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Brownstone Institute

How the EU is Forcing Twitter to Censor (and Musk Can’t Stop It)

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Twitter is obviously at the center of what is commonly known as “Big Tech censorship.” It has been busily using the censorship tools at its disposal – from removing or quarantining tweets to surreptitiously “deboosting” them (shadow-banning) to outright account suspension – for at least two years now. And those who have managed to remain on the platform will have noticed a sharp upturn in its censorship activities starting last summer.

For most of this time, the main focus of Twitter censorship has, of course, been supposed “Covid-19 disinformation.” By now, almost all the most influential advocates of early treatment or critics of Covid-19 vaccines on Twitter have had their accounts suspended, and most have not made it back.

The list of the permanently suspended includes such prominent voices as Robert Malone, Steve Kirsch, Daniel Horowitz, Nick Hudson, Anthony Hinton, Jessica Rose, Naomi Wolf, and, most recently, Peter McCullough.

And myriad smaller accounts have met the same fate for committing such thought crimes as suggesting that the myocarditis risk of both mRNA vaccines (Moderna and BioNTech/Pfizer) outstrips any benefit or pointing to mRNA instability and its unknown consequences for safety and efficacy.

But why in the world would Twitter censor such content? The expression “Big Tech censorship” implies that Twitter et al. are censoring of their own accord, which invariably elicits the retort that, well, they are private companies, so they can do what they want. But why would they want to?

The notion that it is because the denizens of Silicon Valley are “leftists” or “liberals” is clearly not very helpful. They may well be. But whether mRNA vaccines are safe and effective, as advertised, is a factual matter, not an ideological one. And, in any case, the purpose of private for-profit corporations is, needless to say, to make a profit. The motto of the shareholder is not “Workers of the World Unite!” but “Pecunia non olet:” money doesn’t stink. Shareholders expect management to create value, not destroy it.

But what Twitter is doing by censoring is precisely subverting its own business model, thus undermining profitability and putting downward pressure on share price. Free speech is obviously the lifeblood of every social media. Censored speech – like the tweets of a Robert Malone or a Peter McCullough or, for that matter, a Donald Trump – translates into lost traffic for the platform. And traffic is, of course, the key to monetizing unrestricted online content.

We could call this the “Twitter conundrum.” On the one hand, there is no way that Twitter could possibly “want” to censor Covid dissident voices, or indeed any voices, and thus restrict its own traffic. But, on the other hand, if it fails to do so, it risks incurring massive fines of up to 6% of turnover, which would likely represent a deathblow to a company that already has not turned a profit since 2019. Twitter, in effect, has a financial gun to its head: censor or else.

Wait, what? There has been much talk recently of the Biden administration exerting informal pressure on Twitter and other social media to censor unwelcome content and voices, and lawsuits have even been launched against the government for infringing the alleged victims’ 1st Amendment rights. But all that such pressure appears thus far to have consisted of are some chummy nudges in emails.

There has surely not been any threat of fines. How could there be without a law authorizing the executive branch to impose them? And such a law would be blatantly unconstitutional, since precisely what the 1st Amendment states concerning freedom of speech is that “Congress shall make no law…abridging” it.

But there’s the rub. Congress, needless to say, has not made any such law. But what if a foreign power made such a law and it de facto abridged the freedom of speech also of Americans?

Unbeknownst to most Americans, this has in fact occurred and their 1st Amendment rights are being vitiated, namely, by the European Union. There is a financial gun pointed at Twitter. But it is not the Biden administration, but rather the European Commission, under the leadership of Commission president Ursula von der Leyen, that has its finger on the trigger.

The law in question is the EU’s Digital Services Act (DSA), which was passed by the European Parliament last July 5 amidst almost total indifference – in Europe as much as in the United States – despite its momentous and disastrous implications for freedom of speech worldwide.

The DSA gives the European Commission the power to impose fines of up to 6% of global turnover on “very large online platforms or very large online search engines” that it finds to be non-compliant with its censorship requirements. “Very large” is defined as any platform or search engine that has over 45 million users in the EU. Note that while the size criterion is limited to users in the EU, the sanction is based precisely on the company’s global turnover.

The DSA has been designed to function in combination with the EU’s so-called Code of Practice on Disinformation: an ostensibly voluntary code for “combatting disinformation” – aka censoring – that was originally launched in 2018 and of which Twitter, Facebook/Meta and Google/YouTube are all signatories.

But with the passage of the DSA, the Code of Practice is evidently not so “voluntary” anymore. There is no need for complex legal analyses to show that the sanction provisions in the DSA are intended as the enforcement mechanism for the Code of Practice. The European Commission has said so itself – and in a tweet no less!

In fact, the Code has never really been all that voluntary. The Commission had already made its desire to “tame” the US tech giants known previously, and it had already flexed its muscles, imposing massive fines on Google and Facebook for other alleged offenses.

Moreover, it has been brandishing the threat of the DSA fines since December 2020, when it first put forward the DSA legislation. (In the European Union, the Commission, the EU’s executive branch, has sole authority to initiate legislation. Quaint American notions like the separation of powers are not a thing in the EU.) The eventual passage of the legislation by the parliament has always been treated as a mere formality. Indeed, the above-cited tweet was posted on June 16 of this year, three weeks before the parliament voted on the law!

Curiously, the publication of the draft legislation coincided with the authorization and subsequent rollout of the first Covid-19 vaccines in the EU: the legislation was unveiled on December 15 and the first Covid-19 vaccine, that of BioNTech and Pfizer, was authorized by the Commission just six days later. Vaccine skeptics or critics would quickly become the principal target of EU-driven online censorship thereafter.

Six months earlier, in June 2020, the Commission had already placed the focus of the Code firmly on alleged “Covid-19 disinformation” by launching a so-called Fighting COVID-19 Disinformation Monitoring Programme, in which all Code signatories were expected to participate. Some attempts had already been made at monitoring compliance with the Code, and signatories were expected to submit annual reports. But, as part of the Covid-19 monitoring program, signatories were now required – “voluntarily,” of course – to submit monthly reports to the Commission specifically dedicated to their Covid-19-related censorship efforts. The rhythm of submission was subsequently scaled back to bimonthly.

Twitter’s reports, for example, contain detailed statistics on Covid-related content removal and account suspensions. The below chart, showing the evolution of these numbers from February 2021 (shortly after vaccine rollout) through April 2022, is taken from Twitter’s latest available report from June of this year.

Note that the data concerns content removed and accounts suspended globally: i.e. Twitter’s efforts to satisfy the Commission’s censorship expectations do not only affect the accounts of users based in the EU, but of users all around the world.

The fact that many, if not most, of the accounts that have been suspended in this connection were written in English raises particularly troubling issues. In the aftermath of Brexit, after all, only around 1.5% of the EU’s population are native English speakers! Even supposing that policing speech was a good thing, what business does the EU have policing speech, or requiring social media platforms to police speech, in English, any more, say, than in Urdu or Arabic?

The Twitter report and those of other Code signatories can be downloaded here. If the numbers were to be continued, they would undoubtedly show a sharp upturn in censorship activities starting in late June/early July. Twitter users interested in the subject could not help but have noticed the massive purge of Covid dissident accounts that occurred over the summer.

And this upturn was in fact entirely to be expected, since on June 16 – the day the European Commission posted its warning to online platforms reproduced above and three weeks before the passage of the DSA – the Commission announced the adoption of a new, “strengthened” Code of Practice on Disinformation.

The timing was surely not coincidental. Rather, the adoption of the “strengthened” Code of Practice and the passage of the DSA served as a kind of one-two punch, putting “very large online platforms and search engines” – Twitter, Meta/Facebook and Google/YouTube, in particular – on notice about what would be in store for them if they failed to fulfill the EU’s censorship requirements.

Not only does the new Code contain no less than 44 “commitments” that signatories are expected to meet, but it also contains a deadline for meeting them: namely, six months after signature of the Code (cf. paragraph 1(o)). For original signatories of the new Code like Twitter, Meta and Google, this would bring us, namely to December. Hence, the sudden rush of Twitter et al. to prove their censorship bona fides.

The “strengthened” Code was supposedly written by the signatories themselves, but under extensive “guidance” from the European Commission that was first made available in May 2021. Chillingly, the Commission “guidance” refers to the kind of censorship data presented above as “key performance indicators” (pp. 21f). (Different euphemisms are used in the Code itself.)

As part of the new Code, moreover, signatories will participate in a “permanent task-force” chaired by the European Commission and that will also include “representatives of the European External Action Service,” i.e. the EU’s foreign service (Commitment 37).

Think about this for a moment. For the last several months, American commentators have been up in arms about occasional, informal contacts between social media companies and the Biden administration, whereas those same companies have been systematically reporting back to the European Commission on their censorship efforts for the last two years now and they will henceforth be part of a permanent task force on “combatting disinformation” – aka censoring — chaired by the European Commission.

While the former may or may not constitute collusion, the latter is obviously something much more than mere collusion. It is a matter of explicit EU policy and law that directly subordinates online platforms to the Commission’s censorship agenda and requires them to implement it on pain of ruinous fines.

Note that the DSA gives the Commission “exclusive” – in effect, dictatorial – powers to determine compliance and to apply sanction. For the online platforms, the Commission is judge, jury and executioner.

Again, there is no need to enter into the tortuous details of the legislative text to show this. All official EU pronouncements on the DSA highlight the fact. See here, for instance, from the parliament’s Internal Market Committee, which notes that the Commission will also be able to “inspect a platform’s premises and get access to its databases and algorithms.”

Does anyone really imagine that the Biden administration has anything remotely like this sort of capacity to direct the actions of online platforms? Make no mistake about it. Twitter censorship is government censorship. But the government in question is not the US government, but rather the European Union, and the EU is, in effect, imposing its censorship on the entire world.

Those hoping that Elon Musk’s buying Twitter, if it does indeed come to pass, will put an end to Twitter censorship are going to be in for a rude awakening. Elon Musk will be facing the same conundrum as Twitter’s present management and will be just as much hostage to the EU’s censorship requirements.

Lest there be any doubt about this, consider the below video, which, despite the forced smiles, has indeed something of the feel of a hostage video. In early May – just a couple of weeks after Twitter accepted Musk’s original purchase offer and, yet again, before the European parliament had even had the opportunity to vote on the DSA – the EU’s Internal Market Commissioner Thierry Breton traveled to Austin, Texas, to explain the “new regulation” to Musk.

Breton then memorialized Musk’s cringeworthy submission to the EU’s demands in the video posted on his Twitter feed.

Author

  • Robert Kogon is a pen name for a widely-published financial journalist, a translator, and researcher working in Europe. Follow him at Twitter here. He writes at edv1694.substack.com.

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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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