Behind closed doors at the World Economic Forum in Davos in January 2016, senior figures from the Gates Foundation and the World Bank proposed a new approach to pandemic preparedness: large-scale simulations modelled on military war games.

Newly obtained internal emails show how the idea — referred to as “Germ Games” — gained rapid momentum and drew in the US National Institutes of Health (NIH).

A potential land mine

On January 10, 2016, as then-NIH Director Francis Collins prepared to attend the World Economic Forum's annual meeting in Davos, he emailed an advance copy of his schedule to Anthony Fauci, one of his closest advisers.

One session, in particular, caught his attention.

“This Davos session sounds like a potential land mine,” Collins wrote.

The meeting, titled “Vaccine Innovation for Pandemic Preparedness,” brought together executives from GSK, Merck and Johnson & Johnson, along with representatives from the Gates Foundation and the Wellcome Trust.

According to Collins’ report to Health and Human Services Secretary Sylvia Burwell, the pharmaceutical companies were blunt about the conditions for their participation — they could not commit to rapidly developing vaccines for every future outbreak unless governments first resolved who would pay and how liability would be handled.

The companies said they were willing to contribute their vaccine platforms but would not share their commercial intellectual property.

Collins described the emerging proposal as “very sketchy” and warned that it raised serious questions about governance, funding and strategy. He cautioned against any plan that would undermine existing US programmes.

The birth of “Germ Games”

A separate session on preparing for future pandemics proved even more consequential. Chaired by World Bank President Jim Yong Kim, the discussion included Bill Gates.

Gates argued that the world was poorly prepared for a fast-spreading respiratory virus and that more sophisticated simulations could strengthen planning around logistics, communications, quarantine measures, public messaging and vaccine deployment.

Kim seized on the idea. According to Collins’ email, the World Bank president proposed creating “Germ Games” — exercises explicitly modelled on military war games — persuade G20 leaders to invest in pandemic preparedness and avoid complacency once Ebola memories faded.

Kim suggested “tapping into the expertise” of the US Department of Defense, whose war games experience tested command structures, decision-making and crisis response under pressure.

He publicly called on the NIH, the World Bank, the Gates Foundation and the Wellcome Trust to develop the concept together, saying he would “find funds for this.”

Writing to Fauci afterwards, Collins acknowledged that the proposal had quickly gained influential backing. With both the Gates Foundation and the World Bank endorsing the initiative, he wrote, it would be “hard to stop this effort now.”

Collins admitted that large-scale pandemic simulations fell outside his expertise and asked Fauci for his assessment.

Fauci’s reply

Fauci responded that the US government already had considerable experience running simulated “bioterror attacks.”

He explained that the Department of Health and Human Services, the Department of Defense and the Department of Homeland Security had conducted extensive "Table Top" exercises—simulated crisis scenarios in which officials rehearsed responses to biological threats, including aerosolised anthrax, multi-release smallpox and influenza pandemics.

“This may not be ‘exactly’ what [Bill] Gates, [Jeremy] Farrar and [Jim Yong] Kim were referring to,” Fauci wrote, “but it would be pretty close.”

He also suggested involving Nicole Lurie, then Assistant Secretary for Preparedness and Response, noting her previous experience at the RAND Corporation.

Collins quickly looped Lurie and BARDA Director Robin Robinson into the discussion, asking whether support from the World Bank and the Gates Foundation could help upgrade existing US modelling and preparedness work.

Lurie replied that HHS was already updating its pandemic influenza plan and had an entire team conducting regular modelling for a range of biological threats, including H7N9, MERS, Ebola and Zika.

From “Germ Games” to global agenda

The “Germ Games” concept did not remain a one-off idea.

A year later, Collins returned to Davos for the 2017 World Economic Forum meeting.

His schedule included a pilot pandemic simulation organised by the World Bank and the Gates Foundation. The exercise was designed to place senior decision-makers inside a simulated pandemic crisis, using the kind of scenario-based role-playing employed in military war games.

The same approach was later reflected in Event 201, a high-profile simulation of a “fictional coronavirus pandemic” held in October 2019 by the Johns Hopkins Centre for Health Security in partnership with the WEF and the Gates Foundation.

That exercise brought together business leaders, government officials and public health experts to role-play responses to a “hypothetical” pandemic, using the same structured, scenario-based decision-making discussed at Davos three years earlier.

In early 2018, Collins invited Jim Yong Kim to the NIH.

While the public event was a screening of the documentary Bending the Arc, internal planning documents show that officials arranged a closed-door roundtable with Collins, Fauci and nearly every NIH institute director.

The agenda covered pandemic preparedness, airborne threats and deeper collaboration between the NIH and the World Bank.

Collectively, these internal documents show how, from 2016 onwards, pandemic preparedness was increasingly shaped by military planning concepts and biodefence thinking.

What began as discussions at Davos evolved into a sustained international effort to embed simulation-based, war-game-style approaches into global health security — approaches that would later become central to the response to Covid-19.

See also : NIH internal emails reveal pandemic planning years before Covid

Emails uploaded

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A cache of internal emails obtained from within the US National Institutes of Health has exposed years of strategic planning for future pandemics involving governments, foundations, international organisations, and pharmaceutical companies.

The documents, stretching back to at least 2016, show that Dr Francis Collins, Director of the NIH from 2009 to 2021, was at the centre of these efforts.

In that role, he oversaw the allocation of the agency’s substantial research budget, which ran into tens of billions of dollars annually.

The emails reveal Collins working closely with the Gates Foundation, Wellcome Trust, World Bank, World Economic Forum, the African Academy of Sciences, and major pharmaceutical companies to strengthen research infrastructure, regulatory readiness, and international coordination well before Covid appeared.

For the public, the Covid response was presented as an unexpected crisis. Governments appeared to be making difficult decisions while navigating profound uncertainty.

But these emails tell a different story.

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Five years after publication, Toxicology Reports removed a study by independent researcher Neil Miller that analysed reports of sudden infant death following vaccination.

The journal said the paper contained “serious methodological flaws” and that its conclusions were not supported by the data.

Miller strongly disagreed, but the journal withdrew the study nonetheless.

Ordinarily, a dispute over statistical methods would have attracted little attention outside academic circles.

But because the study concerned vaccines and the unexplained deaths of apparently healthy infants, it quickly became part of a much larger debate about scientific publishing, transparency, and how controversial research should be handled.

The controversy escalated when US Health Secretary Robert F. Kennedy Jr. wrote to the journal seeking details about how the decision had been reached, who reviewed the paper, and what evidence justified its removal.

At its core, the dispute raised two questions.

The first concerned the science: did Miller identify a genuine safety signal, or did he misuse a database and draw conclusions the evidence could not support?

The second concerned the process: even if the paper contained methodological problems, was removal the appropriate remedy?

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The Trump administration has already chosen its nominee to lead the US Centers for Disease Control and Prevention (CDC).

But after attending a Brownstone conference in Connecticut this past weekend, I found myself reflecting on the remarks of the physician who didn’t get the job.

Dr Joseph Marine, a cardiologist at Johns Hopkins University who was considered for the role, delivered a remarkably candid assessment of what he believes the CDC must do if it hopes to recover from the damage caused during the Covid years.

His message is simple — before the CDC can regain public trust, it must first confront its own mistakes.

That may be easier said than done. The CDC remains one of the most influential public health agencies in the world, but after the pandemic, it is also one of the most criticised and least trusted.

Policies on lockdowns, school closures, masks, vaccine mandates, and the evidence used to justify many of those decisions have left the agency facing a crisis of credibility that could take years to repair.

Marine’s talk was not a call to dismantle the agency, but rather an attempt to answer a question that few public health leaders seem willing to ask — what does genuine reform actually look like?

His answer begins with ethics.

Public health, he argues, needs a clearer moral foundation — one that respects individual rights, acknowledges uncertainty, avoids unnecessary harm, and uses the least restrictive measures possible to achieve a public health goal.

That principle leads directly to one of his strongest criticisms of the pandemic response: lockdowns.

Marine believes the CDC should formally renounce mass lockdowns as a public health strategy.

Traditional quarantine has long been used to isolate individuals known to have been exposed to a serious threat. Locking down entire populations for months at a time was something very different.

Even if such policies could be shown to reduce transmission, Marine argues, they would still raise profound ethical questions in a free society. The social, educational, and economic costs fell disproportionately on those least able to bear them.

He is equally critical of the role “fear” played during the pandemic.

Doctors are taught that manipulating patients through fear is unethical. Public health, he argues, should be held to the same standard.

“The CDC should lead with courage and confidence, and never with fear,” he says.

Fear may produce compliance in the short term, but it comes at a cost. It damages trust, weakens social cohesion, and can leave the public feeling misled when worst-case scenarios fail to materialise.

Another lesson, he says, is the importance of acknowledging uncertainty.

One of the defining failures of the pandemic response was the tendency to present unsettled questions as ‘settled science.’ Yet science advances through questioning, testing, and revising conclusions as new evidence emerges.

Marine says that the CDC should become more comfortable saying “we don’t know” when the evidence is uncertain, rather than projecting confidence that the data do not support.

That concern extends to the quality of evidence behind public health recommendations.

Marine argues that too many pandemic-era policies rested on observational studies, modelling assumptions, or expert opinion rather than strong clinical evidence.

He cites examples such as six-foot distancing rules, masking recommendations for young children, and prolonged school closures — policies that, in his view, were often presented with greater certainty than the underlying evidence justified.

As a cardiologist, he points to cardiovascular medicine as a model. Clinical recommendations are routinely graded according to the strength of the evidence supporting them. Findings from multiple randomised controlled trials carry more weight than expert opinion alone.

He says public health should adopt the same discipline.

But perhaps Marine’s most striking observation is how little reflection has occurred since the pandemic ended.

Despite what he describes as the “most significant medical event in 100 years,” there has been remarkably little effort by institutions to examine what worked, what failed, and what should be done differently next time.

In medicine, physicians routinely conduct morbidity and mortality conferences where mistakes and poor outcomes are openly reviewed. The goal is not blame — the goal is to learn.

Marine sees no reason why public health should be exempt from the same scrutiny.

He suggests the CDC could lead a national re-examination of the pandemic response through seminars, grand rounds, and public discussions that critically assess both successes and failures.

The absence of that conversation concerns him.

Marine also believes reform requires greater intellectual diversity within public health institutions.

He points to reports showing that nearly all political donations made by CDC employees went to a single political party and questions whether a broader range of perspectives has been excluded from public health institutions.

His broader point is that public trust becomes harder to maintain when an agency is perceived as politically aligned rather than politically independent.

Finally, Marine urges public health leaders to widen their focus.

Future pandemics matter, but so do the chronic diseases that kill far more Americans every year.

Heart disease, diabetes, obesity, and cancer continue to impose a far greater burden on population health than any infectious outbreak. Building a healthier population is itself a form of pandemic preparedness.

Whether the CDC is capable of reform remains an open question.

But if reform is possible, Marine’s prescription is to acknowledge mistakes, strengthen scientific standards, reject fear-based messaging, embrace uncertainty, and return to the ethical principles that should guide medicine and public health.

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Earlier this year, the FDA issued Moderna a Refusal-to-File letter, effectively rejecting the company’s application before a full scientific review could begin.

At the centre of the decision was Vinay Prasad, then director of the FDA’s Center for Biologics Evaluation and Research (CBER), who argued that Moderna had tested its vaccine against the wrong benchmark.

Because the vaccine was intended for older adults, the FDA said Moderna should have compared it against one of the influenza vaccines routinely recommended for people aged 65 and older, rather than a standard-dose flu shot.

The decision immediately sparked controversy.

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The U.S. Centers for Disease Control and Prevention (CDC) has committed more than $735 million to purchase children’s Covid-19 vaccines from Pfizer through the Vaccines for Children (VFC) program, according to federal procurement records.

The agreement was signed on June 1, 2026, and covers updated paediatric Covid-19 vaccines through fiscal years 2026 and 2027.

The purchase, however, presents a legal dilemma.

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For nearly a year, attorney George W. Murgatroyd III tried to compel the retraction of one of the most notorious papers in modern psychiatry.

Now, that effort has come to an end.

A judge dismissed Murgatroyd’s lawsuit against the Journal of the American Academy of Child & Adolescent Psychiatry (JAACAP) and publisher Elsevier over Study 329 — a paper that has been at the centre of scientific controversy for more than two decades.

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The landmark lawsuit that put Merck’s Gardasil HPV vaccine on trial has ended in a confidential settlement.

After years of litigation, extensive discovery, and weeks of courtroom testimony, attorneys for plaintiff Jennifer Robi confirmed that her claims against Merck have ended.

Michael Baum, an attorney with Wisner Baum representing Robi, confirmed the settlement in a statement to MD Reports.

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Today, Professor Wafik El-Deiry will testify at a U.S. Senate hearing titled, “Plausible Mechanisms of COVID-19 Injections Causing Cancer and Attacks on Scientific Publications.”

The hearing will examine not only the biological mechanisms by which mRNA vaccines may contribute to cancer, but also what lawmakers describe as attacks on scientific publications and the researchers behind them.

For El-Deiry, those two issues have become inseparable.

For nearly two years, the Brown University cancer researcher has found himself under sustained attack on PubPeer, a website originally created to improve scientific accountability through post-publication peer review.

PubPeer began with good intentions.

It was launched as a digital extension of the peer review process—an open forum where scientists could flag concerns about published research and continue scrutinising research beyond the walls of academic journals.

At its best, PubPeer offered a space for scientists to highlight genuine errors, expose unethical practices, and improve the quality of the scientific record.

But somewhere along the way, critics say, that mission got lost.

In recent years, PubPeer has morphed into something darker. Anonymous users now comb through scientific papers not to improve science, but to discredit scientists—often over minor, debatable, or decades-old issues.

Critics argue that the platform has become a vehicle for reputational attacks rather than constructive scientific critique.

These anonymous commenters often operate behind pseudonyms. Increasingly, their targets are not fraudsters or charlatans, but respected researchers whose work challenges prevailing narratives or powerful interests.

And when these serial complainers succeed in forcing a correction, investigation, or retraction, it is often celebrated not as a service to science but as a trophy—a scalp to display.

Some have built entire careers around hunting alleged misconduct, earning financial rewards, media attention, speaking engagements and public recognition.

Critics call them something else — vigilantes.

They argue that PubPeer has created a system where anonymous individuals can publicly accuse scientists of misconduct, trigger institutional investigations, and inflict reputational damage without being subject to the same standards of transparency they demand from others.

The result, they say, is a climate of fear. Researchers are increasingly reluctant to pursue controversial questions, challenge orthodoxies, or publish findings that conflict with prevailing narratives.

The risk is not merely criticism, but becoming the target of a prolonged campaign of anonymous allegations that can follow a scientist for years, and shape public perceptions long before any wrongdoing has been established.

The platform has even acquired a nickname among some researchers: Pub-Smear.

El-Deiry is the latest scientist to find himself in the crosshairs.

He is no fringe figure. Over three decades, El-Deiry has built an international reputation in cancer biology, pioneered discoveries in tumour suppressor pathways, founded biotechnology companies, developed cancer therapeutics, and published hundreds of scientific papers.

More recently, he presented concerns about mRNA vaccines and cancer-related pathways to the CDC’s Covid-19 vaccine workgroup and co-authored a paper on the subject with Professor Charlotte Kuperwasser of Tufts University School of Medicine.

According to El-Deiry, the trouble began in 2024.

He published a provocative study suggesting that the SARS-CoV-2 spike protein may interfere with the p53 pathway, one of the body’s most important tumour-suppressor mechanisms.

The paper did not claim that Covid-19 vaccines cause cancer. But it raised uncomfortable questions about whether the spike protein could affect pathways involved in cancer protection, and whether future vaccines could be designed to avoid such effects.

It was a politically charged topic. And in today’s scientific climate, questioning dominant narratives can come at a cost.

Within weeks, anonymous PubPeer users were combing through decades of El-Deiry’s previous publications, alleging flaws, demanding retractions, contacting journals and institutions, and casting doubt on his integrity.

Who were they? What were their scientific qualifications? Did they have conflicts of interest? And who, if anyone, was holding them accountable?

This isn’t about shielding scientists from scrutiny or excusing fraud.

Post-publication review, when conducted transparently and fairly, plays an important role in science. Fraud should be exposed and errors should be corrected.

But there is a profound difference between flagging genuine misconduct and launching a reputational ambush against scientists whose work challenges prevailing narratives.

Science thrives on debate.

It does not thrive on anonymous policing, online vigilantism, or self-proclaimed “science sleuths” pursuing personal crusades under the guise of scientific critique.

The impact on El-Deiry’s own career has been impossible to ignore.

In April, Brown University’s Dean of Medicine announced that El-Deiry would be “stepping down” as director of the Legorreta Cancer Center after seven years in the role.

No public explanation was provided for the change in leadership.

But for many scientists following the case, the development raised uncomfortable questions about the power anonymous actors can wield over careers, institutions, and the direction of scientific inquiry itself.

In the following interview, El-Deiry discusses the personal and professional consequences of becoming a target, the impact the controversy has had on his career, and why he believes PubPeer has become something very different from what its founders originally intended.

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For months, a clear message was circulating through Republican political circles.

Vaccine issues were becoming a liability.

As the Trump administration looked ahead to the 2026 midterm elections, strategists were reportedly urging the president to steer clear of vaccine policy and instead focus on other health priorities, alongside inflation, immigration, and the economy.

Concerns about pharmaceutical industry influence, childhood vaccine mandates and the expanding vaccine schedule were increasingly portrayed as politically risky terrain.

That narrative was reinforced by a polling memo released by Republican pollster Tony Fabrizio in late 2025, which was widely interpreted as showing that scaling back the childhood vaccine schedule was unpopular with voters.

The New York Times, for example, reported that polls indicated “Kennedy’s vaccine agenda is a dud, unpopular even with Republicans” and that the White House wanted Kennedy to downplay vaccine issues and focus instead on his more popular healthy-eating initiatives.

But there was a problem.

At roughly the same time that message was taking hold, another Fabrizio poll was telling a very different story.

According to a recent article by Daily Caller journalist Emily Kopp, Fabrizio conducted a survey in October 2025 that found widespread concern about both childhood vaccine mandates and the influence of pharmaceutical companies.

The poll reportedly found that 73% of voters were concerned about childhood vaccine mandates, while 90% expressed concern about the influence of pharmaceutical companies.

What made the findings particularly noteworthy was that Kopp reported that the survey had been commissioned by MAHA Action, the political organisation aligned with Robert F. Kennedy Jr.'s Make America Healthy Again movement.

Yet the poll was never publicly released.

Kopp’s report on what she described as a “secret poll” immediately raised questions about whether MAHA Action had effectively buried findings that could have bolstered Kennedy’s vaccine agenda.

The story took an unexpected turn when Kopp’s article was later highlighted by The MAHA Report, a publication affiliated with MAHA Action itself.

The article acknowledged that the October survey had never been publicly released, but did not address the obvious question — why hadn’t MAHA Action released the poll.

Seeking clarification, I contacted Tony Lyons, founder of MAHA Action and president of Skyhorse Publishing.

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President Donald Trump has signed an Executive Order directing federal health agencies to re-examine America’s childhood vaccine schedule, reviving an effort that was halted by a federal court earlier this year.

The order instructs the CDC’s Advisory Committee on Immunization Practices (ACIP) to revisit a government review that found significant differences between U.S. vaccine recommendations and those used in several other developed countries.

According to the White House, the goal is to align vaccine recommendations more closely with scientific evidence and international practice while preserving vaccine access and parental choice.

The move reopens a debate that has simmered for months.

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The documentary follows David Feldman, a software engineer who unexpectedly found himself at the centre of one of the most contentious debates in modern medicine — whether high cholesterol drives heart disease.

I first met Feldman around 2018 at a low-carb conference in Colorado. Back then, he was walking around with a laptop full of graphs and data, enthusiastically showing anyone who would listen his theories about cholesterol metabolism.

He wasn’t famous. He wasn’t trying to build a brand. He was just a curious engineer trying to solve a problem that didn’t make sense to him.

Like many people, Feldman had adopted a low-carbohydrate ketogenic diet to improve his health. He lost weight, improved his blood sugar, slept better, and felt healthier overall.

“Everything got better, except one thing. One thing that could not be ignored,” he says in the film.

His LDL cholesterol level skyrocketed.

For most people, that would have been the end of the experiment. They would have abandoned the diet and followed conventional advice, assuming the high cholesterol meant they were heading toward a heart attack.

But not Feldman.

“Suddenly a lot of my fear became fascination,” he says.

Instead of backing away, he started investigating. He tracked everything — meals, blood tests, weight changes, energy intake, and metabolic patterns. What began as self-experimentation soon became an obsession with understanding what was actually happening inside the body.

And that led to the central question driving the entire film:

Why were some people becoming dramatically healthier on ketogenic diets while simultaneously developing extremely high LDL cholesterol?

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In September 2025, then-U.S. Food and Drug Administration (FDA) Commissioner Dr Marty Makary publicly acknowledged that the agency was investigating reports of child deaths following Covid-19 vaccination.

“We do know at the FDA… that there had been children who have died from the COVID vaccine,” Makary said during a CNN interview.

By that stage, however, a fierce internal dispute had already emerged inside the FDA over what investigators believed the evidence showed — and whether the public should ever see the full findings.

“It really did feel like there was some sort of cover-up going on about the Covid-19 vaccines,” said one individual familiar with the discussions.

MD Reports spoke with several current/former agency officials, advisers, and individuals briefed on the discussions, all of whom requested anonymity because they were not authorised to publicly discuss internal FDA deliberations.

At the centre of the controversy was an internal FDA review led by Dr Tracy Beth Høeg, a physician-scientist who was working as a senior scientist inside the FDA’s vaccine division at the time.

FDA officials examined roughly 96 paediatric death reports submitted to the Vaccine Adverse Event Reporting System (VAERS), the government database used to detect potential vaccine-related adverse events.

The review included medical records, autopsy reports, pathology findings, and follow-up investigations conducted by agency staff.

About 25 deaths following Covid vaccination were ultimately considered serious enough for high-level internal discussion inside the agency.

The findings were expected to be presented at a September 2025 meeting of the CDC’s Advisory Committee on Immunisation Practices (ACIP), the federal panel that shapes U.S. vaccine recommendations.

But before that could happen, details of the review leaked to The New York Times and The Washington Post.

Høeg quickly became the focus of intense media scrutiny and criticism from vaccine advocates and unnamed FDA officials who argued she was relying too heavily on VAERS reports and overstating preliminary findings.

People familiar with the fallout said some FDA staff strongly objected to Høeg’s methods and conclusions and allegedly sought to undermine her credibility by leaking details of the review.

The leak effectively ended plans for a public ACIP discussion and deepened divisions within the FDA over how the findings should be handled.

Some officials believed the findings warranted stronger warnings and greater transparency. Others feared public acknowledgement of vaccine-linked child deaths would damage confidence in the Covid vaccines.

“We know that there are these deaths that are due to the vaccine,” said one source, referring to myocarditis cases and published reports from countries including Korea and Israel.

The controversy intensified after then-FDA vaccine chief Dr Vinay Prasad ordered additional investigation into the deaths identified in Høeg’s review.

Months later, another leak brought the issue back into public view.

In November 2025, an internal memo circulated by Prasad became public. In it, Prasad acknowledged that “at least 10” children had died “after and because of receiving Covid-19 vaccination.”

He described the findings as “a profound revelation.”

“COVID-19 vaccines did result in the death of children,” Prasad wrote. “Dr. Hoeg was correct in her assessment.”

The memo triggered another round of backlash from media outlets and vaccine advocates, many of whom accused Prasad of overstating the evidence before the agency’s analysis had been finalised.

Inside Medicine reported on a Dec 5 memo about a subsequent FDA analysis using a World Health Organization causality framework, which classified zero deaths as “certain,” two as “probable/likely,” and five as “possible.”

But individuals involved in the discussions said pressure steadily mounted inside the agency to “downgrade” the findings with each successive review.

“It seemed like there was a lot of pressure to keep decreasing the number of deaths,” said one source.

“It does seem like they tortured the data to get something that was more palatable.”

At the same time, tensions were also growing around another unresolved issue inside the FDA — residual DNA contamination in Covid mRNA vaccines.

The issue surfaced repeatedly during ACIP discussions throughout 2025, with some advisory group members seeking additional information from the FDA about DNA levels and biodistribution studies involving lipid nanoparticles.

According to individuals familiar with the discussions, those requests were repeatedly delayed.

One individual identified Dr David C. Kaslow, director of the FDA’s Office of Vaccines Research and Review (OVRR), as the official responsible for liaising with ACIP on the issue.

Another person involved in the discussions described Kaslow as the person “stonewalling” the issue of DNA contamination.

The controversy has since drawn Congressional scrutiny.

In May 2026, Senator Ron Johnson wrote to Health Secretary Robert F. Kennedy Jr. referencing an FDA memorandum examining paediatric deaths following Covid vaccination.

Johnson said the documents raised concerns about a potential “cover-up” of vaccine safety risks.

The letter confirmed that FDA officials reviewed 96 paediatric deaths following vaccination and ultimately classified seven cases as either “possibly” or “probably” related to Covid vaccination.

It also acknowledged that fatal myocarditis cases represented “new safety information” and documented discussions about revised vaccine warning labels.

By then, the internal dispute at the FDA had expanded beyond the deaths themselves and into a broader fight over vaccine safety warnings.

Høeg later delivered an internal presentation arguing that Covid mRNA vaccines warranted a black box warning — the FDA’s strongest warning reserved for products associated with serious injury or death.

The proposed warning would have explicitly acknowledged the risk of death in children.

“If a vaccine has potential to cause death to children, I think it should be on the label,” said one source familiar with the discussions.

Høeg’s proposal was ultimately rejected by the agency.

In December 2025, Makary publicly confirmed that the FDA had declined an internal recommendation for a black box warning on Covid mRNA vaccines.

Makary argued that earlier safety concerns emerged during the initial multi-dose rollout and might not apply to annual vaccination schedules.

According to individuals familiar with the discussions, Høeg’s persistent probing of Covid vaccine safety issues increasingly isolated her inside the agency.

Her eventual transfer out of the vaccine division and into the FDA’s drug division, CDER, effectively ended her involvement in those investigations.

Only last week, Høeg was fired from the agency after refusing to resign from her position.

To this day, the FDA has never publicly released the full paediatric death review examining 96 VAERS reports of child deaths following Covid vaccination, nor the multiple revised versions of the agency’s subsequent analyses.

“Why do we collect these VAERS reports if we’re not going to explain to the public what we find?” said one source.

Now, months after the internal disputes first erupted, the FDA continues to face questions about what officials knew, when they knew it, and why the agency failed to promptly release its investigations into paediatric deaths following Covid vaccination.

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The U.S. government has taken a major step toward rebuilding the Advisory Committee on Immunisation Practices (ACIP) — the federal panel that helps shape vaccine recommendations.

In a Federal Register notice posted for public inspection today, officials announced the “re-establishment” of ACIP after admitting that an earlier attempt to renew the committee’s charter did not comply with updated federal advisory committee rules.

The notice says an April 6 renewal notice is being “withdrawn” because of “an administrative error” involving updated public notification requirements under the Federal Advisory Committee Act (FACA), which was revised in late 2025.

“As a result, the charter lapsed and the committee must be re-established,” the notice states.

The timing is significant.

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Just days after the resignation of former FDA Commissioner Marty Makary, one of his closest allies says she was summoned to her office and told to resign or be fired.

Dr Tracy Beth Høeg — the physician-scientist who became one of the most visible figures in the FDA’s post-Covid reform movement — says she first learned about her apparent departure through media reports.

At the time, she dismissed the reports as ‘rumours’ because nobody inside the agency had told her anything.

Then, hours later, two FDA officials arrived at her office and told her she could either resign or be terminated.

Høeg refused to resign.

“I said I didn’t want to resign,” Høeg told MD Reports in an exclusive interview. “I said I’m not signing a letter of resignation if it’s not my choice.”

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Dr Marty Makary built a public profile as a medical dissident willing to challenge orthodoxy. But once inside the FDA, reform proved far more complicated — and far more contradictory — than many expected.

His departure closes one of the more turbulent chapters in recent FDA history, marked by internal turmoil, senior staff turnover, and several high-profile resignations, including former vaccine chief Vinay Prasad.

In recent days, legacy media reports suggested Makary had come under increasing political pressure over issues ranging from vaping policy to mifepristone and broader regulatory disputes within the Trump administration.

President Donald Trump publicly shared Makary’s resignation message on social media while quickly naming Deputy Commissioner Kyle Diamantas as acting replacement.

Before entering government, Makary became widely known during the Covid era for criticising lockdowns, school closures, booster mandates for healthy young people, and what he saw as institutional groupthink inside public health.

To many people disillusioned by the pandemic response, he represented something hopeful - a prominent surgeon willing to openly break with medical consensus.

But running the FDA is different from criticising it from the outside.

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New internal documents reveal the U.S. Food and Drug Administration (FDA) examined reports of persistent sexual dysfunction linked to commonly prescribed antidepressants — but stopped short of strengthening warning labels.

In 2018, a citizen petition urged the FDA to update labels for selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs), warning that sexual dysfunction could continue long after discontinuation.

The petition described “genital anaesthesia,” “pleasureless orgasm,” and other symptoms that could persist “for years or indefinitely” after stopping the drugs.

Under federal law, the FDA is required to respond within 180 days, but that response never came.

Years passed without any public indication that the agency had reviewed the evidence or reached a position on the issue.

In 2024, the petitioners sued the FDA to compel a formal response, but the case was dismissed on a technicality after the court ruled the plaintiffs lacked “standing,” meaning they could not show a direct, personal injury caused by the delay.

Now, newly released Freedom of Information Act (FOIA) documents reveal the FDA did in fact examine the evidence internally — but never formally communicated its conclusions to the petitioners or the public.

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Paxlovid, manufactured by Pfizer, was authorised in late 2021 for people aged 12 and older, catapulting the antiviral into one of the most profitable Covid drugs of the pandemic.

Governments bought the drug in bulk, health agencies promoted it aggressively, and by the time the dust settled, Pfizer had generated about US$28 billion in sales.

Now, years later, two major randomised trials published in the New England Journal of Medicine are challenging the illusion that Paxlovid’s effectiveness had ever been firmly established in real world use.

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The United States has moved to address growing concern about the widespread use of psychiatric drugs, with a new federal plan that puts deprescribing on the national agenda.

The U.S. Department of Health and Human Services today announced an initiative to curb what officials describe as overprescribing in mental health and to support patients who want to reduce or stop medication.

At the same time, four major HHS agencies issued a “Dear Colleague” letter urging clinicians to rethink how mental health care is delivered.

Dear Colleague Letter

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The letter calls for expanded use of non-drug approaches, stronger informed consent, and regular review of whether psychiatric medications remain necessary — including, where appropriate, reducing or discontinuing them.

It emphasises that patients should be informed not just at the start of treatment, but throughout — including the risks of side effects, withdrawal and abrupt cessation.

The announcement follows a summit in Washington, D.C. on the over-medicalisation of mental health, hosted by the MAHA Institute in partnership with the Inner Compass Initiative (ICI).

“Too often when people speak about them, their stories are dismissed as merely anecdotal or unfortunate,” said Cooper Davis, executive director of ICI. “But anecdotes are in fact evidence. Subjective experience matters.”

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A 200-page policy report argues that global public health is no longer being driven by the needs of countries, but by financial incentives.

At the centre of that argument is Professor Ramesh Thakur—a former Assistant Secretary-General of the United Nations and principal writer of Kofi Annan’s UN reform report.

He spent years inside the system helping shape it. Now, he argues that in public health, global authority has gone too far.

Thakur says decisions have shifted away from national governments and towards international institutions—particularly the World Health Organization.

The report was developed by a panel of global health and policy experts, co-chaired by David Bell, a former WHO researcher who has been openly critical of pandemic responses.

They are not just calling for reform—they are questioning the entire model: how it’s funded, how decisions are made, and who is actually in charge.

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