by Brenda Baletti, Ph.D. The Defender
This article was published on The Defender—Children’s Health Defense News & ViewsWebsite on August 6, 2024
Big Pharma and its key investors are rolling out a new strategy — “the full takeover of the public sector, specifically the World Health Organization (WHO), and the regulatory system that now holds the entire market hostage”—according to a new investigative report by Unlimited Hangout’s Max Jones.
What’s behind the new strategy? The pharmaceutical industry is facing a “patent cliff” by 2030, as many of its blockbuster drugs are set to lose their patent protection, placing $180 billion in sales at risk and threatening to topple the industry.
According to Jones, for years, when patents expired on profitable drugs, pharmaceutical giants deployed a “mergers and acquisitions” strategy, buying up smaller drug companies to add to their product portfolios.
As a result, the industry is now dominated by a handful of companies, conventional chemical drugs exist for most health issues, and the regulatory process for new ones has become onerous.
Big Pharma has now pivoted to acquiring biotech and biologic companies, whose products are “more complex, unpredictable and difficult and expensive to make,” than chemical-based medicine, Jones wrote.
Conventional drugs are chemically synthesized and have a known structure according to the U.S. Food and Drug Administration (FDA). Biologics come from living humans, animal or microorganism cells, and are technologically altered to target particular proteins or cells in the immune system. The FDA calls biologics “complex mixtures that are not easily identified or characterized.”
As a drug class, biologics offer an appealing solution to the patent cliff problem, because they can’t be easily replicated like generic versions of conventional drugs.
Instead, producers make “biosimilars,” which unlike genetics can’t simply be interchanged with the original drug during a course of treatment without serious safety risks, according to Jones. And while generics are cheap, biosimilars are still expensive to produce. There also are regulatory hurdles to getting biosimilars to market.
However, Jones wrote, the serious safety issues associated with biologics—the high risk of serious adverse events associated with the COVID-19 vaccine, for example—make it difficult for drugmakers to find commercial success in a conventional regulatory environment.
“Luckily for Big Pharma,” Jones wrote, the WHO and its private backers “are pursuing an unprecedented legal process that would cement loopholes that could solve these significant market challenges of at least some biotechnologies.”
Such loopholes made Pfizer and Moderna’s COVID-19 mRNA vaccines—the paradigmatic example of this new strategy—Big Pharma’s highest-selling annual market success ever.
Distribution of the COVID-19 vaccines to approximately 70% of people globally was possible only because of the “fast-tracked, deregulated development and mandated consumption of the experimental drugs,” Jones wrote.
The industry hopes to replicate that model with other drugs. And it has already begun—last month the Biomedical Advanced Research and Development Authority, or BARDA, gave Moderna $176 million to develop an mRNA bird flu vaccine.
Stakeholders behind the WHO have turned it into an arm of Big Pharma
According to Jones, the process of rapidly developed and mandated experimental drugs was first adopted by the U.S. military for bioweapons threats. Now, it is being internationally legitimized by the WHO through the agency’s revisions to the International Health Regulations (IHR) and its continued attempt to push its pandemic treaty.
The amendments were watered down and the treaty was partially thwarted at the last meeting of the World Health Assembly, which ended on June 1. However, the powers added to the amendments and the language in the treaty WHO and its backers are still hoping to advance next year show the type of biotech pandemic market Big Pharma has in the works.
According to Jones, this market:
“Will not be one that depends on the free will of consumers to opt in and out of products—but instead relies on tactics of forced consumption and manipulation of regulatory paradigms.
“At the forefront of this push are the WHO’s public-private-partners/private stakeholders, who directly shape and benefit from this policy. Their influence has, in effect, turned the WHO into an arm of Big Pharma, one so powerful that it already demonstrated its ability to morph the entire international regulatory process for the benefit of the pharmaceutical industry during the COVID-19 pandemic.”
These stakeholders can wield this power in part because the WHO receives 80% of its funding from private stakeholders.
Those stakeholders include private-sector giants like Bill Gates, his public-private partnership organizations like the Coalition for Epidemic Preparedness Innovations (CEPI) and public-sector bureaucrats, such as Dr. Anthony Fauci and Rick Bright, Ph.D., of BARDA and the Rockefeller Foundation, who have been working for years to create a new system that would speed up vaccine production.
During the COVID-19 pandemic period, even states that lacked legal structures to provide emergency authorization for new drugs created them, using the WHO’s Emergency Use Listing Procedure (EUL) as justification, and aided by the WHO’s COVAX vaccine distribution system. COVAX was co-led by the WHO, Gavi, CEPI and Unicef, which are all backed by Gates.
The goal now, Jones wrote, is to institutionalize the procedures that were put in place globally for COVID-19 to pave the way for a new pandemic market.
The One Health agenda, which requires “full-scale surveillance of the human-animal environment,” both before and during pandemics, is central to this plan, he wrote.
The four pillars of the emerging pandemic market
There are four pillars to the plan for securing this market. The pillars are embodied in the WHO’s recently passed IHR amendments and the proposed pandemic treaty.
1. Biosurveillance of “pathogens with pandemic potential”: The WHO is calling on member states to create infrastructure to conduct biosurveillance on entire populations.
WHO private stakeholders, like the Wellcome Trust and the Bill & Melinda Gates Foundation, have been funding such initiatives for years and continue to be at the forefront of similar initiatives today, Jones wrote.
2. Rapid sharing of data and research: Under the IHR amendments, the WHO’s director-general must provide support for member states’ research and development. In the pending treaty, that would include helping them rapidly share data during a pandemic.
Such sharing should help coordinate global pandemic responses and also “pandemic prevention.” That means building a globally coordinated effort to research and share data on diseases that don’t currently pose a public health threat but are allegedly “likely to cause epidemics in the future.”
The WHO’s announcement last week that it is facilitating data-sharing for a new mRNA bird flu vaccine from Argentina is one example.
Experts have raised concerns that incentivizing such “preventive R&D” could incentivize risky gain-of-function research, Jones wrote.
Jones also noted that it is “highly likely” that the same global organizations that partner with the WHO and are funded by its largest private donors will be the ones doing this research and development on vaccines for “future pathogens with pandemic potential” — and also the ones profiting from it.
3. New regulatory pathways: The WHO is developing new regulatory pathways for unapproved medical products to get to market during pandemic emergencies. The IHR amendments are vague on this, Jones wrote, but the proposed language of the treaty aims to speed up emergency authorizations of WHO-recommended investigational “relevant health products.”
The proposed treaty also seeks to compel member countries to take steps to ensure they have the “legal, administrative and financial frameworks in place to support emergency regulatory authorizations for the effective and timely approval of pandemic-related health products during a pandemic.”
4. Global mandates of unapproved products: The final key element in the Big Pharma-WHO plan to pave the way for a new pandemic market is shoring up the global capacity to mandate unapproved medical products.
According to Jones, in July 2023, the WHO adopted the European Union’s (EU) digital COVID-19 passport system, or the “immunity pass” which recorded people’s vaccination records, negative test results or records of previous infections.
“While a digital vaccine passport does not function as a hard mandate in which every citizen of a given population is forced to take a vaccine, it acts as a conditional mandate — one which offers the illusion of choice, but—in reality—restricts the civil liberties of those who do not comply,” Jones wrote.
The 2005 version of the IHR allowed for travel-based mandates that required proof of vaccination to enter countries when there was a public health risk. The new IHR, Jones wrote, expands on this by detailing the kinds of technology that can be used to check such information during future pandemics.
The WHO also is developing its Global Digital Health Certification Network, which expands the EU digital passport system to a global scale. It will digitize vaccination records and health records and will be “interoperable” with existing networks.
While interoperability makes it possible for decentralized data to be shared globally, Jones wrote, “The UN is seeking to impose digital identification as a ‘human right,’ or rather as a condition for accessing other human rights, for the entire global citizenry by 2030, as established in its Sustainable Development Goal 16.9.”
The initiative seeks to provide people with a “trusted, verifiable way” to prove who they are in the physical world and online.
“Verification systems of this size will place the right of citizens to do basic activities—like traveling, eating at a restaurant or working their job—in the hands of governments and potentially employers.
“The rights of civilians will be conditional, dictated by data stored in a massive digital hub that is global in its sharing abilities. Not only will domestic governments have access to the health information of their own citizens under this system, but an entire global bureaucracy will as well.”
This article was published by The Defender—Children Health Defense News & Views Website under Creative Commons license CC BYNCND 4.0.0.
