of the problem, most patients—and most doctors—have no idea.
A 2016 survey published in JAMA asked practising physicians a simple question—what does FDA approval actually mean?
Only 6% got it right.
The rest assumed that it meant the drug had shown clear, clinically meaningful benefits—such as helping patients live longer or feel better—and that the data was statistically sound.
But the FDA requires none of that.
Drugs can be approved based on a single small study, a surrogate endpoint, or marginal statistical findings. Labels are often based on limited data, yet many doctors take them at face value.
Harvard researcher Aaron Kesselheim, who led the survey, said the results were “disappointing, but not entirely surprising,” noting that few doctors are taught about how the FDA’s regulatory process actually works.
Instead, physicians often rely on labels, marketing, or assumptions—believing that if the FDA has authorized a drug, it must be both safe and effective.
But as The Lever investigation shows, that is not a safe assumption.
And without that knowledge, even well-meaning physicians may prescribe drugs that do little good—and cause real harm.
Who Is the FDA Working for?
In interviews with more than 100 experts, patients, and former regulators, Lenzer and Brownlee found widespread concern that the FDA has lost its way.
Many pointed to the agency’s dependence on industry money. A BMJ investigation in 2022 found that user fees now fund two-thirds of the FDA’s drug review budget—raising serious questions about independence.
Yale physician and regulatory expert Reshma Ramachandran said the system is in urgent need of reform.
“We need an agency that’s independent from the industry it regulates and that uses high-quality science to assess the safety and efficacy of new drugs,” she told The Lever. “Without that, we might as well go back to the days of snake oil and patent medicines.”
For now, patients remain unwitting participants in a vast, unspoken experiment—taking drugs that may never have been properly tested, trusting a regulator that too often fails to protect them.
And as Lenzer and Brownlee conclude, that trust is increasingly misplaced.
- Investigative report by Jeanne Lenzer and Shannon Brownlee at The Lever [link]
- Searchable public drug approval database [link]
- See my talk: Failure of Drug Regulation: Declining standards and institutional corruption
Republished from the author’s Substack
Author
From the Brownstone Institute
By 
Anthony Fauci must be furious.
He spent years proudly being the public face of the country’s response to the Covid-19 pandemic. He did, however, flip-flop on almost every major issue, seamlessly managing to shift his guidance based on current political whims and an enormous desire to coerce behavior.
Nowhere was this more obvious than his dictates on masks. If you recall, in February 2020, Fauci infamously stated on 60 Minutes that masks didn’t work. That they didn’t provide the protection people thought they did, there were gaps in the fit, and wearing masks could actually make things worse by encouraging wearers to touch their face.
Just a few months later, he did a 180, then backtracked by making up a post-hoc justification for his initial remarks. Laughably, Fauci said that he recommended against masks to protect supply for healthcare workers, as if hospitals would ever buy cloth masks on Amazon like the general public.
Later in interviews, he guaranteed that cities or states that listened to his advice would fare better than those that didn’t. Masks would limit Covid transmission so effectively, he believed, that it would be immediately obvious which states had mandates and which didn’t. It was obvious, but not in the way he expected.
And now, finally, after years of being proven wrong, the White House has officially and thoroughly rebuked Fauci in every conceivable way.
White House Covid Page Points Out Fauci’s Duplicitous Guidance
A new White House official page points out, in detail, exactly where Fauci and the public health expert class went wrong on Covid.
It starts by laying out the case for the lab-leak origin of the coronavirus, with explanations of how Fauci and his partners misled the public by obscuring information and evidence. How they used the “FOIA lady” to hide emails, used private communications to avoid scrutiny, and downplayed the conduct of EcoHealth Alliance because they helped fund it.
They roast the World Health Organization for caving to China and attempting to broaden its powers in the aftermath of “abject failure.”
“The WHO’s response to the COVID-19 pandemic was an abject failure because it caved to pressure from the Chinese Communist Party and placed China’s political interests ahead of its international duties. Further, the WHO’s newest effort to solve the problems exacerbated by the COVID-19 pandemic — via a “Pandemic Treaty” — may harm the United States,” the site reads.
Social distancing is criticized, correctly pointing out that Fauci testified that there was no scientific data or evidence to support their specific recommendations.
“The ‘6 feet apart’ social distancing recommendation — which shut down schools and small business across the country — was arbitrary and not based on science. During closed door testimony, Dr. Fauci testified that the guidance ‘sort of just appeared.’”
There’s another section demolishing the extended lockdowns that came into effect in blue states like California, Illinois, and New York. Even the initial lockdown, the “15 Days to Slow the Spread,” was a poorly reasoned policy that had no chance of working; extended closures were immensely harmful with no demonstrable benefit.
“Prolonged lockdowns caused immeasurable harm to not only the American economy, but also to the mental and physical health of Americans, with a particularly negative effect on younger citizens. Rather than prioritizing the protection of the most vulnerable populations, federal and state government policies forced millions of Americans to forgo crucial elements of a healthy and financially sound life,” it says.
Then there’s the good stuff: mask mandates. While there’s plenty more detail that could be added, it’s immensely rewarding to see, finally, the truth on an official White House website. Masks don’t work. There’s no evidence supporting mandates, and public health, especially Fauci, flip-flopped without supporting data.
“There was no conclusive evidence that masks effectively protected Americans from COVID-19. Public health officials flipped-flopped on the efficacy of masks without providing Americans scientific data — causing a massive uptick in public distrust.”
This is inarguably true. There were no new studies or data justifying the flip-flop, just wishful thinking and guessing based on results in Asia. It was an inexcusable, world-changing policy that had no basis in evidence, but was treated as equivalent to gospel truth by a willing media and left-wing politicians.
Over time, the CDC and Fauci relied on ridiculous “studies” that were quickly debunked, anecdotes, and ever-shifting goal posts. Wear one cloth mask turned to wear a surgical mask. That turned into “wear two masks,” then wear an N95, then wear two N95s.
All the while ignoring that jurisdictions that tried “high-quality” mask mandates also failed in spectacular fashion.
And that the only high-quality evidence review on masking confirmed no masks worked, even N95s, to prevent Covid transmission, as well as hearing that the CDC knew masks didn’t work anyway.
The website ends with a complete and thorough rebuke of the public health establishment and the Biden administration’s disastrous efforts to censor those who disagreed.
“Public health officials often mislead the American people through conflicting messaging, knee-jerk reactions, and a lack of transparency. Most egregiously, the federal government demonized alternative treatments and disfavored narratives, such as the lab-leak theory, in a shameful effort to coerce and control the American people’s health decisions.
When those efforts failed, the Biden Administration resorted to ‘outright censorship—coercing and colluding with the world’s largest social media companies to censor all COVID-19-related dissent.’”
About time these truths are acknowledged in a public, authoritative manner. Masks don’t work. Lockdowns don’t work. Fauci lied and helped cover up damning evidence.
If only this website had been available years ago.
Though, of course, knowing the media’s political beliefs, they’d have ignored it then, too.
Republished from the author’s Substack
Author
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