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The notice says an April 6 renewal notice is being “withdrawn” because of “an administrative error” involving updated public notification requirements under the Federal Advisory Committee Act (FACA), which was revised in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

The officials — whom Høeg declined to identify — then informed her she would no longer be working at the agency.

“They made it clear that it wasn’t their decision,” she said. “They said it was from someone above them, from someone way above their pay grade.”

Høeg said the encounter was emotional for everyone involved.

“They were both actually quite sad,” she said. “It was a very emotional goodbye.”

The extraordinary account provides a rare glimpse into the turmoil now engulfing the FDA following Makary’s departure and the collapse of what many had seen as an attempt to reform the agency from within.

Høeg had most recently been serving as Head of the FDA’s Center for Drug Evaluation and Research (CDER), one of the agency’s most powerful divisions overseeing prescription drugs.

Before that, she worked closely with Makary and former senior FDA official Vinay Prasad during efforts to reshape vaccine oversight and broader regulatory policy after the Covid era.

The appointments of Makary, Prasad, and Høeg had been closely watched internationally because they appeared to challenge the FDA’s traditional culture and instead, push for stricter scrutiny of pharmaceutical products, particularly vaccines.

Now, within weeks, all three are effectively gone.

Høeg says she believes her removal was connected.

“I suspected it was coming after Marty [Makary] resigned, because I think they didn’t want to have the people there who were closest to him anymore,” she said.

Despite the dramatic ending, Høeg spoke warmly about her time inside the agency and strongly rejected portrayals that the FDA had descended into dysfunction under Makary’s leadership.

“The chaos did not come from within the FDA,” she said. “The chaos came from the media creating stories about things being chaotic.”

According to Høeg, the environment inside CDER was collaborative, highly scientific, and deeply mission-driven.

“It was honestly a wonderful job,” she said. “I worked with wonderful people, and I felt like we were getting a lot of important work done.”

She described career scientists working long hours under intense public scrutiny while receiving little public recognition for their efforts.

“I was so pleasantly surprised by the quality of work the scientists are doing and how hard they work without ever getting recognition,” she said.

“It was incredibly fulfilling,” she added. “I wouldn’t have resigned from it.”

Still, Høeg acknowledged that persistent leaks inside parts of the agency created distrust and steadily poisoned the atmosphere.

“It became difficult to work under those circumstances because it’s hard to trust some of the people you’re working with if they’re leaking,” she said.

Høeg said pressure from industry was constant and often came indirectly through senior management or media narratives surrounding regulatory decisions.

“It’s like phone calls, text messages, pressure from above,” Høeg said. “There are situations where you feel you might lose your job because you’re making people above you unhappy.”

Høeg said she and her colleagues believed they were trying to protect scientific standards inside the agency despite mounting external pressure.

“I think we were committed to sticking to the science,” she said. “We did not want to give into political pressures if it was going to mean making dangerous decisions for public health.”

She added: “Marty and I, and Vinay [Prasad] as well, I think we all leave holding our heads high because we refused to bow to political pressure and to pressure from lobbyists to do things in order to keep our jobs or protect our reputations.”

While Høeg became publicly associated with contentious debates surrounding mRNA Covid-19 vaccines during her time in the FDA’s biologics division, she later moved to CDER where her focus shifted toward broader drug regulation.

There, she says, she became proud not only of products the agency approved, but also of products it refused to approve.

Høeg pointed to faster drug review times, the approval of several therapies for rare diseases, initiatives aimed at reducing animal testing, and efforts to draw attention to safety concerns surrounding SSRI use during pregnancy.

But she said some of the agency’s most important work involved resisting pressure to approve drugs when reviewers believed the evidence was inadequate.

“I was really proud of what we did in CDER — that we held our ground,” she said. “If we didn’t feel like it met the level of evidence for approval, we didn’t give into those pressures.”

Now, with Makary gone, Prasad departed, and Høeg herself abruptly removed, she fears the FDA may drift back toward leadership more acceptable to industry interests.

“I think that’s probably one of the strategies,” she said, when asked whether reform-minded officials were being replaced by figures seen as less confrontational toward pharmaceutical companies.

For now, Høeg says the speed of events has left her still trying to process what happened.

“I’m not sure what’s next,” she said. “I’m just trying to figure it out.”

For the officials who entered the FDA promising reform after Covid, the experiment now appears to be ending almost as abruptly as it began.

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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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Jay Bhattacharya has faced a wave of criticism after reports he stopped publication of a CDC study said to show the “benefits” of COVID vaccination while overseeing the agency.

The paper had been slated for the CDC’s in-house journal, Morbidity and Mortality Weekly Report (MMWR).

The reaction from public health figures and legacy media was immediate and largely one-sided, focusing on suppression rather than the evidence itself.

Now the study has been released.

Published exclusively on Inside Medicine, it reports a 50–55% reduction in COVID-related urgent care visits and hospitalisations — a figure already being used to reinforce claims about vaccine effectiveness.

But the central question has been largely sidestepped — is the study itself reliable?

Critics have not been deterred by the weak study design. If anything, they have doubled down and defended it.

What actually happened

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Recently, I wrote about why the lipid hypothesis won’t die — how the cholesterol story keeps evolving, not by confronting uncertainty, but by shifting the goalposts.

It began with total cholesterol. Then LDL. Then came subfractions, ApoB and Lp(a) — and now, another contender has entered the frame: remnant cholesterol.

Each shift comes with the same promise that this is the missing piece, the explanation for the risk we still can’t account for.

Yet after decades of treatment with cholesterol-lowering drugs, cardiovascular events remain common, even when LDL is low — what’s often described as “residual risk.”

Remnant cholesterol is now being positioned as the explanation for that gap. Some have gone further, promoting it as the next major treatment target.

But our new study suggests it’s time to pause.

When you look at the evidence — not modelling or genetic analyses, but clinical trials where people take drugs and outcomes are measured — the story looks very different.

What is remnant cholesterol?

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Last year, I reported on Robi v Merck — a jury trial in the United States examining claims that Merck’s Gardasil HPV vaccine caused serious harm.

The trial began in January 2025. A jury was empanelled, witnesses were called, and expert evidence was tested in open court.

Then, after 17 days, the proceedings were abruptly adjourned.

Since then, the case has been repeatedly delayed.

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In 2020, Dr Peterson was prescribed the benzodiazepine ‘clonazepam’ during a period of intense personal stress.

According to his family, the medication triggered a prolonged and debilitating reaction that left him with ongoing neurological symptoms.

In her latest update, his daughter says those symptoms have returned, despite him having been off the medication for years.

She describes episodes of akathisia—an extreme state of inner agitation—in stark terms: “the worst thing I’ve ever seen anyone go through… intolerable discomfort that makes people want to crawl out of their skin.”

She also recounts her own experience after stopping an SSRI antidepressant, saying the withdrawal lasted more than two years and left her, at times, unable to function.

Her account is confronting, but it is not unique. It reflects a pattern that has been described for decades and is often under-recognised.

The first time I heard about it

I first came across akathisia more than a decade ago while working on a documentary about antidepressants for the Australian Broadcasting Corporation (ABC TV).

I interviewed patients, as well as psychiatrists and researchers from around the world.

Many patients who had tried to reduce or stop their medications reported a cluster of symptoms—marked agitation, insomnia, and anxiety—that did not fit a straightforward relapse of their original condition.

In one conversation, a patient described the sensation as “unbearable,” saying she felt an urge to jump out of her skin and that it induced suicidal thoughts. The account was consistent with what others reported.

The documentary was researched for months, interviews were completed, and scripts were written. It reached the final stages in the edit suite before being pulled at the last minute.

The network was concerned about the public’s reaction—specifically, that the program might lead some viewers to question their medication, or even stop it—despite repeated messaging that these drugs should not be stopped abruptly and require medical supervision.

That decision censored real patient experiences from the public—especially those that challenged prevailing clinical assumptions.

What is akathisia?

Akathisia is still often described in clinical settings as “restlessness.”

But that description fails to capture the reality of the patient experience.

It is a severe, whole-body state of inner agitation.

It has been described in medical journals as “an intense inner restlessness and a compelling need to be in constant motion,” often accompanied by marked distress and an inability to remain seated.

Case reports describe a feeling of terror, a persistent sense of dread, and an urgent need to escape one’s own body.

This is why akathisia has been associated with suicidal ideation—not necessarily driven by depression, but because the sensation becomes unbearable, and death is perceived as a means of escape.

In some cases, symptoms can persist—a pattern now described in the literature as benzodiazepine-induced neurological dysfunction, or BIND, where neurological and psychological symptoms can continue for months or even years after the drug is stopped.

This has been described in cases like Peterson’s.

Akathisia is not limited to benzodiazepines.

It has long been recognised as a potential adverse effect of a range of psychotropic medications, including antidepressants and antipsychotics.

It is frequently described as ‘rare,’ but the volume and consistency of patient reports suggest it may be more common than often assumed.

Withdrawal and the problem of misdiagnosis

For many years, withdrawal from antidepressants was described as mild and short-lived. That position has begun to shift, particularly as more patients have remained on these medications for years.

Research now shows that withdrawal symptoms are common. More than half of people stopping antidepressants report some form of withdrawal, and a proportion describe those symptoms as severe.

The difficulty is that withdrawal symptoms—anxiety, agitation, insomnia, and despair—overlap with the conditions these drugs are prescribed to treat.

When a patient deteriorates after reducing a dose, the symptoms are often misinterpreted as relapse.

The medication is reinstated or increased, and the cycle continues.

Why tapering cannot be rushed

Patients are often advised to taper over a few weeks, but that is inadequate for many.

Mikhaila Peterson addresses this directly, saying: “If you have a doctor that suggests you wean off of a long-term psych med in two to four weeks — run.”

She argues that reductions need to be much slower and individualised to avoid severe withdrawal.

There is now ample evidence to support this approach.

Researchers such as Dr Mark Horowitz have shown that tapering, for some people, may need to follow a hyperbolic pattern—smaller and smaller reductions as the dose decreases—because of the way these drugs interact with receptors in the brain.

In practice, this can mean tapering over many months or years.

Guidelines from NICE and some medical colleges now recognise that withdrawal can last months and that tapering must be individualised.

Suicidality

Antidepressants are commonly prescribed to treat conditions in which suicidal thoughts may occur.

But in placebo-controlled trials involving children and adolescents, SSRIs were associated with an increased risk of suicidal ideation—approximately 4% on the drug compared to 2% on the placebo.

That signal led to formal black box warnings from regulators.

In other words, in the very population where these drugs are often used to reduce suicide risk, the trials detected an increase in suicidal thinking during treatment.

Separate experimental work has shown that even healthy volunteers, with no psychiatric history, can develop agitation and suicidal thinking when exposed to these drugs.

These findings do not apply to every patient. But they suggest that in some individuals, these medications can produce the very symptoms they are meant to treat.

That reality is still not being communicated clearly.

The gap that remains

After years of reporting on this, it is evident that people are not routinely given clear information about what stopping these drugs may involve.

They are told about the benefits, but are not given meaningful details about withdrawal, akathisia, the need for slow tapering, or the possibility of persistent sexual dysfunction after the medication is discontinued.

That is a failure of informed consent.

The Peterson case has brought attention back to a problem that has never gone away.

Patients have been describing these experiences for years — often dismissed, often misdiagnosed, often left to navigate it alone.

As Dr Horowitz suggests, if a drug can induce physical dependence and withdrawal, then a plan for stopping it should be part of the prescription.

Share

Resources:

Inner Compass Initiative (ICI): theinnercompass.org

Prescribed harm: prescribed-harm.com

Antidepressant Coalition for Education: antidepressantinfo.org

MISSD (MISSD.co)

Taper Clinic: taperclinic.com

Brisbane ACT Centre: brisbaneactcentre.com.au/tapering/

Further reading:

Quitting antidepressants can be tricky

Starting a medication is easy...stopping it can be much harder

Antidepressants can cause ‘chemical castration’

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President Donald Trump has nominated Dr Erica Schwartz to lead the CDC, following a year of instability at the agency.

Schwartz brings strong credentials. A former deputy surgeon general, she has spent decades inside federal health agencies, including leadership roles during national emergencies.

Her nomination now heads to the Senate for confirmation.

Early reactions have been divided.

Former US surgeon general Jerome Adams welcomed the choice, calling Schwartz “a battle-tested leader” with a long record of public service—a response that mirrors the broader establishment reaction.

Others were sharply critical.

Attorney Aaron Siri, a close ally of Robert F. Kennedy Jr., argued the agency doesn’t need “another cheerleader for industry,” warning that her leadership would “likely be a disaster.”

These responses reflect two very different views of what the CDC should be—and what this appointment signals.

The CDC has been on a merry-go-round of acting directors, abrupt exits, and internal disagreements spilling into public view. Stability has been in short supply.

In that environment, the priority shifts to getting someone through the Senate and into the role.

That constraint has already been tested.

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In this interview for Reality Check Radio (RCR), I speak with Retsef Levi, an MIT professor and former member of the Advisory Committee on Immunisation Practices (ACIP), who also chaired its Covid-19 vaccine workgroup.

Levi looks back on the final phase of ACIP’s work before it was abruptly halted last month.

He says discussions within his Covid workgroup were wide-ranging, with “no suppression about any topic.”

But efforts to include vaccine injury within the workgroup’s remit met “strong objections” from CDC leadership, with lawyers drawn into a debate over whether it even fell within ACIP’s scope.

Levi is blunt about the health system itself, describing the way vaccine injuries are recognised and managed as “utterly broken,” with no clear diagnostic pathways and patients often left without answers.

In our conversation, I put the key questions to him — what was on the agenda for the cancelled meeting, how decisions were being shaped, and how he responds to claims the process was being constrained or influenced.

I also put to him a policy document prepared by the Covid workgroup — leaked to MD Reports — and ask him to respond to it.

Levi describes the internal dynamics of the committee, the role of workgroups, and the challenge of navigating risk, uncertainty, and public trust.

He also raises unresolved questions about DNA fragments in mRNA vaccines, saying regulators and manufacturers have failed to provide clear, basic data on what was tested and what was found.

More broadly, Levi addresses reports of child deaths caused by Covid vaccination — including data referenced by the FDA but not publicly released — and says it should be made available to the scientific community.

His account sits alongside other perspectives that have emerged in recent weeks, including from former vice-chair Robert Malone, who publicly criticised the government for not defending the credentials of those appointed to ACIP.

Levi says he understands Malone’s frustration, but takes a different view. He does not feel he needs the government to defend his credentials, adding that his track record speaks for itself.

For anyone trying to understand what was unfolding inside ACIP before it was halted, this conversation is worth hearing in full (75 minutes).

FURTHER READING:

Leaked report to federal advisers calls for urgent recognition of Covid vaccine injuries

Court ruling forces cancellation of ACIP meeting

The presentation ACIP never heard

ACIP charter rewritten — sweeping changes reshape vaccine advisory panel

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The bar for treating high blood pressure has shifted — again.

Last August, the American Heart Association (AHA) and American College of Cardiology (ACC) quietly revised their guidelines.

The numbers haven’t changed since 2017, but the rules for treatment have.

Doctors are now encouraged to start medication earlier — even in people considered lower risk — a move that could push millions more onto lifelong treatment.

It’s part of a familiar pattern in medicine: the steady expansion of who counts as “unwell.”

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Today, the federal government published an updated charter for its vaccine advisory panel — the CDC’s Advisory Committee on Immunization Practices, or ACIP.

The changes significantly expand its scope, reshape its membership, and reframe how vaccine decisions are made.

The document, signed off by Health Secretary Robert F. Kennedy Jr., was posted on the CDC’s website. It replaces the previous charter with a version that goes well beyond routine renewal and is effective through April 1, 2028.

The move comes just weeks after a federal judge halted most of the committee’s membership, leaving ACIP effectively paralysed.

At first glance, the structure appears familiar. The Health Secretary still appoints members. The committee remains advisory, and its recommendations still flow through the CDC.

But beneath that surface, the changes are substantial — and far-reaching.

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It’s one of the most commonly performed operations for shoulder pain.

In England alone, nearly 30,000 of these procedures are carried out every year. Since 2007/08, it has cost the National Health Service more than £1 billion.

The operation is called arthroscopic subacromial decompression, or ASD.

It’s keyhole surgery on the shoulder.

Surgeons go in and clear out tissue or shave bone to create more space — aiming to relieve pressure and ease pain.

It’s widely used and patients are told it will help.

But one of the most rigorous trials ever conducted on this procedure should make people think twice.

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Across much of the world, the HPV vaccine is delivered through school-based programmes to children aged 11 to 13.

The policy is presented as straightforward: vaccinate early to prevent cervical cancer later in life.

It’s a message that suggests the policy rests on rigorous evidence.

But the clinical trials that established the vaccine’s efficacy in reducing early cervical changes did not study children at the age for which the vaccine is now routinely recommended.

That detail is rarely explained in public messaging — or to parents consenting to their children lining up for the vaccine at school.

To understand how this happened, it is necessary to look closely at the trials that first established the vaccine’s efficacy.

What did they measure? Who did they enrol? And how did those findings become the basis for recommending HPV vaccination for millions of schoolchildren around the world?

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This week, Dr Robert Malone did not quietly step away from the CDC’s Advisory Committee on Immunisation Practices (ACIP). He left by tearing into it.

In an extraordinary interview on The HighWire, the former vice-chair delivered a sweeping account of dysfunction inside the federal vaccine advisory system — describing ACIP as a “hot mess,” a “fool’s errand,” and a body that is no longer “providing independent advice to the government.”

Speaking at length about his resignation and the inner workings of the committee, Malone portrayed a system that had been fundamentally “captured” — shaped not only by the CDC bureaucracy but, as Malone alleges, by a “mole” operating inside the administration.

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I’ve spent years looking closely at the role of cholesterol in heart disease, and I keep coming back to the same question: why won’t the lipid hypothesis die?

The idea that LDL cholesterol is a primary cause of heart disease is still debated, but it is no longer treated that way.

It’s embedded in clinical practice, built into guidelines, and repeated in public health messaging with a level of certainty that the underlying evidence does not consistently support.

What’s striking is not just that the model persists, but how it has evolved.

You can see that most clearly in the way the latest US guidelines on cholesterol management and cardiovascular risk have shifted.

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Last week, a federal judge in Massachusetts forced the cancellation of a much-anticipated meeting of the Advisory Committee on Immunization Practices (ACIP).

Among the materials prepared for discussion was a scientific briefing by Professor Charlotte Kuperwasser of Tufts University School of Medicine, and member of the Covid-19 vaccine workgroup.

The presentation was expected to address a central question about what happens to DNA byproducts in mRNA vaccines once they enter the body.

Earlier this week, Kuperwasser wrote for the Brownstone Institute that while these byproducts are known to be present, data on their fate in the body are not available.

The slides prepared for ACIP go further.

They set out a biological mechanism linking these manufacturing byproducts to immune responses that fail to switch off—matching the pattern of illness reported by patients with vaccine injuries.

Below is an exclusive look at the briefing slides that were never presented to ACIP—and have not been made public until now.

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