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Brownstone Institute

A Big Picture Look at the Disastrous Public Health Response to COVID-19

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An underlying principle of public health is, or was, to provide the public with accurate information so that they can make good health choices for themselves and their community.

The past 3 years have seen this paradigm turned on its head, with the public’s money being used to deceive and coerce them, forcing them to follow public health dictates. The public has funded their own incarceration and impoverishment through their taxes, with public funds driving the unprecedented nonpharmaceutical, and then pharmaceutical, response to a virus that kills mainly old sick people near the end of their lives.

Children have had their education downgraded, and economies have been mangled, ensuring future generations will also pay. So, what did the public actually pay for?

COVID-19 was not novel, but a variation on previous respiratory disease.

Most healthy people infected with SARS-CoV-2 recover without any intervention, gaining natural immunity which, in the absence of vaccination, generates a more robust and long-lasting protection with less risk for reinfections as compared to individuals protected by vaccination alone. Globally, the infection fatality rate (IFR) of SARS-CoV-2 is about 0.15% and comparable to seasonal influenza (IFR 0,1 %). The IFR of those under twenty years was only 0.0013 %, and highest for those beyond 70 years. The IFR of COVID-19 among community-dwelling elderly is lower than previously reported in elderly overall.

A higher IFR was found in countries with many long-term care facilities, perhaps because exposure tends to occur through other immune-suppressed elderly, rather than immune competent children with lower viral loads. An aging population goes through the process of immunosenescence and increased incidence and severity of infectious diseases is expected.

Severe COVID-19, or COVID-19 Associated ARDS, is a syndrome within the known ARDS spectrum. Acute Respiratory Distress Syndrome (ARDS) and associated cytokine storm has been recognized for more than 50 years. It occurs when a diverse array of triggers causes acute, bilateral pulmonary inflammation and increased capillary permeability leading to acute hypoxemic respiratory failure.

Although supportive care improved the prognosis, mortality and disabling complications in survivors in intensive care are still high, and have remained relatively unchanged in the last 20 years. In 2013 an estimated 2.65 million deaths worldwide were attributed to Acute Respiratory Tract Infection.

As with other ARDS etiologies, people suffering from (COVID-19) ARDS are mostly elderly people with comorbidities including being overweight, hypertension, Type 2 diabetes and cardiovascular diseases, often using multiple medications. Other restrictions on the immune system, such as vitamin D deficiency, put people at increased risk.

As of July 2022, WHO reported over 601 million confirmed cases and over 6.4 million deaths associated with COVID-19 globally. More than half (3.5 million) died after the rollout of the COVID-19 vaccines, though 67.7 % of the world population has received at least one vaccination. The WHO estimates a total of 14.9 million excess deaths in 2020-2021 associated with COVID-19 directly due to the disease or indirectly due to the impact of the public health response on health systems and society.

Footing the bill for the disposal of orthodox public health

Since COVID-19 was recognized in Western countries in early 2020, expenditures on public health in many of them have more than doubled, imposing over $500 billion in monthly costs on the global economy. Some trillions more have been spent on compensation and stimulus packages for those left without income due to the public health response, whilst economies, and therefore future employment opportunities, have been heavily damaged. This is nearly all funded by taxpayers, or borrowed to be funded with interest by the taxpayers of the future.

Politicians and various experts have claimed that the coercive COVID-19 public health policies are the only way to curb COVID-19, though such measures were advised against by the WHO in its pandemic influenza guidelines of 2019. They would increase poverty and inequality, whilst having (still) unproven efficacy.

Citizens have paid the bill via taxes for novel nonpharmaceutical interventions (lockdowns, mask mandates and frequent testing) and repeated vaccinations of immune people with rapidly waning vaccines, whilst seeing their own incomes reduced. The increase in the money supply to cover relief for forced unemployment has driven inflation, contributing to increased food, water, energy, health and insurance costs. These responses have disproportionately harmed low income families.

Governments take over medical management

Early in the pandemic it became clear that intubating a COVID-19 patient could increase long-term harm and mortality. Unfortunately, many hospitals continued a low threshold for the use of ventilators for the fear that other methods of oxygenation would spread the virus. In 2020 the US spent billions of dollars stockpiling unused ventilators.

In many countries a relatively new antiviral drug, remdesivir, developed with State funding, became the first choice of treatment for hospitalized people with COVID-19. The safety and toxicity of the expensive remdesivir was widely disputed. Yet even after the first results of the WHO’s Solidarity study found little or no effect on reducing hospital stay or Covid deaths, the EU continued a €1.2 billion agreement with Gilead for 500,000 treatments and it continued to be prioritized for use in the United States.

Final results of the Solidarity study confirmed the finding of little or no effect. In contrast, the use of cheaper drugs with antiviral activity, like ivermectin and hydroxychloroquine, was suppressed. Although ivermectin is now included in lists of the US National Institutes of Health in August 2022, governments are silent on its use, preferring to transfer funds to Pharma for newer on-patent drugs.

Expanding lockdowns from prisons to society

Lockdowns may prove to be one of the gravest governmental failures of modern times. A cost-benefit analysis of the response to COVID-19 found lockdowns to be far more harmful to public health (at least 5-10 times) in terms of well-being than COVID-19. Significant collateral damage is not unexpected, as mass business closures and restricted movement have affected billions of people globally through poverty, food insecurity, loneliness, unemployment, educational interruption, and interrupted healthcare. What did not make media headlines is the more than 3 million children who have died from malnutrition in the first year of the pandemic. Together with increasing malnutrition, the world is facing rising burdens of child marriage and child labor, developmental and mental problems, poverty, suicide and chronic disease.

Reviews of the effects of lockdowns on COVID-19 mortality concluded there is no broad-based evidence of noticeable COVID-19 benefit. Pandemic models that guided poverty not only overestimated COVID-19 impact but failed to take into account the collateral damage of lockdowns. The sense of fear, anxiety and helplessness brought to families and 2.2 billion children around the globe with removal of future earning capacity and limited access to healthcare will impact lives in an unprecedented manner for generations.

A recent study analyzing the 50 states of the US, with 10 states that had no lockdown impositions, strongly support the hypothesis that lockdowns place a sudden and severe stress burden on vulnerable demographics and were associated with significant increases in death in those states that used lockdowns as a disease control measure.

Mental health problems, noncommunicable inflammatory diseases, cancer and sudden deaths have increased in people across all age groups, indicating millions of people may now have more compromised immune systems. The links between stress/anxiety, ill-health and early death have long been recognized.

Within Western countries, the most deprived people and neighborhoods have higher risks for severe COVID-19, and higher mortality rates. The underprivileged in society are disproportionately affected by infectious diseases due to poverty, malnutrition, chronic stress, depression and anxiety, a deprived immune system and poor access to health-care. Rather than enhancing the resilience of these populations, the public health response has compounded their poverty, removed education opportunities, and so increased their vulnerability to this and future pandemics.

Testing for sake of testing

State investments were made for COVID-19 diagnostics: PCR tests and point-of-care tests including rapid antigen tests. While billions of tests have been used, they are poor in distinguishing infectiousness and inaccuracy provides a false sense of security, with positive results unnecessary driving fear and sick leave.

The WHO had previously, sensibly, advised against contact tracing once extensive community spread is present – people will be infected eventually, and gain immunity. Spending resources to find a small proportion, not possibly sufficient to stop transmission, is epidemiologically pointless. No reason was provided for reversing this orthodox and logical advice.

Hiding faces to pollute the environment

While there is no sound scientific support for the effectiveness of face mask mandates in the community, including children, state governments invested in the availability of free face masks for all citizens. The two published randomized controlled trials of face masks during COVID-19 showed minimal or no impact, while meta-analyses of previous studiesshow no significant efficacy. Yet in the first half of 2020 importation of face masks in the EU grew 1,800 % to €14 billion, while the industry in 2021 was worth $4.58 billion globally. Face masks with microplastics and nanoparticles are now polluting the environment, and potentially increasing the risk of impaired immune systems.

Getting an awkward technology past the regulators

Despite severe COVID-19 being highly concentrated in elderly people since early 2020, with significant comorbidities and strong evidence of effectiveness of postinfection immunity, the WHO stated in early 2021 that vaccinating the global population against COVID-19 is the only long-term strategy to contain the coronavirus crisis; “No one is safe until everyone is safe”. Rising vaccination rates were said to be necessary to improve healthcare, job prospects and future educational plans.

Unfortunately, the peak efficiency of 97% and 96% respectively claimed for the Moderna and Pizer COVID-19 vaccines against COVID hospitalization waned rapidly after vaccination. The 6-month follow-up reports showed no reduction in all-cause mortality. The COVID-19 adenovector vaccines from Astra-Zeneca and Johnson & Johnson showed better protection against mortality but aren’t used for booster vaccinations in most countries due to the risk of vaccine-related side effects.

A recent peer-reviewed article by Fraiman et al. noted excess risk of serious adverse events analyzing the trial data of both mRNA vaccines that points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. The authors request the public release of participant level datasets from the sponsoring drug companies, which is still not openly available.

Moreover, the vice president of Pfizer, answered the question of Rob Roos, a Dutch Europarlementarier during the European Commission on October 11, 2022, concerning whether the mRNA vaccine of Pfizer had been tested for prevention of transmission of the virus before the release of the vaccine in 2021. She said no, thus indicating the vaccine promotion and coercion was based on false arguments.

For authorization to use medical interventions the benefits need to outweigh the risks. These mRNA vaccines don’t clearly meet this bar for people under 70 years of age. A recent study by nine health experts from major universities found that per COVID-19 hospitalization prevented in previously uninfected young adults, between 18 and 98 serious adverse events were observed. In Scandinavian countries the use of the Moderna mRNA vaccine has been restricted for the potential risk of heart inflammation in adolescents

Although official reports on the side effects of the COVID-19 vaccines by Public Health Institutes have been limited, there is growing data on myocarditis, menstrual irregularities or the excess of all cause mortality and severe outcomes in vaccinated groups. The recent leakage of Israeli safety data and release of US CDC V safe Data show serious safety problems with COVID-19 vaccines that deliberately need further investigations.

Countries with the highest vaccination rates and strongest coercive measures have experienced high numbers of hospitalization and deaths, while some with a low vaccination rate, including many sub-Saharan countries maintained low Covid-19 mortality. Antibody responses are shown to be lower in elderly people while decreased responses or higher infection rates have occurred after repeated vaccinations. The CDC disclosed just how fast mRNA boosters can fail.

This calls into question the mass all-population vaccination and boosting strategy. Pascal Soriot, the CEO of Astra-Zeneca, has suggested that “booster jabs for healthy people on a yearly basis are a waste of tax money.

A temporary reprieve

On August 11, 2022, the US Centers for Disease Control and Prevention (CDC) stated that the virus now poses significantly lower risk due to high levels of immunity from vaccines and infections. On August 19, it changed its recommendations to reflect this, no longer differentiating between vaccine status or post-infection immunity. President Biden declared in September 2022 “The pandemic is over,” though it remains unclear what this means with ‘emergency’ measures remaining in place.

While the global economy has suffered, this is only clear from a specific standpoint. In contrast to the mass of the population, private companies are involved in the response, particularly in the pharmaceutical, biotech and web-based sectors. These companies have increased their wealth by hundreds of billions of dollars in 2020 and 2021, as did high-net-worth individuals, many of whom were advocating for the response that ensured this.

The beguiling vision of fleecing taxpayers to benefit the private sector

The current COVID-19 response has wiped out the gains from decades of global progress in health and income, especiallyfor women and has exacerbated persistent inequities. Unfortunately, a world that is facing the most serious health crisis in a century and the most serious economic and social crises since the second World War is now also on the hook to fund those who would repeat this.

Together with the WHO, world leaders have now called for a global pandemic preparedness treaty to make this state of affairs more readily repeatable. They justify this call for further diversion of public funds through the harms, financial and other, accrued during the COVID-19 outbreak.

This is driven by a vision that health is a political choice based on solidarity and ‘equity’ to be established in a centralized global response delivered via international organizations including the WHO, UNICEF, Gavi, (a global Vaccine Alliance) and the public-private partnership Coalition for Economic Preparedness Information (CEPI), launched in 2017 at the WEF by Bill Gates, the Wellcome Trust, Norwegian Government and others. Finance institutions, including the World Bank, have now stepped in to accelerate the growth of this burgeoning pandemic industry. A new World Bank-hosted Financial Intermediary Fund (FIF) for pandemic prevention, preparedness and response was installed at the G20 Health Ministerial Meeting in June 2022.

A real concern is growing that the new vision of drug and vaccine approval by the FDA and EMA will expand a commercialized market driven by drug manufacturers at the expense of rigorous independent scientific and regulatory review. This risks irreparable harm for many people while boosting the profits of pharmaceutical and biotech companies. Prescribed medications are already estimated to be the third most common contributor to death globally after heart disease and cancer.

Despite their stated intent, the investments in COVID-19 vaccinations and nonpharmaceutical interventions of the past three years have not improved human capital, economic and societal performance. Moreover illnesses, disabilities and mortality show steep rises in the working age group (25-64 years) as observed by insurance companies. Predictions by consultancy firms of the support Covid-19 vaccinations would provide to the economy have been unrealistic. Countries are now facing shortages of healthcare workers in part due to vaccine mandates, reducing healthcare access to people with ill-health who have paid insurance and tax money for healthcare. It might even result in bankruptcy of hospitals.

Good Health, the most precious asset of life 

The CEO of CEPI stated in an interview with McKinsey that “The emergent issue of waning immunity and the threat posed by the evolution of the virus tell us that we need to produce broader and more enduring immune responses.” Mass surveillance, lockdowns, wearing face masks and poorly effective COVID-19 vaccines have contributed to chronic stress, fear and anxiety that reduce the resilience of immunity. Unfortunately, when the immune system (immunosenescence) is weakened vaccinations are also less able to generate effective protection.

More state investments in frequent vaccinations, mass distribution of vaccines, developing new vaccines within 100 days, development of simulating models, and more clinical trials will be poor alternatives to strengthen the underlying immune systems through a life in freedom with high social capital, a healthy diet, education, sports, play, social interactions, equity in decision-making and fair earnings.

Health is key for resilient economies worldwide. The relationship between health and the economy is bidirectional, whereby economic growth enables funding in investments that improve health; and a healthy population contributes to and enhances an economy. Therefore, public and private investments in health for all needs to transform from maximizing value for money to positive cumulative impacts on people’s lives.

Optimizing health is the ultimate goal and a human right. The global response to the coronavirus pandemic has revealed an ethical crisis in public health, in which the pre-pandemic norms of public health ethics have been cast aside.

This has wrecked health, human rights and economies, whilst the people public health was supposed to serve it had to pay for its implementation, and will pay for its harms. It will be a long way back, and recovery will require public health to return to its servant nature, and leave the limelight where it caused such disaster.

Authors

  • Carla Peeters is founder and managing director of COBALA Good Care Feels Better. She obtained a PhD in Immunology from the Medical Faculty of Utrecht, studied Molecular Sciences at Wageningen University and Research, and followed a four-year course in Higher Nature Scientific Education with a specialization in medical laboratory diagnostics and research. She studied at various business schools including London Business School, INSEAD and Nyenrode Business School.

    David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. He is the former Program Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland.

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Brownstone Institute

Net Zero: The Mystery of the Falling Fertility

Published on

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

Published on

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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