If official numbers are to be believed, the United States is one of the worst hit countries in terms of COVID-19 infections and deaths. According to the US Center for Disease Control and Prevention (CDC), at the time of writing, there are supposedly 19 million COVID-19 cases with an alleged 300,000+ deaths suggesting between a 1-2% chance of dying from COVID-19 if infected by it.
However, these numbers are problematic – even before questioning the validity of the statistics themselves leading to them.
For example, asymptomatic cases will likely go both untested and unreported, meaning many more people are actually being infected by COVID-19, exhibiting no symptoms, receiving no treatment, and most certainly not making it into the CDC’s “cases” statistics.
This means that your chances of being infected by COVID-19 and dying are actually much, much less than the often touted claim of 1-2%. Only those who exhibit severe enough symptoms to be tested and/or treated will make it into the statistics of “cases.”
In terms of framing any pandemic, an exaggeration of the lethality of the virus becomes a fundamental issue. If this information by itself is carelessly or dishonestly presented to the public without mention of the many more people likely being infected and exhibiting no symptoms at all, panic can, and clearly has been spread across society and the world, enabling extreme policies to glide through approval, beginning the process of disfigurement society now suffers today.
This was a fact highlighted by the work of Dr. John Ioannidis who, even at the onset of COVID-19, attempted to raise the alarm about needlessly stoking public hysteria, the folly of driving public health policy without proper data, and the catastrophic impact it would have – and is now clearly having – on society if this trend isn’t reversed.
A video interview conducted by Journeyman Pictures from April 2020 noted Dr. Ioannidis’ breakdown of data and the results of his own studies conducted to illustrate exactly this. His study included widespread serological (antibody) testing in Santa Clara County, California to see how many individuals may have been infected by COVID-19 but simply never exhibited symptoms, or symptoms serious enough to seek medical attention and be tested for COVID-19.
Dr. Ioannidis would note:
If you compare the numbers that we estimate to have been infected, which vary from 48,000-81,000, versus the number of documented cases that would correspond to the same time horizon around April 1st, when we had 956 cases documented in Santa Clara County, we realize that the number of infected people is somewhere between 50 and 85 times more compared to what we thought, compared to what had been documented. Immediately, that means that the infection fatality rate, the chance of dying, the probability of dying, if you are infected, diminishes by 50-85 fold, because the denominator in the calculation becomes 50-85 fold bigger. If you take these numbers into account, they suggest that the infection fatality rate for this new coronavirus is likely to be in the same ballpark as seasonal influenza.
Dr. Ioannidis also noted that there was a large gradient regarding death rates based on age and underlying medical conditions, with the risk of death for people under 65 with no underlying medical conditions being virtually negligible.
The need for wider testing to fully establish mature datasets – as Dr. Ioannidis and his team at Stanford illustrated – and efforts to communicate to the public the difference between the infection fatality ratio (IFR) and the case fatality ratio (CFR), have been neglected by Western governments and even more so by the Western corporate media. In some cases, efforts appear to be being made to deliberately obfuscate or confuse this crucial information in order to continue stoking panic and hysteria.
But in addition to this, there is the fact that governments – particularly in the West – have been caught using dubious or disorganized methods to tally COVID-19 deaths – meaning that both IFR and CFR numbers could be easily skewed.
For example, British state-funded media outlet, the BBC in an August 2020 article titled, “Coronavirus: England death count review reduces UK toll by 5,000,” would admit:
A review of how deaths from coronavirus are counted in England has reduced the UK death toll by more than 5,000, to 41,329, the government has announced.
The article also noted that:
The new methodology for counting deaths means the total number of people in the UK who have died from Covid-19 comes down from 46,706 to 41,329 – a reduction of 12%.
The article revealed that Public Health England had “included everyone who had tested positive [for COVID-19], even if they died months afterwards and their death may have had another cause.”
Similar statistical gymnastics are being performed in the US. Even The New York Times raised the issue fairly early on in article, “Is the Coronavirus Death Tally Inflated? Here’s Why Experts Say No,” clearly inferring that there may be a problem with the official methodology, and went on to explain throughout the article how it is impossible to ever know since accurate counts – or even accurate systems to use in counting – may not presently exist in the US.
In other words: the current systems are less than perfect and vulnerable to systemic distortions in the presentation of data. Again, this is a fundamental issue when public health policy is based on the perceived severity of the epidemic.
The Real Impact of COVID-19
Based on what were clearly misused and incomplete statistics, the US, the UK, and much of Western Europe have led the world in stoking unprecedented hysteria, enforcing travel restrictions and lockdowns, including the closing of businesses and schools, and grinding the economies of the world to a halt either directly or indirectly – in a manner similar to but with an impact much greater than the US-led global “War on Terror” starting in 2001.
Pressure from “international organizations” like the World Health Organization (WHO) using its UN-affiliated platform to declare a “global pandemic,” along with Western governments and the corporations that dominate foreign and domestic policy, has created a global crisis – not in terms of human health, but in terms of socioeconomics.
Businesses are closed – not because those who regularly run or patronize them are in hospital beds or dead – but by order of governments, and with official policy backing from organizations like the WHO.
The mainstream media has played a key role in this – not only repeating narratives provided by governments and healthcare institutions uncritically, but refusing to fulfill their role as watchdogs and investigators searching out impropriety.
It is a state of hysteria that is crippling small and medium-sized businesses (SME), but a boon to big-business.
Headlines from papers like the Wall Street Journaladmit, “Big Tech Companies Reap Gains as Covid-19 Fuels Shift in Demand,” or as the Guardian reported, “Amazon third-quarter earnings soar as pandemic sales triple profits,” make it clear that some big-businesses are profiting from the hysteria.
Moreover, the Guardian report, “The mystery of which US businesses are profiting from the coronavirus bailout,” reveals how struggling big-businesses are being bailed out by government money – while the SME sector, the real pulse of any vibrant economy and society – is being left behind.
But there is one industry who stands out above all others to benefit, an industry notorious for its deeply rooted corruption, and an industry that has already been caught using its ties with international organizations like the WHO to declare pandemics, stoke hysteria, and profit handsomely from the resulting chaos.
It’s the West’s pharmaceutical industry.
At no time in human history has it been more powerful and influential than it is now. And at no other time in human history has it been so dangerous.
Big-Pharma: The Least Trustworthy Pandemic Partner
Western Big-Pharma’s profiteering and corruption under ordinary circumstances is already shocking. The current climate of public confusion, panic, and growing socioeconomic desperation only invites the industry’s impropriety to new levels.
Pharmaceutical corporations like Pfizer, Johnson & Johnson, AstraZeneca, and Moderna – having received billions of dollars directly or indirectly from taxpayers to develop COVID-19 vaccines – have long, documented histories of corruption, including bribing regulators, doctors, and governments.
They have also been caught falsifying safety and efficacy data. They have promoted the use of their products for patients in cases not approved of by regulators, including on children.
They have even been caught knowingly selling products they knew were dangerous or even deadly – withholding critical information from both regulators and the public.
Pfizer alone – as its COVID-19 vaccine began rolling out publicly – was under investigation this year, according to its own Security Exchange Commission (SEC) filing, for its Greenstone generics business over antitrust concerns, for manufacturing issues regarding Quillivant XR, regarding quality issues over the manufacturing of auto-injectors, over corruption inquiries regarding its Russian and Chinese operations, and in regards to lawsuits in Mexico over the manufacturing of Zantac and a cancer-causing chemical called N-Nitrosodimethylamine (NDMA) found in the product.
The investigation regarding Zantac finally prompted the US Food and Drug Administration (FDA) – who had originally approved the drug – to request it be pulled from the market after finding it is indeed linked to an increased likelihood of causing cancer.
The Wall Street Journal in a 2020 article titled, “Pfizer Receives Inquiry From SEC Bribery Unit,” would note of Pfizer’s past scandals that:
Pfizer has had past run-ins with U.S. authorities over allegations of bribery among its operations abroad. The company in 2012 agreed to pay $60.2 million to settle investigations by the SEC and the Justice Department into alleged violations of the FCPA in several countries in Europe and Asia, including China and Russia.
The US Department of Justice in its own statement regarding part of the 2012 payout by Pfizer would note:
According to court documents,Pfizer H.C.P. made a broad range of improper payments to numerous government officials in Bulgaria, Croatia, Kazakhstan and Russia – including hospital administrators, members of regulatory and purchasing committees and other health care professionals – and sought to improperly influence government decisions in these countries regarding the approval and registration of Pfizer Inc. products, the award of pharmaceutical tenders and the level of sales of Pfizer Inc. products. According to court documents, Pfizer H.C.P. used numerous mechanisms to improperly influence government officials, including sham consulting contracts, an exclusive distributorship and improper travel and cash payments.
Such bribery might help explain why Pfizer and other pharmaceutical corporations are able to sell dangerous products like cancer-causing Zantac or – in the case of fellow COVID-19 vaccine producer Johnson and Johnson – cancer-causing baby powder – for years before mounting lawsuits and public outrage spur regulators to finally do their job properly.
In Johnson & Johnson’s case, a Reuters investigation would note (emphasis added):
Facing thousands of lawsuits alleging that its talc caused cancer, J&J insists on the safety and purity of its iconic product. But internal documents examined by Reuters show that the company’s powder was sometimes tainted with carcinogenic asbestos and that J&J kept that information from regulators and the public.
What this illustrates is a consistent pattern of corruption stretching across Pfizer’s (and Johnson & Johnson’s) manufacturing process to their business practices and spanning years. It is an entire industry that repeatedly engages in dangerous impropriety, is repeatedly investigated and fined, but allowed to not only continue conducting business – but is still entrusted with matters critical to public healthcare.
The implications it has for the process of developing, approving, producing, and distributing vaccines for COVID-19 should be obvious.
The 2009 H1N1 “Heist”
Despite the immense amount of publicly-known corruption engaged in by the Western pharmaceutical industry and the obviously troubling implications it has for the current COVID-19 vaccine rollout – it is only one dimension of a much wider problem.
There is also the Western pharmaceutical industry’s known history of creating public scares to attract massive government contracts and wield power and influence over public discourse regarding human healthcare issues.
The same large corporate media outlets today helping fuel public hysteria regarding COVID-19 and promoting big-pharma’s vaccine rollout had previously reported on past instances of big-pharma crying “pandemic,” using its influence over international organizations like the WHO, and securing massive government contracts worth billions of dollars for unnecessary and ineffective medication and vaccines.
Think back to 2009 and the H1N1 “Swine Flu” scare. Following the WHO’s dramatic declaration of a “global pandemic,” the headlines and articles from the mainstream Western media read almost identical to those being circulated today regarding COVID-19.
Seven months into the flu pandemic of 2009, North America leads the world in cases, the WHO says.
Unlike elsewhere, the new H1N1 never exited stage left after its debut appearance in late April. In fact, it’s making more noise than ever. Mexico has experienced more cases of pandemic flu since September than it did over the first four months of the pandemic this spring.
The ratcheting up of hysteria continued both from the WHO and across the Western media, accompanied by drives to fund vaccine development and stockpile medication like Roche’s Tamiflu.
The UK Daily Mail in a 2009 article titled, “Tamiflu: What you MUST know as swine flu threatens to strike,” would claim:
The Government has announced that stocks of drugs – known as antivirals – to fight the imminent threat of a swine flu pandemic are being built up to cover more than 50million people – or 80 per cent of the country’s population.
But as hysteria faded, the truth emerged. Articles began to appear like this one from Reuters in 2014 titled, “Stockpiles of Roche Tamiflu drug are waste of money, review finds,” which noted:
Researchers who have fought for years to get full data on Roche’s flu medicine Tamiflu said on Thursday that governments who stockpile it are wasting billions of dollars on a drug whose effectiveness is in doubt.
The article also pointed out:
Tamiflu sales hit almost $3 billion in 2009 – mostly due to its use in the H1N1 flu pandemic – but they have since declined.
There were also Roche’s financial ties to WHO experts who designated the appearance of H1N1 as a “pandemic,” helping pave the way for the public hysteria required to fuel Roche’s profits from selling what was essentially a useless drug to government stockpiles.
The BBC in their 2010 article, “WHO swine flu experts ‘linked’ with drug companies,” would report:
Key scientists behind World Health Organization advice on stockpiling of pandemic flu drugs had financial ties with companies which stood to profit, an investigation has found.
Roche was mentioned by name by the BBC (emphasis added):
The advice prompted many countries around the world into buying up large stocks of Tamiflu, made by Roche, and Relenza manufactured by GlaxoSmithKline.
Despite these revelations post-H1N1 after 2009, the very same actors have taken the stage for a repeat performance in 2020 – with little to no alarm from the same media organizations who ignored the H1N1 “heist” in 2009 and reluctantly reported on it only long after the damage was done.
Big-Pharma’s Pandemic Industrial Complex
Over the past ten years – big pharma’s control over the WHO and its influence over both the media and Western governments has only grown.
Powerful organizations like the Wellcome Trust – which claims to be an “independent foundation” funded through an investment portfolio – counts several large pharmaceutical corporations – Novartis, Roche, Johnson & Johnson, and Abbott Labs – on their list of “significant directly held public equity holdings.”
Its governance includes representatives from the pharmaceutical industry, various Western governments, academia, the media, and of course the WHO itself.
It is an institutionalization of the conflicting interests that have tolerated, accommodated, even helped expand the unwarranted power, wealth, influence, and corruption of big pharma.
And while Wellcome Trust claims to be “independent” of corporate and government ties, alongside the Bill and Melinda Gates Foundation – it has helped create another front organization called The Coalition for Epidemic Preparedness Innovations (CEPI) – through which it accepts and disperses huge amounts of Western taxpayers’ money.
The work of CEPI directly impacts the business prospects of many of the corporations Wellcome Trust owns stocks in – with its investments paying off above average amid this most recent round of public hysteria and government spending on this latest declared pandemic.
International Publishers Limited in an article titled, “Wellcome Trust ‘prospers’ under COVID-19 fallout with 12.3% return,” would report:
Wellcome Trust’s portfolio has not just survived, but prospered, in the highly volatile environment following the COVID-19 outbreak, according to Eliza Manningham-Buller, the charity’s chair, introducing its annual report which unveiled a 12.3% return for the year to 30 September 2020, up on the 6.9% of the previous year.
The trust, which supports medical research worldwide, is the UK’s largest charity, with a £29.1bn (€31.9bn) portfolio at end-September 2020. Wellcome’s investments have returned an average 12.1% a year over the past decade.
It’s worth noting that back in March, both Wellcome and the Bill & Melinda Gates Foundation provided $125 million in “seed funding” to accelerate certain pharmaceutical products claiming to treat COVID-19, including Gilead Science’s antiviral Remdesivir. Despite failing repeatedly in clinical trials, and after the National Institute of Health (NIH) was exposed attempting to rewrite the rules in their attempt to salvage the drug’s reputation as a viable therapeutic for COVID-19 – Remdesivir was continually hyped in the media by Bill Gates and NIH Director Anthony Fauci, and is still defended by the WHO to this day.
It’s also important to note that as of 2020, the number one funder of the World Health Organization is the Bill and Melinda Gates Foundation, who supplied the WHO with approximately $531 million in its 2018-19 biennial budget, roughly 12% of WHO’s total budget.
Unlike the H1N1 scare and multiple scandals that emerged out from behind the smokescreen of public hysteria deliberately created around it, the COVID-19 crisis has been sustained for now nearly a year with enduring regiments being put in place to condition and control the public – and to control the flow of information through traditional channels as well as online and particularly across US-based social media platforms, and direct public funding into the coffers of the healthcare and pharmaceutical industry.
At the same time, other major industries are either being spared the same regulations and restrictions strangling smaller businesses out of existence, or being bailed out by public funding.
It has gone from the “H1N1 Heist” of 2009 to what appears to be a “Pandemic Industrial Complex” taking shape today.
How far this goes in shaping – or more accurately – disfiguring society, is up to those people who can clearly see public and private sectors conspiring together and consisting of the least reliable partners for actually taking on a real pandemic and protecting the public from it – if that is truly what we are facing.
On one hand, even if we believe the statistics and claims being made on a daily basis by the mainstream media and government representatives, we can see for ourselves the corporations elected by the government to create the solutions claimed are needed to end the crisis, are guilty of serial abuses including the production and distribution of entirely unsafe products – products developed and “approved” of by government regulators under normal conditions that would go on to making people ill or even killing them.
But the COVID-19 vaccines being rolled out now aren’t even going through that process. They have instead been rushed through approval and unpredictable results and adverse effects are already emerging.
It hearkens back to another chapter involving a novel virus – 1976’s Swine Flu – where vaccines were rushed into production and resulted in mounting adverse effects, particularly paralyzing Guillain-Barré syndrome in over 400 individuals. And these were only the cases that were reported, as the true total of those who suffered varying degrees of complications will never be fully known.
In 1976, the vaccination program was abandoned and the government’s response deemed a failure of historic proportions. But apparently the lessons learned then, or in 2009, have been lost entirely today – and in some cases – deliberately buried by a complicit media.
If COVID-19 is the crisis we are told it is – why isn’t there a greater demand for more trustworthy and transparent partners to work with to face it? These would be partners capable of acknowledging past mistakes and explaining how their plan today differs from those in the past.
But, unfortunately, history has already taught us that pandemics can be declared – not because they actually exist and/or pose as grave a threat as government, media and corporate stakeholders claim – but because profits are to be made by big pharma, in connection with those in organizations like the WHO who have the unique power to declare pandemics, and perpetuate them regardless of the truth.
We watched for two decades as the West orchestrated an entirely false “War on Terror” around the globe, justifying actions as extreme as invasions, wars, and illegal occupations of other countries and the expenditure of trillions of dollars of taxpayers’ money.
Is it really that hard to imagine as possible, this formula being reworked atop the 2009 H1N1 scandals and pushed forward aggressively?
Chronic stress and inflammation linked to societal and environmental impacts in new study
From anxiety about the state of the world to ongoing waves of Covid-19, the stresses we face can seem relentless and even overwhelming. Worse, these stressors…
From anxiety about the state of the world to ongoing waves of Covid-19, the stresses we face can seem relentless and even overwhelming. Worse, these stressors can cause chronic inflammation in our bodies. Chronic inflammation is linked to serious conditions such as cardiovascular disease and cancer – and may also affect our thinking and behavior.
Credit: Image: Vodovotz et al/Frontiers
From anxiety about the state of the world to ongoing waves of Covid-19, the stresses we face can seem relentless and even overwhelming. Worse, these stressors can cause chronic inflammation in our bodies. Chronic inflammation is linked to serious conditions such as cardiovascular disease and cancer – and may also affect our thinking and behavior.
A new hypothesis published in Frontiers in Science suggests the negative impacts may extend far further.
“We propose that stress, inflammation, and consequently impaired cognition in individuals can scale up to communities and populations,” explained lead author Prof Yoram Vodovotz of the University of Pittsburgh, USA.
“This could affect the decision-making and behavior of entire societies, impair our cognitive ability to address complex issues like climate change, social unrest, and infectious disease – and ultimately lead to a self-sustaining cycle of societal dysfunction and environmental degradation,” he added.
Bodily inflammation ‘mapped’ in the brain
One central premise to the hypothesis is an association between chronic inflammation and cognitive dysfunction.
“The cause of this well-known phenomenon is not currently known,” said Vodovotz. “We propose a mechanism, which we call the ‘central inflammation map’.”
The authors’ novel idea is that the brain creates its own copy of bodily inflammation. Normally, this inflammation map allows the brain to manage the inflammatory response and promote healing.
When inflammation is high or chronic, however, the response goes awry and can damage healthy tissues and organs. The authors suggest the inflammation map could similarly harm the brain and impair cognition, emotion, and behavior.
Accelerated spread of stress and inflammation online
A second premise is the spread of chronic inflammation from individuals to populations.
“While inflammation is not contagious per se, it could still spread via the transmission of stress among people,” explained Vodovotz.
The authors further suggest that stress is being transmitted faster than ever before, through social media and other digital communications.
“People are constantly bombarded with high levels of distressing information, be it the news, negative online comments, or a feeling of inadequacy when viewing social media feeds,” said Vodovotz. “We hypothesize that this new dimension of human experience, from which it is difficult to escape, is driving stress, chronic inflammation, and cognitive impairment across global societies.”
Inflammation as a driver of social and planetary disruption
These ideas shift our view of inflammation as a biological process restricted to an individual. Instead, the authors see it as a multiscale process linking molecular, cellular, and physiological interactions in each of us to altered decision-making and behavior in populations – and ultimately to large-scale societal and environmental impacts.
“Stress-impaired judgment could explain the chaotic and counter-intuitive responses of large parts of the global population to stressful events such as climate change and the Covid-19 pandemic,” explained Vodovotz.
“An inability to address these and other stressors may propagate a self-fulfilling sense of pervasive danger, causing further stress, inflammation, and impaired cognition in a runaway, positive feedback loop,” he added.
The fact that current levels of global stress have not led to widespread societal disorder could indicate an equally strong stabilizing effect from “controllers” such as trust in laws, science, and multinational organizations like the United Nations.
“However, societal norms and institutions are increasingly being questioned, at times rightly so as relics of a foregone era,” said Prof Paul Verschure of Radboud University, the Netherlands, and a co-author of the article. “The challenge today is how we can ward off a new adversarial era of instability due to global stress caused by a multi-scale combination of geopolitical fragmentation, conflicts, and ecological collapse amplified by existential angst, cognitive overload, and runaway disinformation.”
Reducing social media exposure as part of the solution
The authors developed a mathematical model to test their ideas and explore ways to reduce stress and build resilience.
“Preliminary results highlight the need for interventions at multiple levels and scales,” commented co-author Prof Julia Arciero of Indiana University, USA.
“While anti-inflammatory drugs are sometimes used to treat medical conditions associated with inflammation, we do not believe these are the whole answer for individuals,” said Dr David Katz, co-author and a specialist in preventive and lifestyle medicine based in the US. “Lifestyle changes such as healthy nutrition, exercise, and reducing exposure to stressful online content could also be important.”
“The dawning new era of precision and personalized therapeutics could also offer enormous potential,” he added.
At the societal level, the authors suggest creating calm public spaces and providing education on the norms and institutions that keep our societies stable and functioning.
“While our ‘inflammation map’ hypothesis and corresponding mathematical model are a start, a coordinated and interdisciplinary research effort is needed to define interventions that would improve the lives of individuals and the resilience of communities to stress. We hope our article stimulates scientists around the world to take up this challenge,” Vodovotz concluded.
The article is part of the Frontiers in Science multimedia article hub ‘A multiscale map of inflammatory stress’. The hub features a video, an explainer, a version of the article written for kids, and an editorial, viewpoints, and policy outlook from other eminent experts: Prof David Almeida (Penn State University, USA), Prof Pietro Ghezzi (University of Urbino Carlo Bo, Italy), and Dr Ioannis P Androulakis (Rutgers, The State University of New Jersey, USA).
Journal
Frontiers in Science
DOI
10.3389/1239462
Method of Research
Computational simulation/modeling
Subject of Research
Not applicable
Article Title
A multiscale inflammatory map: linking individual stress to societal dysfunction
Article Publication Date
12-Mar-2024
COI Statement
YV is a cofounder of, and stakeholder in, Immunetrics, Inc. and a consultant to Anuna AI. PFMJV is the founder of, and stakeholder in, Eodyne Systems s.l. and Sapiens5 Holding BV. DLK was employed by Tangelo – Intend, Inc. Neither these companies nor the funders mentioned above were involved in the study design, data collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication. The companies mentioned above also did not provide funding for the study. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors YV and PV declared that they are editorial board members of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.
Acadia’s Nuplazid fails PhIII study due to higher-than-expected placebo effect
After years of trying to expand the market territory for Nuplazid, Acadia Pharmaceuticals might have hit a dead end, with a Phase III fail in schizophrenia…
After years of trying to expand the market territory for Nuplazid, Acadia Pharmaceuticals might have hit a dead end, with a Phase III fail in schizophrenia due to the placebo arm performing better than expected.
Steve Davis
“We will continue to analyze these data with our scientific advisors, but we do not intend to conduct any further clinical trials with pimavanserin,” CEO Steve Davis said in a Monday press release. Acadia’s stock $ACAD dropped by 17.41% before the market opened Tuesday.
Pimavanserin, a serotonin inverse agonist and also a 5-HT2A receptor antagonist, is already in the market with the brand name Nuplazid for Parkinson’s disease psychosis. Efforts to expand into other indications such as Alzheimer’s-related psychosis and major depression have been unsuccessful, and previous trials in schizophrenia have yielded mixed data at best. Its February presentation does not list other pimavanserin studies in progress.
The Phase III ADVANCE-2 trial investigated 34 mg pimavanserin versus placebo in 454 patients who have negative symptoms of schizophrenia. The study used the negative symptom assessment-16 (NSA-16) total score as a primary endpoint and followed participants up to week 26. Study participants have control of positive symptoms due to antipsychotic therapies.
The company said that the change from baseline in this measure for the treatment arm was similar between the Phase II ADVANCE-1 study and ADVANCE-2 at -11.6 and -11.8, respectively. However, the placebo was higher in ADVANCE-2 at -11.1, when this was -8.5 in ADVANCE-1. The p-value in ADVANCE-2 was 0.4825.
In July last year, another Phase III schizophrenia trial — by Sumitomo and Otsuka — also reported negative results due to what the company noted as Covid-19 induced placebo effect.
According to Mizuho Securities analysts, ADVANCE-2 data were disappointing considering the company applied what it learned from ADVANCE-1, such as recruiting patients outside the US to alleviate a high placebo effect. The Phase III recruited participants in Argentina and Europe.
Analysts at Cowen added that the placebo effect has been a “notorious headwind” in US-based trials, which appears to “now extend” to ex-US studies. But they also noted ADVANCE-1 reported a “modest effect” from the drug anyway.
Nonetheless, pimavanserin’s safety profile in the late-stage study “was consistent with previous clinical trials,” with the drug having an adverse event rate of 30.4% versus 40.3% with placebo, the company said. Back in 2018, even with the FDA approval for Parkinson’s psychosis, there was an intense spotlight on Nuplazid’s safety profile.
Acadia previously aimed to get Nuplazid approved for Alzheimer’s-related psychosis but had many hurdles. The drug faced an adcomm in June 2022 that voted 9-3 noting that the drug is unlikely to be effective in this setting, culminating in a CRL a few months later.
As for the company’s next R&D milestones, Mizuho analysts said it won’t be anytime soon: There is the Phase III study for ACP-101 in Prader-Willi syndrome with data expected late next year and a Phase II trial for ACP-204 in Alzheimer’s disease psychosis with results anticipated in 2026.
Acadia collected $549.2 million in full-year 2023 revenues for Nuplazid, with $143.9 million in the fourth quarter.
"Beware the Ides of March,” Shakespeare quotes the soothsayer’s warning Julius Caesar about what turned out to be an impending assassination on March 15. The death of American liberty happened around the same time four years ago, when the orders went out from all levels of government to close all indoor and outdoor venues where people gather.
It was not quite a law and it was never voted on by anyone. Seemingly out of nowhere, people who the public had largely ignored, the public health bureaucrats, all united to tell the executives in charge – mayors, governors, and the president – that the only way to deal with a respiratory virus was to scrap freedom and the Bill of Rights.
And they did, not only in the US but all over the world.
The forced closures in the US began on March 6 when the mayor of Austin, Texas, announced the shutdown of the technology and arts festival South by Southwest. Hundreds of thousands of contracts, of attendees and vendors, were instantly scrapped. The mayor said he was acting on the advice of his health experts and they in turn pointed to the CDC, which in turn pointed to the World Health Organization, which in turn pointed to member states and so on.
There was no record of Covid in Austin, Texas, that day but they were sure they were doing their part to stop the spread. It was the first deployment of the “Zero Covid” strategy that became, for a time, official US policy, just as in China.
It was never clear precisely who to blame or who would take responsibility, legal or otherwise.
This Friday evening press conference in Austin was just the beginning. By the next Thursday evening, the lockdown mania reached a full crescendo. Donald Trump went on nationwide television to announce that everything was under control but that he was stopping all travel in and out of US borders, from Europe, the UK, Australia, and New Zealand. American citizens would need to return by Monday or be stuck.
Americans abroad panicked while spending on tickets home and crowded into international airports with waits up to 8 hours standing shoulder to shoulder. It was the first clear sign: there would be no consistency in the deployment of these edicts.
There is no historical record of any American president ever issuing global travel restrictions like this without a declaration of war. Until then, and since the age of travel began, every American had taken it for granted that he could buy a ticket and board a plane. That was no longer possible. Very quickly it became even difficult to travel state to state, as most states eventually implemented a two-week quarantine rule.
The next day, Friday March 13, Broadway closed and New York City began to empty out as any residents who could went to summer homes or out of state.
On that day, the Trump administration declared the national emergency by invoking the Stafford Act which triggers new powers and resources to the Federal Emergency Management Administration.
In addition, the Department of Health and Human Services issued a classified document, only to be released to the public months later. The document initiated the lockdowns. It still does not exist on any government website.
The White House Coronavirus Response Task Force, led by the Vice President, will coordinate a whole-of-government approach, including governors, state and local officials, and members of Congress, to develop the best options for the safety, well-being, and health of the American people. HHS is the LFA [Lead Federal Agency] for coordinating the federal response to COVID-19.
Closures were guaranteed:
Recommend significantly limiting public gatherings and cancellation of almost all sporting events, performances, and public and private meetings that cannot be convened by phone. Consider school closures. Issue widespread ‘stay at home’ directives for public and private organizations, with nearly 100% telework for some, although critical public services and infrastructure may need to retain skeleton crews. Law enforcement could shift to focus more on crime prevention, as routine monitoring of storefronts could be important.
In this vision of turnkey totalitarian control of society, the vaccine was pre-approved: “Partner with pharmaceutical industry to produce anti-virals and vaccine.”
The National Security Council was put in charge of policy making. The CDC was just the marketing operation. That’s why it felt like martial law. Without using those words, that’s what was being declared. It even urged information management, with censorship strongly implied.
The timing here is fascinating. This document came out on a Friday. But according to every autobiographical account – from Mike Pence and Scott Gottlieb to Deborah Birx and Jared Kushner – the gathered team did not meet with Trump himself until the weekend of the 14th and 15th, Saturday and Sunday.
According to their account, this was his first real encounter with the urge that he lock down the whole country. He reluctantly agreed to 15 days to flatten the curve. He announced this on Monday the 16th with the famous line: “All public and private venues where people gather should be closed.”
This makes no sense. The decision had already been made and all enabling documents were already in circulation.
There are only two possibilities.
One: the Department of Homeland Security issued this March 13 HHS document without Trump’s knowledge or authority. That seems unlikely.
Two: Kushner, Birx, Pence, and Gottlieb are lying. They decided on a story and they are sticking to it.
Trump himself has never explained the timeline or precisely when he decided to greenlight the lockdowns. To this day, he avoids the issue beyond his constant claim that he doesn’t get enough credit for his handling of the pandemic.
With Nixon, the famous question was always what did he know and when did he know it? When it comes to Trump and insofar as concerns Covid lockdowns – unlike the fake allegations of collusion with Russia – we have no investigations. To this day, no one in the corporate media seems even slightly interested in why, how, or when human rights got abolished by bureaucratic edict.
As part of the lockdowns, the Cybersecurity and Infrastructure Security Agency, which was and is part of the Department of Homeland Security, as set up in 2018, broke the entire American labor force into essential and nonessential.
They also set up and enforced censorship protocols, which is why it seemed like so few objected. In addition, CISA was tasked with overseeing mail-in ballots.
Only 8 days into the 15, Trump announced that he wanted to open the country by Easter, which was on April 12. His announcement on March 24 was treated as outrageous and irresponsible by the national press but keep in mind: Easter would already take us beyond the initial two-week lockdown. What seemed to be an opening was an extension of closing.
This announcement by Trump encouraged Birx and Fauci to ask for an additional 30 days of lockdown, which Trump granted. Even on April 23, Trump told Georgia and Florida, which had made noises about reopening, that “It’s too soon.” He publicly fought with the governor of Georgia, who was first to open his state.
Before the 15 days was over, Congress passed and the president signed the 880-page CARES Act, which authorized the distribution of $2 trillion to states, businesses, and individuals, thus guaranteeing that lockdowns would continue for the duration.
There was never a stated exit plan beyond Birx’s public statements that she wanted zero cases of Covid in the country. That was never going to happen. It is very likely that the virus had already been circulating in the US and Canada from October 2019. A famous seroprevalence study by Jay Bhattacharya came out in May 2020 discerning that infections and immunity were already widespread in the California county they examined.
What that implied was two crucial points: there was zero hope for the Zero Covid mission and this pandemic would end as they all did, through endemicity via exposure, not from a vaccine as such. That was certainly not the message that was being broadcast from Washington. The growing sense at the time was that we all had to sit tight and just wait for the inoculation on which pharmaceutical companies were working.
By summer 2020, you recall what happened. A restless generation of kids fed up with this stay-at-home nonsense seized on the opportunity to protest racial injustice in the killing of George Floyd. Public health officials approved of these gatherings – unlike protests against lockdowns – on grounds that racism was a virus even more serious than Covid. Some of these protests got out of hand and became violent and destructive.
Meanwhile, substance abuse rage – the liquor and weed stores never closed – and immune systems were being degraded by lack of normal exposure, exactly as the Bakersfield doctors had predicted. Millions of small businesses had closed. The learning losses from school closures were mounting, as it turned out that Zoom school was near worthless.
It was about this time that Trump seemed to figure out – thanks to the wise council of Dr. Scott Atlas – that he had been played and started urging states to reopen. But it was strange: he seemed to be less in the position of being a president in charge and more of a public pundit, Tweeting out his wishes until his account was banned. He was unable to put the worms back in the can that he had approved opening.
By that time, and by all accounts, Trump was convinced that the whole effort was a mistake, that he had been trolled into wrecking the country he promised to make great. It was too late. Mail-in ballots had been widely approved, the country was in shambles, the media and public health bureaucrats were ruling the airwaves, and his final months of the campaign failed even to come to grips with the reality on the ground.
At the time, many people had predicted that once Biden took office and the vaccine was released, Covid would be declared to have been beaten. But that didn’t happen and mainly for one reason: resistance to the vaccine was more intense than anyone had predicted. The Biden administration attempted to impose mandates on the entire US workforce. Thanks to a Supreme Court ruling, that effort was thwarted but not before HR departments around the country had already implemented them.
As the months rolled on – and four major cities closed all public accommodations to the unvaccinated, who were being demonized for prolonging the pandemic – it became clear that the vaccine could not and would not stop infection or transmission, which means that this shot could not be classified as a public health benefit. Even as a private benefit, the evidence was mixed. Any protection it provided was short-lived and reports of vaccine injury began to mount. Even now, we cannot gain full clarity on the scale of the problem because essential data and documentation remains classified.
After four years, we find ourselves in a strange position. We still do not know precisely what unfolded in mid-March 2020: who made what decisions, when, and why. There has been no serious attempt at any high level to provide a clear accounting much less assign blame.
Not even Tucker Carlson, who reportedly played a crucial role in getting Trump to panic over the virus, will tell us the source of his own information or what his source told him. There have been a series of valuable hearings in the House and Senate but they have received little to no press attention, and none have focus on the lockdown orders themselves.
The prevailing attitude in public life is just to forget the whole thing. And yet we live now in a country very different from the one we inhabited five years ago. Our media is captured. Social media is widely censored in violation of the First Amendment, a problem being taken up by the Supreme Court this month with no certainty of the outcome. The administrative state that seized control has not given up power. Crime has been normalized. Art and music institutions are on the rocks. Public trust in all official institutions is at rock bottom. We don’t even know if we can trust the elections anymore.
In the early days of lockdown, Henry Kissinger warned that if the mitigation plan does not go well, the world will find itself set “on fire.” He died in 2023. Meanwhile, the world is indeed on fire. The essential struggle in every country on earth today concerns the battle between the authority and power of permanent administration apparatus of the state – the very one that took total control in lockdowns – and the enlightenment ideal of a government that is responsible to the will of the people and the moral demand for freedom and rights.
How this struggle turns out is the essential story of our times.
CODA: I’m embedding a copy of PanCAP Adapted, as annotated by Debbie Lerman. You might need to download the whole thing to see the annotations. If you can help with research, please do.
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