US FinCen About to Control Global Financial Data

 

US FinCen About to Control Global Financial Data

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Washington is about to control the data of all financial transactions in the world. With the objective of combating financial crimes, the American government is about to pass a law that greatly expands the inspection power of financial regulatory agencies, which will have the freedom to use new technologies that allow them to supervise operations outside American territory. In practice, this could create a scenario of global data enforcement, in which all individuals and organizations would be subject to US agencies.

In early 2021, the US Congress overturned the presidential veto on a last year’s bill that called for new measures to combat money laundering. This law provides new technologies and financial resources to FinCen (Financial Crimes Enforcement Network), an agency under the US Department of the Treasury, which regulates and monitors suspicious financial transactions globally. The project has corporate transparency at its core, which requires all companies to reveal their owners and beneficiaries in the new FinCEN registry, creating a comprehensive data control system.

If this project is put into practice, events such as massive data leaks, as happened last year, could become more and more common. In 2020, FinCen unveiled more than 2,000 money laundering financial transaction documents across multiple countries. In all, illegal transactions amounted to 2 trillion dollars. While the benefit of uncovering illicit schemes is positive, the invasive US policy to monitor transactions in other countries can be a major problem and a real attack on the sovereignty of countries where there are supposedly happening illegal transactions. Last year, FinCen managed to reveal illegal transactions in more than 3,000 financial organizations in the UK, as well as banks in the UAE and Germany, among others. The practice of violating jurisdictions to incriminate bank users and impose new sanctions can be truly dangerous and cause great legal uncertainty in countries monitored by Washington. Still, with these new measures, the American agency will receive much more resources and it is speculated that it will acquire practically unlimited power, “invading” any country to “regulate” financial transactions.

However, it should be noted that currently the focus of American policy to combat money laundering is the control of the cryptocurrency market. The reasons for this are obvious. Cryptocurrencies are an extremely difficult financial mechanism to control and allow virtually any transaction to be carried out by anyone anywhere in the world, from simple individual applications to massive funding of terrorist organizations. Gaining control over the electronic currency market is a challenge for any sovereign national state today, but this obviously does not justify measures that violate the jurisdiction of other states. The cryptocurrency market is currently valued at 1.5 trillion dollars, which motivates Washington to try to impose a strict framework for these assets, considering that the absence of adequate supervision over the circulation of electronic currencies allows the creation of new and more complex forms of money laundering, increasing financial crimes and threatening the financial well-being of businesses and individuals. Recently, the first US government interdepartmental meeting on cryptocurrencies took place. Officials from the Office of the Comptroller of the Currency, the Federal Reserve and the Federal Deposit Insurance Corporation discussed joint strategies regarding cryptocurrencies, elevating the topic to a national security issue under strict control of the US state.

Late last year, FinCen tried to impose strict measures on cryptocurrencies, proposing to force cryptocurrency traders and digital wallets to collect personal information from users. Given the impact that such a measure could have on various financial sectors, Biden interrupted the procedures for implementing the proposal in his first days in power, but the topic remained extremely strong and forced the White House to resume the discussion. Now, the matter is being addressed from the perspective of combating financial crimes and money laundering, which will likely motivate the Biden government to authorize the measures previously proposed.

In short, the US is developing a strategy to combat financial crimes that consists of granting FinCen unlimited powers and a large number of resources for investments in new technologies, which will allow the agency to comprehensively oversee financial transactions carried out across the planet, without any respect for the sovereignty and jurisdiction of States. In addition, FinCen’s new focus will be the control of transactions in cryptocurrencies, which raises even more concerns about how the method of investigation and inspection will take place, considering that the virtual and dynamic flow of these assets will certainly demand even more invasive measures on the part of the American agency for data collection.

Although there is great concern regarding the sovereignty of countries that will be harmed by US inspections, the new measures to combat financial crimes will certainly have a profound impact on the global economy itself. In order to identify some criminal transactions, US authorities will collect data from millions of people and companies, breaking privacy principles and harming lawful businesses. As far as financial crime is concerned, the result will be the development of more complex and confidential forms of money laundering and illegal transactions, while lawful operations will be the most affected.

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Lucas Leiroz is a research fellow in international law at the Federal University of Rio de Janeiro.

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‘Self-Spreading’ Vaccines Pose Multiple Risks to Society — Including the End of Informed Consent

 

‘Self-Spreading’ Vaccines Pose Multiple Risks to Society — Including the End of Informed Consent

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Proponents argue self-disseminating vaccines could mean they no longer have to run complex mass vaccination programs. Critics say the vaccines pose many health risks and would also spell the end of informed consent.

In October 2019, the Johns Hopkins University Center for Health Security co-sponsored the “pandemic exercise,” Event 201.

A little more than a year later, when the Event 201 scenario morphed from “hypothetical” to concrete, it became clear that sponsors of the event intended to see the majority of the world vaccinated against COVID-19.

Accomplishing this goal is a “monumental challenge,” however. In the U.S., more than one-third (38% to 45%) of adults continue to decline the unlicensed, Emergency Use Authorization injections, despite a marketing blitz that has included both carrots (ranging from the chance to win cash payments to a free order of fries) and sticks (such as nasty calls to “get personal” and “shun” the unvaccinated).

Although some of the uninjected tell pollsters they plan to eventually get the vaccine, a solid minority remains committed to never doing so. The same pattern appears to hold true globally: Roughly one-third of adults worldwide said they will not take a COVID shot.

While social and behavioral science researchers apply “soft science” techniques in an attempt to maneuver vaccine confidence into more acquiescent territory, bench scientists have a different option potentially waiting in the wings — genetically engineered vaccines that “move through populations in the same way as communicable diseases,” spreading on their own “from host to host.”

Not mainstream (yet)

In theory, self-spreading vaccines (also referred to as self-disseminating or autonomous) can be designed to be either transferable (“restricted to a single round of transmission”) or transmissible (“capable of indefinite transmission).”

Vaccine scientists concede transmissible vaccines “are still not mainstream, but the revolution in genome engineering poises them to become so.”

The makers of self-disseminating vaccines use recombinant vector technology to build genetic material from a target pathogen onto the “chassis” of a viral vector deemed “benign,” “innocuous” or “avirulent.” This is similar to the viral vector approach used to produce the Johnson & Johnson and AstraZeneca COVID vaccines.

For Johns Hopkins, the appeal of vaccines that are intentionally engineered to be self-disseminating seems obvious. The university’s Center for Health Security made its case explicit in a 2018 report, “Technologies to Address Global Catastrophic Biological Risks.” The report stated, “These vaccines could dramatically increase vaccine coverage in human …  populations without requiring each individual to be inoculated.”

Further spelling out the utilitarian implications of self-disseminating vaccines, the report’s authors stated, “only a small number of vaccinated individuals would be required to confer protection to a larger susceptible population, thus eliminating the need for mass vaccination operations.”

From a programmatic standpoint, this strategy would have the advantage of being “cheaper than vaccinating everyone by hand.” Perhaps even more significantly, however, it would override one of the “thorny ethical questions” that mass vaccination programs routinely wrestle with: informed consent.

As the university’s Center for Health Security briefly acknowledged in its report, self-disseminating vaccines would essentially make it impossible for “those to whom the vaccine subsequently spreads” to provide informed consent at all.

Blame the animals

Writing in 2020 in Nature Ecology & Evolution, researchers observed that viral zoonoses (diseases theorized to jump from animals to humans) have become an entrenched part of the “global mindset” and a central element of the pandemic-obsessed global health zeitgeist.

Despite SARS-CoV-2’s unproven zoonotic origins (cast into doubt by figures such as Robert Redfield, former director of the Centers for Disease Control and Prevention), the past year’s coronavirus hype has helped reinforce the popular perception that wildlife populations represent a menacing cauldron of latent viral threats — requiring only the right set of circumstances to spring into humanity-endangering action.

Parlaying the COVID moment into a convenient scientific opportunity, researchers suggest that the purported “failure to contain the SARS-Cov-2 pandemic” furnishes a rationale for accelerating the rollout of self-disseminating vaccines. As some journalists have phrased the question du jour, “Wouldn’t it be great if wild animals could be inoculated against the various diseases they host so that those microbes never get a chance to spread to humans?”

Transmissible-vaccine research also has ascended the list of funding priorities for government agencies like the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH) and, reportedly, donors such as the Gates Foundation.

At least officially, the primary focus of self-spreading vaccine research has thus far been on wildlife populations. Although the practice of direct wildlife vaccination (for example, against rabies) has been around since the 1960s, it is the longstanding efforts to develop sterilizing vaccines in wildlife (euphemistically called “immunocontraception”), as well as recent advances in genetic engineering, that “have provided a foundation for transmissible-vaccine research.”

Researchers explain how the targeting of wildlife reservoirs is intended to work:

“The idea, essentially, is to vaccinate a small proportion of a [wildlife] population through direct inoculation. These so-called founders will then passively spread the vaccine to other animals they encounter either by touch, sex, nursing, or breathing the same air. Gradually, these interactions could build up population-level immunity.”

When put to the test by Spanish researchers in a limited field trial in rabbits, about 50% of the unvaccinated rabbits developed antibodies after being housed with vaccinated rabbits who had received a transmissible vaccine either via injection or orally. When the researchers assessed second-generation transmission (that is, development of antibodies in another batch of rabbits moved in with the first batch of unvaccinated rabbits), the transmission rate was much lower (two of 24 rabbits).

What could possibly go wrong?

As the Johns Hopkins report made clear in 2018, there is no technical reason why the self-spreading approach could not be applied to humans. The authors admitted to “several big challenges,” however, including the fact that autonomous vaccines (as mentioned above) would render informed consent a moot point and would make it impossible to screen individuals for contraindications such as allergies.

According to Johns Hopkins and others, another major challenge is the “not insignificant risk of the vaccine virus reverting to wild-type virulence,” creating an opportunity for the vaccines to propagate disease rather than prevent it.

In fact, the world is already familiar with this phenomenon in the form of oral polio vaccines. Though not “intentionally designed that way,” oral polio vaccines are considered “a little bit transmissible” and are acknowledged to cause polio.

Hopkins’ researchers pointedly characterized the reversion challenge as “both a medical risk and a public perception risk.” Another Catch-22 articulated in the university’s report is that while reversion risks could perhaps be lessened by engineering the vaccines to be more “weakly transmissible,” this could defeat the purpose of getting vaccines to “go” on their own.

On the other hand, the two scientists who are most strongly promoting transmissible vaccines argue that “even … where reversion is frequent, [their] performance will often substantially exceed that of conventional, directly administered vaccines.”

These same authors have also developed models suggesting that starting the transmissible ball rolling with direct vaccination of newborns could be particularly impactful.

In September 2020, two researchers writing in the Bulletin of the Atomic Scientists agreed that self-spreading vaccines may have significant downsides and could “entail serious risks,” particularly given that scientists lose control of their creation once released. They noted, “While it may turn out to be technically feasible to fight emerging infectious diseases … with self-spreading viruses, and while the benefits may be significant, how does one weigh those benefits against what may be even greater risks?” They outlined several additional questions:

  • Who makes the decisions about the “where and when” of the vaccines’ release?
  • What happens when there are “unexpected outcomes” and “unintended consequences” such as mutation, species-jumping or border-crossing? About unintended consequences, the two authors added, “There always are.”
  • What about bioweapons and “dual use” risks — that is, using the technology to “deliberately cause harm” rather than prevent disease? Advances in pharmacogenomics, drug development and personalized medicine, the two noted, could enable “ultra-targeted biological warfare.”

On the latter point, the Bulletin authors drew readers’ attention to immunocontraception efforts in animals as well as an infamous example of “weaponized biology” against humans in apartheid-era South Africa, called Project Coast, which sought — reportedly unsuccessfully — to develop an “infertility ‘vaccine’ to be used on black women without their knowledge.”

Other scientists have made an even more direct case against transmissible vaccines, arguing the risks of autonomously spreading vaccines do, in fact, “far outweigh potential benefits.” Risks, in their view, include “the unpredictability of mutations of the virus, the inability to safely test at a large scale and the grave potential threat to biosecurity.”

Vaccine science: many unknowns

When measles, rather than COVID, was dominating the headlines a couple years ago, the unvaccinated were heavily scapegoated for apparent outbreaks. This non-evidence-based finger-pointing (used to usher in draconian new vaccine mandates), ignored the well-documented “phenomenon of measles infection spread by MMR (live measles-mumps-rubella vaccine), which has been known about for decades” and has resulted in “detectable measles infection in the vast majority of those who receive it.”

The experimental Pfizer and Moderna COVID vaccines use new messenger RNA (mRNA) technology rather than the traditional live-virus technology featured in vaccines like the MMR, and thus, we are told, they cannot produce the same type of “shedding.”

However, many unvaccinated individuals are reporting unusual symptoms or illness after spending time in proximity to COVID-vaccinated individuals. Pointing to Pfizer’s protocol acknowledging the possibility of exposure via inhalation or skin contact with vaccinated individuals, concerned health professionals have raised the question of whether some novel form of shedding is occurring.

Some of the people raising these questions have pointed to the September 2020 article in the Bulletin of the Atomic Scientists, subtitled, “What could possibly go wrong?” By May 2021, the Bulletin’s editors, apparently uncomfortable with the attention the September article had attracted, were trying to distance themselves by stating the Bulletin’s content was being misused to further conspiracy theories about “highly effective and safe COVID-19 vaccines.”

Whether the COVID injections are “self-spreading” in any sense of the word is a question that cannot currently be answered. However, there is at least one plausible molecular mechanism that could explain the observed vaccinated-to-unvaccinated “shedding” effects.

GreenMedInfo’s Sayer Ji explains that “horizontal information transfer within biological systems [is] mediated by extracellular vesicles, which include a virus-like phenomenon known as microvesicle shedding and/or exosome-mediated transfer of nucleic acids.” Citing a 2017 peer-reviewed study on the “biology and biogenesis of shed microvesicles,” Ji states:

“[I]t is possible that [mRNA vaccines] do, in fact, contribute to microvesicle shedding, which represents an even greater, more persistent threat than live-cell vaccine shedding when it comes to the persistent biological impact the vaccinated can have on the unvaccinated.”

What is even more certain is that scientists themselves do not have all the answers. Some may wish to believe in the possibility of simply genetically engineering a vaccine “in ways that thwart its ability to evolve into something nasty.” But others note “the inevitability of evolutionary change resulting from [transmissible vaccines’] ability to self-replicate and generate extended chains of transmission.”

Techno-thriller author Michael Crichton predicted in 2002 that with the advent of nanotechnology and other technological innovations, the pace of evolutionary change was likely to be “extremely rapid.” Crichton cautioned, “human beings have a poor record of addressing the hazards of new technologies as they arrive.”

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The Campaign against Ivermectin: WHO’s Chief Scientist Served with Legal Notice for Disinformation and Suppression of Evidence

 

The Campaign against Ivermectin: WHO’s Chief Scientist Served with Legal Notice for Disinformation and Suppression of Evidence

On 25 May 2021, the Indian Bar Association (IBA) served a 51-page legal notice on Dr Soumya Swaminathan, the Chief Scientist at the World Health Organisation (WHO), for “her act of spreading disinformation and misguiding the people of India, in order to fulfil her agenda.”

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On 25 May 2021, the Indian Bar Association (IBA) served a 51-page legal notice on Dr Soumya Swaminathan, the Chief Scientist at the World Health Organisation (WHO), for “her act of spreading disinformation and misguiding the people of India, in order to fulfil her agenda.”

The Mumbai-based IBA is an association of lawyers who strive to bring transparency and accountability to the Indian justice system. It is actively involved in the dissemination of legal knowledge and provides guidance and support to advocates and ordinary people in their fight for justice.

The legal notice says Dr Swaminathan has been:

“Running a disinformation campaign against Ivermectin by deliberate suppression of effectiveness of drug Ivermectin as prophylaxis and for treatment of COVID-19, despite the existence of large amounts of clinical data compiled and presented by esteemed, highly qualified, experienced medical doctors and scientists,”

and

“Issuing statements in social media and mainstream media, thereby influencing the public against the use of Ivermectin and attacking the credibility of acclaimed bodies/institutes like ICMR and AIIMS, Delhi, which have included ‘Ivermectin’ in the ‘National Guidelines for COVID-19 management’.”

The IBA states that legal action is being taken against Dr Swaminathan in order to stop her from causing further damage to the lives of citizens of India.

The notice is based on the research and clinical trials carried out by the ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel. These organisations have presented an enormous amount of data that strengthen the case for recommending Ivermectin for the prevention and treatment of COVID-19.

The IBA says that Dr Swaminathan has ignored these studies and reports and has deliberately suppressed the data regarding the effectiveness of Ivermectin, with an intent to dissuade the people of India from using it.

However, two key medical bodies, the Indian Council for Medical Research (ICMR) and the All India Institute of Medical Sciences (AIIMS) Delhi, have refused to accept her stand and have retained the recommendation for Ivermectin, under a ‘May Do’ category, for patients with mild symptoms and those in home isolation, as stated in ‘The National Guidelines for COVID-19 management’.

It is interesting to note that the content of several web links to news articles and reports included in the notice served upon Dr Swaminathan, which was visible before issuing the notice, has either been removed or deleted.

It seems that the vaccine manufacturers and many governments are desperate to protect their pro-vaccine agenda and will attempt to censor information and news regarding the efficacy of Ivermectin.

The legal notice can be read in full on the website of the India Bar Association.

Readers are also urged to look at the article ‘COVID Deaths Plunge after Major World City Introduces Ivermectin’, which recently appeared on the World Net Daily News Center website.

The article  ‘COVID Vaccines: A Faltering Framework’ on the OffGuardian’ website is also recommended. The author argues that for the Pfizer vaccine, 119 people must be injected for it to reduce a ‘COVID case’ in one person; the other 118 receive no benefit whatsoever but placed themselves at genuine (potential) risk from the vaccine itself. The Lancet suggests that 119 number might be even higher.

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Colin Todhunter is a frequent contributor to Global Research and Asia-Pacific Research.

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Colombia’s Partnership with NATO Allows It to Breach Human Rights Without Condemnation

 

Colombia’s Partnership with NATO Allows It to Breach Human Rights Without Condemnation

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Since Joe Biden’s ascendency into the White House on January 20, he has emphasised that the U.S.’ foreign policy will be guided by human rights, even if it means calling out traditional allies. However, Washington is completely silent about the repression of anti-government demonstrations in Colombia, its closest ally in Latin America.

At the end of the May 28 meeting with his Colombian counterpart Marta Lucía Ramírez, U.S. Secretary of State Antony Blinken even expressed “his concern and condolences for the loss of life during recent protests in Colombia and reiterated the unquestionable right of citizens to protest peacefully.” However, on the same day as Blinken’s statement, 13 deaths and hundreds of injuries were reported in Cali, the third city of Colombia. This occurred following demonstrations which degenerated into clashes between protestors and security forces.

People with bulletproof vests and guns shot at demonstrators in front of the police. The situation degenerated so badly that the military arrived to aid police to suppress protests against a new tax reform which will send many in the Middle Class into poverty. According to an official count, there are at least 59 deaths, including two police officers. There are also at least 2,300 injuries and 123 missing since protests began at the end of April. Human Rights Watch reported there were a total of 63 deaths as of May 27.

Yet, the U.S. is highly unlikely to denounce Colombia for this gross treatment of civilian protestors.

Colombia is Washington’s main ally in Latin America. For this reason, it is unsurprising that Colombia is one of the countries with the most security and military cooperation agreements with the U.S. These agreements mostly revolve around drug trafficking, civil conflict and destabilising neighbouring Venezuela.

In addition, Colombia is the only Latin American country to gain recognition as a global partner of NATO. This was achieved in 2018 only because of Washington’s insistence. This agreement allows Colombia to associate with the activities of the Atlanticist alliance, including maritime security and countering terrorism and organized crime. In exchange, Colombia receives military material and equipment from the U.S.

This agreement does not constitute a blank check for decisionmakers in the Colombian capital of Bogota. The bilateral relationship between Washington and Bogota proved to be more fluid under the aegis of Donald Trump, who at the time was being influenced by warhawk John Bolton, his National Security Adviser. However, as Colombia’s right-wing President Iván Duque is not completely ideologically aligned with Biden, many speculate that Washington wants to maintain some distance with the current administration in Bogota.

In order to take the opposite view of his predecessor Trump, who successfully used conservative and quasi-patriotic rhetoric to ascend to power, Biden wants to restore the image of American leadership internationally that was destroyed over the past two decades, particularly following the invasions of Afghanistan and Iraq, through terrorizing journalists and whistleblowers like Julian Assange. Such an approach involves the promotion of human rights and reviving the idea of ​​ Western-styled democracy against so-called authoritarianism – hence Biden’s willingness to take any opportunity to demonize Russia and China as they do not conform to Western liberal standards.

Under this banner of human rights, the Biden administration raised its tone vis-à-vis China, with Blinken accusing the Asian Giant of genocide against the Muslim Uighur minority in Xinjiang province. In addition, Blinken also attempts to incriminate Moscow over the Navalny affair. The American President even promised to discuss human rights issues during his scheduled June 16 meeting in Geneva with his Russian counterpart Putin.

The unrest and fierce crackdown that ensued in Colombia came at the worse time for U.S. diplomacy as it does not correspond to the global image that Biden is attempting to project. The U.S. is faced with a dilemma as it appears that the fundamentals of bilateral relations in Biden’s view, based around human rights, is overlooked in the case of Colombia.

It is likely that Washington is discreetly encouraging Duque to settle the crisis without additional repressive excess. That being said, even if Colombia is to continue its violent repression against protestors, it is unlikely to deeply affect its relationship with the U.S. as the South American country is now an indispensable ally and enacts all of Washington’s demands, even to the detriment of its relations with its neighbours, like Venezuela.

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Paul Antonopoulos is an independent geopolitical analyst.

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Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19

 

Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19

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Abstract

Background

After COVID-19 emerged on U.S shores, providers began reviewing the emerging basic science, translational, and clinical data to identify potentially effective treatment options. In addition, a multitude of both novel and repurposed therapeutic agents were used empirically and studied within clinical trials.

Areas of Uncertainty

The majority of trialed agents have failed to provide reproducible, definitive proof of efficacy in reducing the mortality of COVID-19 with the exception of corticosteroids in moderate to severe disease. Recently, evidence has emerged that the oral antiparasitic agent ivermectin exhibits numerous antiviral and anti-inflammatory mechanisms with trial results reporting significant outcome benefits. Given some have not passed peer review, several expert groups including Unitaid/World Health Organization have undertaken a systematic global effort to contact all active trial investigators to rapidly gather the data needed to grade and perform meta-analyses.

Data Sources

Data were sourced from published peer-reviewed studies, manuscripts posted to preprint servers, expert meta-analyses, and numerous epidemiological analyses of regions with ivermectin distribution campaigns.

Therapeutic Advances

A large majority of randomized and observational controlled trials of ivermectin are reporting repeated, large magnitude improvements in clinical outcomes. Numerous prophylaxis trials demonstrate that regular ivermectin use leads to large reductions in transmission. Multiple, large “natural experiments” occurred in regions that initiated “ivermectin distribution” campaigns followed by tight, reproducible, temporally associated decreases in case counts and case fatality rates compared with nearby regions without such campaigns.

Conclusions

Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.

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Introduction

In early 2020, on the onset of the spreading pandemic, many providers and institutions began to continuously review the rapidly emerging basic science, translational, and clinical data to identify potentially effective treatment options for COVID-19. Although there is now a small and increasing number of therapeutics showing some efficacy in important clinical outcomes, chief of which are corticosteroids in moderate to severe illness, the world continues to suffer from a worsening crisis with the potential of again overwhelming hospitals and intensive care units (ICU). As of February 21, 2020, the number of deaths attributed to COVID-19 in the United States reached 510,248 with more than 9.3 million active cases, the highest number to date. In addition, multiple European countries have imposed new rounds of restrictions and lockdowns.

Further compounding these alarming developments was a wave of recently published results from therapeutic randomized controlled trials conducted on medicines believed effective for COVID-19 that found a lack of impact on mortality in hospitalized patients with the use of remdesivir, hydroxychloroquine, lopinavir/ritonavir, interferon, convalescent plasma, and monoclonal antibody therapy.1–4 One year into the pandemic, the only therapy considered “proven” as a life-saving treatment in COVID-19 is the use of corticosteroids in patients with moderate to severe illness.5,6 Similarly, most concerning is the fact that no agent has yet proven effective in outpatients to prevent disease progression to prevent hospitalization.

More recently, trial results of ivermectin, a widely used antiparasitic medicine with known antiviral and anti-inflammatory properties, have been showing benefits in multiple important clinical and virologic outcomes, including mortality. Although growing numbers of the studies supporting this conclusion have passed through peer review, approximately half of the remaining trials data are from manuscripts uploaded to medical preprint servers, a now standard practice for both rapid dissemination and adoption of new therapeutics throughout the pandemic. Following is a comprehensive review of the available efficacy data as of December 12, 2020, taken from in vitro, animal, clinical, and real-world studies all showing the above impacts of ivermectin in COVID-19.

History of ivermectin

In 1975, Professor Satoshi Omura at the Kitsato institute in Japan isolated an unusual Streptomyces bacterium from the soil near a golf course along the southeast coast of Honshu, Japan. Omura, along with William Campbell, found that the bacterial culture could cure mice infected with the roundworm Heligmosomoides polygyrus. Campbell isolated the active compounds from the bacterial culture, naming them “avermectins” and the bacterium S. avermitilis for the compounds’ ability to clear mice of worms.7 Despite decades of searching around the world, the Japanese microorganism remains the only source of avermectin ever found. Ivermectin, a derivative of avermectin, then proved revolutionary. Originally introduced as a veterinary drug, it soon made historic impacts in human health, improving the nutrition, general health, and well-being of billions of people worldwide ever since it was first used to treat onchocerciasis (river blindness) in humans in 1988. It proved ideal in many ways, given that it was highly effective, broad-spectrum, safe, well tolerated, and could be easily administered.7 Although it was used to treat a variety of internal nematode infections, it was most known as the essential mainstay of 2 global disease elimination campaigns that has nearly eliminated the world of two of its most disfiguring and devastating diseases. The unprecedented partnership between Merck & Co. Inc, and the Kitasato Institute combined with the aid of international health care organizations has been recognized by many experts as one of the greatest medical accomplishments of the 20th century. One example was the decision by Merck & Co to donate ivermectin doses to support the Mectizan Donation Program that then provided more than 570 million treatments in its first 20 years alone.8 Ivermectin’s impacts in controlling onchocerciasis and lymphatic filariasis, diseases which blighted the lives of billions of the poor and disadvantaged throughout the tropics, is why its discoverers were awarded the Nobel Prize in Medicine in 2015 and the reason for its inclusion on the World Health Organization’s (WHO) “List of Essential Medicines.” Furthermore, it has also been used to successfully overcome several other human diseases and new uses for it are continually being found.7

Preclinical studies of Ivermectin’s activity against SARS-CoV-2

Since 2012, a growing number of cellular studies have demonstrated that ivermectin has antiviral properties against an increasing number of RNA viruses, including influenza, Zika, HIV, Dengue, and most importantly, SARS-CoV-2.9–17Insights into the mechanisms of action by which ivermectin both interferes with the entrance and replication of SARS-CoV-2 within human cells are mounting. Caly et al18 first reported that ivermectin significantly inhibits SARS-CoV-2 replication in a cell culture model, observing the near absence of all viral material 48 hours after exposure to ivermectin. However, some questioned whether this observation is generalizable clinically given the inability to achieve similar tissue concentrations used in their experimental model using standard or even massive doses of ivermectin.19,20 It should be noted that the concentrations required for an effect in cell culture models bear little resemblance to human physiology given the absence of an active immune system working synergistically with a therapeutic agent, such as ivermectin. Furthermore, prolonged durations of exposure to a drug likely would require a fraction of the dosing in short-term cell model exposure. Furthermore, multiple coexisting or alternate mechanisms of action likely explain the clinical effects observed, such as the competitive binding of ivermectin with the host receptor-binding region of SARS-CoV-2 spike protein, as proposed in 6 molecular modeling studies.21–26 In 4 of the studies, ivermectin was identified as having the highest or among the highest of binding affinities to spike protein S1 binding domains of SARS-CoV-2 among hundreds of molecules collectively examined, with ivermectin not being the particular focus of study in 4 of these studies.27 This is the same mechanism by which viral antibodies, in particular, those generated by the Pfizer and Moderna vaccines contain the SARS-CoV-2 virus. The high binding activity of ivermectin to the SARS-CoV-2 spike protein could limit binding to either the ACE-2 receptor or sialic acid receptors, respectively, either preventing cellular entry of the virus or preventing hemagglutination, a recently proposed pathologic mechanism in COVID-19.21,22,26–28 Ivermectin has also been shown to bind to or interfere with multiple essential structural and nonstructural proteins required by the virus to replicate.26,29 Finally, ivermectin also binds to the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), thereby inhibiting viral replication.30

Arevalo et al investigated in a murine model infected with a type 2 family RNA coronavirus similar to SARS-CoV-2, (mouse hepatitis virus), the response to 500 μg/kg of ivermectin versus placebo.31 The study included 40 infected mice, with 20 treated with ivermectin, 20 with phosphate-buffered saline, and then 16 uninfected control mice that were also given phosphate-buffered saline. At day 5, all the mice were killed to obtain tissues for examination and viral load assessment. The 20 nonivermectin-treated infected mice all showed severe hepatocellular necrosis surrounded by a severe lymphoplasmacytic inflammatory infiltration associated with a high hepatic viral load (52,158), whereas in the ivermectin-treated mice a much lower viral load was measured (23,192; P < 0.05), with only few livers in the ivermectin-treated mice showing histopathological damage such that the differences between the livers from the uninfected control mice were not statistically significant.

Dias De Melo et al32 recently posted the results of a study they did with golden hamsters that were intranasally inoculated with SARS-CoV-2 virus, and at the time of the infection, the animals also received a single subcutaneous injection of ivermectin at a dose of 0.4 mg/kg on day 1. Control animals received only the physiologic solution. They found the following among the ivermectin-treated hamsters: a dramatic reduction in anosmia (33.3% vs. 83.3%, P = 0.03), which was also sex dependent in that the male hamsters exhibited a reduction in clinical score while the treated female hamsters failed to show any sign of anosmia. They also found significant reductions in cytokine concentrations in the nasal turbinates and lungs of the treated animals, despite the lack of apparent differences in viral titers.

Despite these mounting insights into the existing and potential mechanisms of action of ivermectin both as a prophylactic and treatment agent, it must be emphasized that significant research gaps remain and that many further in vitro and animal studies should be undertaken to better define not only these mechanisms but also to further support ivermectin’s role as a prophylactic agent, especially in the optimal dose and frequency required.

Click here to read the full article published by the American Journal of Therapeutics.

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Full authors

Kory, Pierre MD; Meduri, Gianfranco Umberto MD; Varon, Joseph MD; Iglesias, Jose DO; Marik, Paul E. MD

Featured image is from Novikov Aleksey / Shutterstock

Lettera aperta al signor Luigi di Maio, deputato del Popolo Italiano

ZZZ, 04.07.2020 C.A. deputato Luigi di Maio sia nella sua funzione di deputato sia nella sua funzione di ministro degli esteri ...