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Sorry Seems to Be the Hardest Word

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From the Brownstone Institute

BY

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

  • Jeffrey A. Tucker

    Jeffrey A. Tucker, Founder and President of the Brownstone Institute, is an economist and author. He has written 10 books, including Liberty or Lockdown, and thousands of articles in the scholarly and popular press. He writes a daily column on economics at The Epoch Times, and speaks widely on topics of economics, technology, social philosophy, and culture.

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Brownstone Institute

Net Zero: The Mystery of the Falling Fertility

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From the Brownstone Institute

By Tomas FurstTomas Fürst  

If you want to argue that a mysterious factor X is responsible for the drop in fertility, you will have to explain (1) why the factor affected only the vaccinated, and (2) why it started affecting them at about the time of vaccination.

In January 2022, the number of children born in the Czech Republic suddenly decreased by about 10%. By the end of 2022, it had become clear that this was a signal: All the monthly numbers of newborns were mysteriously low.

In April 2023, I wrote a piece for a Czech investigative platform InFakta and suggested that this unexpected phenomenon might be connected to the aggressive vaccination campaign that had started approximately 9 months before the drop in natality. Denik N – a Czech equivalent of the New York Times – immediately came forward with a “devastating takedown” of my article, labeled me a liar and claimed that the pattern can be explained by demographics: There were fewer women in the population and they were getting older.

To compare fertility across countries (and time), the so-called Total Fertility Rate (TFR) is used. Roughly speaking, it is the average number of children that are born to a woman over her lifetime. TFR is independent of the number of women and of their age structure. Figure 1 below shows the evolution of TFR in several European countries between 2001 and 2023. I selected countries that experienced a similar drop in TFR in 2022 as the Czech Republic.

Figure 1. The evolution of Total Fertility Rate in selected European countries between 2000 and 2023. The data corresponding to a particular year are plotted at the end of the column representing that year.

So, by the end of 2023, the following two points were clear:

  1. The drop in natality in the Czech Republic in 2022 could not be explained by demographic factors. Total fertility rate – which is independent of the number of women and their age structure – dropped sharply in 2022 and has been decreasing ever since. The data for 2024 show that the Czech TFR has decreased further to 1.37.
  1. Many other European countries experienced the same dramatic and unexpected decrease in fertility that started at the beginning of 2022. I have selected some of them for Figure 1 but there are more: The Netherlands, Norway, Slovakia, Slovenia, and Sweden. On the other hand, there are some countries that do not show a sudden drop in TFR, but rather a steady decline over a longer period (e.g. Belgium, France, UK, Greece, or Italy). Notable exceptions are Bulgaria, Spain, and Portugal where fertility has increased (albeit from very low numbers). The Human Fertility Project database has all the numbers.

This data pattern is so amazing and unexpected that even the mainstream media in Europe cannot avoid the problem completely. From time to time, talking heads with many academic titles appear and push one of the politically correct narratives: It’s Putin! (Spoiler alert: The war started in February 2022; however, children not born in 2022 were not conceived in 2021). It’s the inflation caused by Putin! (Sorry, that was even later). It’s the demographics! (Nope, see above, TFR is independent of the demographics).

Thus, the “v” word keeps creeping back into people’s minds and the Web’s Wild West is ripe with speculation. We decided not to speculate but to wrestle some more data from the Czech government. For many months, we were trying to acquire the number of newborns in each month, broken down by age and vaccination status of the mother. The post-socialist health-care system of our country is a double-edged sword: On one hand, the state collects much more data about citizens than an American would believe. On the other hand, we have an equivalent of the FOIA, and we are not afraid to use it. After many months of fruitless correspondence with the authorities, we turned to Jitka Chalankova – a Czech Ron Johnson in skirts – who finally managed to obtain an invaluable data sheet.

To my knowledge, the datasheet (now publicly available with an English translation here) is the only officially released dataset containing a breakdown of newborns by the Covid-19 vaccination status of the mother. We requested much more detailed data, but this is all we got. The data contains the number of births per month between January 2021 and December 2023 given by women (aged 18-39) who were vaccinated, i.e., had received at least one Covid vaccine dose by the date of delivery, and by women who were unvaccinated, i.e., had not received any dose of any Covid vaccine by the date of delivery.

Furthermore, the numbers of births per month by women vaccinated by one or more doses during pregnancy were provided. This enabled us to estimate the number of women who were vaccinated before conception. Then, we used open data on the Czech population structure by age, and open data on Covid vaccination by day, sex, and age.

Combining these three datasets, we were able to estimate the rates of successful conceptions (i.e., conceptions that led to births nine months later) by preconception vaccination status of the mother. Those interested in the technical details of the procedure may read Methods in the newly released paper. It is worth mentioning that the paper had been rejected without review in six high-ranking scientific journals. In Figure 2, we reprint the main finding of our analysis.

Figure 2A. Histogram showing the percentage of women in the Czech Republic aged 18–39 years who were vaccinated with at least one dose of a Covid-19 vaccine by the end of the respective month. Figure 2B. Estimates of the number of successful conceptions (SCs) per 1,000 women aged 18–39 years according to their pre-conception Covid vaccination status. The blue-shaded areas in Figure 1B show the intervals between the lower and upper estimates of the true SC rates for women vaccinated (dark blue) and unvaccinated (light blue) before conception.

Figure 2 reveals several interesting patterns that I list here in order of importance:

  1. Vaccinated women conceived about a third fewer children than would be expected from their share of the population. Unvaccinated women conceived at about the same rate as all women before the pandemic. Thus, a strong association between Covid vaccination status and successful conceptions has been established.
  2. In the second half of 2021, there was a peak in the rate of conceptions of the unvaccinated (and a corresponding trough in the vaccinated). This points to rather intelligent behavior of Czech women, who – contrary to the official advice – probably avoided vaccination if they wanted to get pregnant. This concentrated the pregnancies in the unvaccinated group and produced the peak.
  3. In the first half of 2021, there was significant uncertainty in the estimates of the conception rates. The lower estimate of the conception rate in the vaccinated was produced by assuming that all women vaccinated (by at least one dose) during pregnancy were unvaccinated before conception. This was almost certainly true in the first half of 2021 because the vaccines were not available prior to 2021. The upper estimate was produced by assuming that all women vaccinated (by at least one dose) during pregnancy also received at least one dose before conception. This was probably closer to the truth in the second part of 2021. Thus, we think that the true conception rates for the vaccinated start close to the lower bound in early 2021 and end close to the upper bound in early 2022. Once again, we would like to be much more precise, but we have to work with what we have got.

Now that the association between Covid-19 vaccination and lower rates of conception has been established, the one important question looms: Is this association causal? In other words, did the Covid-19 vaccines really prevent women from getting pregnant?

The guardians of the official narrative brush off our findings and say that the difference is easily explained by confounding: The vaccinated tend to be older, more educated, city-dwelling, more climate change aware…you name it. That all may well be true, but in early 2022, the TFR of the whole population dropped sharply and has been decreasing ever since.

So, something must have happened in the spring of 2021. Had the population of women just spontaneously separated into two groups – rednecks who wanted kids and didn’t want the jab, and city slickers who didn’t want kids and wanted the jab – the fertility rate of the unvaccinated would indeed be much higher than that of the vaccinated. In that respect, such a selection bias could explain the observed pattern. However, had this been true, the total TFR of the whole population would have remained constant.

But this is not what happened. For some reason, the TFR of the whole population jumped down in January 2022 and has been decreasing ever since. And we have just shown that, for some reason, this decrease in fertility affected only the vaccinated. So, if you want to argue that a mysterious factor X is responsible for the drop in fertility, you will have to explain (1) why the factor affected only the vaccinated, and (2) why it started affecting them at about the time of vaccination. That is a tall order. Mr. Occam and I both think that X = the vaccine is the simplest explanation.

What really puzzles me is the continuation of the trend. If the vaccines really prevented conception, shouldn’t the effect have been transient? It’s been more than three years since the mass vaccination event, but fertility rates still keep falling. If this trend continues for another five years, we may as well stop arguing about pensions, defense spending, healthcare reform, and education – because we are done. 

We are in the middle of what may be the biggest fertility crisis in the history of mankind. The reason for the collapse in fertility is not known. The governments of many European countries have the data that would unlock the mystery. Yet, it seems that no one wants to know.


Author

Tomas Furst

Tomas Fürst teaches applied mathematics at Palacky University, Czech Republic. His background is in mathematical modelling and Data Science. He is a co-founder of the Association of Microbiologists, Immunologists, and Statisticians (SMIS) which has been providing the Czech public with data-based and honest information about the coronavirus epidemic. He is also a co-founder of a “samizdat” journal dZurnal which focuses on uncovering scientific misconduct in Czech Science.

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Brownstone Institute

FDA Exposed: Hundreds of Drugs Approved without Proof They Work

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From the Brownstone Institute

By Maryanne Demasi

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 Brownleepublished 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.

Republished from the author’s Substack

 

Author

Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

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