Bulletin N° 1010

 

“The Last Mission”

 [of Dag Hammarskjold]

https://www.youtube.com/watch?v=_M8iBVk71Zk

(1:14:58)

This 1976 documentary, directed by Tristram Powell is a powerful portrayal of moral idealism gone off the rails, with references to Conor Cruise O'Brien’s play, “Murderous Angels.” It depicts the spiritual aspects of the post genocide policies in the Congo, after Belgium troops were forced to leave and western diplomacy took over.

Dag Hammarskjöld, born July 29, 1905, Jönköping, Sweden—died September 18, 1961, near Ndola, Northern Rhodesia [now Zambia]), Swedish economist and statesman who, as the second secretary-general (1953–61) of the United Nations (UN), enhanced the prestige and effectiveness of that organization. He was posthumously awarded the Nobel Prize for Peace in 1961.


 

 

Subject: Post-Humanist cynics fulfilling our destiny: Dr. Fauci and Mother Teresa standing guard by the toilet flush, watching the inevitable occur at the leaking sewer pipes. (FACT CHECK: USA TODAY)

 

Grenoble, November 21, 2021

 

Dear Colleagues and Friends of CEIMSA,

 

As participants in this correspondence community at the CEIMSA research center, you are familiar with the principle objectives we have pursued over the past many years, namely to provide students and colleagues with information about currents events which is circulating in the Anglophone world. As I am a social historian by training, with a Ph.D. from the University of Wisconsin, I have presented in these bulletins many books written by historians who in my opinion have made significant contributions to our understanding of history and our contemporary society. I have no interest in dictating the TRUTH to others, as I have become convinced over the years that truth is a pursuit, and not a destination, and without a wide range of information and points of view there is no possibility of making progress in this endeavor. In the absence of this pursuit, we risk being paralyzed by the injunctions of Dictators –either the so-called “left” or “right” – who historically have easily morphed into Executioners.

It should be abundantly clear that I make no claims to any expertise in the fields of natural science and medicine. The views presented in the articles and essays I have shared in CEIMSA bulletins represent information and discussions that I think must be evaluated openly and publically by all parties concerned. It is precisely through public discussions (the anathema to censorship) that the pursuit of truth is accomplished, and that charlatans and criminals are exposed. The wisdom gained from unimpeded public discussion is reflected in Alfred North Whitehead’s book, Modes of Thought (1958), where he writes: “Thus beyond all questions of quantity, there lie questions of pattern, which are essential for the understanding of nature. Apart from a presupposed pattern, quantity determines nothing.” Commenting on this statement, Barrington Moore Jr. observed, “Whitehead’s reservations about the procedures of the natural sciences and mathematics are to be taken very seriously because, unlike many other critics, he knew thoroughly what he was talking about.”(Dictatorship & Democracy, p.521)

 

It goes almost without saying that any medical advice should be sought from qualified medical experts whom you trust to be well-informed and sincerely concerned with your well being. At best some of the information provided in these selected articles and essays have the heuristic value of raising questions that might be of assistance in private consultations with family physicians to arrive at an authentic experience of “informed consent”.

 

On the other hand, the professional ethics of the historian present their own demands, which are discussed in the conclusion of Barrington Moore, Jr.’s 1966 book, Social Origins of Dictatorship and Democracy: Lord and Peasant in the Making of the Modern World.

     There is a respectable intellectual tradition which denies that objectivity is possible at all, even in principle. This denial seems to rest on confusion between the causes of historical events and their consequences or meaning. The causes of the American Civil War had run their course by the time the first shot was fired at Fort Sumter. No historian’s opinion about these causes can have the remotest effect on what they actually were. The consequences are another matter. They are with us today and may be with us as long as human history continues. This second aspect of the thesis about the permanent ambiguity of history seems to be perfectly valid. Statements by historians about the causes of the Civil War have polemical results now, no matter what their authors intend. It is in this sense that impartiality is an impossibility and an illusion. Whether he knows it or not, to continue the argument the historian has to adopt some principle in selecting and ordering his facts. The same is true for the sociologist studying contemporary affairs. By virtue of what they include and exclude, highlight or deemphasize, these principles have political and moral consequences. Hence they are unavoidably moral principles. It is impossible to opt out of the struggle. The very act of trying to opt out, of trying to take a nonpartisan position, means taking up a form of apolitical pseudo-objectivity that in effect supports the status quo.

     The thesis that neutrality is impossible is a powerful one, convincing at any rate to me. But I do not think that it leads to a denial that objective social and historical analysis is possible. Different perspectives on the same set of events should lead to complementary and congruent interpretations, not to contradictory ones. Furthermore the denial that objective truth is possible in principle flings open the door to the worst forms of intellectual dishonesty. A crude version goes something like this: since neutrality is impossible I will take my stand with the underdog and write history to serve the underdog, helping in this way to reach a ‘higher Truth.’ In plain language that is just cheating No matter what his unavoidable moral premises and predilections, any student of human affairs is bound sooner or later to come across evidence that is profoundly disturbing. Then he has the task of coming to terms with it honestly.

    Gradations of Truth with a capital T, rightly in my estimation, arouse angry suspicion. But this does not mean that objectivity and truth with a small t lead to comfortable complacency. Objectivity is not the same thing as conventional judiciousness. A celebration of the virtues of our own society which leaves out its ugly and cruel features, which fails to face the question of a connection between its attractive and its cruel ones, remains an apologia even if it is spoken in the most measured academic tones. There is a strong tendency to assume that mild-mannered statements in favor of the status quo are ‘objective’ and that anything else is a form of ‘rhetoric.’

     This type of bias, this misinterpretation of objectivity, is the one most common in the West today. It confuses objectivity with triviality and meaninglessness. For reasons already mentioned, any simple straightforward truth about political institutions or events is bound to have polemical consequences. It will damage some group interests. In any society the dominant groups are the ones with the most to hide about the way society works. Very often therefore truthful analyses are bound to have a critical ring, to seem like exposures rather than objective statements, as the term is conventionally used. (This will be true in communist counties too if they ever get to the point of allowing moderately candid accounts of their own past to see the light.) For all students of human society, sympathy with the victims of historical processes and skepticism about the victors’ claims provide essential safeguards against being taken in by the dominant mythology. A scholar who tries to be objective needs these feelings as part of his ordinary working equipment.(pp.521-523)

 

These warning from the past server as a contradistinction to our actual intellectual state of mind in the creeping totalitarianism we are witnessing today, where shameless collaboration is the new normal, and existential fear is the staple diet for the mass manufactured cowards who cling relentlessly to the hem of the Grand Inquisitor’s gown in a desperate search for security.

 

The 26 + items below are offered to CEIMSA readers as points for discussion and meditation in these troubled times. My advice is that you find friends that you trust and that you talk to them (with your Smartphone in the ice box).

 

 

Sincerely,

Francis McCollum Feeley

--

Professeur honoraire de l'Université Grenoble-Alpes
Ancien Directeur des Researches
Université de Paris-Nanterre
Director of The Center for the Advanced Study
of American Institutions and Social Movements
(CEIMSA-in-Exile)
The University of California-San Diego
http://www.ceimsa.org

 

a.

“Gaze Into the Orb to Collect Your Worldcoin”

https://www.corbettreport.com/nwnw20211118/

with James Corbett and James Even Pilato

(29:02)

+

Revealed: Documents Show Bill Gates Has Given $319 Million to

 

Media Outlets

 

https://www.globalresearch.ca/revealed-documents-show-bill-gates-given-319-million-media-outlets/5761976

by Alan MacLeod

+

Bill Gates Caught Buying Positive News Coverage

https://www.youtube.com/watch?v=GcCQVkpWMcE

with Jimmy Dore and Max Blumenthal

(1:00:59)

+

Vaccinated English adults under 60 are dying at twice the rate of unvaccinated people the same age and have been for six months

 

https://alexberenson.substack.com/p/vaccinated-english-adults-under-60?r=7x92e&utm_campaign=post&utm_medium=web&utm_source=copy

by Alex Berenson

 

This chart may seem unbelievable or impossible, but it's correct, based on weekly data from the British government.

+

 

Denis Rancourt Interview - How A Deep Dive Analysis Of COVID Data

 

Reveals A Pandemic Did Not Occur

https://www.thelastamericanvagabond.com/denis-rancourt-interview-how-deep-dive-analysis-covid-data-reveals-pandemic-did-not-occur/

with Ryan Cristián and Denis Rancourt

(1:36:57)

+

‘Fauci's Greatest Covid Failures’ Exposed

https://youtu.be/Vd3e0Vq3iis

with Jimmy Dore

(20:20)

+

Rand Paul Warns ‘Authoritarian’

 

Fauci's ‘Casual Disdain’ For Rights Is ‘Recipe For

 

Totalitarianism’

https://www.zerohedge.com/political/watch-rand-paul-warns-authoritarian-faucis-casual-disdain-rights-recipe-totalitarianism

by Steve Watson via Summit News,

 

Appearing on Fox News Wednesday, Senator Rand Paul continued his long running exposition of Anthony Fauci, warning viewers that Fauci’s latest comments provide yet anoher example of how brazenly “authoritarian” he is.

+

Interview 1675 - The REAL Anthony Fauci with Robert F. Kennedy, Jr.

https://www.corbettreport.com/fauci/?utm_source=feedburner&utm_medium=email

with James Corbett and Robert Kennedy

(1:03:12)

+

The Covid Outbreak: ‘Biggest Health Scam of the 21st Century’

 

Report by 1500 Health Professionals

https://www.globalresearch.ca/the-covid-outbreak-biggest-health-scam-of-the-21st-century-report-by-1500-health-professionals/5737838

by United Health Professionals

 

===========

 

b.

If You Take the COVID Vax, You Can Never Achieve Full Immunity Again

 

– Government Stats Unveil the Horrifying Truth

https://www.globalresearch.ca/covid-vax-you-can-never-achieve-full-immunity-again-government-stats-unveil-horrifying-truth/5759472

by Ethan Huff

+

Everyone Missed this One... Vaccinated People Are Up to Nine Times (9X)

 

More Likely to be Hospitalized than Unvaccinated People

https://www.globalresearch.ca/vaccinated-people-up-9x-more-likely-hospitalized-than-unvaccinated-people/5761930

by Steve Kirsch

+

Trends in Mortality and Morbidity in the Most Vaccinated Countries :

 

Twenty-one Proven Facts

 

https://www.globalresearch.ca/trends-in-mortality-and-morbidity-in-the-most-vaccinated-countries-twenty-one-proven-facts/5761773

by Gérard Delépine

+

FDA report finds all-cause mortality higher among vaccinated

https://www.israelnationalnews.com/News/News.aspx/317091

by David Rosenberg

+

Worldwide Search Trend for "Died Suddenly" Spikes to Record Highs

https://www.globalresearch.ca/worldwide-search-trend-died-suddenly-spikes-record-highs/5762053

by Zero Hedge

+

Vaccine Damage Payouts In UK Could Soar Next Year

https://www.zerohedge.com/covid-19/vaccine-damage-payouts-uk-could-soar-next-year

by Owen Evans via The Epoch Times,

 

The number of claims for the UK’s vaccine injury scheme is expected to be 18 times higher next year, according to a government-backed health body.

 

===========

 

c.

Derrick Broze Interview - The Great Narrative And The Metaverse: Your

 

Coming Dystopian Future

 

https://www.thelastamericanvagabond.com/derrick-broze-interview-great-narrative-metaverse-your-coming-dystopian-future/

with Ryan Cristián

(51:55)

+

This Week's Most Popular Articles

https://www.globalresearch.ca/this-weeks-most-popular-articles-49/5762116  

+

America’s Largest Teachers’ Unions Push Vaccine Mandates That Will

 

Usher in Technocratic Digital ID

https://unlimitedhangout.com/2021/11/investigative-reports/americas-largest-teachers-unions-push-vaccine-mandates-that-will-usher-in-technocratic-digital-id/

by John Klyczek

+

California City Designates Itself ‘Sanctuary City’

 

Against COVID Mandates

 

https://www.globalresearch.ca/california-city-designates-itself-sanctuary-city-against-covid-mandates/5762038

by Leslie Eastman

+

OSHA Suspends Biden’s Employer Vaccine Mandates

 

Following Court Order

 

https://www.globalresearch.ca/osha-suspends-biden-employer-vaccine-mandates-following-court-order/5762043

by 21st Century Wire

+

Homicide Rates In 2020 Surged To 24-Year High...

 

Another Sign Of A Failing Regime

https://www.zerohedge.com/political/homicide-rates-2020-surged-24-year-high-another-sign-failing-regime

by Ryan McMaken via The Mises Institute

+

‘These Are Numbers We Have Never Seen Before’:

 

Drug Overdose Deaths Hit Record High During Pandemic

 

https://www.zerohedge.com/medical/these-are-numbers-we-have-never-seen-drug-overdose-deaths-hit-record-high-during-pandemic

by Tyler Durden

 

As the pandemic swept across the country, a record number of Americans died of drug overdoses in the 12-month period ending in April 2021, according to preliminary data released by the Centers for Disease Control and Prevention (CDC). The more than 100,000 overdose deaths is nearly 30% higher than the 78,000 counted the year before - with much of the blame landing on the availability and potency of synthetic opioids such as Fentanyl - which is up to 50x more potent than heroin, according to Statista, which notes that the CDC has reported more than 60% of overdose deaths last year involved synthetic opioids

+

US drug overdose deaths top 100,000 in one year in 28.5% increase

https://www.aljazeera.com/news/2021/11/17/us-drug-overdose-deaths-top-100000-in-one-year

by Aljazeera

 

===========

 

d.

The Road To Fascism:

 

Paved With Vaccine Mandates And Corporate Collusion

https://www.zerohedge.com/political/road-fascism-paved-vaccine-mandates-and-corporate-collusion

by John W. Whitehead & Nisha Whitehead via The Rutherford Institute

+

Vaccine Injury Attorney Suing the FDA: FDA Asks Federal Judge to

 

Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19

 

Vaccine Data

https://www.globalresearch.ca/vaccine-injury-attorney-suing-fda-fda-asks-federal-judge-grant-until-year-2076-fully-release-pfizer-covid-19-vaccine-data/5762011

by Brian Shilhavy

+

FDA Wants Until 2076 To Fully Release Pfizer Vaccine Data: Lawsuit

 

https://www.zerohedge.com/covid-19/fda-wants-until-2076-fully-release-pfizer-vaccine-data-lawsuitby

by Attorney Aaron Siri via Injecting Freedom

+

More People Died in the Key Clinical Trial for Pfizer's COVID

 

Vaccine

 

than the Company Publicly Reported

https://www.globalresearch.ca/more-people-died-key-clinical-trial-pfizer-covid-vaccine-company-publicly-reported/5761917

by Alex Berenson

+

FDA asks for 55 years to release data on Pfizer's COVID vaccine

 

https://www.israelnationalnews.com/News/News.aspx/317161

by Y Rabinovitz

 

+

COVID-19: Moderna Gets Its Miracle

https://unlimitedhangout.com/2021/10/investigative-reports/covid-19-moderna-gets-its-miracle/

analysis by Whitney Webb

(1:23:45)

 

Story at-a-glance

 

COVID-19 erased the regulatory and trial-related hurdles that Moderna could never surmount before. Yet, how did Moderna know that COVID-19 would create those conditions months before anyone else, and why did they later claim that their vaccine being tested in NIH trials was different than their commercial candidate?

In late 2019, the biopharmaceutical company Moderna was facing a series of challenges that not only threatened its ability to ever take a product to market, and thus turn a profit, but its very existence as a company.

There were multiple warning signs that Moderna was essentially another Theranos-style fraud, with many of these signs growing in frequency and severity as the decade drew to a close. Part I of this three-part series explored the disastrous circumstances in which Moderna found itself at that time, with the company's salvation hinging on the hope of a divine miracle, a "Hail Mary" save of sorts, as stated by one former Moderna employee.

While the COVID-19 crisis that emerged in the first part of 2020 can hardly be described as an act of benevolent divine intervention for most, it certainly can be seen that way from Moderna's perspective. Key issues for the company, including seemingly insurmountable regulatory hurdles and its inability to advance beyond animal trials with its most promising — and profitable — products, were conveniently wiped away, and not a moment too soon.

Since January 2020, the value of Moderna's stock — which had embarked on a steady decline since its IPO — grew from $18.89 per share to its current value of $339.57 per share, thanks to the success of its COVID-19 vaccine.

Yet, how exactly was Moderna's "Hail Mary" moment realized, and what were the forces and events that ensured it would make it through the FDA's emergency use authorization (EUA) process? In examining that question, it becomes quickly apparent that Moderna's journey of saving grace involved much more than just cutting corners in animal and human trials and federal regulations.

Indeed, if we are to believe Moderna executives, it involved supplying formulations for some trial studies that were not the same as their COVID-19 vaccine commercial candidate, despite the data resulting from the former being used to sell Moderna's vaccine to the public and federal health authorities.

Such data was also selectively released at times to align with preplanned stock trades by Moderna executives, turning many of Moderna's highest-ranking employees into millionaires, and even billionaires, while the COVID-19 crisis meant economic calamity for most Americans.

Not only that, but — as Part II of this three-part series will show, Moderna and a handful of its collaborators at the National Institutes of Health (NIH) seemed to know that Moderna's miracle had arrived — well before anyone else knew or could have known.

Was it really a coincidental mix of "foresight" and "serendipity" that led Moderna and the NIH to plan to develop a COVID-19 vaccine days before the viral sequence was even published and months before a vaccine was even considered necessary for a still unknown disease? If so, why would Moderna — a company clearly on the brink — throw everything into and gamble the entire company on a vaccine project that had no demonstrated need at the time?

 

The Serendipitous Origins of Moderna's COVID-19 Vaccine

When early January 2020 brought news of a novel coronavirus outbreak originating in Wuhan, China, Moderna's CEO Stéphane Bancel immediately emailed Barney Graham, deputy director of the Vaccine Research Center at the National Institutes of Health, and asked to be sent the genetic sequence for what would become known as SAR-CoV-2, allegedly because media reports on the outbreak "troubled" him.

The date of that email varies according to different media reports, though most place it as having been sent on either January 6th or 7th. A few weeks before Bancel's email to Graham, Moderna was quickly approaching the end of the line, their desperately needed "Hail Mary" still not having materialized.

"We were freaked out about money," Stephen Hoge would later remember of Moderna's late 2019 circumstances.

Not only were executives "cutting back on research and other expenditures" like never before, but – as STAT News would later report – "cash from investors had stopped pouring in and partnerships with some drug makers had been discontinued. In meetings at Moderna, Bancel emphasized the need to stretch every dollar and employees were told to reduce travel and other expenses, a frugality there were advised would last several years."

At the tail end of 2019, Graham was in a very different mood than Bancel, having emailed the leader of the coronavirus team at his NIH lab saying, "Get ready for 2020," apparently viewing the news out of Wuhan in late 2019 as a harbinger of something significant.

He went on, in the days before he was contacted by Bancel, to "run a drill he had been turning over in his mind for years" and called his long-time colleague Jason McLellan "to talk about the game plan" for getting a head start on producing a vaccine the world did not yet know it needed.

When Bancel called Graham soon afterward and asked about this new virus, Graham responded that he didn't know yet but that "they were ready if it turned out to be a coronavirus." The Washington Post claimed that Graham's apparent foreknowledge that a coronavirus vaccine would be needed before anyone officially knew what type of disease was circulating in Wuhan was a fortunate mix of "serendipity and foresight."

 

 

Dr. Barney Graham and Dr. Kizzmekia Corbett, VRC coronavirus vaccine lead, discuss COVID-19 research with U.S. legislators Sen. Chris Van Hollen, Sen. Benjamin Cardin and Rep. Jamie Raskin, March 6, 2020; Source: NIH

A report in Boston magazine offers a slightly different account than that reported by the Washington Post. Per that article, Graham had told Bancel, "If [the virus] is a coronavirus, we know what to do and have proven mRNA is effective."

Per that report, this assertion of efficacy from Graham referred to Moderna's early stage human-trial data published in September 2019 regarding its chikungunya vaccine candidate, which was funded by the Defense Advanced Research Projects Agency (DARPA), as well as its cytomegalovirus (CMV) vaccine candidate.

As mentioned in Part I of this series, the chikungunya vaccine study data released at that time included the participation of just four subjects, three of whom developed significant side effects that led Moderna to state that they would reformulate the vaccine in question and would pause trials on that vaccine candidate.

In the case of the CMV vaccine candidate, the data was largely positive, but it was widely noted that the vaccine still needed to pass through larger and longer clinical trials before its efficacy was in fact "proven," as Graham later claimed.

In addition, Graham implied that this early stage trial of Moderna's CMV vaccine candidate was somehow proof that an mRNA vaccine would be effective against coronaviruses, which makes little sense since CMV is not a coronavirus but instead hails from the family of viruses that includes chickenpox, herpes, and shingles.

Bancel apparently had reached out to Graham because Graham and his team at the NIH had been working in direct partnership with Moderna on vaccines since 2017, soon after Moderna had delayed its Crigler-Najjar and related therapies in favor of vaccines.

According to Boston magazine, Moderna had been working closely with Graham specifically "on [Moderna's] quest to bring a whole new class of vaccines to market" and Graham had personally visited Moderna's facilities in November 2019. Dr. Anthony Fauci, the director of the NIH's infectious-disease division NIAID, has called his unit's collaboration with Moderna, in the years prior to and also during the COVID-19 crisis, "most extraordinary."

The year 2017, besides being the year when Moderna made its pivot to vaccines (due to its inability to produce safe multidose therapies, see Part I), was also a big year for Graham.

That year he and his lab filed a patent for the "2P mutation" technique whereby recombinant coronavirus spike proteins can be stabilized in a prefusion state and used as more effective immunogens. If a coronavirus vaccine were to be produced using this patent, Graham's team would financially benefit, though federal law caps their annual royalties. Nonetheless, it would still yield a considerable sum for the named researchers, including Graham.

However, due to the well-known difficulties with coronavirus vaccine development, including antibody dependent enhancement risk, it seemed that commercial use of Graham's patent was a pipe dream. Yet, today, the 2P mutation patent, also known as the '070 patent, is not just in use in Moderna's COVID-19 vaccine, but also in the COVID-19 vaccines produced by Johnson & Johnson, Novavax, Pfizer/BioNTech, and CureVac.

Experts at New York University School of Law have noted that the 2P mutation patent first filed in 2016 "sounds remarkably prescient" in light of the COVID crisis that emerged a few years later while later publications from the NIH (still pre-COVID) revealed that the NIH's view on "the breadth and importance of the '070 patent" as well as its potential commercial applications was also quite prescient, given that there was little justification at the time to hold such a view.

On January 10, three days after the reported initial conversation between Bancel and Graham on the novel coronavirus outbreak in Wuhan, China, Graham met with Hamilton Bennett, the program leader for Moderna's vaccine portfolio.

Graham asked Bennett "if Moderna would be interested in using the new [novel coronavirus] to test the company's accelerated vaccine-making capabilities." According to Boston, Graham then mused, "That way ... if ever there came a day when a new virus emerged that threatened global public health, Moderna and the NIH could know how long it would take them to respond."

Graham's "musings" to Bennett are interesting considering his earlier statements made to others, such as "Get ready for 2020" and his team, in collaboration with Moderna, would be "ready if [the virus then circulating in Wuhan, China] turned out to be a coronavirus." Is this merely "serendipity" and "foresight", as the Washington Post suggested, or was it something else?

It is worth noting that the above accounts are those that have been given by Bancel and Graham themselves, as the actual contents of these critical January 2020 emails have not been publicly released.

When the genetic sequence of SARS-CoV-2 was published on January 11, NIH scientists and Moderna researchers got to work determining which targeted genetic sequence would be used in their vaccine candidate. Later reports, however, claimed that this initial work toward a COVID-19 vaccine was merely intended to be a "demonstration project."

Other odd features of the Moderna-NIH COVID-19 vaccine-development story emerged with Bancel's account of the role the World Economic Forum played in shaping his "foresight" when it came to the development of a COVID-19 vaccine back in January 2020.

On January 21, 2020, Bancel reportedly began to hear about "a far darker version of the future" at the World Economic Forum (WEF) annual meeting in Davos, Switzerland, where he spent time with "two [anonymous] prominent infectious-disease experts from Europe" who shared with him data from "their contacts on the ground in China, including Wuhan."

That data, per Bancel, showed a dire situation that left his mind "reeling" and led him to conclude, that very day, that "this isn't going to be SARS. It's going to be the 1918 flu pandemic."

 

 

Stéphane Bancel speaks at the Breakthroughs in Cancer Care session at WEF annual meeting, January 24, 2020; Source: WEF

This realization is allegedly what led Bancel to contact Moderna cofounder and chairman, as well as a WEF technology pioneer, Noubar Afeyan. Bancel reportedly interrupted Afeyan's celebration of his daughter's birthday to tell him "what he'd learned about the virus" and to suggest that "Moderna begin to build the vaccine — for real."

The next day, Moderna held an executive meeting, which Bancel attended remotely, and there was considerable internal debate about whether a vaccine for the novel coronavirus would be needed.

To Bancel, the "sheer act of debating" pursuing a vaccine for the virus was "absurd" given that he was now convinced, after a single day at Davos, that "a global pandemic was about to descend like a biblical plague, and whatever distractions the vaccine caused internally at Moderna were irrelevant."

Bancel spent the rest of his time at the Davos annual meeting "building partnerships, generating excitement, and securing funding," which led to the Moderna collaboration agreement with the Coalition for Epidemic Preparedness Innovations — a project largely funded by Bill Gates.

(Bancel and Moderna's cozy relationship with the WEF, dating back to 2013, was discussed in Part I as were the Forum's efforts, beginning well before COVID-19, to promote mRNA-based therapies as essential to the remaking of the health-care sector in the age of the so-called Fourth Industrial Revolution).

At the 2020 annual meeting attended by Bancel and others it was noted that a major barrier to the widespread adoption of these and other related "health-care" technologies was "public distrust." The panel where that issue was specifically discussed was entitled "When Humankind Overrides Evolution."

As also noted in Part I of this series, a few months earlier, in October 2019, major players in what would become the Moderna COVID-19 vaccine, particularly Rick Bright and Anthony Fauci, had discussed during a Milken Institute panel on vaccines how a "disruptive" event would be needed to push the public to accept "nontraditional" vaccines such as mRNA vaccines; to convince the public that flu-like illnesses are scarier than traditionally believed; and to remove existing bureaucratic safeguards in the vaccine development-and-approval processes.

That panel took place less than two weeks after the Event 201 simulation, jointly hosted by the World Economic Forum, the Bill & Melinda Gates Foundation, and the Johns Hopkins Center for Health Security.

Event 201 simulated "an outbreak of a novel zoonotic coronavirus" that was "modeled largely on SARS but ... more transmissible in the community setting by people with mild symptoms." The recommendations of the simulation panel were to considerably increase investment in new vaccine technologies and industrial approaches, favoring rapid vaccine development and manufacturing.

As mentioned in Part I, the Johns Hopkins Center for Health Security had also conducted the June 2001 Dark Winter simulation that briefly preceded and predicted major aspects of the 2001 anthrax attacks, and some of its participants had apparent foreknowledge of those attacks. Other Dark Winter participants later worked to sabotage the FBI investigation into those attacks after their origin was traced back to a US military source.

It is hard to imagine that Bancel, whose company had long been closely partnered with the World Economic Forum and the Gates Foundation, was unaware of the exercise and surprised by the closely analogous event that transpired within three months.

Given the accounts given by Bancel, Graham, and others, it seems likely there is more to the story regarding the origins of Moderna's early and "serendipitous" push to develop a COVID-19 vaccine.

In addition, given that Moderna was in dire financial circumstances at the time, it seems odd that the company would gamble everything on a vaccine project that was opposed by the few investors that were still willing to fund Moderna in January/February 2020.

Why would they divert their scant resources towards a project born only out of Barney Graham's "musings" that Moderna could try to test the speed of its vaccine development capabilities and Bancel's doomsday view that a "biblical plague" was imminent, especially when their investors opposed the idea?

 

Moderna Gets to Bypass Its Long-Standing Issues With R & D

Moderna produced the first batch of its COVID-19 vaccine candidate on February 7, one month after Bancel and Graham's initial conversation. After a sterility test and other mandatory tests, the first batch of its vaccine candidate, called mRNA-1273, shipped to the NIH on February 24. For the first time in a long time, Moderna's stock price surged. NIH researchers administered the first dose of the candidate into a human volunteer less than a month later, on March 16.

Controversially, in order to begin its human trial on March 16, regulatory agencies had to allow Moderna to bypass major aspects of traditional animal trials, which many experts and commentators noted was highly unusual but was now deemed necessary due to the urgency of the crisis. Instead of developing the vaccine in distinct sequential stages, as is the custom, Moderna "decided to do all of the steps [relating to animal trials] simultaneously."

In other words, confirming that the candidate is working before manufacturing an animal-grade vaccine, conducting animal trials, analyzing the animal-trial data, manufacturing a vaccine for use in human trials, and beginning human trials were all conducted simultaneously by Moderna. Thus, the design of human trials for the Moderna vaccine candidate was not informed by animal-trial data.

 

 

Lt. Javier Lopez Coronado and Hospitalman Francisco Velasco inspect a box of COVID-19 vaccine vials at the Naval Health Clinic in Corpus Christi, TX, December 2020; Source: Wikimedia

This should have been a major red flag, given Moderna's persistent difficulties in getting its products past animal trials. As noted in Part I, up until the COVID-19 crisis, most of Moderna's experiments and products had only been tested in animals, with only a handful able to make it to human trials.

In the case of the Crigler-Najjar therapy that it was forced to indefinitely delay, toxicity concerns related to the mRNA delivery system being used had emerged in the animal trials, which Moderna was now greenlighted to largely skip. Given that Moderna had subsequently been forced to abandon all multidose products because of poor results in animal trials, being allowed to skip this formerly insurmountable obstacle was likely seen as a boon to some at the company.

It is also astounding that, given Moderna's history with problematic animal trials, more scrutiny was not devoted to the regulatory decision to allow Moderna to essentially skip such trials. Animal studies conducted on Moderna's COVID-19 vaccine did identify problems that should have informed human trials, but this did not happen because of the regulatory decision.

For example, animal reproductive toxicity studies on the Moderna COVID-19 vaccine that are cited by the European Medicines Agency found that there was reduced fertility in rats that received the vaccine (e. g., overall pregnancy index of 84.1% in vaccinated rats versus 93.2% in the unvaccinated) as well as an increased proportion of aberrant bone development in their fetuses.

That study has been criticized for failing to report on the accumulation of vaccine in the placenta as well as failing to investigate the effect of vaccine doses administered during key pregnancy milestones, such as embryonic organogenesis. In addition, the number of animals tested is unstated, making the statistical power of the study unknown.

At the very least, the 9 percent drop in the fertility index among vaccinated rats should have prompted expanded animal trials to investigate concerns of reproductive toxicity before testing in humans.

Yet, Moderna declined to further investigate reproductive toxicity in animal trials and entirely excluded reproductive toxicity studies from its simultaneous human trials, as pregnant women were excluded from participation in the clinical trials of its vaccine. Despite this, pregnant women were labeled a priority group for receiving the vaccine after Emergency Use Authorization (EUA) was granted for the Moderna and Pfizer/BioNTech vaccines.

Per the New England Journal of Medicine, this meant that "pregnant women and their clinicians were left to weigh the documented risks of Covid-19 infection against the unknown safety risks of vaccination in deciding whether to receive the vaccine."

Moderna only began recruiting for an "observational pregnancy outcome study" of its COVID-19 vaccine in humans in mid-July 2021, and that study is projected to conclude in early 2024. Nevertheless, the Centers for Disease Control recommends the use of Moderna's COVID-19 vaccine in "people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future."

This recommendation is largely based on the CDC's publication of preliminary data on mRNA COVID-19 vaccine safety in pregnant women in June 2021, which is based on passive reporting systems in use within the United States (i. e., VAERS and v-safe).

Even in the limited scope of this study, 115 of the 827 women who had a completed pregnancy during the study lost the baby, 104 of which were spontaneous abortions before 20 weeks of gestation. Of these 827 pregnant women, only 127 had received a mRNA vaccine before the 3rd trimester.

This appears to suggest an increased risk among those women who took the vaccine before the 3rd trimester, but the selective nature of the data makes it difficult to draw any definitive conclusions.

Despite claims from the New England Journal of Medicine that the study's data was "reassuring", the study's authors ultimately stated that their study, which mainly looked at women who began vaccination in the third trimester, was unable to draw "conclusions about spontaneous abortions, congenital anomalies, and other potential rare neonatal outcomes."

This is just one example of the problems caused by "cutting corners" with respect to Moderna's COVID-19 vaccine trials in humans and animals, including those conducted by the NIH.

Meanwhile, throughout February, March and April, Bancel was "begging for money" as Moderna reportedly lacked "enough money to buy essential ingredients for the shots" and "needed hundreds of millions of dollars, perhaps even more than a billion dollars" to manufacture its vaccine, which had only recently begun trials. Bancel, whose tenure at Moderna had long been marked by his ability to charm investors, kept coming up empty-handed.

Then, in mid-April 2020, Moderna's long-time cooperation with the US government again paid off when Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) awarded the company $483 million to "accelerate the development of its vaccine candidate for the novel coronavirus."

A year later, the amount invested in Moderna's COVID-19 vaccine by the US government had grown to about $6 billion dollars, just $1.5 billion short of the company's entire value at the time of its pre-COVID IPO.

BARDA, throughout 2020, was directly overseen by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), led by the extremely corrupt Robert Kadlec, who had spent roughly the last two decades designing BARDA and helping shape legislation that concentrated many of the emergency powers of HHS under the Office of the ASPR.

Conveniently, Kadlec occupied the powerful role of ASPR that he had spent years sculpting at the exact moment when the pandemic, which he had simulated the previous year via Crimson Contagion, took place. As mentioned in Part I, he was also a key participant in the June 2001 Dark Winter exercise.

In his capacity as ASPR during 2020, Kadlec oversaw nearly all major aspects of the HHS COVID-19 response and had a key role in BARDA's funding decisions during that period, as well as in the affairs of the NIH and the Food and Drug Administration as they related to COVID-19 medical countermeasures, including vaccines.

On May 1, 2020, Moderna announced a ten-year manufacturing agreement with the Lonza Group, a multinational chemical and biotech company based in Switzerland. Per the agreement, Lonza would build out vaccine production sites for Moderna's COVID-19 vaccine, first in the US and Switzerland, before expanding to Lonza's facilities in other countries.

The scale of production discussed in the agreement was to produce 1 billion doses of Moderna's COVID-19 vaccine annually. It was claimed that the ten-year agreement would also focus on other products, even though it was well known at the time that other Moderna products were "nowhere close to being ready for the market."

Moderna executives would later state that they were still scrambling for the cash to manufacture doses at the time the agreement with Lonza was made.

The decision to forge a partnership to produce that quantity of doses annually suggests marvelous foresight on the part of Moderna and Lonza that the COVID-19 vaccine would become an annual or semiannual affair, given that current claims of waning immunity could not have been known back then because initial trials of the Moderna vaccine had begun less than two months earlier and there was still no published data on its efficacy or safety.

However, as will be discussed Part III of this series, Moderna needs to sell "pandemic level" quantities of its COVID-19 vaccine every year in order to avoid a return of the existential crises it faced before COVID-19 (for more on those crises, see Part I).

The implications of this, given Moderna's previous inability to produce a safe product for multidosing and lack of evidence that past issues were addressed in the development of its COVID-19 vaccine, will also be discussed in Part III of this series.

It is also noteworthy that, like Moderna, Lonza as a company and its leaders are closely affiliated with the World Economic Forum. In addition, at the time the agreement was reached in May 2020, Moncef Slaoui, the former GlaxoSmithKline executive, served on the boards of both Moderna and Lonza.

Slaoui withdrew from the boards of both companies two weeks after the agreement was reached to become the head of the US-led vaccination-development drive Operation Warp Speed. Moderna praised Slaoui's appointment to head the vaccination project.

By mid-May, Moderna's stock price — whose steady decline before COVID-19 was detailed in Part I — had tripled since late February 2020, all on high hopes for its COVID-19 vaccine.

Since Moderna's stock had begun to surge in February, media reports noted that "nearly every progress update — or media appearance by Moderna CEO Stephane Bancel — has been gobbled up by investors, who seem to have an insatiable appetite for the stock."

Bancel's tried-and-tested method of keeping Moderna afloat on pure hype, though it was faltering before COVID-19, was again paying off for the company thanks to the global crisis and related panic.

Some critics did emerge, however, calling Moderna's now $23 billion valuation "insane," especially considering that the company had posted a net loss of $514 million the previous year and had yet to produce a safe or effective medicine since its founding a decade earlier.

In January 2020, Moderna had been worth a mere $5 billion, $2 billion less than its valuation at its December 2018 IPO. If it hadn't been for the onset of the COVID crisis and a fresh injection of hype, it seems that Moderna's valuation would have continued to shrink.

Yet, thankfully for Moderna, investors were valuing Moderna's COVID-19 vaccine even before the release of any clinical data. Market analysts at the time were forecasting Moderna's 2022 revenue at about $1 billion, a figure based almost entirely on coronavirus vaccine sales, since all other Moderna products were years away from a market debut.

Yet, even with this forecasted revenue, Moderna's stock value in mid-May 2020 was trading at twenty-three times its projected sales, a phenomenon unique to Moderna among biotech stocks at the time. For comparison, the other highest multiples in biotech at the time were Vertex Pharmaceutical and Seattle Genetics, which were then trading at nine and twelve times their projected revenue, respectively.

Now, with the implementation of booster shot policies around the world, revenue forecasts for Moderna now predict the company will make a staggering $35 billion in COVID-19 vaccine sales through next year.

Moderna's surging stock price went into overdrive when, on May 18, 2020, the company published "positive" interim data for a phase 1 trial of its COVID-19 vaccine. The results generated great press, public enthusiasm, and a 20 percent boost in Moderna's stock price.

Just hours after the press release, Moderna announced a new effort to raise $1.3 billion by selling more stock. It has since been revealed that that Moderna had hired Morgan Stanley to manage that stock sale on May 15.

However, left largely unmentioned by the press or Moderna itself was that the ostensibly "scientific study" only provided data from 8 of the 45 volunteers — 4 volunteers each from the 15- and 100-microgram dose cohorts — regarding the development of neutralizing antibodies.

The age of these mysteriously selected 8 volunteers was also not published, and other key data was missing, making it "impossible to know whether mRNA-1273 [Moderna's COVID-19 vaccine] was ineffective [in the remaining 37 volunteers whose antibody data was not disclosed], or whether the results were not available at this point."

Meanwhile, in the highest-dose cohort, in which volunteers received 250 micrograms, 21 percent of volunteers experienced a grade 3 adverse event, which is defined by the FDA as "preventing daily activity and requiring medical intervention."

STAT published a report the next day that was skeptical of Moderna's press release and seemed to imply the data release was aimed at boosting the company's stock valuation, which hit $29 billion after the news. STAT reporter Helen Branswell called this jump in valuation "an astonishing feat for a company that currently sells zero products."

Branswell's report noted several things, including that several vaccine experts had noted that "based on the information made available [by Moderna], there's really no way to know how impressive — or not — the vaccine may be."

Moderna later defended its withholding of key data in the press release, claiming that it was done to respect "federal securities laws and the rules of scientific journals" and to prevent a potential leak of the data from insiders at the NIH.

Moderna executives have more recently claimed that the "timely" release of these selective data had been linked to their "desperate" fundraising efforts at the time and ultimately prevented them from "losing" the COVID-19 vaccine race.

The STAT report also noted that the National Institute of Allergy and Infectious Diseases (NIAID), which was running the trial referenced by Moderna in the press release, was completely silent on the matter, declining to put out a press release that day and declining to comment on Moderna's announcement.

This was described as uncharacteristic for NIAID, especially considering they were the part of the NIH co-developing the vaccine with Moderna and running the trial. STAT noted that, normally, "NIAID doesn't hide its light under a bushel. The institute generally trumpets its findings." In this case, however, they declined to do so.

It emerged in early June 2020 that Dr. Anthony Fauci, who leads NIAID, had been displeased with Moderna's decision to publish incomplete data on the trial, telling STAT that he would have preferred "to wait until we had the data from the entire Phase 1 ... and publish it in a reputable journal and show all the data."

 

 

Tal Zaks, Chief Scientific Officer at Moderna; Source: The Forward

It subsequently emerged that Moderna's top executives, including chief financial officer Lorence Kim and chief scientific officer Tal Zaks, had used their insider knowledge of the coming press release to trade company stock that netted them several million each following the jump in Moderna's stock that resulted from the press release's positive buzz.

A little over a week after the press release had been published, STAT reported that the top five Moderna executives had cashed out $89 million in shares since the company's stock price had begun to soar earlier in the year.

Per that report, the amount of trades by these five executives alone between January and May 2020 was "nearly three times as many stock transactions than in all of 2019." By September 2020, the amount of stock shed by Moderna executives amounted to $236 million. Less criticized or even mentioned by the press was Moderna's move, less than a month later, to create a tax haven in Europe for its European COVID-19 vaccine sales.

Though the trades were deemed slimy but legal, mainstream media reports essentially confirmed that the early release of the interim data was planned to "raise the share price of Moderna's stock so that executives could cash in during the period of euphoria" that followed. Some watchdog groups called on the SEC to investigate Moderna executives for manipulating the stock market.

The critical reporting on executive stock trades and Moderna's release of incomplete data led the company's stock to temporarily trend downward throughout the rest of May. As previously mentioned, Moderna has repeatedly attempted to explain away the timing of this particular press release, offering new explanations as recently as this week.

 

Moderna's Shocking Claim About Its Vaccine Candidate

In mid-June 2020, researchers at the NIH and Moderna published a manuscript preprint of preclinical data for Moderna's COVID-19 vaccine. This preprint described the vaccine as employing a delivery system covered in a patent owned by the company Arbutus Biopharma and described the results of that vaccine in tests on mice.

As discussed in Part I, Moderna has long been locked in a bitter legal dispute with Arbutus, which has threatened Moderna's ability to ever turn a profit on any product that relies on Arbutus-patented technology regarding lipid nanoparticle (LNP) delivery systems for its mRNA products. Moderna has claimed for years it was no longer using the Arbutus-derived system on which it once entirely relied, with Bancel even going so far as to publicly call it "not very good."

However, Moderna has provided no real evidence that it no longer relies on the technology covered in the Arbutus patents. The June 2020 manuscript preprint from the NIH and Moderna provided evidence indicating that the same Arbutus-derived technology that had caused major toxicity issues in multidose products Moderna had previously attempted to develop was also being used in Moderna's COVID-19 vaccine candidate.

Yet, when Moderna's chief corporate affairs officer, Ray Jordan, was challenged on this point by Forbes, Jordan asserted that the preprint's data had been generated using a formulation of a COVID-19 vaccine that is not the same as the vaccine itself, stating, "while the authors of the preprint used the term 'mRNA-1273' for convenience of the reader, the preprint does not describe the cGMP process by which we make our messenger RNA and LNP or the final drug product composition in our commercial candidate (mRNA-1273)."

When Forbes asked Jordan if he could provide any specifics, including the LNP molar ratio of the new LNP technology to prove that the LNPs in use in the COVID-19 vaccine were in fact different from those covered by the Arbutus patent, Jordan flat out refused.

 

 

Arbutus Biopharma's office in Warminster, Pennsylvania; Source: Philadelphia Business Journal

Despite Jordan's claims, a Moderna preclinical study regarding its COVID-19 vaccine was published a month later, and that July study noted that the Moderna vaccine used LNPs as described in a 2019 paper, which in turn reveals that the LNPs in question were the same as those used in the June study. This paper included the results from the study originally promoted by Moderna in May that led to a jump in Moderna's stock price.

Now published in full, the study generated lots of positive press, including a statement from the NIAID's Fauci that "no matter how you slice this, this is good news." A jump in US government funding of Moderna's COVID-19 vaccine also shortly followed the study's publication.

At the time, CBS News remarked that Moderna's stock price, which had been sliding since its late 2018 IPO, had been essentially rescued by the COVID-19 crisis, as "shares of Moderna — which has never brought a product to market over its ten-year existence — have soared as much as 380 percent since the start of the year as news emerged [in January] of its promising potential for producing a vaccine.

[Moderna's] stock price was less than $20 in early January and around $95 on Friday [July 17, 2020]." Today, by comparison, Moderna has consistently been trading above $300 a share.

Yet, if we take Ray Jordan at his word with respect to the preprint published in June, Moderna appears to have been engaged in rather slimy behavior. If Jordan was telling the truth, it appears that this July study, which appears to use the vaccine candidate containing the same LNPs as those described in the June 2020 preprint, also used a formulation not consistent with the company's commercial vaccine candidate.

If so, given that the July study was the same study referenced by Moderna's controversial May press release tied to insider stock trades, Moderna appears to have used "positive" data generated by a vaccine candidate other than its commercial vaccine candidate to boost stock prices and ameliorate the company's financial situation while also generating millions for executives.

This, of course, says nothing about the separate but critically important issue that the vaccine candidate used in these studies, including the NIH study, is not necessarily the same as the commercial candidate used in clinical trials.

It seems that the only reason that Moderna would make such an outrageous claim to Forbes would be to distance its COVID-19 vaccine from its past controversies that largely have their root in Moderna's LNP-related problems, which it had claimed to have already resolved. It is not clear if the motive behind such a gambit is principally related to the legal dispute with Arbutus or the past safety issues Moderna encountered with multidose therapies.

Adding to the confusion about the LNPs in use in Moderna's products is that, a few days earlier in July, Moderna had published results on a separate vaccine candidate, this one for HIV, that appeared to use the exact same LNP technology that is covered by the Arbutus patent. The LNPs described in that study included the same components as those described in the Arbutus patent and the same molar ratio.

Moderna appeared to be referencing this issue in their August 6, 2020, SEC filing, which states: "There are many issued and pending third-party patents that claim aspects of oligonucleotide delivery technologies that we may need for our mRNA therapeutic and vaccine candidates or marketed products, including mRNA-1273, if approved."

By the end of 2020, Moderna claimed in a December filing with the SEC that, while it had "initially used LNP formulations that were based on known lipid systems," that is, the Arbutus LNPs, it had "invested heavily in delivery science and ha[s] developed LNP technologies, as well as alternative nanoparticle approaches."

Despite the claims it made in this filing, however, it remained unclear as to whether the company's COVID-19 vaccine was using Arbutus technology or the technology it purported to have developed on its own without infringing on Arbutus's intellectual property.

Moderna's claims that it now uses a different LNP system than the one that caused such major issues is based on the company's development and implementation of a lipid structure now known as SM-102. This lipid structure was first revealed by Moderna in a 2019 publication under the name Lipid H, and, in that paper and since, Moderna has claimed that its LNP system is now superior to that which it previously used because it is using SM-102 instead of the original Arbutus lipids.

However, it is critical to note that Moderna's use of SM-102 does not necessarily mean the company is not violating the Arbutus patents, which cover the use of LNPs that combine cationic and PEGylated lipids in specific proportions.

Despite claims from Moderna that SM-102 resolved both the company's patent-related and toxicity issues with its LNP system (as discussed in Part I), Moderna has declined to disclose SM-102's exact structure or whether it carries a net positive charge at physiological pH, the latter of which could lead to proof of continued infringement on the Arbutus patent.

In addition, there are no studies on the distribution, degradation, and/or elimination of SM-102 from the body, meaning that the accumulation of the lipids or their capacity to damage organs is not documented.

The obvious lack of study of SM-102's properties and effects on the human body was largely circumvented by public health authorities during the emergency approval process by using the same criteria for the Moderna vaccine candidate that is used for traditional vaccines that do not utilize the novel mRNA approach. These "traditional" criteria therefore do not include any requirements for data on LNP safety.

Overall, the evidence seems to point toward Moderna's claims that its COVID-19 vaccine doesn't use Arbutus-derived LNPs as being false. The other possibility is that Moderna attempted to modify the LNP system but only slightly so that potential identifiers, such as the molar ratio, remained the same.

In this case, Arbutus could still claim that the LNPs currently in use by Moderna and in its COVID-19 vaccine infringe on their patent. It is also thus likely that the safety issues Moderna had acknowledged with this LNP system were largely unaffected if the potential modifications were indeed minor.

Yet, if either of these scenarios is correct, the question becomes – Why wouldn't Arbutus challenge Moderna once again to obtain royalty payments stemming from its COVID-19 vaccine?

The answer seems to lie mostly in optics and public relations. As STAT wrote last July, were Arbutus to sue Moderna over patent infringement in the midst of the COVID-19 crisis, "that would mean taking the substantial risk that it would be perceived as a company holding up a desperately needed medicine out of concern for its bottom line."

This also seemed to be part of the motive behind Moderna's altruistically framed promise not to enforce its own COVID-19–related patents until the pandemic is declared over.

Observers have noted that this move by Moderna was not only a public relations boon for the company but also "set a disarming tone in the space that may serve to deter others in the space [e.g., Arbutus] from acting too defensively or aggressively," largely due to "fear of the potential public relations backlash."

While July 2020 brought a surge in valuation and positive press for Moderna and its COVID-19 vaccine candidate, it also brought an unfavorable ruling for Moderna in its long-running dispute with Arbutus, one that opened the door for Arbutus to file an injunction against Moderna's COVID-19 vaccine, if they chose, to force the negotiation of a license with Moderna.

The news led to Moderna's stock price falling by 10 percent, wiping out $3 billion in value. However, most likely for the reasons outlined above, Arbutus ultimately declined to jump on the decision to block Moderna's COVID-19 vaccine from advancing in the hopes of securing royalties. Yet, they reserve the ability to do so, if and when the perceived urgency of the COVID-19 crisis fades.

 

 

Ray Jordan, Chief Corporate Affairs Officer at Moderna; Source: PRSA

Moderna has asserted that the decision would not affect its COVID-19 vaccine as the company was "not aware of any significant intellectual property impediments for any products we intend to commercialize."

Thus, Ray Jordan's assertions and the lack of "clear and convincing" evidence that Moderna's COVID-19 vaccine relies on Arbutus-patented technology appears to have been sufficient for Moderna to make this claim.

This seems to be due to a lack of interest by the mainstream media or federal agencies/regulators in demanding concrete evidence that Moderna's LNP system used in its COVID-19 vaccine does not rely on Arbutus-patented technology.

Despite the issues raised above in relation to the vaccine study data published in June and July, the positive press attention — particularly after the July publication — translated just a month later into the US government entering into a significant supply agreement with Moderna on August 11, 2020.

Per that agreement, the government would pay $1.525 billion for 100 million doses with the option to purchase an additional 400 million doses in the future, all of which it has since purchased. Per Moderna's press release, the agreement meant that the US government had, by that point, paid $2.48 billion for "early access" to Moderna's COVID-19 vaccine.

Roughly a month later, it was revealed that the US government had been paying for much more. On September 10, 2020, BARDA joined long-time Moderna funder and "strategic ally" DARPA in scrutinizing contracts that had been awarded to the company due to Moderna's failure to disclose the role government support had played in its numerous patent applications.

The announcement came after Knowledge Ecology International (KEI), which advocates for protecting taxpayer investments in patents, found that none of the patents or applications assigned to Moderna in the company's entire history had disclosed the considerable US government funding it had received at the time those patents were filed, which is required by the 1980 Bayh-Doyle Act and by the regulations of the Patent and Trademark Office.

Per KEI, this translates into the US government owning certain rights over the patents, and thus US taxpayers may have an ownership stake in vaccines made and sold by Moderna.

Despite the clear evidence that Moderna failed to disclose the considerable amount of US government funding prior to and during the COVID crisis in its patent applications, Moderna responded to KEI and the BARDA/DARPA "scrutiny" by stating that it was "aware of and consults with our agency collaborators regarding our contractual obligations under each of these agreements, including those with respect to IP [intellectual property], and believe we comply with those obligations."

As of the writing of this article, BARDA and DARPA have taken no action against Moderna for their illegal omission about having received substantial government funding in their patent applications and filings.

Instead, a month after DARPA claimed to be "scrutinizing" Moderna's patent applications, it awarded the company up to $56 million to develop small-scale mobile means of manufacturing its products — namely, its COVID-19 vaccine and its personalized cancer vaccine.

 

Moderna: "Just Trust Us"

What quickly stands out about Moderna's COVID-19 vaccine candidate over the course of its rapid development in 2020 was the willingness of federal agencies like NIH, BARDA, and others, as well as the mainstream press, to take Moderna at its word concerning critical aspects of its vaccine and its development, even when the evidence appeared to contradict its claims.

This is particularly evident in Moderna claiming that it resolved its LNP issues, both in terms of toxicity and patent infringement, and those claims — despite the company's refusal to release clear supporting evidence — being taken at face value.

This is even more striking when one considers the multiple factors that Moderna was facing before COVID-19 and how the company faced collapse without the success of its COVID-19 vaccine, as this means Moderna was under considerable pressure to have its vaccine succeed.

While the controversial simultaneous conducting of animal and human trials was publicly justified in the name of the urgency of the COVID-19 crisis, can the other examples explored in this article be similarly justified in the name of urgency? Instead, several issues explored above appear to have been driven by conflicts of interest and corruption.

Adding to the ridiculousness is that Moderna got away with claiming that the NIH was conducting safety tests on a COVID-19 vaccine product different from their commercial candidate, without causing a major backlash in either the mainstream media or from the NIH itself.

This is particularly telling as the May 2020 press release and suspiciously timed stock trading by Moderna executives and insiders did garner negative press attention.

However, the subsequent revelation, per Moderna, that its press release was based on the study of a vaccine candidate that was not "necessarily the same" as their commercial COVID-19 vaccine candidate received essentially no coverage, despite raising the unsettling possibility that Moderna could have used another product to essentially rig preliminary data to be positive in order to advance their product to market and make millions through insider stock sales.

How can the claims made by such a company be trusted at face value without independent verification? Furthermore, how can NIH studies of Moderna be trusted when Moderna has claimed that some of the studies that were ultimately factors in the vaccine's emergency use authorization approval by the FDA utilized a different product than that which Moderna later successfully commercialized?

Moderna and the NIH were, nevertheless, taken at their word in November 2020 when they said that their COVID-19 vaccine candidate was 94.5 percent effective. At the time, the main promoters of this claim were Moderna's Bancel and NIAID's Fauci.

The claim came shortly after Pfizer's press release claiming its COVID-19 vaccine candidate was 90 percent effective. Not to be outdone by Moderna, Pfizer revised the reported efficacy of its vaccine just two days after Moderna's November press release, stating that their vaccine was actually 95% effective to Moderna's 94.5%.

In the case of these claims, it was indicative of the now-established yet troubling practice of "science by press release" when it comes to touting the benefit of certain COVID-19 vaccines currently on the market. Since then, real-world data has shattered the efficacy claims that were used to secure emergency use authorization, for which Moderna applied at the end of November 2020 and received only a few weeks later in mid-December of that year.

As Part III of this series will explore, the EUA for the Moderna vaccine got around the issues raised in this article by treating the entire Moderna formulation as a traditional vaccine, which it is not, as traditional vaccines do not utilize mRNA for inducing immunity, and their safety and efficacy depend on several criteria that are entirely different from those of the more novel mRNA.

Thus, the LNP issue, a perpetually sticky one for Moderna that it struggled to circumvent before the onset of the COVID-19 crisis, was largely evaded when it came down to, not just research and development, but receiving EUA.

It appears that this sleight-of-hand by federal regulators was necessary for Moderna, after ten years, to finally get its first product on the market. As noted in Part I, were it not for the COVID-19 crisis and its fortuitous timing, Moderna might not have survived the severe challenges that threatened its entire existence as a company.

Part III will also examine how Moderna's "Hail Mary" moment in the COVID-19 crisis was only the beginning of its miraculous rescue from a Theranos-like fate, as the company has not only expanded its partnership with the government but now with a CIA-linked firm.

This shows that Moderna and key power players in Big Pharma and the US national-security state envision Moderna's COVID-19 vaccine being sold in massive quantities for several years to come. As previously noted, without annual or semiannual sales of booster doses, Moderna's pre-COVID crisis will inevitably return.

The push for Moderna booster-dose approval has advanced despite real-world data not supporting Moderna's past claims of safety and efficacy for its COVID-19 vaccine, the recent decision of several European governments to halt the vaccine's use, and the FDA's own infighting and recent admissions that the Moderna COVID-19 vaccine is one of the more dangerous currently in use, particularly in terms of adverse effects on the cardiovascular system.

The obvious question here then becomes – How costly will Moderna's "Hail Mary" save ultimately be, not just in terms of the $6 billion US taxpayer money already spent on it, but also in terms of public health?

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Will the Military Industrial Complex Permit Good Relations

 

Between the U.S. and China?

http://www.informationclearinghouse.info/56865.htm

by Brian Cloughley

 

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e.

CREEPY PFIZER AD TO ENCOURAGE CHILDREN

 

TO TAKE THE COVID-19 VACCINE

https://odysee.com/@RealNewsforever:a/Pfizer-Vaccine-Ad-Targets-Children:5  

by Real Newsforever

(1:28)

 

This ad was produced by Pfizer.

The FDA vaccine advisory panel voted almost unanimously on Tuesday, November 2 recommending the vaccination of young children with the Covid-19 vaccines.
The FDA accepted that recommendation and approved the Covid-19 vaccinations for children 5-11. This is in spite of the fact that the CDC reports 474 deaths for the age group 5 to 18 from Covid-19 from 1-4-2020 to 10-30-2021.
https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-Focus-on-Ages-0-18-Yea/nr4s-juj3

The approval of the Covid-19 vaccine for children as young as 5 is insane, unnecessary and proves that Big Pharma, the FDA, the CDC and the Public Health special interest have too much power

Many children die from accidents each year than have died of Covid-19.

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#Heineken #SocialiseResponsibly

Heineken | The Night is Young

https://www.youtube.com/watch?v=akxfPV-A_C0

(1:03)

 

Heineken

578K subscribers

These recent months we’ve had to give up the simple moments we used to take for granted, like enjoying a beer with friends. We want to celebrate people's resilience and inventiveness to keep going and say... keep it up!

 

“We will meet each other again.”

 

These recent months we’ve had to give up the simple moments we used to take for granted, like enjoying a beer with friends. We want to celebrate people's resilience and inventiveness to keep going and say... keep it up!

Click here for more: https://www.youtube.com/user/heineken Follow Heineken on Instagram: https://www.instagram.com/heineken/ Follow Heineken on Twitter: https://twitter.com/heineken

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Britons Sing About Where To Stick Their Poison Vaccines

https://www.bitchute.com/video/NvI4Er74uIqq/

(00:59)

 

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f.

The Great Heart Disease Cover-up, Long-Haul Illusion Exposed

 

& Your Endless Booster Future Admitted

https://www.thelastamericanvagabond.com/great-heart-disease-coverup-long-haul-illusion-exposed-your-endless-booster-future-admitted/

with Ryan Cristián

(3:19:06)

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Steve Kirsch presents to FDA:

 

Age 5-11 Review Board on EUA Pfizer Vaccines

https://odysee.com/@VSRF:d/Steve-Kirsch-clip-FDA-presentation:1

(3:26)

 

Steve Kirsch, Speaks to FDA Vaccine Committee regarding the EUA Review for Ages 5-11-year-olds. Serious data signals concerning children exist. Why are children dropping like flies after the vaccine? How can a healthy 16-year-old drop dead during a Math Zoom class? Why did a 15-year-old die in his sleep? How were all these safety signals missed including Pulmonary Embolism, Thrombosis, Myocarditis, Ischaemic stroke, DVT? Questions you need to ask before approving this EUA.

See Full FDA VRBPAC Panel Discussion: Vaccines and Related Biological Products Advisory Committee 10/26/21 here: https://youtu.be/laaL0_xKmmA

See Slides for FDA VRBPAC Committee presentation: https://www.skirsch.com/covid/VRBPAC-10-26-21.pdfSee Steve Kirsch Presentation: False Narrative Takedown Series, Covid Vaccines have killed over 200,000 Americans https://rumble.com/vm8ayu-tfnt-1-covid-vaccines-have-killed-over-200000-americans.html

Who is Steve Kirsch?
Steve Kirsch is Executive Director of the Covid-19 Early Treatment Fund and is the CEO of the M10 Networks, which develops digital money technology for banks and central banks. He is the inventor of the optical mouse and one of the first Internet search engines, Infoseek. As the founder of 7 high tech companies, two with billion-dollar market caps, Steve is focused on modernizing payment infrastructure. He has a BS/MS in Electrical Engineering and Computer Science from MIT.

#covid19earlytreatmentfund #kirsch #fda #fdapanel #heartattacks #vaccines #vaccinereactions #pfizer #news #covid19 #today #fdavrbpac #maddiedegaray #teenvaccines #covidvaccines ##myocarditis #pericarditis #myocarditisvaccines #vsrf #myocarditisvaccine #vrbpac

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Top 1% Gains More Wealth Than GDPs Of Japan, Germany, UK, France,

 

India, & Italy Combined;

 

Bottom 50% - You Get Nothing

 

https://www.zerohedge.com/markets/top-1-gains-more-wealth-gdps-japan-germany-uk-france-india-italy-combined-bottom-50-you-get

by  Charles Hugh Smith via OfTwoMinds blog

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Food as a Weapon: Starving Us into Submission

 

https://www.globalresearch.ca/food-weapon-starving-us-submission/5761613

by S. M. Smyth

 

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g.

Applying brakes on 'Warp Speed' COVID-19 vaccinations for children

https://m.washingtontimes.com/news/2021/oct/28/applying-brakes-on-warp-speed-covid-19-vaccination/

by Dr. Larry Kwak, Dr. Steven T. Rosen and Dr. Idit Shachar

October 28, 2021

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Vaccine Development and Social Control: A Psychopathology of Impaired

 

Reasoning in the Global Push for Mass Compliance

https://ijvtpr.com/index.php/IJVTPR/article/view/29/55

by Daniel Broudy

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OSHA Suspends Biden’s Employer Vaccine Mandates Following

 

Court Order

https://www.globalresearch.ca/osha-suspends-biden-employer-vaccine-mandates-following-court-order/5762043

by 21st Century Wire

 

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h.

From: Children's Health Defense [mailto:team@childrenshealthdefense.org]
Sent: Saturday, November 13, 2021 2:33 AM
To: Francis Feeley
Subject: 112 Kids Get Wrong COVID Vaccine + 21 Studies Proving Vaccine Mandates Not Science-Based + More

 

Having trouble viewing this email? View it in your web browser

November 12, 2021

Top News of the Day

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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i.

From: The Grayzone [mailto:grayzoneproject@gmail.com]
Sent: Sunday, November 14, 2021 5:24 PM
To: francis.feeley@wanadoo.fr
Subject: From Nicaraguan revolutionaries to US embassy informants: How Washington recruited ex-Sandinistas like Dora María Téllez and her MRS party

 

 

 

 


From Nicaraguan revolutionaries to US embassy informants: How Washington recruited ex-Sandinistas like Dora María Téllez and her MRS party - By Ben Norton
The story of how Nicaragua’s former guerrilla Dora María Téllez and her anti-Sandinista MRS party allied with the right wing and became coup-supporting informants for the US embassy.

 


Debunking myths about Nicaragua’s 2021 elections, under attack by USA/EU/OAS - By Ben Norton
The US, EU, and OAS are launching a new coup attempt against Nicaragua’s Sandinista government, refusing to recognize its 2021 elections. The Grayzone observed the vote on the ground, and dispels myths aimed at discrediting the process.

 

Ex CIA analyst on hidden realities of Syria war and new novel ‘Damascus Station’ - By Aaron Maté 
Former CIA analyst David McCloskey, who covered Syria from 2008 to 2014, on the roots of Syria’s war, the US role, and his new novel set during the conflict’s early years, “Damascus Station.”

 

Meet the Nicaraguans Facebook falsely branded bots and censored days before elections - By Ben Norton
Facebook, Instagram, and Twitter suspended hundreds of influential pro-Sandinista journalists and activists days before Nicaragua’s November 7 elections, falsely claiming they were government trolls. The Grayzone interviewed them to reveal the truth.

 

CrowdStrike one of Russiagate’s ‘biggest culprits’: ex-House investigator - By Aaron Maté
Former Congressional investigator Kash Patel, who helped expose the Steele dossier fraud, on the overlooked, suspicious role of another Clinton campaign contractor, CrowdStrike, which accused Russia of hacking the DNC.

 

 

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Antiwar.com

https://www.antiwar.com/

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Selected Articles at Global Research

https://www.globalresearch.ca/selected-articles-vaccinated-people-nine-times-9x-more-likely-hospitalized-than-unvaccinated-people/5762004

November 18, 2021

 

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j.

Treating Long-Haul Syndrome

https://www.vax.guide/2021/11/20/treating-long-haul-syndrome/

with Dr. Al Johnson and Dr. Peter McCullough

(41:29)

Story at-a-glance

 

Long COVID, also known as long-haul COVID, chronic COVID or long-haul syndrome, refers to symptoms that persist for four or more weeks after an initial COVID-19 infection.1 Board-certified internist and cardiologist Dr. Peter McCullough discusses potential treatments for long-haul COVID in the video above,2 including which tests may be necessary and when to seek emergency medical care.

Many of the symptoms can also mirror those caused by COVID-19 shots, and McCullough details the four categories of COVID-19 shot-injury syndromes that he’s seen in his practice. While anyone can experience long COVID, those who are sick enough to be hospitalized in the ICU are most often affected.

According to McCullough, 50% of this group will have manifestations of long COVID syndrome. “So the sicker someone is, and the longer the duration of COVID, the more likely they are to have long COVID syndrome. That’s the reason why we like early treatment. We shorten the duration of symptoms and there’s less of a chance for long COVID syndrome.”3

 

Common Symptoms of Long COVID

Signs and symptoms of long COVID, which persist for four weeks or more after you’ve been diagnosed with COVID-19, include:4

Fatigue

Shortness of breath or difficulty breathing

Cough

Joint pain

Chest pain

Memory, concentration or sleep problems

Muscle pain or headache

Fast or pounding heartbeat

Loss of smell or taste

Depression or anxiety

Fever

Dizziness when you stand

Worsened symptoms after physical or mental activities

These symptoms are a result of damage to the following body systems:5

According to McCullough, a paper presented by Dr. Bruce Patterson at the International COVID Summit in Rome, September 12 to 14, 2021, showed that in “individuals who’ve had significant COVID illness, 15 months later the s1 segment of the spike protein is recoverable from human monocytes.” He added:6

“That means the body literally has been sprayed with the virus and it spends 15 months, in a sense, trying to clean out the spike protein from our tissues. No wonder people have long COVID syndrome.”

 

Be on the Lookout for Blood Clots for 90 Days

If you’ve had COVID-19, especially if it was a severe case, be aware that blood clots and heart problems, including heart attack, can occur for 90 days or more. It’s believed that remnants of the virus remain in the nervous system, the lungs, the heart and other organs.

If the symptoms include major shortness of breath, cough with blood in it or pain on one side when you take a deep breath, it could be due to a late pulmonary embolism or a blood clot going to the lungs. “We’ve seen this on more than one occasion,” McCullough said.7

In this case, McCullough recommends a chest CT with contrast and, if a blood clot is found, oral blood thinners for three to six months. McCullough also uses full-dose aspirin — 325 milligrams a day — in almost everyone with long COVID syndrome who doesn’t have a major blood clot, in addition to other medications.

However, a safer and likely equally effective alternative to aspirin is digestive fibrinolytic enzymes like lumbrokinase and serrapeptase. You can alternate between the two enzymes — one day take lumbrokinase and the next take serrapeptase — because you’ll need to be on it for about three months and you can develop a sensitivity to them over time.

Anyone who had COVID-19, especially with significant symptoms, should consider taking digestive fibrinolytic enzymes to be sure you don’t have any clotting. An alternative to determine if clotting is occurring is a test called D-dimer, although it can be pricey. D-dimer is a protein fragment produced by the body when a blood clot dissolves.

It’s typically undetectable or present only at very low levels, buts its level may significantly rise when the body is forming and breaking down blood clots.8 If your d-dimer test is low, then you don’t need to take the enzymes. Likewise, if you had a very mild, cold-like case, of COVID-19, you probably don’t need them.

Aside from a CT scan to rule out pulmonary embolism if you’re having symptoms and possibly a D-dimer test, McCullough suggests a high-sensitivity C-reactive protein (CRP) test, which provides a general index of inflammation. Keep in mind, though, as McCullough said:

“This pursuit of a blood clot is very important. I’ve seen multiple cases now where blood clots have been missed … this is now almost a daily occurrence, particularly within the first 90 days after COVID-19. I think after that period of time it becomes progressively less likely.”

 

Heart Problems and Neurological Issues Are Common

Inflammation around the lining of the heart — pericarditis — and the lining of the lungs — pleuritis — may also occur in long COVID. “The virus can set up inflammation and the spike protein is in the body, it’s triggered inflammation and, importantly, that’s really a clinical diagnosis,” McCullough said.9 He prescribes steroids and colchicine, an anti-inflammatory drug commonly used for gout to reduce high uric acid, in such cases.

There’s a real risk for heart attack or stroke to occur without warning in long COVID, so McCullough warns those recovering to “be on your guard,” especially if you have a heart stent or carotid stenosis.

Neurologic syndromes in long COVID also occur, although they aren’t well described. Symptoms include joint and muscle pain, headaches, brain fog and tinnitus (ringing in the ears). Some people also have changes in the autonomic nervous system, such as elevated heart rate, and sensory neuropathies, including numbness and weakness in the legs.

McCullough’s host in the video, Dr. Al Johnson, recommends using a foam roller on your back, three to five times a day, to relax your nervous system, as well as to relieve rib pain from all the coughing. McCullough has had some success treating neurologic symptoms with an older SSRI called fluvoxamine.

 

Supplements That Play a Role in Long COVID Syndrome

Dr. Johnson recommends several supplements to support healing from long COVID. Among them:

McCullough, an enlightened allopathic physician, recognizes the role that dietary and integrative therapies play in helping people recover from long COVID:10

“As an allopathic doctor, I’m not skilled in understanding how to use vitamins and supplements like our integrative, holistic and naturopathic colleagues, but they’ve played a big role in COVID-19. I’ll just make the observation that COVID-19 is an enormous catabolic strain … the weight loss is tremendous.

It is such a strain on the body … we want to avoid sugary foods. When someone has acute COVID-19 and moves into the long COVID, post-COVID syndrome, we want to stay away from sugary foods … the sugar seems to feed the virus. It seems to feed inflammatory processes.”

McCullough has also referred some patients to chiropractors in his area, noting that “long COVID syndrome, out of all the illnesses we face, is one for collaborative care, for integrative care. There’s a lot of elements to it.”11 Likewise, Johnson suggests a combination of physical therapy and exercise — but not overexercising — to get back normal function of your musculoskeletal system.

 

Support a Healthy Microbiome

Research by Dr. Sabine Hazan has shown that your microbiome plays an incredible role in COVID-19.12 According to McCullough, she’s figured out that one reason why certain people within the same household don’t develop COVID-19 while others do comes down to the gut. A healthy microbiome score is protective against developing COVID-19. Bifidobacterium, McCullough notes, is among the leading bacteria that appear to fight off COVID-19.13

“COVID-19 is clearly a GI syndrome,” he said. SARS-CoV-2 collects in your nose and mouth, and as you swallow it’s introduced to your GI tract. According to Forbes, Li Tongzeng, deputy director of the respiratory and infectious diseases department at Beijing You An Hospital, cited research that SARS-CoV-2 survives longer in the anus and feces than in the respiratory tract.

Due to this, an anal swab may be able to more accurately detect mild or asymptomatic cases than a nose or throat test.14

Staying away from irritants to the GI tract is important, and Johnson recommends eating a clean diet with organic food and glass-bottled spring water, if possible. Eating fermented foods, or taking a high-quality probiotic, is also essential for gut health, as is avoiding unnecessary antibiotics usage and processed foods.

 

Chronic Fatigue and Sleep Disturbances

Chronic fatigue is a major problem for many with long-haul COVID, and for this Johnson recommends hyperbaric oxygen therapy (HBOT). One of the reasons I'm fascinated by HBOT, in particular, is because of its ability to improve mitochondrial function.15 As Johnson explained, “Toxins affect the mitochondria … the little engines in our body that create ATP, which is our energy system.”16

HBOT protects against mitochondrial dysfunction,17 speeding up the mitochondria and ATP production, which helps increase energy while decreasing brain fog and fatigue. Further, Johnson added, it helps heal body tissues like your lungs, heart and muscles while decreasing inflammation and lessening symptoms.

If sleep disturbances are an issue — and they often are for long haulers — McCullough recommends avoiding alcohol for at least a month, as “just one drink in 28 days will destroy sleep architecture.” The Front Line COVID-19 Critical Care Working Group (FLCCC) has a management protocol — I-RECOVER18 — for long haul COVID-19 syndrome that includes melatonin, which can also help with sleep disturbances.

 

Shot-Induced Myocarditis Is Worse Than COVID’s

McCullough detailed the non-fatal syndromes that are occurring after COVID-19 shots, which cause symptoms similar to that of long COVID in many cases. The shot-induced syndromes fall into four areas, the first being cardiac.

Myocarditis is a recognized effect of both COVID-19 and COVID-19 shots, but they’re completely different, McCullough said. “A child is more likely to be hospitalized with myocarditis after a Pfizer or Moderna [shot] than actually being hospitalized with COVID-19,” he said. Further:19

“The myocarditis in COVID-19 is mild. It’s inconsequential. I don’t want anyone to think that the myocarditis we’re seeing with the natural infection is anything like what we’re seeing with the [shots] … there are studies suggesting the lipid nanoparticles actually go right into the heart, the heart expresses the spike protein, the body attacks the heart.

There are dramatic EKG changes. The troponin, the blood test for heart injury with the vaccine myocarditis, is 10 to 100 volts higher than the troponin we see with the natural infection. It’s a totally different syndrome. When the kids get myocarditis after the vaccine, 90% have to be hospitalized … so vaccine-induced myocarditis is a big deal, and in children it’s way more serious and more prominent than a post-COVID myocarditis.”

In addition to myocarditis, atrial fibrillation in young people and pericarditis can also occur post-COVID-19 shot. The second category of shot-induced syndromes is neurologic, which causes neurological symptoms similar to those among COVID-19 long haulers, as well as additional, more serious, effects. This includes Guillain-Barré syndrome, which can be fatal, bell’s palsy, seizures, persistent headaches and blood clots in the brain.

The third category is immunologic, which includes suppression of lymphocyte count and reactivation of other viral syndromes, including Epstein-Barr virus and shingles. The fourth category — hematologic — occurs about two weeks after the shot and describes vaccine-induced thrombocytopenic purpura.

Signs include bruising all over the body, bleeding from the gums and nose and dark urine. If you notice these signs in the weeks after receiving a COVID-19 injection, get to a hospital immediately.

“What happens,” McCullough says, “is the [shot] tricks the body and gives excessive antigenic presentation of platelets to the spleen, the spleen produces an antibody that actually pins platelets against blood vessel walls … and that’s what drives vaccine-induced thrombocytopenic purpura.”

For those suffering from these shot-induced syndromes, FLCCC’s I-RECOVER20 protocol for long-haul COVID syndrome has been used to treat shot-induced symptoms with similar success. The protocol can be downloaded in full,21 giving you step-by-step instructions on how to treat long-haul COVID syndrome and/or reactions from COVID-19 injections.

 

Sources and References

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Blaylock’s COVID Vaccine Protocol

https://www.blaylockreport.com/

by Dr. Russell Blaylock

 

Dr. Blaylock was not only known for being an amazing neurosurgeon, he’s a lecturer, author, founder of Theoretical Neuroscience Research, LLC and Associate Editor of the Neuroinflammation section of Surgical Neurology International. (He also writes The Blaylock Wellness Report, which I highly recommend subscribing to.)

Dr. Blaylock has also become one of my very good friends and gave me permission to share his COVID vaccine protocol with you. This post is not medical advice. It is for information purposes only. Use (or don’t use) this protocol at your own risk. If you want to keep your blinders on and pretend that these quackxines have zero negative effects whatsoever on your body, you should stop reading here. Otherwise, proceed to the protocol.

  1. 50 billion CFU of several acidophilus and bifidobacterial strains — along with a GOS probiotic — each morning before breakfast
  2. A B-complex vitamin (Pure Encapsulation)
  3. Nano-vitamin C 500mg capsules (three between each meal)
  4. Buffered Vitamin C with Hepseridin — three 500mg capsules with each meal.
  5. L-carnitine 500 mg three times a day with meals.
  6. NAD+ nicotinamide — one capsule a day
  7. Nano-Curcumin — two 250mg capsules with each meal
  8. Nano-Quercetin — one 250mg capsules with each meal
  9. Nano-Bacopa — two capsules twice a day with a meal
  10. NAC 900 mg capsules — two capsules taken with a meal once a day.
  11. Mixed tocotrienols — 150 mg a day
  12. Magnesium citrate/malate (Pure Encapsulation) a powder — 250mg dissolved in 4 ounces of water three times a day
  13. Baicalin 250 mg dissolved in water (4 ounces) twice a day
    Note: This can be mixed with the magnesium, and is a powerful antiviral.
  14. Pterostilbene — 200 mg twice a day with a meal.
  15. CoQ10 — 600mg taken three times a day with food (Doctor’s Best)
  16. Astragalus — one capsule a day (enhances lymphocyte production)
  17. Benfotiamine in a dose of 150mg twice a day with a meal for brain protection.
  18. One adult aspirin for day if magnesium + nanocurcumin are not available and an emergency “stop-gap” is needed.

For those unable to take pills, numbers 2, 4, 5, 7, 8, 12 and 13 can be dissolved in water and have very little taste when mixed together.

Blaylock said the main effects of COVID vaccines are centered around inflammation and macrophage/microglial activation. “These supplements listed above powerfully inhibit these two processes,” he said.

COVID vaccines also induce thrombosis (blood clots) and micro-thrombosis, thus many of these supplements will slightly thin the blood and prevent blood clots, such as the magnesium, nano-quercetin and nano-curcumin.

Blaylock said magnesium is the most important thing on the list, as it alters the rheology of the red blood cells to reduce risks and also acts as a mild anticoagulant, while vitamin C inhibits excessive coagulation.

“Hydration is also essential,” he said. “One should drink at least five or six glasses of purified water a day. White tea also inhibits the inflammation and suppresses many viruses.”

For conventional vaccines, Blaylock recommended using a cold pack on the injection site to block the immune reaction. For COVID vaccines the opposite may be true:

Heat may inactivate the nanolipid carrier and destroy the mRNA, which is why they keep most of the vaccine in very cold storage. Later, say days to weeks, it may be helpful to take very cold showers or if available use the cold treatments at a special center, such as Core Cryotherapy center. Cold blocks the immune reactions and could prevent the damage that occurs later. IV vitamin C plus magnesium infusions would also help reduce symptoms. 

Dr. Blaylock said I was free to use his protocol as I pleased, so I’m assuming the same applies to all of you. Good luck!

Editor’s note: To locate these supplements, you will have to do your own online search. (I had no issue finding them.) Ideally, you would be on this protocol shortly before getting vaccinated, but if you already have been, it’s better late than never. How long you should do the protocol depends on the person -- age, weight, health issues, adverse events, vaccine etc. There’s no one-size fits all. Some have done it for six months. Others have stayed on it longer. Assess your own health, gauge your symptoms and use your best judgment.

______________________

Critiques of this Vaccine Protocol. . . .

https://meganredshaw.substack.com/p/covid-vaccine-protocol-what-to-do/comment/3273000

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k.

November 18, 2021

https://childrenshealthdefense.salsalabs.org/11-18-21defender4?wvpId=189b60d2-dd1a-44a8-9bb7-17e10fa51f5e

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l.

NIH and EcoHealth Colluded to Evade Research Restrictions

 

https://www.youtube.com/watch?v=wwGVMA51xDo

Analysis by Dr. Joseph Mercola Fact Checked

 

Story at-a-glance

 

The walls are closing in on Dr. Anthony Fauci as emails reveal the National Institutes of Health colluded with EcoHealth Alliance to circumvent federal restrictions on gain-of-function (GOF) research.

The damning revelations were published by The Intercept1 and Daily Caller,2 November 3, 2021. While the NIH has kept the grant correspondence secret, only allowing select congressional staff to review the documentation in a private session, The Intercept was given access to their personal notes.

Considering federal grants are of clear public interest, the NIH’s decision to not make the correspondence public is suspicious in and of itself. Are they hiding something? You bet. As reported by Intercept journalists Sharon Lerner and Mara Hvistendahl:3

“Emails show that NIH officials allowed EcoHealth Alliance to craft oversight language governing its own gain-of-function research ...

Detailed notes on NIH communications obtained by The Intercept show that beginning in May 2016, agency staff had an unusual exchange with Peter Daszak, the head of EcoHealth Alliance, about experiments his group was planning to conduct on coronaviruses under an NIH grant called ‘Understanding the Risk of Bat Coronavirus Emergence’4 ...

EcoHealth was entering the third year of the five-year, $3.1 million grant that included research with the Wuhan Institute of Virology and other partners. In a 2016 progress report, the group described to NIH its plans to carry out two planned experiments infecting humanized mice with hybrid viruses, known as ‘chimeras.’

The plans triggered concerns at NIH. Two staff members — Jenny Greer, a grants management specialist, and Erik Stemmy, a program officer handling coronavirus research — wrote to EcoHealth Alliance to say that the experiments ‘appear to involve research covered under the pause,’ referring to a temporary moratorium5 on funding for gain-of-function research that would be reasonably anticipated to make MERS and SARS viruses more pathogenic or transmissible in mammals ...

Initially, NIH staff appeared intent on enforcing the funding pause ... But what happened next sets off alarm bells for biosafety advocates: Agency staff adopted language that EcoHealth Alliance crafted to govern its own work.

The agency inserted several sentences into grant materials describing immediate actions the group would take if the viruses they created proved to become more transmissible or disease-causing as the result of the experiments.”

 

NIH Tries to Evade Responsibility

The NIH is now trying to evade responsibility by shifting blame for the unlawful research onto EcoHealth Alliance. October 21, 2021, NIH principal deputy director Lawrence Tabak, Ph.D., sent a letter6,7,8 to James Comer, ranking member of the Committee on Oversight and Reform, “to provide additional information and documents regarding NIH's grant to EcoHealth Alliance Inc.”

In the letter, Tabak acknowledged that Fauci lied to Congress when he emphatically insisted the NIH/NIAID have never funded GOF research. However, when it comes to circumventing the research moratorium, Tabak lays the blame squarely at the feet of EcoHealth. According to Tabak:9

“The limited experiment described in the final progress report provided by EcoHealth Alliance was testing if spike proteins from naturally occurring bat coronaviruses circulating in China were capable of binding to the human ACE2 receptor in a mouse model ...

In this limited experiment, laboratory mice infected with the SHC014 WIV 1 bat coronavirus became sicker than those infected with the WIV1 bat coronavirus. As sometimes occurs in science, this was an unexpected result of the research, as opposed to something that the researchers set out to do ...

The research plan was reviewed by NIH in advance of funding, and NIH determined that it did not to fit the definition of research involving enhanced pathogens of pandemic potential (ePPP) because these bat coronaviruses had not been shown to infect humans. As such, the research was not subject to departmental review under the HHS P3CO Framework.

However, out of an abundance of caution and as an additional layer of oversight, language was included in the terms and conditions of the grant award to EcoHealth that outlined criteria for a secondary review, such as a requirement that the grantee report immediately a one log increase in growth.

These measures would prompt a secondary review to determine whether the research aims should be re-evaluated or new biosafety measures should be enacted. EcoHealth failed to report this finding right away, as was required by the terms of the grant.”

In other words, EcoHealth’s experiment “accidentally” turned into GOF. At that point, EcoHealth should have alerted the NIH, but allegedly didn’t. So, according to Tabak, NIH bears no responsibility as they relied on EcoHealth to follow the terms of the grant.

EcoHealth has denied this charge, saying “These data were reported as soon as we were made aware, in our year four report in April 2018 ... At no time did program staff indicate to us that this work required further clarification or secondary review.”10,11

As noted by The Intercept,12 Tabak implies the NIH created that reporting rule “out of an abundance of caution,” but according to the correspondence The Intercept reviewed, “the language was inserted at Daszak’s suggestion,” and “the NIH and EcoHealth Alliance worked together to evade additional oversight.”

 

Illogical Justifications

How did they evade additional oversight? Through illogical and contradictory risk assessments. While Tabak claims the resulting virulence was unintentional, how could that be, since the experiment in question was supposed to test the “emergency potential” of bat coronaviruses in the human population?

The name of the grant itself tells us they’re going to assess the possibility of a bat coronavirus mutating into something that can affect humans, and to do that, they will likely try to manipulate the virus to see if it can gain that function.

EcoHealth president, zoologist Peter Daszak, suggested to the NIH that the experiment should not be categorized as restricted GOF because his proposed hybrid viruses were so different from the SARS virus (which is known to infect humans). The Intercept continues:13

“Daszak also pointed out that WIV1, the parent of the proposed chimeric SARS-like viruses, ‘has never been demonstrated to infect humans or cause human disease,’ according to the transcribed emails.

And he said that previous research ‘strongly suggests that the chimeric bat spike/bat backbone viruses should not have enhanced pathogenicity in animals.’ The NIH would go on to accept these arguments.

But the group’s argument that its viral research did not pose a risk of infection appears to contradict the justification for the work: that these pathogens could potentially cause a pandemic.

‘The entire rationale of EcoHealth’s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk,’ said [Fred Hutchinson Cancer Research Center virologist, Jesse] Bloom.

‘Given that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?’”

But Daszak’s justification makes no sense for yet another reason. Three months before Daszak wrote that determination for the NIH — where he suggests the WIV1 virus they were going to use as the backbone for the chimeras had “never been demonstrated to infect humans or cause human disease” — his collaborator, Ralph Baric, Ph.D., had published a paper14 showing WIV1 did indeed have the ability to infect humans.15

This is terrific! We are very happy to hear that our Gain of Function research funding pause has been lifted. ~ Dr. Peter Daszak, email to NIH

Baric, who works at UNC Chapel Hill, had found the WIV1 virus “readily replicated efficiently in human airway cultures and in vivo,” and posed an “ongoing threat” to the human population. This completely contradicts Daszak’s statement, and it’s doubtful that Daszak would not be aware of the paper published by Baric three months earlier. It’s doubtful the NIH would be ignorant of Baric’s finding as well.

 

NIH Accepted Daszak’s Escape Clause

As explained by The Intercept, Daszak came up with a solution that would allow his group and the NIH to perform research they all knew was prohibited at the time:16

“If the recombinant viruses grew more quickly than the original viruses on which they were based, [Daszak] suggested, EcoHealth Alliance and its collaborators would immediately stop its research and inform their NIAID program officer ...

In a July 7 letter to EcoHealth Alliance, NIH’s Greer and Stemmy formally accepted Daszak’s proposed rule. The chimeric viruses were ‘not reasonably anticipated’ to ‘have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route,’ the administrators concluded ...

The language that the NIH later inserted into the grant was strikingly similar to what Daszak proposed: ‘Should any of the MERS-like or SARS-like chimeras generated under this grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain you must stop all experiments with these viruses.’”

In a July 2016 email to the NIH, Daszak expresses his satisfaction that the agency decided to accept his justifications for why the research should not be considered restricted GOF. “This is terrific!” he wrote. “We are very happy to hear that our Gain of Function research funding pause has been lifted.”17 Daszak even admits that what they’re REALLY doing is GOF right in that email.

 

Clear Regulatory Failure

When EcoHealth’s scientists performed the experiment, one of the chimeric viruses grew much faster than the others during the first week of the experiment, producing a viral load that was four logs greater than the parent virus.

As noted earlier, Tabak claims EcoHealth didn’t inform the NIH program officer about this gain of function, and EcoHealth claims it did, and was permitted by default to continue, as no one at the NIH objected.

Incidentally, Daszak was relying on Wuhan Institute of Virology researcher Shi Zhengli — known to have ties to the Chinese military — to notify him if any of the viruses in the experiment had enhanced replication. Daszak in turn informed the NIH about this chain of reporting, so they knew the legality of the research basically rested in the hands of a Chinese operative, who may or may not have incentive to downplay such findings. 

Richard Ebright, a molecular biologist at Rutgers University who has criticized the lack of oversight of gain-of-function research, told The Intercept that the correspondence between the NIH and EcoHealth points to clear regulatory failure. “The oversight process clearly failed,” he said. Ebright also spoke to the Daily Caller, stating:18

“The NIH, incredibly, accepted EcoHealth’s belief that this work would not be considered gain of function, and accepted EcoHealth’s rationale for this belief, and accepted EcoHealth’s policy-noncompliant proposal for a [10 times] allowance for increased viral growth before stopping work and reporting results.

The NIH, in effect, delegated to EcoHealth Alliance the authority to determine whether its research was, or was not gain of function research subject to the funding pause, the authority to set criteria for the determination, and the authority to over-ride federal policies implemented by the White House ...”

The same sentiment was expressed by House Energy and Commerce Committee ranking member Rep. Cathy McMorris Rodgers and several other Republican lawmakers in an October 27, 2021, letter19,20 to NIH director Dr. Francis Collins. As reported by Daily Caller:21

“’EcoHealth portrayed the risks of these experiments as if they were not of concern, and the NIH accepted EcoHealth’s assertions without a searching inquiry,’ the Republican lawmakers told Collins. ‘However, the assessment of the risks by both EcoHealth and the NIH do not seem to square with the understanding of the research risks at that time ...

Although the engineered viruses at the WIV were far from SARS CoV-2 on the coronavirus family tree, this research reflected a high tolerance for risk,’ the lawmakers said, adding that there is no evidence that EcoHealth took action to notify the NIH that it created viruses that exhibited enhanced growth in humanized cells.

‘If EcoHealth and NIH could not handle compliance and oversight of such a basic policy, it raises more concerns about the overall adequacy of the oversight of this research, which leaves the public vulnerable to a serious lab accident,’ the lawmakers wrote.”

 

CNN Grills NIH Director

In a rare attempt at real journalism, CNN’s Pamela Brown kept Collins strapped to the hot seat in a recent interview, repeatedly grilling him about why the NIH was funding dangerous GOF research.22 Even Josh Rogin from the liberal Washington Post picked up on Brown’s dogged demands for Collins to come clean on the issue in the face of Collins’ attempts to sidetrack her:

“Everyone should watch this interview with outgoing NIH director Francis Collins to see how Collins uses misleading talking points to avoid any acknowledgement NIH was caught completely unaware its grantee was doing risky bat coronavirus research in Wuhan ... Collins uses every rhetoric trick to dissemble and distract ...” Rogin tweeted.23

To her credit, Brown repeatedly brought the interview back on track, pressing Collins for answers, demanding to know:

“Why should Americans trust you and the NIH on the issue of COVID origins, when you didn’t even know about the programs it was funding with taxpayer dollars in China?"

When Collins tried to circumvent the question by diving into semantics about the definition of GOF, Brown interrupted him, again asking how he can be so certain that NIH funding isn’t being used for GOF, when he claims the NIH only recently found out about how the money was used in 2016?

Collins also reiterated that while EcoHealth “did some things they should have told us about ... they did not do the kind of gain-of-function research that requires special, high-level oversight.” Really? As noted by ZeroHedge:24

“... if EcoHealth HAD reported its research results, it WOULD HAVE triggered extra, high-level oversight. Why is Collins pretending he knows they would have been exempt from that?”

Despite Collins’ insistence that the NIH was above-board and honest in all its communications, Brown refused to let him off the hook, ending the interview with: “This is U.S. taxpayer dollars going to risky research and I believe every American deserves to know about it.”

On a sidenote, like Fauci’s, Collins’ halo is rapidly tarnishing as alternative media have started digging into their backgrounds. While appearing squeaky clean on the surface, a closer look reveals both men have supported all sorts of questionable research, including research on aborted fetuses.

For an overview of Collins’ alleged sins, see First Things’ article, “The Cautionary Tale of Francis Collins.”25 Unlike Fauci, though, Collins seems to sense he won’t escape public judgment. In October 2021, he announced his retirement from the NIH. He’s reportedly planning to step down by the end of the year. Time will tell if Fauci will have the good sense to resign, or if our political leaders will finally boot him out and press charges.

 

We Must Ban GOF Research

The evidence of regulatory failure by the NIH further strengthens the call for a permanent ban on most kinds of GOF. As Bloom told The Intercept:26

“We urgently need a broader discussion about whether it’s a good idea to be making novel chimeras of coronaviruses that are at this point universally acknowledged to pose a pandemic risk to humans.”

Indeed, it appears we got off easy this time. SARS-CoV-2 has a very low mortality rate, despite spreading quite easily. The next Frankenstein pathogen to escape from a lab might not be as benign.

Seeing how the people in charge of making decisions about what research is to be allowed cannot be trusted with making sensible decisions, the public really needs to step up and let our representatives know we will not tolerate federal funds — taxpayer money — being used for research that has the potential to wipe us all out.

 

Sources and References

+

Fake News: How an ivermectin story got amplified around the world

when nobody seemed to check the facts

https://sharylattkisson.com/2021/09/fake-news-how-an-ivermectin-story-got-amplified-around-the-world-when-nobody-seemed-to-check-the-facts/

by Sharyl Attkisson

+

From: Dragan Pavlovic
Sent: Saturday, November 20, 2021
Subject: Re: Legal history made in Alberta, Canada: Light at the end of the tunnel?

 

Part I

“Selection Bias in the Covid-19 Clinical Studies”[1]

Retractions of The Lancet and The NEJM Hydroxychloroquine Papers

 

_______________________________________________________________

 

Dragan Pavlovic (corresponding author)

Adjunct Professor of Anesthesiology

Department of Anesthesia, Pain Management and Perioperative Medicine

Dalhousie University, Halifax
QEII Health Sciences Centre
10 West Victoria, 1276 South Park Street
Halifax, NS B3H 2Y9 Canada

dragan.pavlovic@gmail.com

 

______________________________________________________________________

 

Abstract.

It was claimed that a combination of hydroxychloroquine and azithromycin may have some preventive effects for Covid-19 infection. Nevertheless, this has been challenged between others by two large retrospective clinical studies, by a group from Harvard Medical School, whose articles were published in The Lancet and the New England Journal of Medicine and then 10 days after, the articles were retracted because of legal reasons. We claim no knowledge about the efficacy of the hydroxychloroquine (HCQ) and do not discuss the agent at all. However, here we claim that besides legal reasons, the methodological reasons for the withdrawal of the papers were even more important. The patients that receive HCQ during spring 2020. were predominantly the high-risk patients and it was not possible to have a retrospective study that would not suffer from selection bias. This means that the studies compared incomparable groups and failed to demonstrate the link between the agent and the outcome. The error is so flagrant that it is impossible that the investigators, 3 highest medical authorities as well as and primarily The Lancet or NEJM reviewers, overlooked it. We proposed that even if correctly performed, some eventual Randomised Controlled Trial ( RCT) will be very hard to interpret because of always present potential various hidden errors and that the conclusion of such studies should always be taken with much reserve. Probably some more reliable methods of clinical research should be developed in the future.

 

Keywords: hydroxychloroquine, chloroquine, Covid-19, Randomised Controlled Trials, The Lancet, retracted article.

 

DOI: 10.35088/e4xq-1q16

____________________________________________________________________

 

Introduction

Clinical research is a complex enterprise and methodological errors are hard to avoid. Most often the researchers are not conscious of the errors that their otherwise solid research projects contain. Even the journals of the highest reputation will sometimes be victims of pressures to publish research papers that may have hidden fundamental mistakes. This may particularly be the case if the issue is important and the political and public pressures are high, as is the case now with the Covid-19 pandemic since presently, there is no causal therapy for this viral infection.

 

It was claimed that a combination of hydroxychloroquine and azithromycin may have some preventive effects for Covid-19 infection. Nevertheless, this has been challenged between others by two large retrospective clinical studies, by a group from Harvard Medical School, whose articles were published in The Lancet and the New England Journal of Medicine and then 10 days after, the articles were retracted because of legal reasons. We claim no knowledge about the efficacy of the hydroxychloroquine (HCQ) and do not discuss the agent at all. However, here we claim that besides legal reasons, the methodological reasons for the withdrawal of the papers were even more important.

 

Below, we will first give a shortlist of the problems and mistakes and then discuss just the first cited paper initially published by The Lancet.1 The third cited article, by Cavlacanty et al.2 has similar mistakes as the first two and will not be analysed in detail. The paper of the Marseilles group,3 that somehow initiated the debate, will be just cited but not analysed. The three concerned papers, one from The Lancet and two from the NEJM, are as follows (a, b, c):

  1. Mandeep R Mehra et al. Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis1
  2. Mandeep R. Mehra et al. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-194

and

  1. Cavalcanti, A. B. et al., Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-192

 

Our Commentary on the first, The Lancet paper, by Mehra et al,1 that we submitted on 23 May 2020 (corrected in the following 2 days under the code: “THELANCET-D-20-11873”) was ignored by The Lancet. No reply to the second appeal has been received.

 

The researchers from the Harvard Medical School produced the above-mentioned papers (2 first papers) in May 2020. Nine months after that scandal, I believe since the spirits are calmed, we can look at the matter with more reason. We claim that the articles, besides the probable absence of the facts and truths and legal problems, (that we do not address), contained methodological mistakes. The research that concerned HCQ therapy was in the focus of all media. The controversy is nothing strange in science. Yet, the real problems, no doubt, are those Harvard papers that were, methodologically, a failure. Harvard University is (or has been) one of the top universities in the world. Besides, the papers were published in the most valued "worldly" medical journals – and then retracted as “almost” frauds. While the Marseilles paper3 that initiated the debate, was a simple report on the use of a possible drug for the Covid-19 patients that urgently needed therapy, Тhe Lancet and the NEJM papers were scientific failures combined with a major public scandal.

 

The following calendar of the events will be useful to understand the problem:

13th  January 2020, withdrawal of HCQ from the pharmacies in France

End of March 2020, HCQ forbidden to be used by the GPs for the COVID-19 patients in France.

22nd May 2020, The Lancet paper appeared online.

23rd  May 2020, HCQ was forbidden by the WHO and in France to be used for COVID-19 outside of the specialised institutions.

Then, on 2-3 July, the WHO forbids again the experimentation with HCQ - despite the publication (one day before) of the Arshad et al. large Detroit study which confirms certain (important) effects of the HCQ therapy.5

 

It is not easy to believe that just by mistake (i) the Harvard scientists would conceive such a study, (ii) that the two most prominent medical journals would accept to publish such papers, that (iii) the World Health organisation (WHO), (iv) the French government and (v) the French Scientific counsel would, one day after the publication of The Lancet paper, ban the use of the HCQ.6 Where was the methodological problem?

 

Selection bias and Covid-19 Therapy

The work by Mehra et al.3 is an interesting analysis of a multinational registry. However, first of all, the reader should be reminded that this analysis is based on retrospective, historical data - a type of clinical studies that have been known for years to contain many errors that not randomized historical approach research may have. It looks like the analyses that were often praxis in the fifties and sixties of the past century, often based on retrospectively big collections of data that, unfortunately, produced many unreliable conclusions. Particularly if they were multicentre and very large studies. The problems with such studies are abundant and it will be impossible to list even the most important. Indeed, we will discuss here only The Lancet paper methodology, restricting our discussion just to a small trivial fraction of the methodological problems. The legal questions have been communicated by several other commentators directly to The Lancet (the journal never disclosed them to the public) and they were such that the authors retracted the two papers (the NEJM paper also) 10 days after publication. Indeed we think that the methodological questions are of extreme importance for the scientific community and should not be neglected. They are indeed quite simple and visible to almost anyone.

 

The paper maintained, for example, that since non-survivals received more often HCQ than survivals - HCQ was a cause of death of those patients. The problem with such a conclusion is more than evident. An example with oxygen may be sufficient. For example, the non-survivals had more often oxygen - why then cannot the conclusion be that oxygen killed some COVID-19 patients? This would certainly be confusing risk factors with causal factors, or even including completely irrelevant factors. Or being over 65, obese, being in the ICU, would be the risk factors but not causal factors. Similarly, a therapy that saves the lives of some seriously ill patients cannot be confounded with causal factors just because a majority of patients that die, receive such therapy, while the patients that are not so gravely affected by the disease, survive “because they do not have such a treatment”. This just sounds trivially false.

 

Furthermore, how do we know that the control groups were comparable to the treatment groups? The authors do not tell us this. In such a study it is very hard to retrospectively fulfil the demands for fair randomisation. If more patients at risk were in the group that was receiving HCQ and the healthier, not at-risk patients, were in the control group, then the outcome would be heavily biased. The tables show that the patients were similar (see the tables in the cited paper), but do not show the degree of risks, which could be very different to start with. One COPD is not the same as any other COPD. As looked at from the outcome side, the non-survivals had much more often comorbidities than survivals (Table 1, ref. 1), which implies a selection bias also.

 

So let us now look at the study from two sides, (A) before and (B) after the event of disease and treatment and describe how this was done in reality.

A) How would it look from the start to the intervening physician? If we assume normal behaviour of the physicians or just see how it was in France when the government and the Scientific commission finally accepted to encourage clinical studies, quite logically: the HCQ (that was withheld at first) had to be administered only in hospitals and just to the patients at risk and with more advanced serious symptoms. In fact, on March 24, 2020, HCQ was permitted to be given only to patients with grave symptoms.7 The atmosphere in France was against HCQ and for the use only in the patients with high risk (of dying) - the agent was requisitioned by the governmental order already in January 2020 for these purposes. The drug was not prescribed without bias already from January 2020. The situation in the world was probably also influenced by this "Zeitgeist".

 

Indeed, the Mehra et al. study1 included 50 European hospitals, but the real question is: from which hospitals and how many patients from France for example were included? A large number of Covid-19 patients in France were to be included in the "Discovery" studies which should involve over 800 hospitals only in France and should have included 3200 hospitals in the world. These studies examined the mentioned agents only in patients at risk or gravely ill. If HCQ was given more to patients that had more chances to die (what the regulation from 24. march, 2020 imposed) than for those that did not receive it, a selection bias was programmed. Besides, not to state in the study how the hospitals and countries were chosen is a problem, since the number of hospitals was large and the criteria of choice needed to be communicated and the method about how the bias was avoided needed to be disclosed.

 

Also, the decision to administer or not the chloroquine or HCQ to the patients presented with the Corona-19 symptoms (in the hospitals all over the world - France included) was most probably spontaneously guided by the known risk factors that the patients presented.

 

B) Let us then examine now how this looks like from the point of the present time, retrospectively. No wonder, then, that we find, when we look retrospectively, that more non-survivals received the mentioned HCQ therapy. The finding that non-survivals have had the mentioned agent as therapy, was no doubt, due to conscious, intelligent human intervention, a coherent behaviour of the caring physicians or because the French physicians were obliged to administer the agent only to the patients that had a higher risk of dying.

 

Also, it seems that coronary artery disease, congestive heart failure, and arrhythmia patients, received HCQ. Yet those were considered to be contraindications for administrating the mentioned agents and can explain cardiac complications that were observed in the study, in the groups that received those agents. The most likely conclusion will then be that the agents produce undesirable complications if used beyond the recommendations.

 

In conclusion, this is again one in the series of non-randomized or in many different ways problematic studies that try to evaluate the relevance of the initial Marseille study.3 The Marseille study is apparently in the middle or upper part of the low level on the Evidence-Based Medicin Level scales8 so it is not to be rejected at this stage.

 

The analyses of Mehra et al. and Cavalcanty et al., papers1,2 could only demonstrate that the examined agents probably are not of much use for the COVID-19 patients who are in the advanced phase of the disease and that if used, the well-known contraindications should be respected. However, we desperately need a study that verifies the initial Marseille finding,3 a coherent randomized clinical trial with the results that will contain hard facts. Certainly, we should be aware that this will not be finally "a clarification" but just a start of the efforts that will aim at finding out whether HCQ may have some effects on COVID-19. The agent seems to have antiviral properties in vitro9 and at least, for the respiratory infections, apriori its use as aerosol may be envisaged preventively. We will not elaborate more on this hypothesis here. What is needed is to establish acceptable arguments in favour of its use, or its dismissal. Indeed, the question that remains is what kind of randomised Clinical Trial (RCT) would be able to establish a piece of reliable information. One different response is urgently needed too: how the highest medical authorities (the World Health Organisation [WHO)], the French government, the French Scientific Commission) might have committed such a series of incoherent acts in concert? Since this cannot be just an example of the “Swiss cheese model” of an accident, there is little doubt that we had a serious, maybe even conscious, methodological, scientific failure.

 

In the paper published in 2005, Ioannidis summarised some of the objections to the RCT that I discussed above.10 A better approach may be a clear pathophysiological method where we would rely on basic science and look for mechanisms of the diseases and the mechanisms of action of the agents. The principles of the RCT are wonderful, the principle of the "intention to treat" is fine, but we need more. We need to know our patients better, The method that we need should be the method that corresponds more to the subject of the investigation that belongs somewhere in between pure science, medical science and social science. We need to know the mechanisms of actions, cause-effect relations, and the patients in all their sophistication. And before all, we need morally fully justified methods, and we, certainly, need Reason.

 

Literature

1. Mehra, Mandeep R, Sapan S Desai, Frank Ruschitzka, Amit N Patel, Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, The Lancet, online of 23. May 2020,

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)31180-6.pdf (Viewed on 23rd May 2020); RETRACTED June 5, 2020:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31324-6/fulltext (Viewed on June 5, 2020)

 

2. A.B. Cavalcanti, et al, Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19,  NEJM, 383; 21, 2020; 2041 – 2052.

This article was published online on July 23, 2020, at the NEJM.

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2019014?articleTools=true  (Viewed on 23rd August 2020)

 

3. Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents 2020;  56, 1, 105949.

Published online March 20. DOI:10.1016/j.ijantimicag.2020.105949. (Viewed on 23rd May 2020)

 

4. Mehra, Mandeep R., M.D., Sapan S. Desai, M.D., PhD, SreyRam Kuy, M.D., M.H.S., Timothy D. Henry, M.D., and Amit N. Patel, M.D. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19, NEJM, online, May 1, 2020,

https://www.nejm.org/doi/full/10.1056/NEJMoa2007621 (Viewed on 23rd August 2020)

RETRACTED June 5, 2020

https://www.nejm.org/doi/full/10.1056/NEJMc2021225?medium=organic-social&source=nejmtwitter; (Viewed on 23rd August 2020)

 

5. Arshad, Samia, Paul Kilgore, Zohra S. Chaudhry, et al.Treatment with hydroxychloroquine, azithromycin, and combination in patients hospitalized with COVID-19, Int J Infect Dis. 2020; 97: 396–403.

On line: https://www.ijidonline.com/article/S1201-9712(20)30534-8/fulltext (Viewed on 23rd August 2020)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7330574/(Viewed on 23rd August 2020)

 

6. Matthias Blamont, Alistair Smout, Emilio Parodi, EU governments ban malaria drug for COVID-19, trial paused as safety fears grow, Available:

https://www.reuters.com/article/us-health-coronavirus-hydroxychloroquine/france-bans-hydroxychloroquine-to-treat-covid-19-idUSKBN233197?il=0 (Viewed on 27th May 2020)

 

7. France allows drug chloroquine to be given to gravest coronavirus cases, AFP, 24 March 2020.

https://www.thelocal.fr/20200324/france-allows-chloroquine-to-be-given-to-gravest-coronavirus-cases (Viewed on 23rd May 2020)

 

8. From the Centre for Evidence-Based Medicine, Oxford. For the most up-to-date levels of evidence, see www.cebm.net/?o=1025.

Or, Stony Brok Univesity Library, Frank Melville Jr., Memorial Library, Stony Brook University, Stony Brook, NY 11794-3300.

https://guides.library.stonybrook.edu/evidence-based-medicine/levels_of_evidence

(Viewed on 23rd May 2020)

 

9. Wang, Manli, Ruiyuan Cao, Leike Zhang, Xinglou Yang, Jia Liu, Mingyue Xu, Zhengli Shi, Zhihong Hu, Wu Zhong and Gengfu Xiao, Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Cell Research, 2020; 30:269–271; https://doi.org/10.1038/s41422-020-0282-0.

 

10. Ioannidis JPA (2005) Why most published research findings are false. PLoS Med 2(8): e124

 

*) Some important Internet sites, viewed on 23rd May 2020:

 

Launch of a European clinical trial against COVID-19, Press release | 22 Mar 2020 - 13h00, INSERM PRESS OFFICE . Available:

https://presse.inserm.fr/en/launch-of-a-european-clinical-trial-against-covid-19/38737/ (Viewed on 23rd June 2020)

 

Arrêté du 13 janvier 2020 portant classement sur les listes des substances vénéneuses

NOR : SSAP2001007A
ELI :
https://www.legifrance.gouv.fr/eli/arrete/2020/1/13/SSAP2001007A/jo/texte,

JORF n°0012 du 15 janvier 2020, Texte n° 13. Available :

https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000041400024 (The hydroxychloroquine is classified as a poisonous substance and practically withdrawn from the pharmacies.) (Viewed on 23rd June 2020)

 

Benoît Zagdoun, Agnès Buzyn et son mari, Didier Raoult et la chloroquine… On a examiné au microscope les 20 affirmations d'un message censé prouver un "scandale d'Etat", Les allégations contenues dans un message devenu viral sur les réseaux sociaux sont soit fausses soit imprécises. Mais, surtout, elles ne prouvent rien. Franceinfo. Available :

https://www.francetvinfo.fr/sante/maladie/coronavirus/agnes-buzyn-et-son-mari-didier-raoult-et-la-chloroquine-on-a-examine-au-microscope-les-20-affirmations-d-un-message-cense-prouver-un-scandale-d-etat_3891385.html (Viewed on 23rd June, 2020)

 

Décret n° 2020-314 du 25 mars 2020 complétant le décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l'épidémie de covid-19 dans le cadre de l'état d'urgence sanitaire, Dernière mise à jour des données de ce texte : 26 mars 2020, NOR : SSAZ2008362D. Available :

https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000041755775&categorieLien=id (Viewed on 23rd June, 2020)

 

L’hydroxychloroquine n’est plus autorisée en France pour traiter le Covid-19. La décision suit l’avis rendu mardi par le Haut Conseil de la santé publique. Vendredi, une vaste étude internationale concluait à un risque aggravé de mortalité chez les patients atteints de Covid-19 traités avec ce médicament. Le Monde avec AFP. Publié le 27 mai 2020 à 11h09 - Mis à jour le 27 mai 2020 à 13h54. Available :

https://www.lemonde.fr/sciences/article/2020/05/27/le-gouvernement-abroge-l-autorisation-de-l-hydroxychloroquine-pour-traiter-le-covid-19_6040915_1650684.html (Viewed on 23rd June 2020)

 

Part II

“Facts or Values, that is the Question”

Scientific and moral implications of The Lancet and the NEJM Hydroxychloroquine papers retractions.

 

_______________________________________________________________

 

Dragan Pavlovic (corresponding author)

Adjunct Professor of Anesthesiology

Department of Anesthesia, Pain Management and Perioperative Medicine

Dalhousie University, Halifax
QEII Health Sciences Centre
10 West Victoria, 1276 South Park Street
Halifax, NS B3H 2Y9 Canada

dragan.pavlovic@gmail.com

 

______________________________________________________________________

 

Abstract

The search for some effective therapy of Covid-19 infection was marked at the very beginning of the pandemic by an observational study where some positive effects of the combination therapy with hydroxychloroquine and azithromycin were reported. These results were challenged by at least two large, what was presented as clinical studies from Harvard Medical School by Mehra et al. that were published and then 10 days after retracted from The Lancet and the New England Journal of Medicine. The studies contained serious errors: on the one hand, illegal use of the patients' data and then, on the other hand, the selection bias. Here we examined the various other sources of errors of reasoning or possible technical difficulties linked to the Randomised Controlled Trial (RCT) protocols executions, and some more fundamental theoretical problems of reasoning, like vulgar contextualism. We proposed that the RCT impose the confrontation of the facts with values which could be caused by some errors of logic and that the results of such studies should always be taken with much reserve and that probably some more reliable methods of clinical research should be developed.

 

Keywords: hydroxychloroquine, chloroquine, Covid-19, Randomised Controlled Trials, The Lancet, retracted article.

 

____________________________________________________________________

 

 

Introduction

Clinical research is a complex enterprise and several methodological errors are hard to avoid. Most often the researchers are not conscious of the errors that their otherwise solid research projects contain. Sometimes the journals of the highest reputation will be victims of pressures to publish solid research papers that may have hidden fundamental mistakes. This may particularly be the case if the issue is important and the political and public pressures are high, as is the case now with the Covid-19 pandemic.

 

The Harvard Medical School produced two important papers in May 2020 that claimed that controversial therapy for Covid-19, hydroxychloroquine (HCQ) was not only ineffective but dangerous1, 2. After about 10 days, the papers were quickly retracted and HCQ was banned in many countries. We still do not have a definitive answer to that dispute. The controversy is nothing strange in science. Yet, the real problems, no doubt, are the consequences of those Harvard papers that were, methodologically, a failure. Harvard University is (or has been) one of the top universities in the world. Yet, in addition, the papers were published in the most valued "worldly" medical journals – and then retracted as “almost” frauds. While the Marseilles paper3 that initiated the debate, was a simple report on the use of a possible drug for the Covid-19 patients that urgently needed therapy, Тhe Lancet and NEJM papers were scientific failures combined with a major public scandal (5 highest state health institutions taking inconsequent actions). The study contained serious errors, on the one hand, illegal use of the patients' data and then, on the other hand, the selection bias.

 

The analyses of Mehra et al. and Cavalcanty et al., papers1,3 demonstrate that the examined agents probably are not of much use for the COVID-19 patients who are in the advanced phase of the disease and that if used, the well-known contraindications should be respected. However, we desperately need a study that verifies the initial Marseille finding,4 a coherent randomized clinical trial (RCT) with the results that will contain hard facts. Certainly, we should be aware that this will not be finally "a clarification" but just a start of the efforts that will aim at finding out whether HCQ may have some effects on COVID-19. The agent seems to have antiviral properties in vitro5 and at least, for the respiratory infections, apriori its use as aerosol may be envisaged preventively. We will not elaborate more on this hypothesis here. What is needed is to establish acceptable arguments in favour of its use, or its dismissal. Indeed, the question that remains is what kind of RCT would be able to offer a piece of reliable information. One different response is urgently needed too: how 5 scientific, state and international institutions might have committed such a series of incoherent acts in concert?

 

Vulgar Contextualism

The problem of scientific misconduct and the evaluation of the scientific work may be linked with fallacious reasoning. It has become popular to abandon classical reasoning that employs formal logic and to apply various sorts of advanced forms of reasoning that can be described by informal logic6 (intensional logic in particular). While the formal logic concerned manipulation with the arguments without assigning meanings to the symbols that formally represent the arguments, informal logic is supposed to pay attention to the specific meaning of the arguments represented by a variety of logical symbols and depends not only on the formal aspects of the arguments but much more on the truth values of the facts, on how the world is, time, place, a relation of the facts and other similar aspects. Therefore, in informal logic attention is paid to the two aspects of the terms, at the families of the aspects of the terms like sense/reference7 (that are Sinn/Bedeutung in Frege), intension/extension, and connotation/denotation. In general the first would stand for the meaning of the term while the second would concern the range of the items to which the term applies8 (p. 21, ref 12). The concept of intension would refer here to the meaning of the terms and not the intentionality of consciousness (written with “t”).9

 

The evaluation of scientific text is often linked to some theoretical reflection about truth, beliefs, and meanings of the empirical evidence and the way of presenting and evaluating their cognitive values. There are contexts, which may be mutually exclusive and incompatible. Besides in some context, it appears that truth and falsehood are losing their formal independent meaning. Some global context can be accepted or rejected and therefore declared to be true or false, but the truth values of some entities that are inherent in these contexts are taken to be epistemically irrelevant and are overdetermined by the normative definitions of the context to which they belong, irrespective of their isolated meanings and character. This may lead to some absurdities, of course. One of the most important applications of the method of Popper’s method of piecemeal social engineering14 that refers to the individual entities, i.e, that their cognitive value can be viewed to great extent in isolation from the context can resolve the mentioned absurdities and such an approach would remove some grave mistakes which are due to the pernicious effects of the assumed context.

 

In everyday life, we are obliged to base our actions on belief, not knowledge, because knowledge is not available to us in new situations, and operational conditioning has a delayed effect and requires a chain of reinforcing mechanisms.10 Also, we cannot count on estimates based on the probability of an outcome that would allow for perhaps adequate but belated actions. Belief, in turn, relies on experiences related to the “typical contexts” of global conditions10 (p. 50) for which we already have typical answers. The problem is that global conditions, these typical contexts, are also beliefs.

 

Yet, in such circumstances, blind mixing formal and informal logic reasoning may, as said, produce absurdities. We know that the meanings of some propositions are context-dependent, i.e. that their truth value depends on the context, like various aspects of the situation, time, place and maybe some other conditions. Such propositions or sentences need informal logical semantics where the meanings are derived from the intension and extension or the conceptual content of the proposition. This exemplifies the intention or in the other words, sense (Sinn), where the conceptual context itself is the extension, or reference (Bedeutung). Obviously, the propositions may have different extensions in different contexts. As stated in the terms of the intensional logic, such sentences may have multiple references (Bedeutung), i.e. as stated above, multiple extensions. The sentences that we normally use in science are content-independent, could be expressed by the traditional logic and are not the subjects of intensional logic. In fact, the aim of the scientific method is exactly this: to make the propositions of science context neutral. Certainly, knowing how our concepts are in the real world is important, but this is another aspect that is relevant but of a different nature.11

 

The fallacy employed in the above mentions studies was in strong tendencies to make it content-dependent what transformed the meanings of its propositions to be strongly content-dependent too, which had repercussions on the meanings of the very facts that were contained in the propositions. Concretely, in the present studies, the obvious fact that the method of the study did not eliminate the selection bias was taken to be irrelevant. Or it was taken that, contrary to the clear evidence demonstrated in some empirical studies about the effects of some agents on Covid-19, for example, the preventive effects of HCQ, it was also taken to be spurious and irrelevant. On the contrary, the studies with the mentioned selection bias were taken to be relevant. The context of the predominant opinions was taken to be detrimental for the meanings of the experimental or historical clinical trial findings. This introduced rare scientific fallacy, rare at least in the natural sciences.

 

Such fallacies are difficult to avoid in social sciences and have large implications in politics and other social sciences in principle.12 Such approach will sometimes lead the postmodernist interpreters of social events and social theories to catastrophic conclusions: that everything is relative, that there is no truth, no morals, no justice and that facts have no value of truth but that the context is sufficient to determine the truth values. The belated interpreters of these theories forget that such conclusions still basically belong only to a specific context as well - to whom this theory belongs, and that they cannot be literally translated outside their contextual framework. All the mentioned conclusions may be completely wrong and the result will be an unauthorized departure from the very context of the mentioned theories.13 I do not hide my conviction that I believe that the various aspects of the crisis of today's world (social, moral, political (yet not the subjects of this paper) are the direct result of the above-mentioned pernicious way of thinking, "enriched", in the central and leading political circles, by a favourite utilitarian logic.14, 15, 16, 17 This way of thinking makes the journals, especially those from the social sciences, have their own specific publishing "worlds". This makes it almost impossible to publish something in a group of journals that differs in terms of macro concepts from the concepts to which the text submitted to the press belongs - if they are different. The authors are thus divided into groups belonging to special, clearly differentiated clans that do not mix.

 

The problems then multiply. Such an approach has further consquences leading to the view that the improvement of society cannot be achieved by improving and correcting individual facts and by small improvements, but that only global changes lead to progress. It was not only the French Revolution that spread such beliefs, but also Marxism or postmodernism; the same, only in a slightly altered form we still have it on many micro-levels. And that is absurd. And the root of that resides, for the most part, whether we like it or not, in our scientific misconceptions. This belief was resisted by Karl Popper.18 Discussing the need for social change, the Austrian philosopher argued that the general improvement of society (meaning social justice) is achieved by small advances, a gradual grain-by-grain technique of piecemeal social engineering.19

 

In our case, just withdrawing the first two articles from The Lancet and the NEJM suggests no doubt about the piecemeal social engineering methodology at work. Unfortunately, the behaviour of the World Health Organization, the response of the French government and the highest medical bodies in France, points at the strong influence of context on the decisions made and the neglect of the meaning of the facts themselves.

 

Randomised Controlled Trials (RCT) - an illusion of certainty

Scientific theories are ephemeral20, 21, as was maintained by the philosophers Karl Popper and Thomas Kuhn. To illustrate this, let us first list some very well known examples from the history of medical therapy. Low dose hydrocortisone in septic shock was mandatory, it is not any more; Albumin was prohibited in sepsis, now it is recommended; HAES (hydroxyethyl starch) was good as a volume replacement in sepsis, now it is prohibited; intensified insulin therapy (initially proposed by van den Berghe) was highly recommended; it is not any more; every ICU patient had to regularly have Bisolvon (expectorant) in the past - certainly no more. Cimetidine and Ranitidine until recently were administered without exception to such patients; not any more. We gave APC (activated protein C) to the septic patients 10 years ago - now no more. Or just remember what was the cardio-pulmonary resuscitation protocol 30 years ago. Do you remember bicarbonate or the frequency of lung inflation? Many therapeutical measures were fundamentally changed, some methods banned. Therapy is verified again and again in clinical trials and then either accepted, some therapy modified, some rejected and even prohibited. Often, the corrections happen in the form of retraction.22,23

 

Many articles are “retracted” silently, over time the scientific community replaces some agents, withdraw them from use or they are not recommended any more or prohibited. Most of the time without any particular publicity. Science has its history, knowledge increases, some old concepts are corrected, abandoned and newly introduced. Some knowledge of today will be the ignorance of tomorrow. What is then the value of a clinical study in principle and in the long run? We do not know. The example of the above-mentioned problems is useful to look a bit deeper into the problem of knowledge and particularly the methodology of clinical research.

 

"Why on Earth Dr Raoult did not do one RCT, this was so simple. Why?" was one of the frequently repeated objections to the Marseilles group and their paper mentioned above. Some journalists and several reputed professors of medicine insist on (sic) "one RCT about HCQ" that would "solve" the controversy of that agent (HCQ) and, as a result of such a study, Professor Raoult would be saved from the attacks and receive maybe the Nobel prize... or proved to be wrong and his therapy banned. This was advanced by the media repeatedly. Yet this is, I think, sadly a clear sign of ignorance. The RCT do not in principle verify whether the agent by itself has some effect on a particular disease. As we tried to show,16 such studies establish only whether the particular therapy in some social settings (hospital, outpatient, or any other well-determined settings) produces some effect that is different from the effects of placebo. An ideal setting, that would be at the same time of the investigation and therapy, the same place, identical groups, identical all confounding factors, is impossible to arrange. Clinical studies than in fact establish - together with the effects of the examined agents, the effects of more than tens of more reasonably well or less well-controlled factors, but including also several uncontrolled factors. The result is often hard to interpret if the real differences of the presumed effects are small. Even worse. If the differences found between groups are very small, they may be accidental, despite coherent statistics. Often such studies are organised in many medical centres where the conditions (that include human and objective factors), from recruitment until therapy are so varied that no homogeneity of the conditions is ever to be aspired to. Enormous efforts are made to make clinical research as objective as possible but controversies persist.24 As we could see, for example in the Cavlacanty et al. study3 it has apart from the above-mentioned shortcomings, other mistakes like late admission, various selection bias versions, the exclusion of the patients that had previously HCQ or Azithromycin, and the mentioned intention to treat protocols.

 

Some other objections to the RCT are however fatal. One trivial but serious is that if series of RTCs are undertaken to find the existence of the effects of some agent, even if the agent has no effect, it is probable that just one of 10 or more studies will show differences just by accident. This is why the studies are supposed to be registered before they will be undertaken. This is however not respected everywhere. More deep problems are linked to what we said above. The fact that the set conditions, criteria, measurements of different studies cannot be in principle completely standardised, the studies cannot be compared one with another with sufficient confidence. The mentioned conditions change with time also, comparison with the earlier studies is hard if not impossible. It will not help if the methods of the studies are described in all details. Several sets of conditions would differ anyway, and the undeclared conditions, which certainly introduce further variations of unknown factors, always accompany such large studies.

 

Finally, even if one such study would establish efficacy or no efficacy of for example the HCQ for therapy for Covid-19, we will need a next study to confirm the initial results, and this will not stop there. And we are on the way to an infinite regress. So we will never be satisfied. When we know the history of science and medicine and are aware that probably 30% of the results of the studies, after about 30 years, are considered invalid and some agents often even considered as contraindicated, we must conclude that to look for some better methods (the more complex RTC?) is necessary. Besides, one other “demon” disturbs us too: the moral problem25 of not treating the sick patients in the control groups in the RCT has been lurking around for many years now and we have just to wait for it to emerge with devastating effects since it is simply insurmountable.

 

The future

In the paper published in 2005, Ioannidis summarised some of the objections to the RCT that I discussed above.26 The conditions that will render the results less likely, i.e. the research findings to be true, after Ioannidis, would be: The small studies; small effect size; the greater the number and the lesser the selection of tested relationships; the greater the flexibility in designs, definitions, outcomes, and analytical modes; On the contrary, the greater the financial and other interests and prejudices, and the hotter a scientific field (with more scientific teams involved), more chances will be to miss the important issues and fail.

A better approach may be a clear pathophysiological method where we would rely on basic science and look for mechanisms of the diseases and the mechanisms of action of the agents. The method that we need should be the method that corresponds more to the subject of the investigation that belongs somewhere in between pure science, medical science and social science. We need to know the mechanisms of actions, cause-effect relations, and the patients in all their sophistication. And before all, we need morally fully justified methods, and we, certainly, need Reason.

 

 

Literature

1. Mehra, Mandeep R, Sapan S Desai, Frank Ruschitzka, Amit N Patel, Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, The Lancet, online of 23. May 2020,

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)31180-6.pdf (Viewed on 23rd May 2020); RETRACTED June 5, 2020:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31324-6/fulltext (Viewed on June 5, 2020)

 

2. Mehra, Mandeep R., M.D., Sapan S. Desai, M.D., PhD, SreyRam Kuy, M.D., M.H.S., Timothy D. Henry, M.D., and Amit N. Patel, M.D. Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19, NEJM, online, May 1, 2020,

https://www.nejm.org/doi/full/10.1056/NEJMoa2007621 (Viewed on 23rd August 2020)

RETRACTED June 5, 2020

https://www.nejm.org/doi/full/10.1056/NEJMc2021225?medium=organic-social&source=nejmtwitter; (Viewed on 23rd August 2020)

 

3. A.B. Cavalcanti, et al, Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19,  NEJM, 383; 21, 2020; 2041 – 2052.

This article was published online on July 23, 2020, at the NEJM.

https://www.nejm.org/doi/pdf/10.1056/NEJMoa2019014?articleTools=true  (Viewed on 23rd August 2020)

 

4. Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents 2020;  56, 1, 105949.

Published online March 20. DOI:10.1016/j.ijantimicag.2020.105949. (Viewed on 23rd May 2020)

 

5. Wang, Manli, Ruiyuan Cao, Leike Zhang, Xinglou Yang, Jia Liu, Mingyue Xu, Zhengli Shi, Zhihong Hu, Wu Zhong and Gengfu Xiao, Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro, Cell Research, 2020; 30:269–271; https://doi.org/10.1038/s41422-020-0282-0.

 

6. Gilbert Ryle, The theory of meaning, in: Caton CE (ed), Philosophy and ordinary language, Urbana, University of Ilinois Press, 1963. p 128 and later.

 

7. Gottlob Frege, Begriffsschrift, eine der arithmetischen nachgebildete Formelsprache des reinen Denkens, Halle a. S., 1789.

 

8. Anthony Grayling, An Introduction to Philosophical Logic, Blackwell Publishing, (1982), 1998, chapter 2.

 

9. Brentano, F., , Psychology from an Empirical Standpoint, London: Routledge and Kegan Paul. (1874, 1911), 1973.

 

10. Robert Nozick, The Nature of Rationality, Prиnсtone University Press, 1993, 93-100.

 

11. Dragan Pavlovic. Two problems of empirical biomedical science: example of awareness monitoring with bispectral analysis. Eur J Anesth, 2009; 26: 87-9.

 

12. Richard Dawkins, Postmodernism Disrobed, Nature 1998; 394:141–143.

 

13. Alan Sokal et Jean Bricmont, Impostures intellectuelles, Éditions Odile Jacob, 1997.

 

14. Dragan Pavlovic, Christian Lehmann, Michael Wendt, For an indeterminist ethics. The emptiness of the rule in dubio pro vita and life cessation decisions, Philos Ethics Humanit Med. 4(1), 6. http://www.peh-med.com/content/pdf/1747-5341-4-6.pdf (viewed 3. 6. 2018).

 

15. Bernard Williams, Utilitarianism: For and Against Edited by: Smart JJ, Bernard Williams. Cambridge University Press; 1973.

 

16. John Rawls, A Theory of justice, Oxford University Press; (1972) 1973, p. 170 and 320―325.

 

17. John Rawls, Political liberalism, Columbia University Press, New York; 1993, p. 162.

 

18. Karl Popper, The myte of the fraimwork, Routledge. 1994 (chapter 2 treats the ftaimwork, chapter 3 piecemiel engeniring).

 

19. Karl Popper, Open society and its enemies, (Routledge 1996) (1945), book 1, chapter 9 notes for this chapter). Karl Popper, The povery of historicism, (1957) Routledge 1991; 3, 21.

 

20. Popper Karl, Conjectures and Refutations, Harper and Row, 1968, ch 10.

 

21. Kuhn, Thomas, The structure of scientific revolutions, University of Chicago Press, 1962.

 

22. Famous retractions. Available: https://retractionwatch.com/the-retraction-watch-leaderboard/top-10-most-highly-cited-retracted-papers/

 

23. Top retractions in 2019, available: https://www.the-scientist.com/news-opinion/the-top-retractions-of-2019-66852

 

24. Vincent, Jean-Louis, We should abandon randomized controlled trials in the intensive care unit, Critical Care Medicine: 2010; 38, 10: S534-S538.

 

25. Louhiala P., The ethics of the placebo in clinical practise revisited, J Med Ethics, 2009;  35: 407-409.

 

26. Ioannidis JPA (2005) Why most published research findings are false. PLoS Med 2(8): e124

 

*) Some important Internet sites, viewed on 23rd May 2020:

 

Launch of a European clinical trial against COVID-19, Press release | 22 Mar 2020 - 13h00, INSERM PRESS OFFICE. Available:

https://presse.inserm.fr/en/launch-of-a-european-clinical-trial-against-covid-19/38737/ (Viewed on 23rd June 2020)

 

Arrêté du 13 janvier 2020 portant classement sur les listes des substances vénéneuses

NOR : SSAP2001007A
ELI :
https://www.legifrance.gouv.fr/eli/arrete/2020/1/13/SSAP2001007A/jo/texte,

JORF n°0012 du 15 janvier 2020, Texte n° 13. Available :

https://www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000041400024 (The hydroxychloroquine is classified as a poisonous substance and practically withdrawn from the pharmacies.) (Viewed on 23rd June 2020)

 

Benoît Zagdoun, Agnès Buzyn et son mari, Didier Raoult et la chloroquine… On a examiné au microscope les 20 affirmations d'un message censé prouver un "scandale d'Etat", Les allégations contenues dans un message devenu viral sur les réseaux sociaux sont soit fausses soit imprécises. Mais, surtout, elles ne prouvent rien. Franceinfo. Available :

https://www.francetvinfo.fr/sante/maladie/coronavirus/agnes-buzyn-et-son-mari-didier-raoult-et-la-chloroquine-on-a-examine-au-microscope-les-20-affirmations-d-un-message-cense-prouver-un-scandale-d-etat_3891385.html (Viewed on 23rd June, 2020)

 

Décret n° 2020-314 du 25 mars 2020 complétant le décret n° 2020-293 du 23 mars 2020 prescrivant les mesures générales nécessaires pour faire face à l'épidémie de covid-19 dans le cadre de l'état d'urgence sanitaire, Dernière mise à jour des données de ce texte : 26 mars 2020, NOR : SSAZ2008362D. Available :

https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000041755775&categorieLien=id (Viewed on 23rd June, 2020)

 

L’hydroxychloroquine n’est plus autorisée en France pour traiter le Covid-19. La décision suit l’avis rendu mardi par le Haut Conseil de la santé publique. Vendredi, une vaste étude internationale concluait à un risque aggravé de mortalité chez les patients atteints de Covid-19 traités avec ce médicament. Le Monde avec AFP. Publié le 27 mai 2020 à 11h09 - Mis à jour le 27 mai 2020 à 13h54. Available :

https://www.lemonde.fr/sciences/article/2020/05/27/le-gouvernement-abroge-l-autorisation-de-l-hydroxychloroquine-pour-traiter-le-covid-19_6040915_1650684.html (Viewed on 23rd June 2020)

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COVID Shots Are the Deadliest ‘Vaccines’ in Medical History

https://articles.mercola.com/sites/articles/archive/2021/11/21/covid-vaccine-statistics.aspx?ui=16ffacbab8fe00a7a80fb43e8fc0419cd5e8d4732c8e99e4a93505e1afa83400&sd=20210925&cid_source=dnl&cid_medium=email&cid_content=art1HL&cid=20211121&mid=DM1042378&rid=1328157452

analysis by Dr. Joseph Mercola Fact Checked

(1:37:33)

 

Story at-a-glance

 

In this interview, Steve Kirsch, executive director of the COVID-19 Early Treatment Fund, reviews some of the COVID jab data he’s presented to the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention during various meetings.

For example, during the September 17, 2021, FDA VRBPAC (Vaccines and Related Biological Products Advisory Committee) meeting,1 Kirsch cited data suggesting 1 in 317 boys aged 16 to 17 will get myocarditis from the shots, and after a third booster, that number may be even higher. He also cited data showing the Pfizer shot kills far more people than it saves. I’ll provide more details about that below.

Kirsch didn’t come into this due to some preconceived opinion about vaccines. He and his family have all received two doses of the COVID jab. It wasn’t until after the fact that he started hearing about problems from others that he started taking deep dives into the data. He explains:

“After I got vaccinated, a woman asked me, ‘Should I get vaccinated?’ And I said, ‘Of course, you should. This is the safest thing ever. Nobody's died and there are no side effects. You've got to get this modern technology.’ I'm singing from the hymn book.

And then she said something that threw me off course because I said, ‘Why are you asking such a stupid question?’ And she said, ‘Well, three of my relatives got the vaccine and they died within a week.’ I said, ‘No, no, that can't be true. There's no way that can happen.’

I'm trying to convince her that she's mistaken, that it must have been something else. I wrote her saying, ‘Statistically, you can't have three people dying from the vaccine, which doesn't kill anyone.’ And she wrote back and she said, ‘Yeah, but they're dead.’

That was a game-changing moment for me ... but I was still in denial ... I was operating [from the position] that the FDA is still operating the same [conservative] way [they used to before], but they're not ... nor did I understand that the U.S. Centers for Disease Control and Prevention is now mission driven, and the mission is to get a needle in every arm. My trust was in the agencies.

The next incident involved my carpet cleaner, Tim Damroth. He showed up wearing a mask. And I'm saying, ‘Hey, you should all get vaccinated. Once you get vaccinated you don't have to wear a mask.’ And he said, ‘Well, I did get vaccinated, but I had an extreme reaction. I had a heart attack two minutes after I got injected.’ He also described that his wife had [developed] Parkinson's-like symptoms. Her left hand was shaking uncontrollably.”

 

The Price Truth-Tellers Pay

The data are ultimately what convinced him that people must be told the truth about these shots because, without that, they cannot give informed consent. He’s sacrificed a lot to do just that, including professional relationships and millions of dollars in lost income.

“I basically put my life on hold and started looking in the various databases and talking to people to understand what was going on,” Kirsch says. “And every place I looked, [the truth] became more clear to me. And so, on May 25, 2021, I wrote this 250-page article for TrialSiteNews. It may be the longest article for TrialSiteNews ever published.

When I wrote that article, within a week, every member of my [COVID-19 Early Treatment Fund’s] scientific advisory board quit — there were 14 scientists from all over the United States and in different fields with different expertise. They said I was ‘an evil person’ and that they never wanted to talk to me again in their life.

I pleaded with them, saying, ‘Look, if I've got the analysis wrong, then tell why can’t you tell me where I got it wrong.’ And they wouldn't say anything. They just said, the vaccines are safe and I should be ashamed of myself.”

Kirsch also created and submitted a 177-page PDF slideshow to the October 26, 2021, VRBPAC hearing, titled, “Questions About the COVID Vaccine.”2 It’s an absolute treasure trove of information and I would encourage you to review this great resource that he is updating in real time.

 

VAERS Data Likely Off by Factor of 41

In his video, “Vaccine Secrets: COVID Crisis,”3 the first episode of “The False Narrative Takedown Series,” Kirsch explains how to estimate COVID jab mortality, which he and a team of statisticians have done based on a variety of sources, including but not limited to the U.S. Vaccine Adverse Events Reporting System (VAERS).

Kirsch estimates VAERS reporting is off by a factor of 41, and that anywhere from 150,000 to 300,000 Americans have died from the COVID shots.

“We looked at eight different ways and VAERS is just one of the ways. So, when people say, ‘You can't use VAERS for this, you can't [calculate] causality [based on VAERS data], I'm saying, ‘Fine. We got the same answer using seven other ways.

In the VAERS analysis, we determined that VAERS was under-reported by a factor of 41, which is quite reasonable ... Ten years ago we had a system where we could actually discover all the unreported things in VAERS, and they discovered VAERS was severely underreported by as much as 95 times. Vaccines that we thought were safe, they're not safe at all. So, what did they do? They killed the project.

So, the reason that we have such a bad system today is that it is intentional. If we had a good system, it would show all the flaws for all of these vaccines that we've been giving people.”

The system is clearly intentionally designed from a technical standpoint to radically decrease the number of cases entered. It takes more than 30 minutes to complete a single report and you can’t save it until completed, so if you walk away and get timed-out, you have to start all over.

Kirsch knows a neurologist in California who claims to have 2,000 COVID jab-injured patients (out of a client base of 20,000), but she’s only filed two reports to VAERS. She doesn’t have time for the rest. So, she’s under-reporting by a factor of 1,000. Also, while doctors are required by law to file adverse event reports, there’s no enforcement, and no punishment for not filing.

It is also important to note that no one is paid to enter this data. That could be a part time job for most clinicians, were they to responsibly report all the side effects and deaths.

 

COVID Shots Are Far Deadlier Than the Infection

Overall, his team’s calculations suggest we’re killing 411 people per million doses (and remember Moderna and Pfizer are both two-dose regimens), worldwide. And that’s just the short-term mortality. We still have no concept of how these shots might impact mortality in the longer term.

To put things into further perspective, October 21, 2021, an Italian investigation found that by changing the COVID mortality definition to only include cases where COVID-19 was the primary cause of death and there were no comorbidities decreased the death toll by 97%, from 130,000 to fewer than 4,000.

Kirsch believes the real death tally from COVID-19 in the U.S. may be about 50% of the reported number. This means about 380,000 Americans died from COVID-19 (rather than with COVID), whereas the COVID “vaccine” has killed as many as 300,000. In other words, it’s possible that the cure may be worse than the disease.

 

COVID Shot Is the Deadliest ‘Vaccine’ Ever Created

It gets even worse though. In Pfizer’s children’s trial, one of the participants, 12-year-old Maddie De Garay, suffered a number of devastating events, including paralysis. This side effect was misreported, however, and put down as “abdominal pain.” Neither the FDA nor the CDC has investigated the case, despite promising to do so. Pfizer has refused to investigate it as well.

These COVID vaccines are over 800 times deadlier than the deadliest vaccine in human history. So, this isn't a close call. These vaccines are the deadliest vaccines ever created by man. And they're promoted as safe and effective. ~ Steve Kirsch

In the youth trial, 1 out of 1,131 children was paralyzed. Meanwhile, Pfizer’s adult trial shows that the shot saves one COVID death for every 22,000 fully-vaccinated people. But for children, it’s estimated we need to fully vaccinate over 630,000 kids to save one life. That means we may permanently disable as many as 557 kids per life saved. Meanwhile, there’s not a single report of a healthy child dying from SARS-CoV-2 infection anywhere in the world.

This means the number needed to vaccinate to save one otherwise healthy child from COVID death is actually infinite, as they’re not dying from COVID to begin with. There simply is no doubt that in children, the COVID shot is no benefit and all risk. Kirsch notes:

“Dr. Paul Offit was interviewed 20 years ago on ‘CBS 60 Minutes,’ and he said the smallpox vaccine is so dangerous that we would never consider doing that in modern times. It's the most dangerous vaccine ever invented ... and the smallpox vaccines only kills one person per every million-people vaccinated, which is a lot.

You vaccinate 300 million people, you're going to kill 300 people. That is unacceptable according to Offit, but he just voted for a vaccine that kills 822 people per million fully vaccinated [assuming a two-dose regimen].

That means these COVID vaccines are over 800 times deadlier than the deadliest vaccine in human history. So, this isn't a close call. These vaccines are the deadliest vaccines ever created by man. And they're promoted as safe and effective.”

 

COVID Shot Gets Deadlier the Younger You Are

Based on a request from Dr. Peter McCullough, Kirsch also analyzed COVID jab mortality based on age using the VAERS data. For 80-year-olds, he found we kill two people to save one. For 20-year-olds, we kill six to save one.

The younger you are, the greater the risk. The Kostoff analysis4 found this general pattern as well. Ronald N. Kostoff is a research affiliate in Gainesville, Virginia, who in 2016 wrote an expert review on under-reporting of adverse events in the biomedical literature.5

In a review published in October 2021, Kostoff found five elderly are killed by the shots for each elderly person saved, and the ratios get worse as you go down in age. That said, “the vaccines don't make sense for any age group, which is exactly the same thing I found independently,” Kirsch says.

“Nobody should get these vaccines. There is no cost-benefit analysis that I have seen that shows it is beneficial ... I mean, you're not going to take an intervention that is just as likely to kill you as to save you.

You want to take an intervention which is at least 10 times more likely to save you than to kill you, because it's an optional intervention. What kind of business do you have taking an intervention which has a marginal benefit for a completely unknown short- and long-term risk profile?

The other thing I want to say is that, the societal benefit argument, people are saying, ‘You're selfish because you didn't get vaccinated.’ Well, that's irrational.

Have you ever seen a CDC analysis showing you the societal benefit of being vaccinated? It doesn't exist. And there's a reason it doesn't exist, because the societal benefit would be so tiny that it’s ludicrous. Today, we know the vaccinated are as likely to spread the virus as the unvaccinated. So where is the societal benefit?

If there are no downsides [to the shot], then people would say, sure, maybe there's some societal benefit. I'll do that. But here your life is at stake and the data show that roughly 1 in 1,000 will get killed by these vaccines. So, if I say, hey, suppose sacrificing your life could save 100 person years (e.g., 10 people given another 10 years of life).

When I asked this live in a clubhouse room with a few hundred people, nobody raised their hand to volunteer to do that — to sacrifice their life to save 100 person years. And I said, ‘OK, what about 1,000 person years? If you could sacrifice your life to save people 1,000 person years, would you do it? Nobody would do that. It's nonsensical.

We have a constitutional right to life ... And I don't think you're being selfish about it. You have a family, you have friends, you have loved ones, you have people you interact with ... Why would I ask you to sacrifice your life? To save people you don’t know?

Everybody has their own special way that they contribute to society. Why would we ever ask somebody to [sacrifice their life for a potential social benefit]? Maybe we should ask Joe Biden, ‘Joe, if you could give up your life to save 1,000 person-years, would you do that?’ It would be very interesting to see what he says.”

 

CDC Performs Statistical Magic, Again

Countering all of this data we have a recent CDC analysis,6 which concluded that people who get the COVID shot are two-thirds less likely to die of any cause. 

“I sent Janet Woodcock my deck of 180 questions. I said, ‘Janet, I bet you can't answer any of these 180 questions. Doesn't this concern you?’ She sends back an email saying, ‘Look at the CDC analysis, showing that after you get the jab, there's this two-thirds drop in mortality.’

My friends and I, when we saw in that paper, we were laughing our heads off over here. The stats on 18- to 44-year-olds [show] 35% die from accidents. The rest die from disease — cancer, heart disease, whatever.

The only way to get a two-thirds reduction [in all-cause mortality] is if nobody dies from anything anymore — any disease — and we also reduce the number of accidents that they have ... This is the immortality drug. All kidding aside, there's no mechanism of action that could possibly justify that people are going to be better off from a health perspective after getting these vaccinations. Zero.

Nothing is improved. You are not immortal. You are just the opposite; your immune system is compromised. You're also more likely to get COVID. In the U.K., the government numbers show that 40-year-olds, after the honeymoon period is over, were more than twice as likely to get infected if they were vaccinated.

In the U.S., you have hospitals where you have a 50% community vaccination rate and the hospital admissions are 90% vaccinated people. You can't make these statistics up.

In fact, the CDC was confronted by these statistics by Aaron Siri, who wrote about it on his substack, and they just ignored them. So, they make up stuff [and] this paper shows the CDC can put out anything and as long as it has that little CDC logo on it, people are going to believe it no matter how ridiculous it is.

And nobody in the medical community criticized it. I wrote a very popular article about it on my substack entitled, ‘FDA Discovers Fountain of Youth.’”

 

Biggest Fraud in History

All things considered, the COVID vaccination campaign is the biggest medical fraud in modern history. As Kirsch says, it’s a house of cards, held together by belief in data that aren’t there and avoidance of confronting the safety signals in the VAERS system and other studies that don’t comport with the narrative.

They even avoided the determination of one of the world’s top pathologists (Peter Schirmacher) that at least 30% to 40% of the deaths two weeks post-vaccine were caused by the vaccine. The still claim there are no deaths that have been attributed to the Pfizer or Moderna vaccines. That’s ridiculous.

“I've never seen anything like this, and I've never heard of anything like this because the conspirators who are telling this false narrative are all the three-letter agencies under the Department of Health and Human Services — the FDA, CDC and NIH.

They're all in on it, Congress is all in on it, mainstream media's all in on it, and the medical community is all in on it. They can’t afford to back down now because they are in it too deep. It would be too embarrassing to them.

We have been saying for months, ‘You guys have to look at the VAERS data,’ and they have been ignoring and censoring us rather than engaging us with dialogue — and none of these people will engage us in dialogue.

We tell the so-called ‘fact checkers’ where to look and what questions to ask the CDC to verify our stories and they never follow up. The ‘fact checkers’ all refuse to get on a recorded phone or Zoom call since they don’t want to be exposed as being biased.

One strategy for changing this is that we're going to run a series of ads. Each of the ads will feature a unique personality, like a Dr. Peter McCullough, a sports figure, doctors, victims and so on. They'll relate their personal anecdotes for what's happened to them. And they will say, ‘Look, before you get vaccinated, check the facts. Listen to the other side of the story.’

It's a reasonable ask. And we’ll direct them where to go to hear the side of the story that the mainstream media aren’t allowing them to hear. And then we let them make up their own mind. People aren't hearing the other side of the story, and the White House is helping suppress it. When the White House has a hit list of censorship, it's very clear what is going on. When in history have we done that?

Do you ever see McCullough on CNN? No, because they want to give you only one side and they're deliberately giving you only one side of it, and they know it. If they want to give the impression they are balanced, they’ll pick someone who isn’t an expert and interview them. Robert Malone is never going to be on CNN. Malone invented the mRNA vaccine and yet he doesn’t qualify to talk about it on CNN?

America used to be a country that embraced a diversity of views, and you had freedom of speech, you had freedom to express your opinion. You had the freedom to tell the truth. No more. That freedom has been taken away.

If you don't agree with the mainstream narrative, you're silenced. And so, what we're going to do is run the series of ads, and we'll only be able to run it on alternate media because the mainstream media won't run our ads because the ads encourage people to hear the other side of the issue.”

 

More Information

Again, you can download Kirsch’s 177-page PDF, jam-packed with questions and data on the COVID “vaccine.” I also urge you to review his “False Narrative Takedown” (TFNT) series, which you can find on his Rumble channel.

You can also peruse his website, skirsch.io, or follow him on his social media accounts, which include Twitter, Gab, Telegram and LinkedIn. To keep on top of his latest investigations, you can subscribe to his Substack channel. If you can afford it, consider signing up for a paid subscription. Select articles can also be found on TrialSiteNews.

“Substack is really important because they don’t censor people who tell the truth,” Kirsch says. “So, I really encourage people to support platforms like Substack. I also get a portion of that, and any money I get, I will donate 100% to funding ads and to fighting this. If we can get 100,000 subscribers at $5 a month, that's $500,000 a month we can spend to combat false narrative. That's serious fire power.

People ask me, why am I doing this? I'm not making any money off of this. I have no conflicts of interest. I have no history as a conspiracy theorist or spreader of misinformation. We’ve lost all our friends. I was forced out of my job because I wanted to speak out against the vaccines.

I'm losing money on this because I'm funding a lot of the things out of my personal pocketbook. The donors that donated to the early treatment fund, none of them, not a single one, is supporting the effort to get the truth out about how dangerous these vaccines are and how wrong the mandates are.

My motivation is a 100% on saving lives. That's my reward in life. If I can save one life, my life was worth living. If I can save 100 lives, even better. If I can save 100,000 lives, that is more meaningful than anything I’ve ever done or will do.”

 

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Now Defined As 3 Shots & OSHA Suspends Biden Jab Mandate

 

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We can decide that we won’t live and die on these terms

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Why Are Moderna’s Billionaires Airbrushing Scientists

 

Out of the Vaccine Patent Picture?

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The Marine Corps won’t expel all unvaccinated Marines en masse

 

on the Nov. 28 deadline, Navy secretary says

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20 Years After Patriot Act,

 

Surveillance of Arabs and Muslims Is Relentless

 

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60 US Health Groups Urge Companies

 

to Voluntarily Implement Blocked Vaccine Rule

 

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Pegasus is Just the Tip of the Israeli Cyber Spying Iceberg

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with Whitney Webb and Mnar Adley

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Did Israel's May attack cause miscarriages?

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Miss South Africa shamed for refusing to boycott Israel

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Exposing Israel's Use of Settler Aggression to Grab Palestinian Land

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Meet Blackstone Israel's secret weapon

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q.

Democratic accountability keeps revolutions alive

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with Marc Steiner and Circles Robinson

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Even in solidly blue states, Democrats aren’t pursuing

 

serious progressive change

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by Luke Savage

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Operation Coronavirus:

 

How the Masses Were Hypnotized into the COVID Cult

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by Makia Freeman

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Censorship is the Last Gasp of the Liberal Class

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by Danny Haiphong

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Adam Schiff And The End Of Shame In American Politics

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by Jonathan Turley

 

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Australian War Propaganda Keeps Getting Crazier

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by Caitlin Johnstone

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New files expose Australian govt’s betrayal of Julian Assange

 

and detail his prison torment

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by Kit Klarenberg

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Former prime minister Paul Keatin addresses the National Press Club

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with former Australian prime minister Paul Keatin

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The managed destruction of Australia’s oldest faculty of Arts

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“Welcome to the New Economy”

 

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with James Corbett

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Davos Billionaires Want to Save the Planet…

 

‘The Repackaging of Eugenics’

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Leases for more oil drilling are flying to anyone who can write the U.S.

 

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by William Rivers Pitt

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9/11 and the Politics of Fear and Self-Preservation

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with Whitney Webb

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Kellogg’s strikers hold the line and prepare for winter

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by Mel Buer

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Two climate activists halt operations at world's largest coal port

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by Julia Conley

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Baltimore museum workers are fighting for a 'wall-to-wall' union

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with Maximillian Alvarez, Laura Albans, and Matt Papich

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Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical

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COVID Waves On Red States

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by ‘IM' via 'Unmasked' Substack

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Access to Information Is the Key to Truth

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byThe Global Research Team

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How to Find Deleted Videos

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with James Corbett

(9:26)

 

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Locking Down Unvaccinated-Only ‘Not About Science,

 

It’s About Punishing People’

 

https://www.globalresearch.ca/locking-down-unvaccinated-only-not-about-science-about-punishing-people/5762033

by Jeremy Loffredo

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Vidéos of growing protests against the vaccine

 

that are censored in the corporate media

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Days Into Lockdown For The Unvaccinated,

 

Austria COVID Cases Hit Record High

 

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by Tyler Durden

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Austrian cops and military joining the resistance

 

to Big Pharma’s Anschluss

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by Mark Crispin Miller

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Germany Preparing To Impose Austria-Style

 

Lockdown On The Unvaxx'd

 

https://www.zerohedge.com/covid-19/germany-preparing-impose-austria-style-lockdown-unvaxxd

by Paul Joseph Watson via Summit News

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Frozen Deutschland

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by Pepe Escobar

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Italian Governors Call For Unvaccinated To Be Put Under Lockdown

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by Paul Joseph Watson via Summit News

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93%-Vaccinated Ireland Has Gone Back Into 'Partial Lockdown',

 

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Myth vs. Reality in COVID Russia

 

 

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by Riley Waggaman

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NATO Increases Military Flights Along Belarus Border

 

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https://www.zerohedge.com/geopolitical/g7-nations-issue-scathing-condemnation-belarus-using-irregular-migration-hybrid-tactic

by Tyler Durden

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G7 Nations Issue Scathing Condemnation Of Belarus

 

Using ‘Irregular Migration’ As A ‘Hybrid Tactic’

 

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The nature of neoliberalism and its consequences

https://youtu.be/53Ckm-e1LxQ

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‘I Wish We Had A Real Border Czar’:

 

 

Texas Dem Congressman Slams VP Kamala Harris

https://www.zerohedge.com/political/i-wish-we-had-real-border-czar-texas-dem-congressman-slams-vp-kamala-harris

by Tyler Durden

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Over $53 Million In Meth, Coke, & Pot Seized By Border Patrol

 

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by Thom Hartmann

 

===========

 

x.

The Tripartite World Order and the Hybrid World War

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by Dmitry Orlov

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How The "Grand Chessboard" Led To US Checkmate In Afghanistan

 

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by Max Parry via Off-Guardian.org,

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U.S. Terrorism 101: The Bert Sacks Story

 

http://www.informationclearinghouse.info/56868.htm

by Edward Curtin

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How the U.S. Lost the "Great Game" in Central Asia

 

https://covertactionmagazine.com/2021/11/08/how-the-u-s-lost-the-great-game-in-central-asia/

by Aidan O’Brien

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Syria's My Lai? US massacred 70 civilians and covered it up

 

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by Aaron Maté

 

===========

 

y.

Organizing Against Racism and Class Oppression

http://www.blackagendareport.com/organizing-against-racism-and-class-oppression

by Danny Haiphong

+

Don’t black lives matter if those “vaccines” take them?

https://markcrispinmiller.com/2021/08/dont-black-lives-matter-if-those-vaccines-take-them/

by Mark Crispin Miller

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F.W. de Klerk: Requiem for a Racist Murderer

 

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===========

 

z.

Let a Hundred Socialist Flowers Bloom:

 

A Conversation with Issa Shivji

 

http://www.blackagendareport.com/let-hundred-socialist-flowers-bloom-conversation-issa-shivji

by Issa Shivji

+

Glen Ford: In Memoriam

 

http://www.blackagendareport.com/glen-ford-memoriam

by Peter James Hudson and Jemima Pierre

+

Vietnamese National Hero, Colonel Đặng Văn Việt,

 

Who Helped Vietnam End Its Colonial Scourge,

 

Dies at Age 102

https://covertactionmagazine.com/2021/11/17/vietnamese-national-hero-colonel-dang-van-viet-who-helped-vietnam-end-its-colonial-scourge-dies-at-age-102/

by Felix Abt

+

From: Jim O'Brien via H-PAD
Sent: Monday, November 22, 2021
Subject: [H-PAD] H-PAD Notes 11/22/21: Panels on "Twenty Years of War"; Links to recent articles of interest

 

Note: Historian Tejasvi Nagaraja at Cornell University will host two free online panels under the theme of "Twenty Years of War." The first, "The War on Terror, Security Statecraft, and Racial Justice," takes place November 30 and the second, "Coalitions of War and Antiwar," on December 7, both at 3pm EST.

 

Links to Recent Articles of Interest

"To Govern the Globe: Washington's World Order and Catastrophic Climate Change
By Alfred McCoy, TomDispatch.com, posted November 18
Based on the author's new book, To Govern the Globe (Dispatch Books, November 2021), which covers the last 600 years of "world orders" and their unmaking, this article argues that climate change is eclipsing America's world order and offering only a short duration for the China-dominated order that is likely to follow. The author teaches history at the University of Wisconsin.

"Are We Witnessing a 'General Strike' in Our Own Time?"
By Nelson Lichtenstein, Washington Post, posted November 18
Compares the current phenomenon of workers leaving their jobs, sometimes called "The Great Resignation," with W. E. B. Du Bois's use of the term "general strike" for actions by African Americans' in the South during and after the Civil War. The author is a labor historian and a research professor at the University of California, Santa Barbara.

"As One of the First White Kids in a Black School, I Learned Not to Fear History"
By Woody Holton, Washington Post, posted November 12
A personal account by University of South Carolina historian Woody Holton, who attended a newly integrated public school in Richmond in the early 1970s. His father, Linwood Holton, was the Republican governor of Virginia at the time and accepted federal court orders to desegregate the schools. The older Holton died on October 28 of this year.

"The 1619 Project and the Long Battle over U.S. History"
By Jake Silverstein, New York Times, posted November 9
"Fights over how we tell our national story go back more than a century — and have a great deal to teach us about our current divisions." The author is the editor-in-chief of the New York Times Magazine and a key figure in the 1619 Project.

"Educational Gag Orders: Legislative Restrictions on the Freedom to Read, Learn, and Teach."
A report by PEN America, posted November 8
A detailed survey of the 54 bills introduced in 24 state legislatures during January-September 2021 to restrict teaching and training in K-12 schools, public universities, and state agencies. "These bills appear designed to chill academic and educational discussions and impose government dictates on teaching and learning. In short: They are educational gag orders."

"The CIA Undermined Postcolonial Africa from the Start"
By Alex Park, Jacobin, posted November 7
A review essay on Susan Williams's book White Malice: The CIA and the Recolonization of Africa (Public Affairs Press, 2021), a deeply researched account of how the CIA undermined leftist governments in the Congo and Ghana in the late 1950s and early 1960s. The reviewer is a freelance journalist with a particular interest in foreign investments in Africa.

"White Backlash Is America's Most Destructive Habit"
By John S. Huntington and Lawrence B. Glickman, The Atlantic, posted November 7
Gives historical examples, starting with Reconstruction, showing that "Each time political minorities advocate for and achieve greater equality, conservatives rebel, trying to force a reinstatement of the status quo." The authors teach history at Houston Community College and Cornell University, respectively.

"Armaud Arbery Suspects' Trial Defense Taps a Racist Legal Legacy"
By Alan Singer, Think, posted November 5
"The idea of citizen’s arrest laws dates to Europe in the 13th century, but it became melded with American efforts to prevent slave escapes." The author is a historian and director of social studies education at Hofstra University.

"Loose Talk"
By Steven Shapin, London Review of Books, posted November 4
A lengthy review-essay on Alex Wellerstein's book Restricted Data: The History of Nuclear Secrecy in the United States (U. of Chicago Press, 2021). The reviewer is a professor emeritus of the history of science at Harvard University.

"The Historians Are Fighting"
By William Hogeland, Slate, posted October 30
An informative and entertaining account of the recent face-off at the Massachusetts Historical Society between Woody Holton and Gordon Wood on the 1619 Project and the nature of the American Revolution. The author has published several books on early American history, including Inventing America (MIT Press, 2009).

Thanks to an anonymous reader for flagging some of the articles included above, and to Steve Gosch for valuable consultation. Suggestions can be sent to jimobrien48@gmail.com.