Brownstone Institute
WHO IHR Modifications Were Illegally Approved
From the Brownstone Institute
By
The 77th meeting of the World Health Assembly concluded Saturday, June 01, 2024. This particular Assembly meeting, the first following the Covid crisis, failed to achieve agreement on the wording or passage of a proposed World Health Organization (WHO) pandemic “treaty,” also referred to as an “agreement.” In parallel to the treaty, the World Health Assembly (in close cooperation with the US HHS/Biden administration) has been working on “updating” the existing (2005) International Health Regulations (IHR) agreement, which historically functioned as a voluntary accord establishing international norms for reporting, managing, and cooperating in matters relating to infectious diseases and infectious disease outbreaks (including “pandemics”).
In blatant disregard for established protocol and procedures, sweeping IHR amendments were prepared behind closed doors, and then both were submitted for consideration and accepted by the World Health Assembly quite literally in the last moments of a meeting that stretched late into Saturday night, the last day of the meeting schedule.
Although the “Article 55” rules and regulations for amending the IHR explicitly require that “the text of any proposed amendment shall be communicated to all States Parties by the Director-General at least four months before the Health Assembly at which it is proposed for consideration,” the requirement of four months for review was disregarded in a rush to produce some tangible deliverable from the Assembly. This hasty and illegal action was taken in direct violation of its own charter, once again demonstrating an arbitrary and capricious disregard of established rules and precedent by the WHO under the leadership of the Director-General.
There was no actual vote to confirm and approve these amendments. According to the WHO, this was achieved by “consensus” among this unelected insider conclave rather than a vote; “Countries agreed by consensus to amend the International Health Regulations, which were last changed in 2005, such as by defining the term “pandemic emergency” and helping developing countries to gain better access to financing and medical products,” a WHO statement reported, continuing that “countries” agreed to complete negotiations on the pandemic accord with the year, “at the latest.”
Representatives from many WHO member nation-states were not in the room, and the ones that were there were encouraged to keep quiet. After the non-vote, there was giddy celebration of this achievement, clearly demonstrating the lack of somber maturity, commitment to both rules and careful diplomatic consensus, and absence of serious intent and purpose warranted by the topic.
This was clearly an insider clique acting unilaterally to circumvent normal process and mirrors a similar process used to confirm the re-appointment of Tedros Ghebreyesus to the Director-General position. This unelected WHO clique of “true believers” clearly signals that it believes itself above any requirements to comply with established international norms and standards, including its own. By their actions you will know them; the giddy arrogance of these actions predicts that WHO decision-making will continue to be arbitrary, capricious, and politicized, and will continue to reflect the will of various insider interest groups (and nation-states) rather than anything even approximating a broad-based international consensus.
Here in the United States, these unilateral actions, backed by an executive branch and bureaucracy that repeatedly demonstrates a deep disdain for the rule of law and the US Constitution, may require that individual States pass legislation to reject the WHO Amendments to IHR based on the illegality of the process and violation of Article 55. Similar discussions are occurring in the UK and across many WHO member states, adding momentum to the emerging WHO-exit movement.
For those not familiar, the current WHO Director-General Tedros Adhanom Ghebreyesus is neither a physician nor a trained public health or epidemiology specialist, but rather is an Ethiopian microbiologist, malaria researcher, and politician.
The hastily approved IHR consolidates virtually unchecked authority and power of the Director-General to declare public health emergencies and pandemics as he/she may choose to define them, and thereby to trigger and guide the allocation of global resources as well as a wide range of public health actions and guidances. These activities include recommendations relating to “persons, baggage, cargo, containers, conveyances, goods and postal parcels,” but based on earlier draft language of proposed IHR amendments and the WHO pandemic “accord” are likely to extend to both invasive national surveillance and mandated public health “interventions” such as vaccines and non-pharmaceutical interventions such as social distancing and lockdowns. Not to mention the continuing weaponization of public health messaging via censorship of dissenting voices and liberal use of the fear-based tactics known as information or psychological bioterrorism to mobilize public opinion in favor of WHO objectives.
The IHR amendments retain troubling language regarding censorship. These provisions have been buried in Annex 1,A.2.c., which requires State Parties to “develop, strengthen and maintain core capacities…in relation to…surveillance…and risk communication, including addressing misinformation and disinformation.”
The requirement that nations “address” “misinformation and disinformation” is fraught with opportunities for abuse. None of these terms is defined in the document. Does “addressing” it mean censoring it, and possibly punishing those who have offered divergent opinions? We have already seen how doctors and scientists who disagreed with the WHO narrative under Covid-19 were censored for their views – views that turned out to be true. Some who offered protocols not recommended by the WHO even had their licenses to practice medicine threatened or suspended. How much worse will this censorship be if it is baked in as a requirement of the International Health Regulations?
The “surveillance” requirement does not specify what is to be surveilled. The IHR amendments, however, should be read together with the proposed Pandemic Treaty, which the WHO is continuing to negotiate. Article 5 of the most recent draft of the Treaty sets forth the “One Health Approach,” which connects and balances human, animal, plant, and environmental health, giving a pretext for surveillance on all these fronts.
Meanwhile, Article 4: Pandemic Prevention and Public Health Surveillance, states:
The Parties recognize that environmental, climatic, social, anthropogenic [climate change caused by people], and economic factors increase the risk of pandemics and endeavor to identify these factors and take them into consideration in the development and implementation of relevant policies…” Through the “One Health” approach, the WHO is asserting its authority over all aspects of life on earth, all of which are apparently to be surveilled.
Regarding the IHR, Article 35 details the requirements of “Health Documents,” including those in digital format. The system of digital health documents is consistent with, and in my opinion a precursor to, the Digital IDs described by the World Economic Forum. According to the attached WEF Chart, people will need a Digital ID to:
- Access healthcare insurance and treatment
- Open bank accounts and carry out online transactions
- Travel
- Access Humanitarian Services
- Shop and conduct business transactions
- Participate in social media
- Pay taxes, vote, collect government benefits
- Own a communication device [such as a cell phone or a computer]
In other words, individuals will need Digital IDs to access almost every aspect of civilized society. All of our actions, taken with the use of Digital IDs, will be tracked and traced. If we step out of line, we can be punished by, for example, being severed from our bank accounts and credit cards – similar to what happened to the Canadian Truckers. Digital IDs are a form of mass surveillance and totalitarian control.
These Digital IDs are currently being rolled out by the World Health Organization in collaboration with the European Union. Most of us will agree that this is not the way forward to make the world safer but rather is a path leading towards a techno-totalitarian hellscape.
To support decision-making, the IHR authorizes the Director-General to appoint an “IHR Expert Roster,” an “Expert Committee” selected from the “IHR Expert Roster,” as well as a “Review Committee.” However, although the committees may make recommendations, the Director-General will have final decision authority in all relevant matters.
To further illustrate the point, the revised IHR directs that “The Director-General shall invite Member States, the United Nations and its specialized agencies and other relevant intergovernmental organizations or nongovernmental organizations in official relations with WHO to designate representatives to attend the Committee sessions. Such representatives may submit memoranda and, with the consent of the Chairperson, make statements on the subjects under discussion. They shall not have the right to vote.”
The approved amendments redefine the definition of a “Pandemic Emergency;” include a newly added emphasis on “equity and solidarity;” direct that independent Nations (“States Parties”) shall assist each other to support local production capacity for research, development, and manufacturing of health products; that equitable access to relevant health products for public health emergencies including pandemics shall be facilitated; and that developed nations shall make available “relevant terms of their research and development agreements for relevant health products related to promoting equitable access to such products during a public health emergency of international concern, including a pandemic emergency.”
The amended IHR also directs that each nation (“States Parties”) shall “develop, strengthen and maintain core capacities” for “preventing, preparing for and responding to public health risks and events,” including in relation to:
- Surveillance
- On-site Investigations
- Laboratory diagnostics, including referral of samples
- Implementation of control measures
- Access to health services and health products needed for the response
- Risk communication, including addressing misinformation and disinformation
- Logistical assistance
The amended IHR also includes copious new language, terms, and conditions relating to the responsibilities of “States Parties” to perform surveillance and transparent timely reporting of information relating to infectious disease outbreaks. This includes multiple references to information gathering, sharing, and distribution, including the need to counter the distribution of “misinformation and disinformation”.
There is the appearance that some of this new text may be informed by the recent failure of China (PRC/CCP) to provide timely and complete reporting of events and information relating to the initial SARS-CoV-2 outbreak. Unfortunately, this failure to inform in a timely manner was not unique. There is a long history of repeated, chronic problems with transparent national reporting of infectious disease outbreaks. A variety of adverse economic and political impacts are associated with infectious disease outbreaks, and this creates a strong incentive for both local politicians and public health officials to minimize initial reporting of unusual infectious disease signals or findings.
The amended IHR frequently refers to “scientific principles as well as the available scientific evidence and other relevant information” as a key factor in guiding decision-making. However, the IHR does not acknowledge the diversity of opinion surrounding what are considered sound and valid “scientific principles” or “scientific evidence,” and there is no indication that the World Health Assembly or the WHO recognizes how readily “scientific principles” and “scientific evidence” were manipulated or otherwise biased during prior public health crises, and the likelihood that this will continue to happen on a regular basis unless reforms designed to respect diversity of opinion and interpretation are implemented. There seems to be a complete lack of self-awareness of the rampant groupthink that chronically characterizes WHO decision-making during both the Covid crisis as well as prior public health events of concern.
Although many of these revisions are generally reasonable and aligned with good and practical international public health norms and actions, and in some cases are greatly improved relative to prior draft language, the recent history of WHO mismanagement and actual WHO spreading and amplification of mis- and disinformation regarding SARS-CoV-2 virology, immunology, and pathophysiology, pharmaceutical and non-pharmaceutical interventions for SARS-CoV-2 raise legitimate concerns about how these words will be interpreted and implemented.
Furthermore, the pattern of repeated arbitrary, capricious, and scientifically unjustifiable decisions regarding Covid and monkeypox suggests that expanding the authority of either the Director-General or the WHO is unwise at this time. Rather, more mature, thoughtful, and prudent evaluation of that recent experience argues for reduced rather than expanded authority, and for a more decentralized, multilateral model for the management of global and regional public health risks and events. The world does not need more condescending authoritarianism from those entrusted to facilitate international cooperation in public health.
Just speaking in terms of best practices, it is clearly inappropriate to rely on administrators with such a vested personal interest in the outcome to be so intimately involved in crafting sweeping international policy changes. This revision process should have been managed by an independent commission of seasoned, objective experts who were carefully vetted to minimize potential conflict of interest.
The hasty willingness to bypass its own charter by unilaterally and arbitrarily jamming these changes through on extremely short notice raises further concerns regarding the reliability, maturity, and competency of the WHO, the World Health Assembly, and the Director-General to provide the calm, steady hand so sorely needed after the mismanaged major public health catastrophe and global trauma which all have experienced over the last four years.
The world, its inhabitants, those who work to provide medical care, and the overall world health enterprise deserve better.
From the Brownstone Institute
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 BMJ investigation 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]
- Searchable public drug approval database [link]
- See my talk: Failure of Drug Regulation: Declining standards and institutional corruption
Republished from the author’s Substack
Author
From the Brownstone Institute
By 
Anthony Fauci must be furious.
He spent years proudly being the public face of the country’s response to the Covid-19 pandemic. He did, however, flip-flop on almost every major issue, seamlessly managing to shift his guidance based on current political whims and an enormous desire to coerce behavior.
Nowhere was this more obvious than his dictates on masks. If you recall, in February 2020, Fauci infamously stated on 60 Minutes that masks didn’t work. That they didn’t provide the protection people thought they did, there were gaps in the fit, and wearing masks could actually make things worse by encouraging wearers to touch their face.
Just a few months later, he did a 180, then backtracked by making up a post-hoc justification for his initial remarks. Laughably, Fauci said that he recommended against masks to protect supply for healthcare workers, as if hospitals would ever buy cloth masks on Amazon like the general public.
Later in interviews, he guaranteed that cities or states that listened to his advice would fare better than those that didn’t. Masks would limit Covid transmission so effectively, he believed, that it would be immediately obvious which states had mandates and which didn’t. It was obvious, but not in the way he expected.
And now, finally, after years of being proven wrong, the White House has officially and thoroughly rebuked Fauci in every conceivable way.
White House Covid Page Points Out Fauci’s Duplicitous Guidance
A new White House official page points out, in detail, exactly where Fauci and the public health expert class went wrong on Covid.
It starts by laying out the case for the lab-leak origin of the coronavirus, with explanations of how Fauci and his partners misled the public by obscuring information and evidence. How they used the “FOIA lady” to hide emails, used private communications to avoid scrutiny, and downplayed the conduct of EcoHealth Alliance because they helped fund it.
They roast the World Health Organization for caving to China and attempting to broaden its powers in the aftermath of “abject failure.”
“The WHO’s response to the COVID-19 pandemic was an abject failure because it caved to pressure from the Chinese Communist Party and placed China’s political interests ahead of its international duties. Further, the WHO’s newest effort to solve the problems exacerbated by the COVID-19 pandemic — via a “Pandemic Treaty” — may harm the United States,” the site reads.
Social distancing is criticized, correctly pointing out that Fauci testified that there was no scientific data or evidence to support their specific recommendations.
“The ‘6 feet apart’ social distancing recommendation — which shut down schools and small business across the country — was arbitrary and not based on science. During closed door testimony, Dr. Fauci testified that the guidance ‘sort of just appeared.’”
There’s another section demolishing the extended lockdowns that came into effect in blue states like California, Illinois, and New York. Even the initial lockdown, the “15 Days to Slow the Spread,” was a poorly reasoned policy that had no chance of working; extended closures were immensely harmful with no demonstrable benefit.
“Prolonged lockdowns caused immeasurable harm to not only the American economy, but also to the mental and physical health of Americans, with a particularly negative effect on younger citizens. Rather than prioritizing the protection of the most vulnerable populations, federal and state government policies forced millions of Americans to forgo crucial elements of a healthy and financially sound life,” it says.
Then there’s the good stuff: mask mandates. While there’s plenty more detail that could be added, it’s immensely rewarding to see, finally, the truth on an official White House website. Masks don’t work. There’s no evidence supporting mandates, and public health, especially Fauci, flip-flopped without supporting data.
“There was no conclusive evidence that masks effectively protected Americans from COVID-19. Public health officials flipped-flopped on the efficacy of masks without providing Americans scientific data — causing a massive uptick in public distrust.”
This is inarguably true. There were no new studies or data justifying the flip-flop, just wishful thinking and guessing based on results in Asia. It was an inexcusable, world-changing policy that had no basis in evidence, but was treated as equivalent to gospel truth by a willing media and left-wing politicians.
Over time, the CDC and Fauci relied on ridiculous “studies” that were quickly debunked, anecdotes, and ever-shifting goal posts. Wear one cloth mask turned to wear a surgical mask. That turned into “wear two masks,” then wear an N95, then wear two N95s.
All the while ignoring that jurisdictions that tried “high-quality” mask mandates also failed in spectacular fashion.
And that the only high-quality evidence review on masking confirmed no masks worked, even N95s, to prevent Covid transmission, as well as hearing that the CDC knew masks didn’t work anyway.
The website ends with a complete and thorough rebuke of the public health establishment and the Biden administration’s disastrous efforts to censor those who disagreed.
“Public health officials often mislead the American people through conflicting messaging, knee-jerk reactions, and a lack of transparency. Most egregiously, the federal government demonized alternative treatments and disfavored narratives, such as the lab-leak theory, in a shameful effort to coerce and control the American people’s health decisions.
When those efforts failed, the Biden Administration resorted to ‘outright censorship—coercing and colluding with the world’s largest social media companies to censor all COVID-19-related dissent.’”
About time these truths are acknowledged in a public, authoritative manner. Masks don’t work. Lockdowns don’t work. Fauci lied and helped cover up damning evidence.
If only this website had been available years ago.
Though, of course, knowing the media’s political beliefs, they’d have ignored it then, too.
Republished from the author’s Substack
Author
What Connor Should Say To Oilers: It’s Not You. It’s Me.
Ontario man launches new challenge against province’s latest attempt to ban free expression on roadside billboards
Federal fiscal anchor gives appearance of prudence, fails to back it up
The Passage of Bill C-5 Leaves the Conventional Energy Sector With as Many Questions as Answers
-
Business1 day agoOttawa Funded the China Ferry Deal—Then Pretended to Oppose It
-
COVID-192 days agoNew Peer-Reviewed Study Affirms COVID Vaccines Reduce Fertility
-
MAiD2 days agoCanada’s euthanasia regime is not health care, but a death machine for the unwanted
-
Business1 day agoWorld Economic Forum Aims to Repair Relations with Schwab
-
Alberta2 days agoThe permanent CO2 storage site at the end of the Alberta Carbon Trunk Line is just getting started
-
Alberta1 day agoAlberta’s government is investing $5 million to help launch the world’s first direct air capture centre at Innisfail
-
Business2 days agoMunicipal government per-person spending in Canada hit near record levels
-
Business1 day agoA new federal bureaucracy will not deliver the affordable housing Canadians need