{"id":12529,"date":"2025-06-28T07:50:35","date_gmt":"2025-06-28T14:50:35","guid":{"rendered":"https:\/\/jasonsblog.ddns.net\/?p=12529"},"modified":"2025-06-28T07:50:35","modified_gmt":"2025-06-28T14:50:35","slug":"fda-exposed-hundreds-of-drugs-approved-without-proof-they-work","status":"publish","type":"post","link":"https:\/\/jasonsblog.ddns.net\/index.php\/2025\/06\/28\/fda-exposed-hundreds-of-drugs-approved-without-proof-they-work\/","title":{"rendered":"FDA Exposed: Hundreds of Drugs Approved without Proof They Work"},"content":{"rendered":"\n

These white coats will murder or harm you and are absolutely captured and clueless.<\/p>\n\n\n\n

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That study wasn\u2019t completed<\/a> for 18 years\u2014and when it was, it showed Elmiron was no better than placebo.<\/p>\n\n\n\n

In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalised with colitis. Some died.<\/p>\n\n\n\n

Yet Elmiron is still on the market today. Doctors continue to prescribe it.<\/p>\n<\/blockquote>\n\n\n\n

https:\/\/brownstone.org\/articles\/fda-exposed-hundreds-of-drugs-approved-without-proof-they-work\/<\/a><\/p>\n\n\n

<\/div><\/div><\/div>\n\n\n
\"FDA<\/figure>\n\n\n\n

By Maryanne Demasi<\/p>\n\n\n\n

The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work\u2014and in some cases, despite evidence that they cause harm.<\/p>\n\n\n\n

That\u2019s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee<\/strong>, published<\/a> by The Lever<\/em>.<\/p>\n\n\n\n

Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.<\/p>\n\n\n\n

One expert put it bluntly\u2014the FDA\u2019s threshold for evidence \u201ccan\u2019t go any lower because it\u2019s already in the dirt.\u201d<\/p>\n\n\n\n

A System Built on Weak Evidence<\/h3>\n\n\n\n

The findings were damning\u201473% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating \u201csubstantial evidence\u201d of effectiveness.<\/p>\n\n\n\n

Those four criteria\u2014presence 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\u2014are supposed to be the bedrock of drug evaluation.<\/p>\n\n\n\n

Yet only 28% of drugs met all four criteria\u201440 drugs met none<\/em>.<\/p>\n\n\n\n

These aren\u2019t obscure technicalities\u2014they are the most basic safeguards to protect patients from ineffective or dangerous treatments.<\/p>\n\n\n\n

But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called \u201cregulatory flexibility.\u201d<\/p>\n\n\n\n

Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.<\/p>\n\n\n\n

In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before<\/strong><\/em> proving that they work, with the promise of follow-up trials later.<\/p>\n\n\n\n

But, as Lenzer and Brownlee revealed, \u201cNearly half of the required follow-up studies are never completed\u2014and those that are often fail to show the drugs work, even while they remain on the market.\u201d<\/p>\n\n\n\n

\u201cThis represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,\u201d they added.<\/p>\n\n\n\n

More than half the approvals examined relied on preliminary data\u2014not solid evidence that patients lived longer, felt better, or functioned more effectively. <\/p>\n\n\n\n

And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.<\/p>\n\n\n\n

The result: a regulatory system where the FDA no longer acts as a gatekeeper\u2014but as a passive observer.<\/p>\n\n\n\n

Cancer Drugs: High Stakes, Low Standards<\/h3>\n\n\n\n

Nowhere is this failure more visible than in oncology.<\/p>\n\n\n\n

Only 3 out of 123 cancer drugs approved between 2013 and 2022 met all four of the FDA\u2019s basic scientific standards.<\/p>\n\n\n\n

Most\u201481%\u2014were approved based on surrogate endpoints like tumour shrinkage, without any evidence that they improved survival or quality of life.<\/p>\n\n\n\n

Take Copiktra, for example\u2014a drug approved in 2018 for blood cancers. The FDA gave it the green light based on improved \u201cprogression-free survival,\u201d a measure of how long a tumour stays stable.<\/p>\n\n\n\n

But a review<\/a> of post-marketing data showed that patients taking Copiktra died 11 months earlier<\/strong><\/em> than those on a comparator drug.<\/p>\n\n\n\n

It took six years after those studies showed the drug reduced patients\u2019 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 \u201can increased risk of treatment-related mortality.\u201d<\/p>\n\n\n\n

Elmiron: Ineffective, Dangerous\u2014And Still on the Market<\/h3>\n\n\n\n

Another striking case is Elmiron<\/strong>, approved in 1996 for interstitial cystitis\u2014a painful bladder condition.<\/p>\n\n\n\n

The FDA authorised it based on \u201cclose to zero data,\u201d on the condition that the company conduct a follow-up study to determine whether it actually worked. <\/p>\n\n\n\n

That study wasn\u2019t completed<\/a> for 18 years\u2014and when it was, it showed Elmiron was no better than placebo.<\/p>\n\n\n\n

In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalised with colitis. Some died.<\/p>\n\n\n\n

Yet Elmiron is still on the market today. Doctors continue to prescribe it.<\/p>\n\n\n\n

\u201cHundreds 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,\u201d Lenzer and Brownlee reported.<\/p>\n\n\n\n

\u201cDangling Approvals\u201d and Regulatory Paralysis<\/h3>\n\n\n\n

The FDA even has a term\u2014\u201ddangling approvals\u201d\u2014for drugs that remain on the market despite failed or missing follow-up trials.<\/p>\n\n\n\n

One notorious case is Avastin<\/strong>, approved in 2008 for metastatic breast cancer.<\/p>\n\n\n\n

It was fast-tracked, again, based on \u2018progression-free survival.\u2019 But after five clinical trials showed no improvement in overall survival\u2014and raised serious safety concerns\u2014the FDA moved to revoke<\/a> its approval for metastatic breast cancer.<\/p>\n\n\n\n

The backlash was intense. <\/p>\n\n\n\n

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\u2019s building.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Billions Wasted, Thousands Harmed<\/h3>\n\n\n\n

Between 2018 and 2021, US taxpayers\u2014through Medicare and Medicaid\u2014paid $18 billion<\/a> for drugs approved under the condition that follow-up studies would be conducted. Many never were.<\/p>\n\n\n\n

The cost in lives is even higher.<\/p>\n\n\n\n

A 2015 study<\/a> found that 86% of cancer drugs approved between 2008 and 2012 based on surrogate outcomes showed no evidence that they helped patients live longer.<\/p>\n\n\n\n

An estimated<\/a> 128,000 Americans die each year from the effects of properly prescribed medications\u2014excluding opioid overdoses. That\u2019s more than all deaths from illegal drugs combined.<\/p>\n\n\n\n

A 2024 analysis<\/a> by Danish physician Peter G\u00f8tzsche found that adverse effects from prescription medicines now rank among the top three causes of death globally.<\/p>\n\n\n\n

Doctors Misled by the Drug Labels<\/h3>\n\n\n\n

Despite the scale of the problem, most patients\u2014and most doctors\u2014have no idea.<\/p>\n\n\n\n

A 2016 survey published<\/a> in JAMA<\/em> asked practising physicians a simple question\u2014what does FDA approval actually mean?<\/p>\n\n\n\n

Only 6% got it right.<\/p>\n\n\n\n

The rest assumed that it meant the drug had shown clear, clinically meaningful benefits\u2014such as helping patients live longer or feel better\u2014and that the data was statistically sound.<\/p>\n\n\n\n

But the FDA requires none of that.<\/p>\n\n\n\n

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.<\/p>\n\n\n\n

Harvard researcher Aaron Kesselheim, who led the survey, said the results were \u201cdisappointing, but not entirely surprising,\u201d noting that few doctors are taught about how the FDA\u2019s regulatory process actually<\/em> works.<\/p>\n\n\n\n

Instead, physicians often rely on labels, marketing, or assumptions\u2014believing that if the FDA has authorised a drug, it must be both safe and effective.<\/p>\n\n\n\n

But as The Lever<\/em> investigation shows, that is not<\/strong><\/em> a safe assumption.<\/p>\n\n\n\n

And without that knowledge, even well-meaning physicians may prescribe drugs that do little good\u2014and cause real harm.<\/p>\n\n\n\n

Who Is the FDA Working for?<\/h3>\n\n\n\n

In interviews with more than 100 experts, patients, and former regulators, Lenzer and Brownlee found widespread concern that the FDA has lost its way.<\/p>\n\n\n\n

Many pointed to the agency\u2019s dependence on industry money. A BMJ<\/em> investigation<\/a> in 2022 found that user fees now fund two-thirds of the FDA\u2019s drug review budget\u2014raising serious questions about independence.<\/a><\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

Yale physician and regulatory expert Reshma Ramachandran said the system is in urgent need of reform.<\/p>\n\n\n\n

\u201cWe need an agency that\u2019s independent from the industry it regulates and that uses high-quality science to assess the safety and efficacy of new drugs,\u201d she told The Lever<\/em>. \u201cWithout that, we might as well go back to the days of snake oil and patent medicines.\u201d<\/p>\n\n\n\n

For now, patients remain unwitting participants in a vast, unspoken experiment\u2014taking drugs that may never have been properly tested, trusting a regulator that too often fails to protect them.<\/p>\n\n\n\n

And as Lenzer and Brownlee conclude, that trust is increasingly misplaced.<\/p>\n\n\n\n