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The Fraying of the Liberal International Order

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From the Brownstone Institute

BY Ramesh ThakurRAMESH THAKUR

International politics is the struggle for the dominant normative architecture of world order based on the interplay of power, economic weight and ideas for imagining, designing and constructing the good international society. For several years now many analysts have commented on the looming demise of the liberal international order established at the end of the Second World War under US leadership.

Over the last several decades, wealth and power have been shifting inexorably from the West to the East and has produced a rebalancing of the world order. As the centre of gravity of world affairs shifted to the Asia-Pacific with China’s dramatic climb up the ladder of great power status, many uncomfortable questions were raised about the capacity and willingness of Western powers to adapt to a Sinocentric order.

For the first time in centuries, it seemed, the global hegemon would not be Western, would not be a free market economy, would not be liberal democratic, and would not be part of the Anglosphere.

More recently, the Asia-Pacific conceptual framework has been reformulated into the Indo-Pacific as the Indian elephant finally joined the dance. Since 2014 and then again especially after the Russian invasion of Ukraine in February last year, the question of European security, political and economic architecture has reemerged as a frontline topic of discussion.

The return of the Russia question as a geopolitical priority has also been accompanied by the crumbling of almost all the main pillars of the global arms control complex of treaties, agreements, understandings and practices that had underpinned stability and brought predictability to major power relations in the nuclear age.

The AUKUS security pact linking Australia, the UK, and the US in a new security alliance, with the planned development of AUKUS-class nuclear-powered attack submarines, is both a reflection of changed geopolitical realities and, some argue, itself a threat to the global nonproliferation regime and a stimulus to fresh tensions in relations with China. British Prime Minister (PM) Rishi Sunak said at the announcement of the submarines deal in San Diego on March 13 that the growing security challenges confronting the worldā€”ā€œRussia’s illegal invasion of Ukraine, China’s growing assertiveness, the destabilising behaviour of Iran and North Koreaā€ā€”ā€œthreaten to create a world codefined by danger, disorder and division.ā€

For his part, PresidentĀ Xi JinpingĀ accused the US of leading Western countries to engage in an ā€œall-around containment, encirclement and suppression of China.ā€

The Australian government described the AUKUS submarine project as ā€œthe single biggest investment in our defence capability in our historyā€ that ā€œrepresents a transformational moment for our nation.ā€ However, it could yet be sunk by six minefields lurking underwater: China’s countermeasures, the time lag between the alleged imminence of the threat and the acquisition of the capability, the costs, the complexities of operating two different classes of submarines, the technological obsolescence of submarines that rely on undersea concealment, and domestic politics in the US and Australia.

Regional and global governance institutions can never be quarantined from the underlying structure of international geopolitical and economic orders. Nor have they proven themselves to be fully fit for the purpose of managing pressing global challenges and crises like wars, and potentially existential threats from nuclear weapons, climate-related disasters and pandemics.

To no one’s surprise, the rising and revisionist powers wish to redesign the international governance institutions to inject their own interests, governing philosophies, and preferences. They also wish to relocate the control mechanisms from the major Western capitals to some of their own capitals. China’s role in the Iran–Saudi rapprochement might be a harbinger of things to come.

The ā€Restā€ Look for Their Place in the Emerging New Order

The developments out there in ā€œthe real world,ā€ testifying to an inflection point in history, pose profound challenges to institutions to rethink their agenda of research and policy advocacy over the coming decades.

On 22–23 May, the Toda Peace Institute convened a brainstorming retreat at its Tokyo office with more than a dozen high-level international participants. One of the key themes was the changing global power structure and normative architecture and the resulting implications for world order, the Indo-Pacific and the three US regional allies Australia, Japan, and South Korea. The two background factors that dominated the conversation, not surprisingly, were China–US relations and the Ukraine war.

The Ukraine war has shown the sharp limits of Russia as a military power. Both Russia and the US badly underestimated Ukraine’s determination and ability to resist (ā€œI need ammunition, not a ride,ā€ President Volodymyr Zelensky famously said when offered safe evacuation by the Americans early in the war), absorb the initial shock, and then reorganise to launch counter-offensives to regain lost territory. Russia is finished as a military threat in Europe. No Russian leader, including President Vladimir Putin, will think again for a very long time indeed of attacking an allied nation in Europe.

That said, the war has also demonstrated the stark reality of the limits to US global influence in organising a coalition of countries willing to censure and sanction Russia. If anything, the US-led West finds itself more disconnected from the concerns and priorities of the rest of the world than at any other time since 1945. A study published in October from Cambridge University’s Bennett Institute for Public Policy provides details on the extent to which theĀ West has become isolated from opinion in the rest of the worldĀ on perceptions of China and Russia. This was broadly replicated in a February 2023 study from the European Council on Foreign Relations (ECFR).

The global South in particular has been vocal in saying firstly that Europe’s problems are no longer automatically the world’s problems, and secondly that while they condemn Russia’s aggression, they also sympathise quite heavily with the Russian complaint about NATO provocations in expanding to Russia’s borders. In the ECFR report, Timothy Garton-Ash, Ivan Krastev, and Mark Leonard cautioned Western decision-makers to recognise that ā€œin an increasingly divided post-Western world,ā€ emerging powers ā€œwill act on their own terms and resist being caught in a battle between America and China.ā€

US global leadership is hobbled also by rampant domestic dysfunctionality. A bitterly divided and fractured America lacks the necessary common purpose and principle, and the requisite national pride and strategic direction to execute a robust foreign policy. Much of the world is bemused too that a great power could once again present a choice between Joe Biden and Donald Trump for president.

The war has solidified NATO unity but also highlighted internal European divisions and European dependence on the US military for its security.

The big strategic victor is China. Russia has become more dependent on it and the two have formed an effective axis to resist US hegemony. China’s meteoric rise continues apace. Having climbed past Germany last year, China has just overtaken Japan as the world’s top car exporter, 1.07 to 0.95 million vehicles. Its diplomatic footprint has also been seen in the honest brokerage of a rapprochement between Iran and Saudi Arabia and in promotion of a peace plan for Ukraine.

Even more tellingly, according to data published by the UK-based economic research firm Acorn Macro Consulting in April, the BRICS grouping of emerging market economies (Brazil, Russia, India, China, South Africa) now accounts for a larger share of the world’s economic output in PPP dollars than the G7 group of industrialised countries (Canada, France, Germany, Italy, Japan, UK, USA). Their respective shares of global output have fallen and risen between 1982 and 2022 from 50.4 percent and 10.7 percent, to 30.7 percent and 31.5 percent. No wonder another dozen countries are eager to join the BRICS, prompting Alec Russell to proclaim recently in The Financial Times: ā€œThis is the hour of the global south.ā€

The Ukraine war might also mark India’s long overdue arrival on the global stage as a consequential power. For all the criticisms of fence-sitting levelled at India since the start of the war, this has arguably been the most successful exercise of an independent foreign policy on a major global crisis in decades by India. Foreign Minister S. Jaishankar even neatly turned the fence-sitting criticism on its head by retorting a year ago that ā€œI am sitting on my groundā€ and feeling quite comfortable there. His dexterity in explaining India’s policy firmly and unapologetically but without stridency and criticism of other countries has drawn widespread praise, even from Chinese netizens.

On his return after the G7 summit in Hiroshima, the South Pacific and Australia, PM Narendra Modi commented on 25 May: ā€œToday, the world wants to know what India is thinking.ā€ In his 100th birthday interview with The Economist, Henry Kissinger said he is ā€œvery enthusiasticā€ about US close relations with India. He paid tribute to its pragmatism, basing foreign policy on non-permanent alliances built around issues rather than tying up the country in big multilateral alliances. He singled out Jaishankar as the current political leader who ā€œis quite close to my views.ā€

In a complementary interview with The Wall Street Journal, Kissinger also foresees, without necessarily recommending such a course of action, Japan acquiring its own nuclear weapons in 3-5 years.

In a blog published on 18 May, Michael Klare argues that the emerging order is likely to be a G3 world with the US, China, and India as the three major nodes, based on attributes of population, economic weight and military power (with India heading into being a major military force to be reckoned with, even if not quite there yet). He is more optimistic about India than I am but still, it’s an interesting comment on the way the global winds are blowing. Few pressing world problems can be solved today without the active cooperation of all three.

The changed balance of forces between China and the US also affects the three Pacific allies, namely Australia, Japan, and South Korea. If any of them starts with a presumption of permanent hostility with China, then of course it will fall into the security dilemma trap. That assumption will drive all its policies on every issue in contention, and will provoke and deepen the very hostility it is meant to be opposing.

Rather than seeking world domination by overthrowing the present order, says Rohan Mukherjee in Foreign Affairs, China follows a three-pronged strategy. It works with institutions it considers both fair and open (UN Security Council, WTO, G20) and tries to reform others that are partly fair and open (IMF, World Bank), having derived many benefits from both these groups. But it is challenging a third group which, it believes, are closed and unfair: the human rights regime.

In the process, China has come to the conclusion that being a great power like the US means never having to say you’re sorry for hypocrisy in world affairs: entrenching your privileges in a club like the UN Security Council that can be used to regulate the conduct of all others.

Instead of self-fulfilling hostility, former Australian foreign secretary Peter VargheseĀ recommends a China policy of constrainment-cum-engagement. Washington may have set itself the goal of maintaining global primacy and denying Indo-Pacific primacy to China, but this will only provoke a sullen and resentful Beijing into efforts to snatch regional primacy from the US. The challenge is not to thwart but to manage China’s rise—from which many other countries have gained enormous benefits, with China becoming their biggest trading partner—by imagining and constructing a regional balance in which US leadership is crucial to a strategic counterpoint.

In his words, ā€œThe US will inevitably be at the centre of such an arrangement, but that does not mean that US primacy must sit at its fulcrum.ā€ Wise words that should be heeded most of all in Washington but will likely be ignored.

Author

  • Ramesh Thakur

    Ramesh Thakur, a Brownstone Institute Senior Scholar, is a former United Nations Assistant Secretary-General, and emeritus professor in the Crawford School of Public Policy, The Australian National University.

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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 aĀ pieceĀ for a Czech investigative platformĀ InFaktaĀ 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.Ā Denik N – a Czech equivalent of theĀ New York Times – immediately came forward with a ā€œdevastating takedownā€ 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-calledĀ Total Fertility RateĀ (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.Ā 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. TheĀ data for 2024Ā 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 ProjectĀ databaseĀ 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:Ā It’s Putin!Ā (Spoiler alert: The war started in February 2022; however, children not born in 2022 were not conceived in 2021).Ā It’s the inflation caused by Putin!Ā (Sorry, that was even later).Ā It’s the demographics!Ā (Nope, see above, TFR is independent of the demographics).

Thus, the ā€œvā€ 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 translationĀ 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 dosesĀ during pregnancyĀ were provided. This enabled us to estimate the number of women who were vaccinated before conception. Then, we usedĀ open dataĀ on the Czech population structure by age, andĀ open dataĀ 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 releasedĀ 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.Ā 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.Ā Figure 2B.Ā 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.Ā 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 wereĀ unvaccinatedĀ 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 theĀ vaccinatedĀ 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:Ā Is this association causal?Ā In other words, did the Covid-19 vaccines reallyĀ preventĀ 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 theĀ whole populationĀ dropped sharply and has been decreasing ever since.

So,Ā somethingĀ 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,Ā 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 thatĀ X = the vaccineĀ 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.Ā 

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 ā€œsamizdatā€ 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

ByĀ 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 journalistsĀ Jeanne Lenzer and Shannon Brownlee,Ā publishedĀ byĀ 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 ā€œcan’t go any lower because it’s already in the dirt.ā€

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 ā€œsubstantial evidenceā€ 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 metĀ 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 ā€œregulatory flexibility.ā€

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 approvedĀ beforeĀ proving that they work, with the promise of follow-up trials later.

But, as Lenzer and Brownlee revealed, ā€œNearly 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.ā€

ā€œThis represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,ā€ 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 ā€œprogression-free survival,ā€ a measure of how long a tumour stays stable.

But aĀ reviewĀ of post-marketing data showed that patients taking Copiktra died 11 monthsĀ earlierĀ 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 ā€œan increased risk of treatment-related mortality.ā€

Elmiron: Ineffective, Dangerous—And Still on the Market

Another striking case isĀ Elmiron, approved in 1996 for interstitial cystitis—a painful bladder condition.

The FDA authorized it based on ā€œclose to zero data,ā€ on the condition that the company conduct a follow-up study to determine whether it actually worked.

That study wasn’tĀ completedĀ 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.

ā€œHundreds 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,ā€ Lenzer and Brownlee reported.

ā€œDangling Approvalsā€ and Regulatory Paralysis

The FDA even has a termā€”ā€dangling approvalsā€ā€”for drugs that remain on the market despite failed or missing follow-up trials.

One notorious case isĀ Avastin, approved in 2008 for metastatic breast cancer.

It was fast-tracked, again, based on ā€˜progression-free survival.’ But after five clinical trials showed no improvement in overall survival—and raised serious safety concerns—the FDA moved toĀ revokeĀ 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—paidĀ $18 billionĀ for drugs approved under the condition that follow-up studies would be conducted. Many never were.

The cost in lives is even higher.

A 2015Ā studyĀ found that 86% of cancer drugs approved between 2008 and 2012 based on surrogate outcomes showed no evidence that they helped patients live longer.

AnĀ estimatedĀ 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 2024Ā analysisĀ by Danish physician Peter GĆøtzsche 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 surveyĀ publishedĀ inĀ JAMAĀ 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 ā€œdisappointing, but not entirely surprising,ā€ noting that few doctors are taught about how the FDA’s regulatory processĀ actuallyĀ 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 asĀ The LeverĀ investigation shows, that isĀ notĀ 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. AĀ BMJĀ investigationĀ 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.

ā€œWe 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,ā€ she toldĀ The Lever. ā€œWithout that, we might as well go back to the days of snake oil and patent medicines.ā€

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’sĀ 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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