Brownstone Institute
Twenty Grim Realities Unearthed by Lockdowns

From the Brownstone Institute
BY
It’s common now to speak of the before times in contrast to the after times. The turning point was of course March 16, 2020, the day of 15 Days to Flatten the Curve, though authoritarian trends predate that. Rights were suddenly broadly throttled, even religious rights. We were told to conduct every aspect of our lives in accordance with the priorities of the bio-medical security state.
Very few people anticipated such a shocking development. It was the onset of a new state-conducted war and the enemy was something we could not see and hence could be anywhere. No one has ever doubted the omnipresence of potentially dangerous pathogens but now we were being told that life itself depended entirely on avoidance of them and the only guide going forward would be public-health authorities.
Everything changed. Nothing is the same. The trauma is real and lasting. The claim of “15 Days” was revealed to be a ruse. The emergency lasted three years and then some. The people and machinery that did this are still in power. The pick to head the CDC has a long track record of enabling and cheering the lockdowns and all that followed.
It’s a helpful exercise to summarize the new things we’ve all discovered in these years. Together they account for why the world seems different and why we all feel and think differently now than we did just a few years ago.
Twenty terrible realities unearthed by lockdowns
1. Surveillance and censorship by Big Tech. The resistance eventually found each other but it took months and years. A censorship regime descended on all major social platforms, technologies designed with the intention of keeping us more connected and expanding the range of opinion we could experience. We did not know it was happening, but we eventually learned of the crackdown, which is why so much of us felt so alone. Others could not hear us and we could not hear them. The regime faces a bold court challenge on many fronts but it still goes on today, with all but Twitter constantly policing their networks in ways that are unpredictably authoritarian. We have ironclad evidence now that they are all captured.
2. Power and influence of Big Pharma. It was April 2020 when someone asked me if the goal of the vaccine produced by the pharmaceutical cartel was really behind the lockdowns. The idea would be to terrify us and ruin our lives until we were begging for shots. I thought the whole idea was insane and that the corruption could not possibly reach this deep. I was wrong. Pharma had been at work on a vaccine since January of that year and called in every form of purchased influence to eventually make them mandatory. Now we know that the major regulators are wholly owned and controlled, to the point that necessity, safety, and efficacy don’t really matter.
3. Government propaganda by Big Media. It was relentless from day one: the major media proved hardcore partisans of Anthony Fauci. The powers that be could tap the New York Times, National Public Radio, Washington Post, and all the rest, whenever and however they wanted. Later the media was deployed to demonize those who violated lockdowns, refused masks, and resisted the shots. Gone was the idea that “democracy dies in darkness” and the “paper of record” replaced by darkness itself and constant propaganda. They showed no real curiosity of the other side. The Great Barrington Declaration itself began as an effort to educate journalists but only a few dared even show up. Now we get it: the mainstream media too is wholly owned and completely compromised. They already knew what to report and how to report it. Nothing else mattered.
4. Corruption of public health. Who in their right minds would have predicted that the CDC and NIH, not to mention the World Health Organization, would be deployed as frontline workers in the imposition of totalitarian control? Some observers perhaps predicted this but implausibly so. But in fact it was these agencies which were responsible for all the absurd protocols from closing hospitals to non-Covid cases, putting up Plexiglas everywhere, keeping schools closed, demonizing repurpose therapeutics, masking toddlers, and forcing shots. They knew no limits to their power. They revealed themselves to be faithful agents of the hegemon.
5. Consolidation of industry. Free enterprise is supposed to be free but when workers, industries, and brands were divided between essential and nonessential, where were the howls from Big Business? They weren’t there. They proved willing to put profit ahead of the system of competition. So long as they benefited from the system of consolidation, cartelization, and centralization, they were fine with it. The big-box stores got to wipe out the competition and gain a leg up in industrial standing. Same with remote learning platforms and digital technology. The biggest businesses proved to be the worst enemies of real capitalism and the biggest friends of corporatism. As for arts and music: we know now that the elites consider them dispensable.
6. Influence and power of administrative state. The Constitution established three branches of government but lockdowns were not managed by any of them. Instead it was a fourth branch that has grown up over the decades, the permanent class of bureaucrats that no one elected and no one from the public controls. These permanent “experts” were completely unleashed and unhinged with no check on their power, and they cranked out protocols by the hour and enforced them as legislatures, judges, and even presidents and governors stood by powerless and in awe. We know now that there was a coup d’etat on March 13, 2020 that transferred all power to the national security state but we certainly did not know it then. The edict was classified. The administrative state still rules the day.
7. Cowardice of intellectuals. The intellectuals are the most free to speak their minds of any group. Indeed that is their job. Instead, they stayed quiet for the most part. This was true of right and left. The pundits and scholars just went along with the most egregious attacks on human rights in this generation if not in all living memory. We employ these people to be independent but they proved themselves to be anything but that. We stood by in shock as even famed civil libertarians looked out at the suffering and said “This is fine.” A whole generation among them is today completely discredited. And by the way, the few who did stand up were called horrible names and often lost their jobs. Others took note of this reality and decided instead to behave by staying quiet or echoing the ruling-class line.
8. Pusillanimity of universities. The origin of modern academia is with the sanctuaries from war and pestilence so that great ideas could survive even the worst of times. Most universities – only a handful excepted – completely went along with the regime. They closed their doors. They locked students in their dormitories. They denied paying customers in-person education. Then came the shots. Millions were jabbed unnecessarily and could only refuse on pain of being kicked out of degree programs. They showed a complete lack of principle. Alumni should take note and so should parents who are considering where to send their high school seniors next year.
9. Spinelessness of think tanks. The job of these huge nonprofits is to test the boundaries of acceptable opinion and drive the policy and intellectual world in the direction of progress for everyone. They are also supposed to be independent. They don’t depend on tuition or political favor. They can be bold and principled. So where were they? Almost without exception they clammed up or became craven apologists for the lockdown regime. They waited and waited until the coast was clear and then eked out little opinions that had little impact. Were they just being shy? Not likely. The financials tell a different story. They are supported by the very industries that stood to benefit from the egregious policies. Donors who believe in freedom should take note!
10. Madness of crowds. We’ve all read the classic book Extraordinary Popular Delusions and the Madness of Crowds but we thought it was a chronicle of the past and probably impossible now. But within an instant, mobs of people fell into medieval-style panics, hunting down non-compliers and hiding from the invisible miasma. They had a mission. They were ferreting out dissidents and ratting out the non-compliers. None of this would have happened otherwise. Just like in the Cultural Revolution of China, these would-be members of the Red Guard became foot soldiers for the state. Mathias Desmet’s book on Mass Formation now stands as a classic explanation of how a population devoid of meaningful lives can turn these sorts of political frenzies into deluded crusades. Most of our friends and neighbors went along.
11. Lack of ideological conviction of both right and left. Both right and left betrayed their ideals. The right abandoned its affections for limited government, free enterprise, and the rule of law. And the left turned against its traditional stand for civil liberties, equal freedoms, and free speech. They all became compromised, and they all made up fake rationales for this pathetic situation. Had this all began under a Democrat, the Republicans would have been screaming. Instead they went quiet. Then the Covid regime passed to a Democrat and so they stayed quiet while the Republicans, embarrassed at their previous silence, stayed silent for far too long. Both sides proved ineffective and toothless throughout.
12. Sadism of the ruling class. The kids were denied a year or two of school in some locations. People missed medical diagnostics. Weddings and funerals were on Zoom. The aged were forced into desperate loneliness. The poor suffered. People turned to substance abuse and put on added pounds. The working classes were exploited. Small businesses were wrecked. Millions were forced to move and millions more were displaced from their jobs. The ruling class that advertised its wonderful altruism and public spiritedness became callous and completely disregarded all this suffering. Even when the data poured in about suicide ideation and mental illness from loneliness, it made no difference. They could not muster any concern. They changed nothing. The schools stayed closed and the travel restrictions stayed in place. Those who pointed this out were called terrible names. It was a form of grotesque sadism of which we did not know they were capable.
13. The real-life problem of massive class inequality. Would any of this have happened 20 years ago when a third of the workforce was not privileged enough to take their work home and pretend to produce from laptops? Doubtful. But by 2020, there had developed an overclass that was completely disconnected from the lives of those who work with their hands for a living. But the overclass didn’t care that they had to face the virus bravely and first. These workers and peasants did not have privileges and apparently they didn’t matter much. When it came time for the shots, the overclass wanted their health care workers, pilots, and delivery people to get them too, all in the interest of purifying society of germs. Huge wealth inequalities turn out to make a big difference in political outcomes, especially when one class is forced to serve the other in lockdowns.
14. The cravenness and corruption of public education. A universal education was the proudest achievement of progressives one hundred years ago. We all assumed it was the one thing that would be protected above all else. The kids would never be sacrificed. But then for no good reason, the schools were all closed. The labor unions representing the teachers rather liked their extended paid holiday and tried to make it last as long as possible, as the students got ever further behind in their studies. These are schools for which people paid for with their taxes for many years but no one promised a rebate or any compensation. Homeschooling went from existing under a legal cloud to being suddenly mandatory. And when they opened back up, the kids faced mass silencing with masks.
15. Enabling power of central banking to fund it all. From March 12, 2020, and onward, the Federal Reserve deployed every power to serve as a Congressional printing press. It slammed rates back to zero. It eliminated (eliminated!) reserve requirements for banks. It flooded the economy with fresh money, eventually reaching a peak of 26 percent expansion or $6.2 trillion in total. This of course later translated into price inflation that quickly ate away the actual purchasing power of all that free stimulus dispensed by government, thus harming on net both producers and consumers. It was a great head fake, all made possible by the central bank and its powers. Further damage came to the structure of production by a prolongation of low interest rates.
16. The shallowness of the faith communities. Where were the churches and synagogues? They closed their doors and kept out the people they had sworn to defend. They canceled holy days and holiday celebrations. They utterly and completely failed to protest. And why? Because they went along with the propaganda that ceasing their ministries was consistent with public health priorities. They went along with the state and media claim that their religions were deeply dangerous to the public. What this means is that they don’t really believe in what they claim to believe. When the opening finally came, they discovered that their congregations had dramatically shrunk. It’s no wonder. And who among them did not go along? It was the supposed crazy and odd ones: the Amish, the estranged Mormons, and the Orthodox Jews. How non-mainstream they are. How marginal! But apparently they were among the only ones whose faith was strong enough to resist the demands of princes.
17. The limitations on travel. We didn’t know the government had the power to limit our travel but they did it anyway. First it was internationally. But then it became domestic. For a few months there, it was hard to cross state lines because of the demands that everyone who did so had to quarantine for a fortnight. It was strange because we didn’t know what was and what was not legal nor did we know the enforcement mechanism. It turned out to be a training exercise for what we know now they really want, which is 15-minute cities. Apparently a people on the move are harder to control and corral. We were being acculturated toward a more medieval and tribal existence, staying put so that our masters can keep tabs on us.
18. The tolerance for segregation. Vaccine uptake was certainly disproportionate by race and income. Richer and whiter populations went along but some 40 percent of the non-white and poorer communities didn’t trust the jab and refused. That did not stop 5 major cities from imposing vaccine segregation and enforcing it with police power. For a time, major cities were segregated with disparate impact by race. I don’t recall a single article in a major newspaper that pointed this out, much less decried it. So much for public accommodations and so much for enlightenment! Segregation turns out to be just fine so long as it fits with government priorities – same now as it was in the bad old days.
19. The goal of a social credit system. It is not paranoia to speculate that all this segregation was really about the creation of a vaccine passport system running off a national base, the one they want very much to implement. And part of this is the real and long-term goal of creating a China-style social credit system that would make your participation in economic and social life contingent on political compliance. The CCP has mastered the art and imposed totalitarian control. We know for sure now that major aspects of the pandemic response were scripted in Beijing and imposed through the influence of China’s ruling class. It is completely reasonable to assume that this is the real goal of vaccine passports and even Central Bank Digital Currency.
20. Corporatism as the system under which we live, giving lie to existing ideological systems. For many generations, the great debate has been between capitalism and socialism. All the while, the real goal has passed us by: the institutionalization of an interwar-style corporatist state. This is where property is nominally private and concentrated in only top industries in major sectors but publicly controlled with an eye to political priorities. This is not traditional socialism and it certainly isn’t competitive capitalism. It is a social, economic, and political system designed by the ruling class to serve its interests above all else. Here is the main threat and the existing reality but it is not well understood by either right or left. Not even libertarians seem to get this: they are so attached to the public/private binary that they have blinded themselves to the merger of the two and the ways in which major corporate players are actually driving the advance of statism in their own interests.
If you haven’t changed your thinking over the last three years, you are a prophet, indifferent, or asleep. Much has been revealed and much has changed. To meet these challenges, we must do so with our eyes wide open. The greatest threats to human liberty today are not the ones of the past and they elude easy ideological categorization. Further, we have to admit that in many ways the plain human desire to live a fulfilling life in freedom has been subverted. If we want our freedoms back, we need to have a full understanding of the frightening challenges before us.
Brownstone’s work and influence in this regard is far beyond any that we’ve told publicly. You would be astonished at the extent of it. The times demand circumspection in overt institutional aggrandizement.
We are grateful to our donors for having faith in the power of ideas. We are daily amazed at the ability of passionate and scrupulous writers and intellectuals to make a real difference for the cause of freedom. Please, if you can, join our donor community to keep the momentum going, for the hill is perhaps the steepest we’ve climbed in our lives. We have no “development department” and no corporate or government benefactors: you can make a difference.
Brownstone Institute
Net Zero: The Mystery of the Falling Fertility

From the Brownstone Institute
By
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.

So, by the end of 2023, the following two points were clear:
- 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.
- 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 2 reveals several interesting patterns that I list here in order of importance:
- 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.
- 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.
- 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
Brownstone Institute
FDA Exposed: Hundreds of Drugs Approved without Proof They Work

From the Brownstone Institute
By
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
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