Those who have been attending or listening to my recent talks and podcasts may have noticed that I have repeatedly stated that my opinion is that SARS-CoV-2 virus was created in the Wuhan Institute of Virology and somehow entered the general population approximately September 2019. Based on their report, this appears to also be the interim minority opinion of the Senate Committee on Health Education, Labor and Pensions Minority Oversight Staff, which has been archived at the Malone Institute under the government corruption tab, and can be found here.
Here is the cautiously worded but still stunning conclusion of this interim report:
As noted by the WHO Scientific Advisory Group for the Origins of Novel Pathogens, the COVID19 Lancet Commission, and the U.S. Office of the Director of National Intelligence 90-Day Assessment on the COVID-19 Origins, more information is needed to arrive at a more precise, if not a definitive, understanding of the origins of SARS-CoV-2 and how the COVID-19 pandemic began (see footnote). Governments, leaders, public health officials, and scientists involved in addressing the COVID-19 pandemic and working to prevent future pandemics, must commit to greater transparency, engagement, and responsibility in their efforts.
Based on the analysis of the publicly available information, it appears reasonable to conclude that the COVID-19 pandemic was, more likely than not, the result of a research-related incident. New information, made publicly available and independently verifiable, could change this assessment. However, the hypothesis of a natural zoonotic origin no longer deserves the benefit of the doubt, or the presumption of accuracy. The following are critical outstanding questions that would need to be addressed to be able to more definitively conclude the origins of SARS-CoV-2:
What is the intermediate host species for SARS-CoV-2? Where did it first infect humans?
Where is SARS-CoV-2’s viral reservoir?
How did SARS-CoV-2 acquire its unique genetic features, such as its furin cleavage site?
Advocates of a zoonotic origin theory must provide clear and convincing evidence that a natural zoonotic spillover is the source of the pandemic, as was demonstrated for the 2002-2004 SARS outbreak. In other words, there needs to be verifiable evidence that a natural zoonotic spillover actually occurred, not simply that such a spillover could have occurred.
A summary of examples concerning how the corporate media have previously covered the “Lab Leak Hypothesis” explanation of the origins of the COVID-19 pandemic can be found below:
By way of relevant historical context, on approximately 04 January, 2020 I received an unexpected phone call from Dr. Michael Callahan (known to me to have been a CIA agent, and separately confirmed to me by NY Times reporter Davey Alba in February 2022 as a “former” CIA agent).
During this call, Dr. Callahan revealed to me that he was calling from China, and that he was in country under cover of his Harvard Professor appointment. Further information regarding Dr. Callahan can be found in this article by Raul Diego, with research support by Whitney Webb, entitled “DARPA’s Man in Wuhan”. It is important to know that Callahan has provided advice in the White House to at least three US Presidents, including Obama and Trump.
On 04 January 2020, Dr. Callahan told me that there was a novel coronavirus circulating in the Wuhan region, it was looking like a significant biothreat, and I should get “my team” engaged in seeking ways to mitigate the risk of this new agent. My sense from this and subsequent discussions with Dr. Callahan over the next few months during 2020 was that he had been in China as part of an exchange program, sent there under his joint appointment at a Chinese sister hospital of the Massachusetts General Hospital/Harvard Medical School, where he has maintained a faculty appointment since 2005.
Dr. Callahan asserted to me that he had been directly involved in managing hundreds of cases of COVID-19 in Wuhan during early 2020, and according to journalist Brendan Borrell, who has acted as a close ally of Dr. Callahan and published many stories (and a recent book) about his various exploits, Dr. Callahan escaped Wuhan surreptitiously by boat immediately prior to the lockdown of the region on 23 January 2020. If you believe Borrell’s story line (and I do not- Callahan is a CIA trained liar, and I have previously seen Borrell publish unverifiable falsehoods), the heroic Dr. Callahan first stepped into a Wuhan hospital the day before the lockdown:
He went to Wuhan anyway and hunkered down in a guest house, waiting to get the word from his friends. “They had to check in to make sure things were safe for me.” On Jan. 22, Callahan slipped on medical scrubs and donned an N95 mask and a pair of goggles to pass through the entrance of the Wuhan Central Hospital, a boot-shaped glass building rising up from the city’s empty streets. There, his colleagues registered him as a “guest clinical educator,” a title that would allow him into the wards as an observer. The next day, the city locked down. Callahan had just made it into the white-hot center of the outbreak.
Note the careful dissembling and cover that Borrell provides Callahan (and the CIA):
If he went to Wuhan, Callahan knew he couldn’t worry his wife by telling her about his plan. He had to be careful about telling anyone. He didn’t have official permission to travel there, after all. “It was not sanctioned, not authorized,” he said.
When Callahan set down his bag in the lobby of the Westin Hotel and was handed the key card to his room, he had to smirk. There’s 400 rooms in this hotel, and I get the same room every time? he thought. It was a fine room. Clean bathroom, firm mattress. It was also a tell. Ever since Chinese hackers stole a database containing information about his high-level security clearance, Callahan knew that someone might be watching his every move. “I’m not that good-looking of a guy, but you’d think I was Brad Pitt when I go down and get a beer,” he said. “Honeypots. But, you know, we get training for that.”
Who is the “we” that get training to avoid honeypots? Yet another tell….
Borrell now asserts that Callahan left Wuhan one week after his arrival:
All told, Callahan spent almost a week on the ground helping his colleagues keep the hospital functioning, learning about the virus’s toll on the human body, and taking note of what drugs doctors were throwing at the virus. Chinese officials were planning to tighten Wuhan’s quarantine measures, banning residents even from stepping out to buy food. Callahan slipped across the river by boat — “the black-market way” — and returned to Nanjing, where he and his colleagues had a video link with the ICU units in two hospitals in Wuhan and could provide advice and track patient outcomes. Callahan knew he needed to report what he was seeing to his friends in the U.S. government.
Which would mean that Callahan, who reported to me that he had helped manage hundreds of cases of COVID-19 while in Wuhan (600 as I recall Michael bragging, but Borrell says 277), did so early in the outbreak within a one week period. In retrospect, this is yet another lie.
Clearly this story told by Borrell is a limited hangout, as was his prior April 26, 2020 story that Callahan had examined a series of 6,000 Chinese cases during that time and discovered the activity of Famotidine as a COVID-19 treatment. I know for a fact that he never used Famotidine to treat COVID-19 while he was in Wuhan or later when he was managing the Diamond Princess outbreak and setting up the portable hospital in New York City, and only began looking into the potential efficacy after I reported to him on the findings of the group that I was leading (and my own personal experience self-treating with Famotidine when I was infected during the Boston Wuhan-1 outbreak at the end of Feb 2020).
To this point, when this false narrative was published in Science magazine, I requested from Borrell, Callahan, and Science Magazine a copy of the database which was purportedly used to make this discovery, and none of these were able to provide it. I once asked Borrell if he was also CIA, or as Callahan often says “a member of the secret handshake club”. Borrell denied any association, but there is no question in my mind that for some inexplicable reason Borrell has been publishing Callahan’s cover stories for many years. Like this one for example: “95,000 stranded at sea: What happens when a cruise ship becomes a hot zone”.
After returning from China to report to his longstanding close associate Dr. Bob Kadlac (then serving as the Assistant Secretary of Preparedness and Response to the Trump administration), back in Washington DC, Callahan was then deployed to help managing both the Diamond Princess outbreak during the first week of February, 2020, as well as the March 08 Grand Princess outbreak. Which would mean that he would have arrived in Nanjing, China under cover of his Harvard appointment, beginning 22 Jan traveled to Wuhan and managed between 200 and 600 COVID-19 patients, emailed Bob Kadlac on Jan 28 alerting him of the emerging threat (weeks after he had called me), escaped Wuhan by boat returning to Nanjing, continued to monitor hospital COVID-19 management practices remotely from Nanjing, returned to Washington DC to report to Kadlac, and then deployed to the Diamond Princess in Japan during the first week of February.
And during this time, was supposedly was involved in a detailed statistical analysis of a 6,000 patient Chinese database (which no one else has ever seen) to discover that Famotidine is active against COVID-19. I know from personal communication with Michael that he then designed and managed deployment of the tent hospital in NY City, and then deployed to manage and set US policy for COVID-19 treatment and infection control in nursing homes. I also know that he presented the data from our research group at White House and WHO meetings as the support for advocating for Famotidine as a COVID-19 repurposed drug treatment, but did not present data from the ephemeral 6000 person Chinese data base analysis.
As for myself, I downloaded the sequence of the “Wuhan Seafood Market Virus” available on the NIH servers on January 10, and got busy with volunteers from the DTRA-funded project group at Alchem Laboratories in Alachua Florida, which contract (focused on use of biorobots and computational modeling to identify inhibitors of organophosphate chemical toxins) I had helped write and win and for which I was then serving as project manager. I directed the group to focus on identifying repurposed drugs which could inhibit the Papain-like protease of the virus (3-ClPro) as opposed to the main serine protease (M-Pro) which has been the primary focus of Pharmaceutical company research into SARS-1 inhibitors.
Computational docking studies lead to a ranked priority list which included Famotidine, and I confirmed the activity of this agent by treating myself after I was infected during the last week of February 2020. Jill got busy beginning January 04 after the Callahan call, and with my help wrote and self-published (Amazon) a book designed for a lay audience to help them prepare and protect themselves from the novel coronavirus. The highly referenced book (written by a PhD and an MD/MS with decades of experience in infectious disease outbreaks) was published during the first week of February, 2020, and was censored/deleted by Amazon in March 2020 due to “violating community standards” which were not otherwise specified at the time. No appeal.
The fact that Jill and I were able to produce and published this book in a month has been cited by some conspiracy theorists as evidence that I was “in on the game” well before January 04, but I can assure you that this is merely a testimony to the commitment and efforts of Dr. Jill-Glasspool Malone to warn and help our friends, community, social media followers, and the general population. To have this product of such hard work and commitment summarily deleted without appeal by Amazon was deeply damaging to her morale, as it would be to yours.
On a side note, early in February 2020, I directly asked Michael for his opinion on the possibility that the “2019 Novel Coronavirus” (not yet named SARS-CoV-2) originated from a laboratory. His response was that “my people have carefully analyzed the sequence, and there is no evidence that this virus was genetically engineered”. We now know that this was another lie, and that there is clear evidence that SARS-CoV-2 was genetically engineered.
Based on this timeline and history, as well as my own direct personal communication with Dr. Callahan, I strongly suspect that both the gross clinical mismanagement of ventilatory support during the first phase of the outbreak (responsible for up to 30,000 deaths) as well as the stunningly poor management practices of Nursing Home and Extended Care facilities throughout the USA can be directly traced to the influence of Dr. Michael Callahan, DARPAs Man in Wuhan and arguably the top US Government/CIA expert in both biowarfare and gain of function research.
Consistent with this being a limited hangout, much later during early 2022 I received a call from Dr. David Hone, Ph.D., a longtime associate (since he was a post-doctoral student at University of Maryland) and former employee of Dr. Robert Gallo’s Institute of Human Virology, in which he told me that Callahan was not present in Wuhan on January of 2020, that “we did not have anyone there at that time”, and that I should stop asserting otherwise. Dr. Hone was serving as a GS-15 rank DTRA CB civilian rank employee of the DoD at the time, essentially as the Chief Scientific Officer of DTRA CB. Clearly, this timeline is a sensitive topic, and deserves further congressional investigation. Sworn testimony from both Drs. Hone and Callahan should be obtained.
Robert W. Malone is a physician and biochemist. His work focuses on mRNA technology, pharmaceuticals, and drug repurposing research. You can find him at Substack and Gettr
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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:
The drop in natality in the Czech Republic in 2022 could not be explained by demographic factors. Total fertility rate – which is independent of the number of women and their age structure – dropped sharply in 2022 and has been decreasing ever since. The data for 2024 show that the Czech TFR has decreased further to 1.37.
Many other European countries experienced the same dramatic and unexpected decrease in fertility that started at the beginning of 2022. I have selected some of them for Figure 1 but there are more: The Netherlands, Norway, Slovakia, Slovenia, and Sweden. On the other hand, there are some countries that do not show a sudden drop in TFR, but rather a steady decline over a longer period (e.g. Belgium, France, UK, Greece, or Italy). Notable exceptions are Bulgaria, Spain, and Portugal where fertility has increased (albeit from very low numbers). The Human Fertility Project database has all the numbers.
This data pattern is so amazing and unexpected that even the mainstream media in Europe cannot avoid the problem completely. From time to time, talking heads with many academic titles appear and push one of the politically correct narratives: It’s Putin! (Spoiler alert: The war started in February 2022; however, children not born in 2022 were not conceived in 2021). It’s the inflation caused by Putin! (Sorry, that was even later). It’s the demographics! (Nope, see above, TFR is independent of the demographics).
Thus, the “v” word keeps creeping back into people’s minds and the Web’s Wild West is ripe with speculation. We decided not to speculate but to wrestle some more data from the Czech government. For many months, we were trying to acquire the number of newborns in each month, broken down by age and vaccination status of the mother. The post-socialist health-care system of our country is a double-edged sword: On one hand, the state collects much more data about citizens than an American would believe. On the other hand, we have an equivalent of the FOIA, and we are not afraid to use it. After many months of fruitless correspondence with the authorities, we turned to Jitka Chalankova – a Czech Ron Johnson in skirts – who finally managed to obtain an invaluable data sheet.
To my knowledge, the datasheet (now publicly available with an English translation here) is the only officially released dataset containing a breakdown of newborns by the Covid-19 vaccination status of the mother. We requested much more detailed data, but this is all we got. The data contains the number of births per month between January 2021 and December 2023 given by women (aged 18-39) who were vaccinated, i.e., had received at least one Covid vaccine dose by the date of delivery, and by women who were unvaccinated, i.e., had not received any dose of any Covid vaccine by the date of delivery.
Furthermore, the numbers of births per month by women vaccinated by one or more doses during pregnancy were provided. This enabled us to estimate the number of women who were vaccinated before conception. Then, we used open data on the Czech population structure by age, and open data on Covid vaccination by day, sex, and age.
Combining these three datasets, we were able to estimate the rates of successful conceptions (i.e., conceptions that led to births nine months later) by preconception vaccination status of the mother. Those interested in the technical details of the procedure may read Methods in the newly released paper. It is worth mentioning that the paper had been rejected without review in six high-ranking scientific journals. In Figure 2, we reprint the main finding of our analysis.
Figure 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:
Vaccinated women conceived about a third fewer children than would be expected from their share of the population. Unvaccinated women conceived at about the same rate as all women before the pandemic. Thus, a strong association between Covid vaccination status and successful conceptions has been established.
In the second half of 2021, there was a peak in the rate of conceptions of the unvaccinated (and a corresponding trough in the vaccinated). This points to rather intelligent behavior of Czech women, who – contrary to the official advice – probably avoided vaccination if they wanted to get pregnant. This concentrated the pregnancies in the unvaccinated group and produced the peak.
In the first half of 2021, there was significant uncertainty in the estimates of the conception rates. The lower estimate of the conception rate in the vaccinated was produced by assuming that all women vaccinated (by at least one dose) during pregnancy were unvaccinated before conception. This was almost certainly true in the first half of 2021 because the vaccines were not available prior to 2021. The upper estimate was produced by assuming that all women vaccinated (by at least one dose) during pregnancy also received at least one dose before conception. This was probably closer to the truth in the second part of 2021. Thus, we think that the true conception rates for the vaccinated start close to the lower bound in early 2021 and end close to the upper bound in early 2022. Once again, we would like to be much more precise, but we have to work with what we have got.
Now that the association between Covid-19 vaccination and lower rates of conception has been established, the one important question looms: Is this association causal? In other words, did the Covid-19 vaccines really prevent women from getting pregnant?
The guardians of the official narrative brush off our findings and say that the difference is easily explained by confounding: The vaccinated tend to be older, more educated, city-dwelling, more climate change aware…you name it. That all may well be true, but in early 2022, the TFR of the whole population dropped sharply and has been decreasing ever since.
So, something must have happened in the spring of 2021. Had the population of women just spontaneously separated into two groups – rednecks who wanted kids and didn’t want the jab, and city slickers who didn’t want kids and wanted the jab – the fertility rate of the unvaccinated would indeed be much higher than that of the vaccinated. In that respect, such a selection bias could explain the observed pattern. However, had this been true, the total TFR of the whole population would have remained constant.
But this is not what happened. For some reason, the TFR of the whole population jumped down in January 2022 and has been decreasing ever since. And we have just shown that, for some reason, this decrease in fertility affected only the vaccinated. So, if you want to argue that a mysterious factor X is responsible for the drop in fertility, you will have to explain (1) why the factor affected only the vaccinated, and (2) why it started affecting them at about the time of vaccination. That is a tall order. Mr. Occam and I both think that X = the vaccine is the simplest explanation.
What really puzzles me is the continuation of the trend. If the vaccines really prevented conception, shouldn’t the effect have been transient? It’s been more than three years since the mass vaccination event, but fertility rates still keep falling. If this trend continues for another five years, we may as well stop arguing about pensions, defense spending, healthcare reform, and education – because we are done.
We are in the middle of what may be the biggest fertility crisis in the history of mankind. The reason for the collapse in fertility is not known. The governments of many European countries have the data that would unlock the mystery. Yet, it seems that no one wants to know.
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.
The US Food and Drug Administration (FDA) has approved hundreds of drugs without proof that they work—and in some cases, despite evidence that they cause harm.
That’s the finding of a blistering two-year investigation by medical journalists Jeanne Lenzer and Shannon Brownlee, published by The Lever.
Reviewing more than 400 drug approvals between 2013 and 2022, the authors found the agency repeatedly ignored its own scientific standards.
One expert put it bluntly—the FDA’s threshold for evidence “can’t go any lower because it’s already in the dirt.”
A System Built on Weak Evidence
The findings were damning—73% of drugs approved by the FDA during the study period failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.
Those four criteria—presence of a control group, replication in two well-conducted trials, blinding of participants and investigators, and the use of clinical endpoints like symptom relief or extended survival—are supposed to be the bedrock of drug evaluation.
Yet only 28% of drugs met all four criteria—40 drugs met none.
These aren’t obscure technicalities—they are the most basic safeguards to protect patients from ineffective or dangerous treatments.
But under political and industry pressure, the FDA has increasingly abandoned them in favour of speed and so-called “regulatory flexibility.”
Since the early 1990s, the agency has relied heavily on expedited pathways that fast-track drugs to market.
In theory, this balances urgency with scientific rigour. In practice, it has flipped the process. Companies can now get drugs approved before proving that they work, with the promise of follow-up trials later.
But, as Lenzer and Brownlee revealed, “Nearly half of the required follow-up studies are never completed—and those that are often fail to show the drugs work, even while they remain on the market.”
“This represents a seismic shift in FDA regulation that has been quietly accomplished with virtually no awareness by doctors or the public,” they added.
More than half the approvals examined relied on preliminary data—not solid evidence that patients lived longer, felt better, or functioned more effectively.
And even when follow-up studies are conducted, many rely on the same flawed surrogate measures rather than hard clinical outcomes.
The result: a regulatory system where the FDA no longer acts as a gatekeeper—but as a passive observer.
Cancer Drugs: High Stakes, Low Standards
Nowhere is this failure more visible than in oncology.
Only 3 out of 123 cancer drugs approved between 2013 and 2022 met all four of the FDA’s basic scientific standards.
Most—81%—were approved based on surrogate endpoints like tumour shrinkage, without any evidence that they improved survival or quality of life.
Take Copiktra, for example—a drug approved in 2018 for blood cancers. The FDA gave it the green light based on improved “progression-free survival,” a measure of how long a tumour stays stable.
But a review of post-marketing data showed that patients taking Copiktra died 11 months earlier than those on a comparator drug.
It took six years after those studies showed the drug reduced patients’ survival for the FDA to warn the public that Copiktra should not be used as a first- or second-line treatment for certain types of leukaemia and lymphoma, citing “an increased risk of treatment-related mortality.”
Elmiron: Ineffective, Dangerous—And Still on the Market
Another striking case is Elmiron, approved in 1996 for interstitial cystitis—a painful bladder condition.
The FDA authorized it based on “close to zero data,” on the condition that the company conduct a follow-up study to determine whether it actually worked.
That study wasn’t completed for 18 years—and when it was, it showed Elmiron was no better than placebo.
In the meantime, hundreds of patients suffered vision loss or blindness. Others were hospitalized with colitis. Some died.
Yet Elmiron is still on the market today. Doctors continue to prescribe it.
“Hundreds of thousands of patients have been exposed to the drug, and the American Urological Association lists it as the only FDA-approved medication for interstitial cystitis,” Lenzer and Brownlee reported.
“Dangling Approvals” and Regulatory Paralysis
The FDA even has a term—”dangling approvals”—for drugs that remain on the market despite failed or missing follow-up trials.
One notorious case is Avastin, approved in 2008 for metastatic breast cancer.
It was fast-tracked, again, based on ‘progression-free survival.’ But after five clinical trials showed no improvement in overall survival—and raised serious safety concerns—the FDA moved to revoke its approval for metastatic breast cancer.
The backlash was intense.
Drug companies and patient advocacy groups launched a campaign to keep Avastin on the market. FDA staff received violent threats. Police were posted outside the agency’s building.
The fallout was so severe that for more than two decades afterwards, the FDA did not initiate another involuntary drug withdrawal in the face of industry opposition.
Billions Wasted, Thousands Harmed
Between 2018 and 2021, US taxpayers—through Medicare and Medicaid—paid $18 billion for drugs approved under the condition that follow-up studies would be conducted. Many never were.
The cost in lives is even higher.
A 2015 study found that 86% of cancer drugs approved between 2008 and 2012 based on surrogate outcomes showed no evidence that they helped patients live longer.
An estimated 128,000 Americans die each year from the effects of properly prescribed medications—excluding opioid overdoses. That’s more than all deaths from illegal drugs combined.
A 2024 analysis by Danish physician Peter Gøtzsche found that adverse effects from prescription medicines now rank among the top three causes of death globally.
Doctors Misled by the Drug Labels
Despite the scale of the problem, most patients—and most doctors—have no idea.
A 2016 survey published in JAMA asked practising physicians a simple question—what does FDA approval actually mean?
Only 6% got it right.
The rest assumed that it meant the drug had shown clear, clinically meaningful benefits—such as helping patients live longer or feel better—and that the data was statistically sound.
But the FDA requires none of that.
Drugs can be approved based on a single small study, a surrogate endpoint, or marginal statistical findings. Labels are often based on limited data, yet many doctors take them at face value.
Harvard researcher Aaron Kesselheim, who led the survey, said the results were “disappointing, but not entirely surprising,” noting that few doctors are taught about how the FDA’s regulatory process actually works.
Instead, physicians often rely on labels, marketing, or assumptions—believing that if the FDA has authorized a drug, it must be both safe and effective.
But as The Lever investigation shows, that is not a safe assumption.
And without that knowledge, even well-meaning physicians may prescribe drugs that do little good—and cause real harm.
Who Is the FDA Working for?
In interviews with more than 100 experts, patients, and former regulators, Lenzer and Brownlee found widespread concern that the FDA has lost its way.
Many pointed to the agency’s dependence on industry money. A BMJinvestigation in 2022 found that user fees now fund two-thirds of the FDA’s drug review budget—raising serious questions about independence.
Yale physician and regulatory expert Reshma Ramachandran said the system is in urgent need of reform.
“We need an agency that’s independent from the industry it regulates and that uses high-quality science to assess the safety and efficacy of new drugs,” she told The Lever. “Without that, we might as well go back to the days of snake oil and patent medicines.”
For now, patients remain unwitting participants in a vast, unspoken experiment—taking drugs that may never have been properly tested, trusting a regulator that too often fails to protect them.
And as Lenzer and Brownlee conclude, that trust is increasingly misplaced.
Investigative report by Jeanne Lenzer and Shannon Brownlee at The Lever [link]
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.
