Fifth Circuit Rebukes FDA for Banning Ivermectin for Covid-19

By Jerome R. Corsi

The U.S. Court of Appeals for the Fifth Circuit issued a unanimous three-judge decision on September 1, 2023, holding that the Federal Drug Administration (FDA) overstepped its statutory authority by attempting to ban using ivermectin to treat COVID-19. In Apter v. Department of Health and Human Services, court concluded, “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.”

Writing for the three-judge panel, Circuit Judge Don R. Willett began the court’s opinion by citing the strident nature of the FDA’s opposition to ivermectin as a COVID-19 treatment. Willett opened his opinion as follows:

“You are not a horse.”

Or so the Food and Drug Administration (“FDA”) alerted millions of Americans via social media, midway through the COVID-19 pandemic. The agency had discerned that some people were treating their symptoms using the animal version of a drug called ivermectin. FDA decided to target the practice via the “horse” message—and others like it. The messaging traveled widely across legacy and online media. Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.

The case involved three physicians, Robert L. Apter, Mary Talley Bowden, and Paul E. Marik, each of whom jeopardized his or her professional career by prescribing ivermectin for COVID-19 in defiance of the FDA warnings. Apter and Bowden claim to have treated or consulted more than 9,000 COVID-19 patients, with each experiencing a 99 percent survival rate, despite regularly prescribing them ivermectin off-label as a treatment.

Under FDA regulations, any licensed physician may prescribe “off label” any medication the FDA has approved, even if the FDA has not approved the medication for the illness for which the physician is writing the prescription. In 1996, the FDA approved ivermectin to treat in humans parasitic diseases caused by parasites. For daring to ignore the FDA’s vociferous public relations campaign demonizing the use of ivermectin to treat COVID-19, the Courthouse News Service reported “a major Houston hospital system forced Talley Bowden to resign her privileges; Apter was referred to physician regulatory boards of Arizona and Washington state for discipline; Marik was forced to resign from his post at Eastern Virginia Medical School, where he was a medical professor and chief of pulmonary and critical care.” Pharmacies across the nation quit filling prescriptions for ivermectin to treat COVID-19 based solely upon the FDA’s stridently broadcast admonitions not to do so.

Marik joined Pierre Kory, M.D., MPA, co-author of the 2023 book The War on Ivermectin: The Medicine that Saved Millions and Could Have Ended the Pandemic, as one of the critical care specialists co-founding the Front Line COVID-19 Critical Care Alliance (FLCCC), the 501(c)3 organization that brought the case to federal court. In federal court, FLCCC attorneys argued that the FDA’s messaging interfered with their individual “ability to exercise professional medical judgment in practicing medicine.” The doctors also alleged that the FDA’s internet posts on social media demonizing the use of ivermectin to treat COVID-19 “harmed their reputations.”

The Fifth Circuit’s decision does not mean that the FDA now approves of ivermectin to treat COVID-19. But by ruling that Apter et al. had standing to bring the case, the Fifth Circuit’s admonition that the FDA had overstepped its legislative authorization was loud and clear. The Fifth Circuit reversed the district court’s ruling that FLCCC lacked standing to bring the case against the FDA, remanding the case back to the district court.

Still, the decision could not be more important, given that the World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus is already warning that there are “concerning trends for COVID-19 ahead of the winter season in the northern hemisphere,” including increased ICU admissions and hospitalization in Europe. CNN sounded the alarm over a “highly mutated new variant of the virus,” BA.2.86. The newest version is nicknamed “Pirola” and “has more than 30 amino acid changes to its spike protein compared with its next closest ancestor, the BA.2 subvariant of Omicron, according to Dr. Jesse Bloom, who studies viral evolution at the Fred Hutchinson Cancer Center in Seattle.”

In the War on Ivermectin, Dr. Kory wrote:

The government has lost my trust—and not just with regard to medicine. Climate change, the war in Ukraine, oil shortages, a banking collapse—whatever the new “narrative” is, I’m inclined to suspect it’s usually and mostly false; willfully constructed not for the common good, but for the good of those who control the institutions of society. It’s so bad that I am now even suspicious of the relentless refrain, “Ninety-eight percent of climate change scientists agree that C02 is the root cause of global warming.” Do you know why? Because I heard that same “consensus” about ivermectin, HCQ, and the vaccines. It might be true; it may not be. I may have time to “do my own research” someday; I may not. Regardless, they blew it. I will never again believe a word they say without verifying it myself through exhaustive investigation.

According to SOMO’s research report, “Pharma’s Pandemic Profits,” published on February 27, 2023, Pfizer, BioNTech, Moderna, and Sinovac made an extraordinary $90 billion in profits on their COVID-19 vaccines and medicines in 2021 and 2022. Government National Institutes of Health (NIH) scientists raked in more than $325 million in royalties from Chinese and Russian entities—as well as pharmaceutical companies—for their research on vaccinations. Former National Institutes of Allergy and Infectious Diseases (NIAID) director Dr. Anthony Fauci was among the thousands of government physicians to be paid royalties from pharmaceutical companies between September 2009 and October 2020.

With this much money to be made off COVID-19, it is no wonder the FDA demonized ivermectin (and hydroxychloroquine), common inexpensive medications that possibly could have ended the COVID-19 pandemic before the NIH began demanding that President Trump lock down the U.S. economy. The question now is whether the American public is being set up for another round of COVID-19 scare so big pharma can continue raking in the billions from COVID-19 booster shots that may or may not work.

Most Intensive Ivermectin Use Had 74 Percent Reduction in Excess Deaths in Peru: New Study

Megan Redshaw, J.D.

Aug 17 2023

According to a new peer-reviewed ecological study, a natural experiment occurred when the government of Peru authorized ivermectin for use during the COVID-19 pandemic resulting in evidence of the drug’s effectiveness and ability to reduce excess deaths.

The paper’s results, published August 8 in Cureus, found a 74 percent reduction in excess deaths in 10 states with the most intensive ivermectin use over a 30-day period following peak deaths during the pandemic. When analyzing data across 25 states in Peru, researchers found these reductions in excess deaths correlated closely to ivermectin use during four months in 2020.

When ivermectin was available without restriction, there was a fourteenfold reduction in nationwide excess deaths. Once access to ivermectin was restricted by the government, a thirteenfold increase in excess deaths was observed in the two months following the limitation of its use. The findings align with summary data from the World Health Organization for the same time period in Peru.

Ivermectin is a widely-known and inexpensive treatment against parasitic diseases. Scientists believe the drug can also bind to the spike protein of the SARS-CoV-2 virus, limiting its morbidity and infectivity.

Peru Promoted Then Restricted Access to Ivermectin

Before Peru implemented COVID-19 vaccine mandates, the country relied on mitigation strategies such as lockdowns and therapeutics to control the SARS-CoV-2 virus that causes COVID-19, as did many other nations.

The Peruvian Ministry of Health, on May 8, 2020, approved ivermectin widely for use prompting 25 states in Peru to implement inpatient and outpatient treatments with ivermectin to different extents and in different time frames. Additionally, through the Mega-Operación Tayta (MOT)—a national program led by the Ministry of Defense—Peru’s government began distributing ivermectin on a wide scale.

Through a partnership with 11 other government agencies, MOT aimed to reach every targeted region with rapid response teams to detect COVID-19 cases, administer ivermectin, and provide food to encourage people to isolate for 15 days. Shortly thereafter, MOT began distributing the therapeutic to everyone identified as high-risk, regardless of whether they tested positive or were symptomatic for COVID-19.

The government of Peru independently tracked daily COVID-19 deaths and all-cause deaths through numerous Peruvian national health databases, allowing researchers to calculate excess deaths. Additionally, they extensively tracked data for deaths and other public health parameters allowing analysis of the potential efficacy of interventions such as ivermectin during the pandemic.

When President Francisco Sagasti took office on Nov. 17, 2020, the government stopped distributing ivermectin and made it available only by prescription. This made the drug significantly more difficult for people to obtain and allowed researchers to see nationwide changes in daily excess all-cause deaths before and after restrictions went into place.

Impact of Ivermectin on Excess Deaths

Excess all-cause deaths were calculated from the total deaths recorded for January through February 2020. During this period, monthly all-cause deaths fluctuated with a mean value of 5.2 percent and a standard deviation of 3.8 percent. By May 2020, total deaths fluctuated by more than double the baseline value calculated in January through February.

An analysis of excess all-cause deaths was performed state-by-state for those aged 60 years and older to establish the date of peak excess deaths during the pandemic’s first wave. Decreases in excess deaths from the peak date of death to 30 and 45 days afterward were tracked. The 25 states were then grouped by the extent of ivermectin distribution: maximal distribution—occurring through operation MOT, medium, and minimal.

Results showed that the 10 MOT states had a sharp decrease in excess deaths after reaching peak values—with a 74 percent drop at 30 days and an 86 percent drop at 45 days after the date of peak deaths. For 14 states that locally administered ivermectin, excess deaths dropped by 53 percent at 30 days and 70 percent at 45 days.

In Lima, where ivermectin treatments were delayed until August—four months after its initial pandemic surge in April—excess deaths only dropped by 25 percent at 30 days and 25 percent at 45 days after peak deaths on May 30.

According to the study, mean reductions in excess deaths 30 days after peak deaths were 74 percent, 53 percent, and 25 percent, respectively, for the maximal, medium, and minimal states that distributed ivermectin. Forty-five days after peak deaths, mean reductions were 86 percent, 70 percent, and 25 percent.

The researchers noted that ivermectin distribution may have yielded such positive numbers due to the drug’s ability to both prevent and treat COVID-19 when distributed to an at-risk population on a greater scale.

Similar Results Observed in Uttar Pradesh, India

Researchers noted similar results with ivermectin distribution in Uttar Pradesh, India, where government teams moved across 97,941 villages as part of a COVID-19 management program to distribute home medication kits that contained ivermectin, doxycycline, zinc, vitamins C and D3, and acetaminophen tablets.

After the mass distribution of ivermectin, the seven-day moving average of COVID-19 deaths in Uttar Pradesh decreased by 97 percent. The cumulative total of COVID-19 deaths per million in population from July 7, 2021, through April 1, 2023, was 4.3 in Uttar Pradesh, compared with 70.4 in all of India and 1,596.3 in the United States, according to the study.

Although Peru had more comprehensive data, the Uttar Pradesh data suggests using ivermectin may prevent and potentially treat COVID-19.

“These encouraging results from IVM [ivermectin] treatments in Peru and similar positive indications from Uttar Pradesh, India, which have populations of 33 million and 229 million, respectively, offer promising models for further mass deployments of IVM, as needs may arise, for both the treatment and prevention of COVID-19,” researchers concluded.

The authors considered factors that could influence their findings, such as the effects of a social isolation mandate imposed in May 2020, the varying genetic makeup of the SARS-CoV-2 virus, differences in seropositivity rates, and population densities across the 25 states. Still, researchers stated the extent and reliability of data showed other factors did not significantly influence study outcomes.

The War on Ivermectin

A lie will circle the world before the truth has a chance to get its' shoes on.

ROBERT W MALONE MD, MS

25 MAY 2023

Today lets talk a bit about the history of the use of Ivermectin for treating COVID-19, and in particular the new book which will be out in just a few days from Dr. Pierre Kory and Jenna McCarthy titled “The War on Ivermectin”.

To kick this off, there is a fake/fabricated storyline circulating that the US DoD/DTRA- Chem-Bio defense (DOMANE) program actively suppressed the use of Ivermectin as a COVID-19 treatment option, that I was the leader of the DOMANE program, and that I am personally responsible for the advancement and licensure of Remdesivir and the suppression of Ivermectin as a treatment option. The same self-styled “independent journalist” promoting these obvious falsehoods also asserts that I am responsible for 9-11 and the Anthrax attacks.

The following paragraphs are the first time I have directly addressed aspects of my involvement in drug repurposing for COVID involving Ivermectin.

Historically I primarily have spoken out about the COVID genetic vaccines, because that is what people (and podcasters) wanted to hear from me. But that work is only a small subset of my efforts to provide ways to mitigate the damages caused by SARS-CoV-2, COVID-19 and the COVIDcrisis response since January of 2020. My work in repurposing drugs for early COVID-19 treatment, which consumed all of 2020 and most of 2021, is not something that I have emphasized in my public activities for three general reasons: First, others have spoken at length about their work, so the topic of drug repurposing has been fairly well covered. Second, much of my work was performed as a consultant/subcontractor under various non-disclosure agreements. Nothing nefarious here, just normal business practices for a small consulting shop. Third, despite what some may darkly mutter, my public activities have not been about self-promotion, but rather have been focused on trying to educate and help the general public deal with the upside down clown world of the COVIDcrisis public response that they have been subjected to since January 2020.

I have a general rule of thumb to not talk to the crazies, online or otherwise, and so have not previously felt any particular need to address these various unfounded conspiracy theories promoted by a self-styled “independent journalist” who mostly seems to be obsessed with trying to belittle, gaslight, and denigrate me without bothering to actually do the investigative research which would immediately refute his theories. I have no idea who pays this person to spread his theories and attacks on me and many others.

For the record,

• DOMANE is a DoD/DTRA program. I have never been a DTRA employee. I have never been a member of DTRA (or DOMANE) leadership. All lies. In my role as CEO of my consulting business RWMaloneMD LLC I served as a subcontractor for three DTRA-related contracts. One contract was issued to a small company called Allchem, which at the time was owned by Dr. Jim Talton. That contract was focused on discovering inhibitors of organophosphate toxins (nerve gases and certain pesticides) using high throughput computational and robotic screening methods. The other contract was with MIT Lincoln Lab, where I served as a consultant on that DOMANE contract, which was focused on discovering repurposed drugs for treatment of COVID-19 (including Ivermectin) and advancing sponsored clinical research to test those agents. The third one (also acting as a consultant/subcontractor) was managed by Leidos, and involved development of an advanced patient-centered outcomes research software tool and use in supporting both outpatient (virtual) clinical trials as well as parallel inpatient trials of the repurposed pharmaceutical agents ivermectin, celecoxib, and famotidine. No Remdesivir. Amazingly, the FDA blocked that program (and the DoD) from testing Ivermectin, informing that clinical trials of that agent would not be allowed to proceed until in vitro (in the test tube) studies demonstrated the mechanism of action of Ivermectin as an anti-viral for SARS-CoV-2.
• DOMANE is not the program which advanced and advocated Remdesivir for COVID-19. Another obvious lie. That would be Dr. Anthony Fauci and the NIAID. The historic record is clear on that. DOMANE claims credit for funding the initial development of Remdesivir because it funded the development of this drug as a potential anti-Ebola agent, for which application it failed largely due to toxicity and lack of effectiveness.
• I was an early and continued advocate for use of Ivermectin for treatment of COVID-19. Some, although not this particular “investigative journalist” in question, will remember that I was specifically attacked by “independent journalist” Mr. Alex Berenson for my advocacy of the repurposed agent as a treatment for COVID-19. Reviewing my over 3,400 email correspondences involving Ivermectin since January 01, 2020 (there were many more before that date), I find that the first in this time frame is dated January 10, 2020, and involved internal correspondence with the Alchem team (who were volunteering their time to try to identify repurposed drugs for SARS-CoV-2 treatment). Most are also not aware that further back in time I had been an advocate for the use of Ivermectin as an agent for treating Yellow Fever Virus infection and many other viruses, and even filed a field of use patent (since abandoned) for Ivermectin as an antiviral.
• Searching my email accounts for the key words “Ivermectin” and “Kory” (as in Pierre) reveals 936 email correspondences, the first being on 11/19/2020 (almost 200 days prior to the Bret Weinstein/Pierre Kory DarkHorse Podcast. This first notification of the potential efficacy of Ivermectin was part of a summary provided by senior (since retired) DTRA/DOMANE scientist Dr. Howard Haimes. On December 08, 2020, I wrote to the project officer for the DTRA/DOMANE contractor Leidos concerning the following article posted on Trial Site News, and advocating for clinical testing of Ivermectin within the funded program:

Prominent Physician/Researchers to Present Case for Ivermectin to U.S. Senate Committee on Homeland Security & Governmental Affairs

The U.S. Senate Committee on Homeland Security & Governmental Affairs will hold a full committee hearing on December 8, 2020, at 10:00 AM at the Senate Dirksen Building and via video conference. Titled “Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II,” invited witnesses to include Jane M. Orient, MD, Executive Director Association of American Physicians and Surgeons, Pierre Kory, MD, Associate Professor of Medicine, St. Luke’s Aurora Medical Center, Jean-Jacques Rajter, MD, Pulmonologist, Broward Health Medical Center and ICON study co-author and Ramin Oskoui, MD, Vice President of Medical Staff, Sibley Memorial Hospital and Chief Executive Officer of Foxhall Cardiology. Prominent among discussion topics will be the use of ivermectin as a treatment for early-stage, mild to moderate COVID-19 cases. To date, although well over $12 billion U.S. dollars have been spent by the taxpayers, there has been no breakthrough for early-stage treatment, an incredibly important period to get COVID-19 under control. There is evidence that some generic-based treatments can help accomplish this objective.

In the same email, I further advocated for clinical trial testing of Ivermectin by including a link to this website:

COVID-19 treatment studies for Ivermectin

On December 05, 2020, I reached out to Pierre’s co-author on an informal review of Ivermectin as a COVID-19 treatment (which had been published informally on the internet), which lead to my being introduced to Pierre, launching what I hope will be a lifelong friendship.

Dear Dr Lieberman,

Alexis - Please consider preparing and submitting a report summarizing experiences treating COVID-19 with Ivermectin! We have set up this special topic of Frontiers in Immunology specifically so that there will be a forum for physicians and scientists such as yourself to report observations that may not yet meet the criteria for publication in high profile journals, but which are not otherwise being reported and published. This journal is "open source", and so does charge for managing and formatting each publication. Best wishes Robert Malone, MD, MS

Frontiers in Pharmacology has launched a new Research Topic, Treating COVID-19 With Currently Available Drugs. As a leading expert in your field, we would like you to participate by submitting your research.

Pierre wrote back on December 11, 2020:

Alexis, Robert,

Thank you for making our acquaintance and I so appreciate your mention of the short period to publication because:

We know many many lives are at stake with every day that this manuscript takes through peer review. I cannot stress this enough

I am just now getting offers from other journals also emphasizing speed. I am much more attracted to quality and speed right now than just impact factor etc (this is also a first for me in publishing manuscripts, i.e. journals reaching out to me

Anyway, Robert, I thank you for your interest, it is very encouraging – do you know what kind of time-line to on-line publication we can expect if it passes peer review and/or requires only minor revisions. If anything more gets required, we understand it would take much longer. Anyway, thanks for your interest and please advise – thanks, Pierre

Pierre Kory, MD, MPA

President, Front-Line Covid-19 Critical Care Alliance

Associate Professor of Medicine

Advocate Aurora Critical Care Service

St. Luke’s Aurora Medical Center, Milwaukee, WI

Front Line COVID-19 Critical Care Alliance
Prophylaxis & Treatment Protocols for Covid-19
www.covid19criticalcare.com
www.flccc.net

Thus launched at initiative which unfortunately ended poorly. Pierre submitted his manuscript to Frontiers and I was assigned as editor for the submission. I selected four highly qualified reviewers - 1) a senior pharmaceutical scientist, 2) the most senior FDA clinical reviewer, 3) another senior FDA pharmaceutical scientist from the office of the Chief Scientist, and 4) a front line ICU physician practicing at a major academic medical center in NYC/Brooklyn. These four put the manuscript through extensive review and revisions. It was accepted for publication. Pierre and the FLCCC paid the required publication fee. As was the usual practice for Frontiers in Pharmacology, the abstract was published as a pre-print/teaser. It accrued a record number of views in just a few short days. And then all hell broke loose.

The editor in chief of Frontiers forced the paper to be withdrawn. This set off a cascade which eventually lead to resignation of the editors (including myself) who had created this special edition of Frontiers in Pharmacology specifically to enable publication of COVID-19 repurposed drug research, and closing down of that special volume without publication. At the time, the Editor in Chief was warned that if he took these actions, he would be responsible for large numbers of avoidable deaths. Time has validated that assertion, along with so many others which were made along the way but attacked at the time.

The resulting mess (and Frontiers’ denials of culpability) were then covered in two articles by a UK publication named “The Scientist”:

Frontiers Removes Controversial Ivermectin Paper Pre-Publication

A review article containing contested claims about the tropical medicine drug as a COVID-19 treatment was listed as “provisionally accepted” on the journal’s website before being removed this week.

Frontiers Pulls Special COVID-19 Issue After Content Dispute

The issue’s guest editors resign after falling out with the publisher over the management of papers, including a rejected manuscript on ivermectin, that were submitted for a special issue on drug repurposing for COVID-19.

So, I ask you. Based on the evidence above, did I serve as the leader of DOMANE, act to promote Remdesivir and block Ivermectin? These are lies which are being promoted for some undisclosed ulterior motive by someone who self-identifies as an “investigative journalist” and has posted literally thousands of on-line attacks on my character and integrity. As are the assertions that I am somehow responsible for 9-11 and the Anthrax attacks (at which time I was actually living in Rockville MD working on developing a Breast Cancer research facility and tissue bank in Windber, PA under a John Murtha porkbarrel project called the Windber Research Institute, while also starting a US-based company called Inovio).

The record clearly shows that I was an early and strong advocate for use of Ivermectin (and celecoxib, and famotidine) as repurposed drug agents for treating COVID-19, and a strong advocate for the work of Dr. Pierre Kory and his colleagues at the FLCCC.

The good news to come out of this horrid chapter in the COVIDcrisis story was that through all of this drama and trauma, and subsequently in so much other travel (thousands of emails!), meetings and discussions (including both “DEFEAT THE MANDATES” rallies, I have been able to develop what I hope will be a livelong friendship with Dr. Pierre Kory and his close colleague Dr. Paul Marik.

Dr. Pierre Kory is the kind of guy people love to love. A native New Yorker with a huge heart and a knack for numbers, Kory is equal parts affable and academic, quick to crack a joke or rattle off complex medical statistics from memory. He’s been on the Covid front lines from the beginning, searching for answers, testifying before the senate, and advocating for both patient and physician rights—a journey he eloquently and assiduously documents in his forthcoming book, The War on Ivermectin (Skyhorse, June 2023). Kory has been called everything from a fringe doctor to a medical misinformationist—two terms that in today’s upside-down world translate into “someone you definitely want to listen to.” It’s my pleasure to share the first chapter of his book, written with author Jenna McCarthy and featuring a foreword by Del Bigtree. Kory’s is a powerful, highly-anticipated story filled with facts, humor and truth that will edify and enlighten readers around the world.

The War on Ivermectin, Chapter One: Before the Beginning

Here’s to the crazy ones. The misfits. The rebels. The trouble­makers. The round pegs in the square holes. The ones who see things differently. They’re not fond of rules. And they have no respect for the status quo. You can quote them, disagree with them, glorify or vilify them. About the only thing you can’t do is ignore them. Because they change things. They push the human race forward. And while some may see them as the crazy ones, we see genius. Because the people who are crazy enough to think they can change the world are the ones who do.

—Steve Jobs

I do quite a bit of public speaking these days, and part of my schtick has become somewhat of an “ode to the old Pierre.” When I say old, of course, I mean pre-Covid.

Old Pierre believed that the elite, esteemed medical journals represented the best of scientific thought and study. The Lancet or the New England Journal of Medicine said so? It was settled then. Old Pierre religiously read the New York Times from cover to cover, because it was the paper of record; the arbiter of truth. If you wanted to know what was really going on, you read the Times. Period. He voted for Biden (although in his defense, he wasn’t exactly a fan and never put a BIDEN-HARRIS ring around any of his social media profile photos), trusted the government (I know!), and actu­ally believed that public health agencies were committed to safeguarding and improving . . . wait for it . . . public health. He knew—knew, I tell you!—that vitamins were a scam and that hospitals were life-saving centers of care, compassion, and excellence. Old Pierre dutifully lined up for his own annual flu shot and followed the childhood immunization schedule to the letter with his three daughters.

He was a clueless sonofabitch.

Nobody, least of all me, could have predicted the insane series of events, discoveries, and decisions that would transform him (me) into the wildly different doctor—and man—that I am today.

But here we are.

So this is my story. What started as a daily brain dump, a place to record the happenings and heartbreaks occurring at work and at home, slowly mor­phed into this crazy peek into a decidedly broken medical system. I set out to understand and expose what was happening with repurposed drugs, iver­mectin specifically. By October of 2020, we had identified an inexpensive, safe, widely available medication that was showing tremendous potential not just as a treatment for Covid but also as a preventative. As the weeks and months wore on, the data supporting its safety and efficacy were astound­ing. And yet the backlash against it was swift and furious. Positive studies were overturned and retracted. Negative studies appeared out of thin air. Around the world it was quietly being used to tremendous, almost impos­sible success, and yet doctors were punished for prescribing it, pharmacies refused to fill valid prescriptions for it, and the media would only touch it to call it “the horse dewormer.” To a physician fighting on the front lines of this battle, this systematic smear campaign was unfathomable.

I soon discovered that the corruption and deceit were hardly limited to the pharmaceutical space. The entire medical industrial complex—including our governmental and international regulatory agencies, Big Pharma, pub­lic and private health care systems and hospital networks, medical schools and their journals, and at least one centi-billionaire “philanthropath”—had been collectively captured. According to Wikipedia (which I don’t often use as a reference source, incidentally, but their explanation was most succinct), “When regulatory capture occurs, a special interest is prioritized over the general interests of the public, leading to a net loss for society.”1

You can say that again.

At the risk of sounding arrogant or self-congratulatory, when it came to Covid, I got a lot of things right from the beginning. So often and so over­whelmingly, in fact, that I was dubbed “Lucky Pierre,” first by the editor of the New England Journal of Medicine in a magazine interview, and then by my colleagues and friends. I want to acknowledge here, up front, that I ascribe much of that consistent, almost implausible “rightness” to this: practically from day one, I was part of a group of highly credible, extensively experienced professors, scientists, and clinicians who were deeply studied on nearly every aspect of medicine even remotely related to Covid. We shared a spirit and a purpose well before we had a name (the Front Line Covid Critical Care Alliance, or FLCCC), a website, or a nonprofit designation.

The whole is always greater than the sum of its parts, and that is expo­nentially true with the FLCCC. After all, we’re the misfits, the troublemak­ers, the round pegs in the square holes. We’re the ones standing up to the system; the child watching the bare-assed Emperor parade down the street who just can’t hold his tongue.

“But he hasn’t got anything on,” we’ve been shouting. At first, people pointed and laughed at us and called us names, but we didn’t care. That fat bastard was naked, and nothing could make us see or think otherwise! And do you know what? People are starting to catch on. More and more, some might say in droves, they’re seeing what we see and have seen for a few years now.

That is the power and spirit of the collaboration and camaraderie behind the FLCCC. From the beginning, we were bound by mutual passion and respect, and committed to uncovering and speaking the truth—no matter how difficult or isolating that proved to be.

So yeah, we’ve gotten a lot right. It turns out, that’s actually not so hard to do when you’re surrounded by greatness and your hearts are in the right place.

Excerpted from The War on Ivermectin by Dr. Pierre Kory with Jenna McCarthy

Is Quercetin a Safer Alternative to Hydroxychloroquine?

Joseph Mercola

Feb 10 2023

(photo_gonzo/Shutterstock)

Evidence suggests hydroxychloroquine works for COVID-19 because it acts as a zinc ionophore, meaning it shuttles zinc into your cells. Canadian and Chinese researchers are collaborating on a study to assess the effectiveness of this alternative powerful immune booster and broad-spectrum antiviral.

STORY AT-A-GLANCE

• A Chinese trial comparing clinical outcomes of COVID-19 patients treated with the antimalarial drug hydroxychloroquine and those receiving standard of care alone reports “disappointing” results.
• The hydroxychloroquine group only had a 28-day negative conversion rate of 85.4 percent compared to the control group’s rate of 81.3 percent. No difference in the alleviation of symptoms was observed between the two groups.
• The study did not, however, use supplemental zinc, which helps prevent viral replication. Evidence suggests hydroxychloroquine works for COVID-19 because it acts as a zinc ionophore, meaning it shuttles zinc inside your cells.
• A Brazilian chloroquine trial stopped the high-dose arm of the study early due to patients developing ventricular tachycardia, a dangerous heart rhythm problem. Chloroquine is known to be more toxic than hydroxychloroquine.
• Quercetin is a naturally occurring zinc ionophore. Taken with zinc, it may be helpful to prevent and potentially treat COVID-19. Research is currently underway to assess quercetin’s effectiveness against COVID-19.

The debate about whether the antimalarial drug hydroxychloroquine is an effective treatment for COVID-19 continues, as a Chinese trial (1)(2)(3) comparing clinical outcomes of those treated with the drug and those receiving standard of care alone reports “disappointing” results.

Hydroxychloroquine Trial Reports Disappointing Results

Seventy-five COVID-19 patients at 16 Chinese treatment centers received 1,200 milligrams of hydroxychloroquine (HCQ) in addition to standard of care for the first three days of treatment, followed by a maintenance dose of 800 mg per day for two weeks in mild to moderate cases and three weeks for severe cases. Another 75 patients received standard of care only.

The primary endpoint was a 28-day negative conversion rate of SARS-CoV-2 (viral load reduction). Secondary endpoints included an improvement rate of clinical symptoms and the normalization of C-reactive protein and blood lymphocyte count within 28 days.

According to the authors, the hydroxychloroquine group only had a 28-day negative conversion rate of 85.4 percent compared to the control group’s rate of 81.3 percent. No difference in the alleviation of symptoms was observed between the two groups.

Adverse events were also higher in the hydroxychloroquine group (30 percent) compared to controls (8.8 percent). You can find a listing of the adverse events in Table 2 of the study. (4)

The most common adverse event, at 10 percent, was diarrhea. That said, the authors point out that: (5)

“A significant efficacy of HCQ [hydroxychloroquine] on alleviating symptoms was observed when the confounding effects of anti-viral agents were removed in the posthoc analysis (Hazard ratio, 8.83, 95 percent CI, 1.09 to 71.3).

“This was further supported by a significantly greater reduction of CRP [c-reactive protein] (6.986 in SOC [standard of care] plus HCQ versus 2.723 in SOC, milligram/liter, P=0.045) conferred by the addition of HCQ, which also led to more rapid recovery of lymphopenia, albeit no statistical significance.

“Conclusions: The administration of HCQ did not result in a higher negative conversion rate but more alleviation of clinical symptoms than SOC alone in patients hospitalized with COVID-19 without receiving antiviral treatment, possibly through anti-inflammatory effects. Adverse events were significantly increased in HCQ recipients but no apparent increase of serious adverse events.”

Limitations of This Study

A few things are worth noting about this study. Aside from its small size, the patients received a far higher dose of hydroxychloroquine than typically used in the U.S.—1,200 milligrams for the first three days, followed by 800 mg per day for two to three weeks, compared to the U.S. Food and Drug Administration’s suggested dosage of 800 mg on day one, followed by 400 mg per day for four to seven days, depending on severity. (6)

Secondly, most patients had mild disease with little hypoxemia, and thirdly, treatment was administered quite late, on average 16 to 17 days after the onset of disease. Commenting on the findings, Josh Farkas, associate professor of pulmonary and critical care medicine at the University of Vermont wrote:

“Much of the pathogenesis of critical illness seems to result from dysregulated inflammation, rather than direct viral cytopathic effect. This raises a question of whether any antiviral treatment will be beneficial for late-presenting patients with severe illness.

“Of course, it is possible that earlier use of hydroxychloroquine could be beneficial (e.g., perhaps at the first signs of illness on an out-patient basis). This is under investigation and additional data is likely to be forthcoming soon. Even if this does work in the outpatient clinic, it would probably have little impact on the management of these patients within the intensive care unit.”

Editor’s note: This blog was deleted and wiped clean from the internet later. I am leaving it here to illustrate how something controversial can quickly disappear, even when well-documented and sourced at the time it’s used.

This Study Failed to Use Zinc

Perhaps most important, however, is the absence of zinc, which Farkas does not mention. We now know that chloroquine and hydroxychloroquine act as zinc ionophores, (7)(8) meaning they shuttle zinc into your cells, and zinc appears to be a “magic ingredient” required to prevent viral infection. (9)

If given early, zinc along with a zinc ionophore should, at least theoretically, help lower the viral load and prevent the immune system from becoming overloaded. Without zinc, hydroxychloroquine may be more or less useless.

So, in my view, I doubt this study is worth placing too much stock in, seeing how it did not administer supplemental zinc. As noted in the preprint paper, “Does Zinc Supplementation Enhance the Clinical Efficacy of Chloroquine/Hydroxychloroquine to Win Today’s Battle Against COVID-19?” published April 8, 2020: (10)

“Besides direct antiviral effects, CQ/HCQ [chloroquine and hydroxychloroquine] specifically target extracellular zinc to intracellular lysosomes where it interferes with RNA-dependent RNA polymerase activity and coronavirus replication.

“As zinc deficiency frequently occurs in elderly patients and in those with cardiovascular disease, chronic pulmonary disease, or diabetes, we hypothesize that CQ/HCQ plus zinc supplementation may be more effective in reducing COVID-19 morbidity and mortality than CQ or HCQ in monotherapy. Therefore, CQ/HCQ in combination with zinc should be considered as an additional study arm for COVID-19 clinical trials.”

Chloroquine Trial Stopped Due to Side Effects

In related news, a Brazilian chloroquine trial (11) (12) stopped the high-dose arm of the study early due to patients developing ventricular tachycardia, a dangerous heart rhythm problem. As reported by Live Science: (13)

“The Brazilian researchers planned to enroll 440 people in their study to test whether chloroquine is a safe and effective treatment for COVID-19. Participants took either a ‘high dose’ of the drug (600 milligrams twice daily for 10 days) or a ‘low dose’ (450 mg for five days, with a double dose only on the first day) …

“However, after enrolling just 81 patients, the researchers saw some concerning signs. Within a few days of starting the treatment, more patients in the high-dose group experienced heart rhythm problems than did those in the low-dose group. And two patients in the high dose group developed a fast, abnormal heart rate known as ventricular tachycardia before they died.”

As explained in my previous article, “Antimalarial Medications: A COVID-19 Treatment Option?” chloroquine and hydroxychloroquine have been shown to be effective in the lab against the SARS coronavirus that appeared in 2003. (14)(15)(16) Laboratory testing also suggests chloroquine is effective in cell cultures against COVID-19 when combined with an antiviral drug, remdesivir. (17)

However, chloroquine (Aralen) appears to be a more hazardous choice than hydroxychloroquine (Plaquenil), which is a derivative of chloroquine. (18) Both use the same pathway, but hydroxychloroquine is thought to be about 40 percent less toxic (19) and, overall, has a safer side effect profile. (20)(21)

Quercetin is found in berries, citrus fruits, grapes, and more. (pilipphoto/Shutterstock)

Quercetin–A Safer Alternative to Hydroxychloroquine?

Considering the risks of chloroquine and hydroxychloroquine, and the evidence suggesting the reason these drugs work for COVID-19 is because they act as zinc ionophores, it’s worth questioning whether other more natural zinc ionophores can be used.

One prime example would be quercetin, which is a naturally occurring zinc ionophore. (22) As reported by the Green Stars Project, (23) “Researchers from Oak Ridge National Lab used the world’s most powerful supercomputer, SUMMIT, to look for small molecules that might inhibit the COVID-19 spike protein from interacting with human cells and, interestingly, quercetin is fifth on that list.” (24)

Quercetin is one of only three natural products found to inhibit the SARS-CoV-2 spike protein. The only natural product found to be slightly more effective is luteolin, a polyphenol found in radicchio, green peppers, serrano and green hot chili peppers, chicory, celery, and many other foods. (25)

Quercetin is another flavonols compound found in a variety of foods, including apples, Brassica vegetables, capers, onions, tea, and tomatoes, just to name a few. It’s also contained in medicinal products such as ginkgo biloba, St. John’s Wort (Hypericum perforatum), and elderberry (Sambucus canadensis).

Research has already demonstrated that quercetin is a powerful immune booster and broad-spectrum antiviral. As noted in a 2016 study (26) in the journal Nutrients, quercetin’s mechanisms of action include the inhibition of lipopolysaccharide (LPS)-induced tumor necrosis factor α (TNF-α) production in macrophages.

TNF-α is a cytokine involved in systemic inflammation, secreted by activated macrophages, a type of immune cell that digests foreign substances, microbes, and other harmful or damaged components. Quercetin also inhibits the release of pro-inflammatory cytokines and histamine by modulating calcium influx into the cell. (27)

According to this paper, quercetin also stabilizes mast cells and has “a direct regulatory effect on basic functional properties of immune cells,” which allows it to inhibit “a huge panoply of molecular targets in the micromolar concentration range, either by down-regulating or suppressing many inflammatory pathways and functions.” (28)

Another 2016 study (29) concluded it helps modulate the NLRP3 inflammasome, an immune system component involved in the uncontrolled release of pro-inflammatory cytokines that occurs during a cytokine storm.

In vitro studies (30)(31)(32) have shown quercetin exerts antiviral activity against SARS-CoV, and preliminary findings (33) suggest quercetin can inhibit the SARS-CoV-2 main protease as well. You can get even more details about the anti-inflammatory and antiviral powers of quercetin in “Quercetin Lowers Your Risk for Viral Illnesses.”

Quercetin Being Studied for Its Use Against COVID-19

The good news is researchers are in fact planning to study the use of quercetin against COVID-19. (34) As reported by Maclean’s, (35) Canadian researchers Michel Chrétien and Majambu Mbikay began investigating quercetin in the aftermath of the SARS epidemic that broke out across 26 countries in 2003.

They discovered a derivative of quercetin provided broad-spectrum protection against a wide range of viruses, including SARS. (36)(37) The Ebola outbreak in 2014 offered another chance to investigate quercetin’s antiviral powers and, here too, they found it effectively prevented infection in mice, “even when administered only minutes before infection.”

So, when the COVID-19 outbreak was announced in Wuhan City, China, in late December 2019, Chrétien contacted colleagues in China with an offer to help. In February 2020, Chrétien and his team received an official invitation to begin clinical trials. According to Maclean’s: (38)

“The Canadian and Chinese scientists would collaborate on the trials, which would include about 1,000 test patients. Chrétien and Mbikay plan to join colleagues from the non-profit International Consortium of Antivirals—which Chrétien co-founded with Jeremy Carver in 2004 as a response to the SARS epidemic—in manning a 24/7 communications center as soon as clinical trials go ahead.

“The U.S.-based Food and Drug Administration has already approved quercetin as safe for human consumption, which means the researchers can skip testing on animals. If the treatment works, it’ll be readily available … Chrétien’s team says their treatment would cost only $2 a day.”

Dosage Recommendations for Quercetin and Zinc

While the COVID-19 pandemic is in full swing—and for any future influenza season—supplementing with quercetin and zinc may be a good idea for many, in order to boost your immune system’s innate ability to ward off infectious illness. As for dosage, here are some basic recommendations:

• Quercetin: According to research from Appalachian State University in North Carolina, taking 500 mg to 1,000 mg of quercetin per day for 12 weeks results in “large but highly variable increases in plasma quercetin … unrelated to demographic or lifestyle factors.” (39)
• Zinc (and copper): When it comes to zinc, remember that more is not necessarily better. In fact, it can backfire. When taking zinc, you also need to be mindful of maintaining a healthy zinc-to-copper ratio. As noted by Chris Masterjohn, who has a doctorate in nutritional sciences,(40) in an article (41) and series of Twitter posts: (42)

“In one study, 300mg/day of zinc as two divided doses of 150 mg zinc sulfate decreased important markers of immune function, such as the ability of immune cells known as polymorphonuclear leukocytes to migrate toward and consume bacteria.

“The most concerning effect in the context of COVID-19 is that it lowered the lymphocyte stimulation index threefold. This is a measure of the ability of T cells to increase their numbers in response to a perceived threat. The reason this is so concerning in the context of COVID-19 is that poor outcomes are associated with low lymphocytes …

“The negative effect on lymphocyte proliferation found with 300 mg/day and the apparent safety in this regard of 150 mg/d suggests that the potential for hurting the immune system may begin somewhere between 150-300 mg/d …

“It is quite possible that the harmful effect of 300 mg/d zinc on the lymphocyte stimulation index is mediated mostly or completely by induction of copper deficiency …

“The negative effect of zinc on copper status has been shown with as little as 60 mg/d zinc. This intake lowers the activity of superoxide dismutase, an enzyme important to antioxidant defense and immune function that depends both on zinc and copper …

“A study done with relatively low intakes of zinc suggested that acceptable ratios of zinc to copper range from 2:1 to 15:1 in favor of zinc. Copper appears safe to consume up to a maximum of 10 mg/d.

“Notably, the maximum amount of zinc one could consume while staying in the acceptable range of zinc-to-copper ratios and also staying within the upper limit for copper is 150 mg/d.”

How Much Zinc Do You Need?

Masterjohn goes into even greater detail in his zinc article, discussing maximum absorption rates and much more. (43) In summary, he recommends taking 7 mg to 15 mg of zinc four times a day, ideally on an empty stomach, or with a phytate-free food.

The recommended dietary allowance in the U.S. is 11 mg for adult men and 8 mg for adult women, with slightly higher doses recommended for pregnant and breastfeeding women, (44) so we’re not talking about taking significantly higher dosages.

Additionally, you can take one zinc acetate lozenge per day, which will provide you with an additional 18 mg of zinc. If you’re exposed to the virus, take one additional lozenge after the exposure.

Masterjohn stresses that you’ll want to keep your total zinc intake below 150 mg per day to avoid negative effects on your immune system. He also recommends getting at least 1 mg of copper from food and supplements for every 15 mg of zinc you take.

Keep in mind that there are many food sources of zinc, so a supplement may not be necessary. I eat about three-fourths of a pound of ground bison or lamb a day, which has 20 mg of zinc. I personally don’t take any zinc supplement other than what I get from my food, which is likely in an optimal form to maximize absorption.

Originally published April 27, 2020, on Mercola.com

◇ References:

(1) Medrxiv.org April 14, 2020 DOI: 10.1101/2020.04.10.20060558 [Preprint]

(2) Medrxiv.org April 14, 2020 DOI: 10.1101/2020.04.10.20060558 [Preprint] (PDF full study)

(3) Reason April 16, 2020

(4) Medrxiv.org April 14, 2020 DOI: 10.1101/2020.04.10.20060558 [Preprint] (PDF) Table 2, Page 37

(5) Medrxiv.org April 14, 2020 DOI: 10.1101/2020.04.10.20060558 [Preprint]

(6) FDA.gov Fact Sheet, EUA of Hydroxychloroquine (PDF)

(7) PLOS ONE 2014; 9(10): e109180

(8) Preprints April 6, 2020 DOI: 10.20944/preprints202004.0124.v1

(9) Preprints April 6, 2020 DOI: 10.20944/preprints202004.0124.v1

(10) Preprints April 6, 2020 DOI: 10.20944/preprints202004.0124.v1

(11) Medrxiv.org April 11, 2020 DOI: 10.1101/2020.04.07.20056424

(12) Medrxiv.org April 11, 2020 DOI: 10.1101/2020.04.07.20056424 (PDF full study)

(13) Live Science April 13, 2020

(14) Antiviral Research, 2020;177:104762 Highlight bullest

(15) Clinical Infectious Disease, 2020; 10.1093/cid/ciaa237 Abstract

(16) Virology Journal, 2005;2(69) Abstract/Conclusion

(17) Cell Research, 2020;30:269 Abstract

(18) Nature March 18, 2020; 6 Article number 16, Correspondence

(19) Nature March 18, 2020; 6 Article number 16, Correspondence

(20) Clinical Infectious Diseases, 2020; doi.org/10.1093/cid/ciaa237 Abstract

(21) Medicinenet.com Chloroquine vs Hydroxychloroquine

(22) Journal of Agricultural and Food Chemistry 2014, 62, 32, 8085-8093

(23) Greenstarsproject.org March 27, 2020

(24) ChemRxiv.org March 11, 2020 (PDF full study), Table 3

(25) Myintakepro.com Luteolin Rich Foods

(26) Nutrients 2016 Marck; 8(3): 167, 5.1.2 Mechanism of Action

(27) Nutrients 2016 March; 8(3): 167, Table 1: Mast cell

(28) Nutrients 2016 March; 8(3): 167, 5.1.2 Mechanism of Action

(29) Mediators of Inflammation 2016; 2016, Article ID 5460302

(30) Journal of Virology Oct. 2004: 11334-11339 (PDF)

(31) Biotechnology Letters Feb. 15, 2012; 34: 831-838

(32) Bioorg Med Chem 2010 Nov 15;18(22):7940-7

(33) Preprints.org March 12, 2020

(34) CBC Feb. 28, 2020

(35) Maclean’s Feb. 24, 2020

(36) Bioorg Med Chem. 2006 Dec 15;14(24):8295-306

(37) Journal of Virology Sep 2004, 78 (20) 11334-11339, Antiviral activity of an analog of luteolin

(38) Maclean’s Feb. 24, 2020

(39) Appalachian State University, The Variable Plasma Quercetin response to 12-Week Quercetin Supplementation (PDF)

(40) Chrismasterjohnphd.com

(41) Chrismasterjohnphd.com Best Dose of Zinc for COVID-19 Prevention

(42) Twitter, Chris Masterjohn April 10, 2020

(43) Chrismasterjohnphd.com Best Dose of Zinc for COVID-19 Prevention

(44) NIH Zinc Fact Sheet

Ivermectin Is Safe and Effective: The Evidence

Colleen Huber

Dec 25 2022

Decades of use with nearly four billion doses to humans preceded recent use with COVID patients. From the chapter ‘Ivermectin sends COVID to lockdown,’ in my book The Defeat Of COVID.

Ivermectin is on the World Health Organization (WHO) List of Essential Medicines and is approved by the US Food and Drug Administration (FDA).  This well-tolerated but potent anti-parasitic medicine has been prescribed billions of times in its 36-year history against a wide range of parasites. It is a drug in the avermectin family, so named because those compounds are produced by the soil organism Streptomyces avermitilis.   It has also been studied and used against a wide range of viruses especially over the last decade, and there is evidence of potent antiviral effects against Influenza A and over a dozen other viruses tested. [309]

In a meta-analysis of 63 studies of ivermectin versus COVID-19 in humans, 100% of these have shown positive results.  Studies were from all continents except Antarctica.  Considered individually, 29 of those studies were found to be statistically significant regarding use of ivermectin alone.   Over the 63 studies in meta-analysis, pooled effects showed 69% improvement in early treatment, and prophylactic use showed 86% improvement.   Of those studies in the meta-analysis that were peer-reviewed, overall improvement in early treatment was found to be 70% (64% in randomized controlled trials), and 86% of those in which ivermectin was used prophylactically showed improvement (84% in randomized controlled trials).

Mortality from COVID-19 over all time periods of delay in treatment was 76% improved over controls (69% in randomized controlled trials), whereas mortality was improved 84% in early treatment of COVID-19 (82% in randomized controlled trials).  Forty studies were excluded from the meta-analysis for complicating factors or insufficient detail reported, and these also showed 100% positive results.

It is estimated that the likelihood of an ineffective treatment showing such positive results as the above results in the 63 studies in the meta-analysis to date is exceedingly small.   That probability is estimated to be one in one trillion. [310]  The overall results of the meta-analysis were not only found to be “overwhelmingly positive,” but also “very consistent, and very insensitive to potential selection criteria, effect extraction rules, and/or bias evaluation.”   The data in the meta-analysis are as of date of this article, and are continually updated as new studies are reported.

The first clinical trial of ivermectin in COVID-19 patients was an observational study in four Florida hospitals from March to May 2020.    Even in patients with severe pulmonary involvement, mortality was 38.8% in the treatment group vs 80.7% in controls, and this group showed the strongest mortality difference from controls, which raised the possibility of ivermectin also being available as a salvage or rescue treatment. [311]

In a randomized controlled trial, patients given ivermectin were 8 times more likely to be medically released than those in the placebo group.  This was even though the average age and number of comorbidities were later found to be somewhat higher in the experimental group than in the control group. [312]

The African continent has had remarkably low incidence of COVID-19, particularly equatorial African countries.  It may be helpful to look at African countries where ivermectin has been used commonly for decades against the onchocerciasis that it has been prescribed for, to observe population-wide effects.  In this population comparison, risk of COVID-19 death was found to be 88.2% lower and morbidity 85.7% lower in 31 countries where onchocerciasis is endemic and ivermectin is commonly used than in 22 countries where neither is the case, even though the latter group of countries has a higher life expectancy, 66 years vs 61 years. [313]

Ivermectin, for all its power against viruses, is among the safest of medicines that are in long-term and widespread use. [314]  There are no known serious drug-related adverse events. [315] Again, it is commonly taken by the populations of 31 African countries for effect against endemic parasites.  Dosing has been given as a single annual dose of 150 mcg/kg against filariasis.  There have been very few serious adverse events reported over more than 30 years of use.  37 of approximately 14,000 patients treated in Ghana had symptomatic posture hypotension, associated with fainting or sweating or tachycardia.  These were treated with corticosteroids. [316]  This Lancet study determined its safety in pregnant women, and the risk of fetal damage was not greater than in control women’s fetuses. [317]

However, despite this safety data going back 3 decades, the US FDA has alleged, “Any use of ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established.”  The FDA offered no supporting evidence for their claim. [318]   One concerning risk is that ivermectin is sold over the counter for veterinary use, and if people feel desperate to use it to ward off COVID-19, they might break off too large a piece from a large horse pill.  For this reason, it is much better to consult a healthcare provider for ivermectin use and dosing.  To further enhance safety, liposomal ivermectin carriers have been developed.  When these were used against Dengue fever, cytotoxicity was reduced up to 5 times, absorption was faster and in vivo efficacy was improved. [319]

Despite the spectacular worldwide effect profile, of excellent effect against COVID-19, with 0.26% observed minor side effects, and its use across several continents, ivermectin is widely shunned and ignored in western Europe and in the US.    Here is a brief synopsis of how that came to be.

Ivermectin was invented in Japan in 1975 as an anti-parasitic drug by Satoshi Omura, a Kitasato University professor emeritus, which earned Dr. Omura the Nobel Prize in Biochemistry.   Ivermectin turned out to be quite effective against a broad spectrum of parasites. The drug was so effective in eliminating a range of parasitic infections, and at very low cost, about $0.10 US, that 3.7 billion doses have been delivered to much of the world’s population since its invention. [320]

A cell culture study in April 2020 showed a 5000 times reduction in SARS-CoV-2 from one dose over 48 hours, compared to control samples. [321]  Several Latin American countries, Egypt and India soon began to use it for COVID-19, and then South Africa and several European countries as well.  However, resistance remained strong in the US and western Europe, following the vocal disapproval of The World Health Organization (WHO), The US National Institutes of Health (NIH), the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA).  These agencies all expressed disapproval of ivermectin for use with COVID-19 patients.  Even after more than 20 randomized controlled clinical trials showed promising effect without adverse reactions, many western countries have still not adopted its use.

Caly, Druce, et al illustrate the IMP inhibition as follows:

Figure © L Caly, J Druce, et al., Endnote 321

Social media companies censored ivermectin research.  Even when the WHO commissioned and reported a meta-analysis of ivermectin, it was censored by YouTube.  Only negative commentaries were permitted in western media. [322]

How does ivermectin send SARS-CoV-2 to lockdown?  There are a number of mechanisms by which components of SARS-CoV-2 need to stay mobile and active in order to replicate, and thus to spread throughout the human body.  It turns out that ivermectin binds several of these, which inactivates the virus.  Let’s look at exactly what happens to bind or to lock down SARS-CoV-2.

RNA-dependent RNA-polymerase (RdRp) is one of the main enzymes used by SARS-CoV-2 to achieve RNA replication.  It is required for viral genome replication, and therefore it is helpful if a nutrient or drug can act on it as an obstacle in some way.  173 drugs were tested in this study for their ability to bind RdRp (making it unavailable or inactive), including two examined in this book, hydroxychloroquine and vitamin C, although vitamin C was also found to have relatively high binding energy for RdRp in this study.  Of all the drugs tested, ivermectin was found to bind RdRp with higher binding any energy than any other drug. [323]

One strategy against SARS-CoV-2, as well as other endemic and pandemic RNA viruses, has been to interfere with transport of viruses into a host cell’s nucleus.  Ivermectin has been shown to accomplish this by binding, destabilizing and inhibiting the protein IMP alpha/beta1.  When this protein is inhibited, viruses are unable to enter a cell’s nucleus, and therefore unable to replicate.  Decreased infection results.  IMP alpha/beta 1 has been inhibited in SARS-CoV-2 entry into nuclei by ivermectin. [324]  Previously, it has been observed that ivermectin inhibited that same protein from entry of other RNA viruses, giving it a broad-spectrum antiviral effect. [325] [326] [327]

It turns out that ivermectin not only binds tightly to RdRp on SARSCoV-2, and IMP alpha/beta1; it also strongly binds the spike protein on SARS-CoV-2.  This particular spike protein is trimeric, meaning it has 3 subunits which vary in amino acid sequences or other ways.  It was observed that ivermectin binds all three of the SARS-CoV-2 subunits, both the structural S2 subunit, as well as both of the two functional S1 subunits. [328]  This binding of all 3 subunits of the trimeric spike protein may be considered a trifecta of fortunate results of ivermectin in favor of the human host and in opposition to the SARS-CoV-2 virus.

Ivermectin has different mechanisms against parasites, already a miraculous healing drug for that use alone through much of the world’s population.  However, now that we learn of its tremendous effect in binding both RdRp and all three trimers of the spike protein of SARS-CoV-2, we are certainly fortunate to have this medicine in our arsenal against COVID-19.  It is inexpensive, and full COVID-19 treatment of an individual, from first dose till last needed can be less than one US dollar.  Ivermectin is therefore available to even the poorest communities in the world.  Ivermectin is being compared to the discovery of penicillin in its enormous impact, and perhaps was one of the greatest discoveries of the 20th century. [329]  The fact that this tremendously effective, safe and low-cost antiviral drug is not as thoroughly known to the world as penicillin is a chasm of inexcusable and deadly ignorance that the COVID era is giving the world an opportunity to correct.

Reposted from the author’s Substack

References

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The Truth About Ivermectin

Medical miracle or notorious lynchpin of misinformation?

Marina Zhang

Nov 21 2022

Ivermectin has been hailed as a “wonder drug” and, according to the UNESCO World Science Report, a critical component of “one of the most triumphant public health campaigns ever waged in the developing world.”

However, since the onset of the COVID-19 pandemic, the National Institutes of Health (NIH) and affiliated health authorities have vociferously recommended against ivermectin as a potential treatment for the virus.

Though the Food and Drug Administration (FDA) has approved ivermectin for human use in treating conditions caused by parasites, it has also insisted that ivermectin “has not been shown to be safe or effective” when it comes to treating COVID-19.

In a social media message that has gone viral, the FDA labeled it as a drug for horses and not fit for human consumption: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

The post made headlines and was one of the FDA’s most successful social media campaigns. Yet, research findings seem to contradict the public health organization’s recommendations.

A growing body of research shows that ivermectin is an essential treatment for COVID-19. Many doctors have praised the drug for its broad yet effective antiparasitic, antiviral, antibacterial, anti-inflammatory, anti-cancer, and autophagic properties.

Ivermectin: Antiparasitic Beginnings

Ivermectin made its name through its significant benefits in treating parasitic infections.

In 1973, Satoshi Omura and William C. Campbell, working with the Kitasato Institute in Tokyo, found an unusual type of Streptomyces bacteria in Japanese soil near a golf course.

In laboratory studies, Omura and Campbell discovered that this Streptomyces bacteria could cure mice infected with the roundworm Heligmosomoides polygyrus. Campbell isolated the bacteria’s active compounds, naming them avermectins, and the bacteria was thus called S. avermitilis.

Despite decades of searching worldwide, researchers have yet to find another microorganism that can produce avermectin.

It was changing one of the bonds of avermectin through a chemical process that produced ivermectin, which was proven successful in treating onchocerciasis and lymphatic filariasis, both of which are debilitating diseases common in the developing world.

A portrait of William Campbell and an illustration describing his work displayed on a screen during a press conference of the 2015 Nobel Medicine Prize. William Campbell and Satoshi Omura won the Nobel Medicine Prize for their discoveries of treatments against parasites—Avermectin, which was modified to Ivermectin. (JONATHAN NACKSTRAND/AFP via Getty Images)

Though its broad antiparasitic functions are not well understood, it is known that ivermectin penetrates parasites’ nervous systems, turning off their neurons’ actions, possibly deactivating and killing them.

As part of a donation campaign launched in 1988 by Merck & Co., Inc., the manufacturer of ivermectin, the drug was used in Africa to treat river blindness. Also called onchocerciasis, river blindness is a tropical disease caused by Onchocerca volvulus worms. It is the second-most common cause worldwide of infectious blindness.

The Onchocerca worms mature in the skin of an infected individual (“the host”). After mating, female worms can release into the host’s skin up to 1,000 microfilariae a day; the female worms live for 10 to 14 years. The presence of these worms can lead to scarring in the tissues and, when microfilariae invade the eye, can cause visual impairment or complete loss of vision.

The World Health Organization estimates that 18 million people are infected globally, and 270,000 have been blinded by onchocerciasis.

When Merck distributed ivermectin in areas hardest hit by the disease, treatment benefited the residents’ overall health and led to economic recovery. Ivermectin replaced previous drugs that had devastating side effects.

“Ivermectin proved to be virtually purpose-built to combat Onchocerciasis,” Omura wrote in a study he co-authored in 2011.

Ivermectin has also proven effective against lymphatic filariasis, known as elephantiasis. Parasitic worms transmitted through the bite of an infected mosquito can grow and develop in lymphatic vessels, which regulate the body’s water balance. When certain vessels are blocked, the areas—typically the legs and genitals—can swell, with the legs enlarging to elephant-like stumps.

Worldwide, more than 120 million people are infected, 40 million of whom are seriously incapacitated and disfigured.

The World Health Organization listed ivermectin as an essential drug and has advised many countries to run annual campaigns to rid people of these parasites. Such recommendations are a solid testament to ivermectin’s safety.

For their work, including the discovery of avermectin, in 2015, Omura and Campbell were among three recipients of the Nobel Prize in Physiology or Medicine.

It is an indispensable drug for the underdeveloped world, with about 3.7 billion doses administered as part of global campaigns during the past 30 years. To this day, ivermectin remains a staple drug of tropical areas and an essential drug in treating onchocerciasis, lymphatic filariasis, strongyloidiasis, and scabies.

Ivermectin and COVID-19

Analyses of studies on ivermectin have found it effective as a prevention, a treatment for acute COVID-19, and in advanced stages of infection by the virus.

1. Ivermectin as a Prophylaxis

Prophylaxis intervenes in the first phases of COVID-19 infection, which is mainly asymptomatic, when the virus replicates to increase its viral load—symptom onset occurs after the viral load peaks.

Ivermectin can be effective in the early stages of infection. Outside the cells, ivermectin can attach to parts of the virus, immobilizing it and preventing it from entering and infecting human cells.

Ivermectin can also enter the cell to prevent the virus from replicating. SARS-CoV-2 needs cell replication machinery to make more of the virus; ivermectin attaches and blocks a protein critical to this process, preventing viral production.

Additionally, ivermectin can be absorbed from the skin and stored in fat cells for a long time.

“Because it’s lipid soluble, it is stored and slowly released, [so] once you’ve taken a prophylactic dose, and I think it’s like the cumulative dose of about 400mg, that your risk of getting COVID is close to zero and you can actually stop it for a while,” said Dr. Paul Marik, a widely published critical care specialist with 500 peer-reviewed papers to his name, in an interview with The Epoch Times. Marik co-founded the Front Line COVID-19 Critical Care Alliance (FLCCC), a group of physicians formed in the early days of the pandemic and dedicated to treating COVID-19. According to interviews, many of the group’s doctors have successfully treated COVID-19 with ivermectin. The organization’s other co-founder, Dr. Pierre Kory, has written a book about ivermectin’s use and controversy during the pandemic.

Dr. Sabine Hazan, a gastroenterologist with 22 years of experience in clinical research, told The Epoch Times that she would advise ivermectin use for only a short time in critical patients rather than recommending the use of it as a prophylaxis. Continuous use of ivermectin—as with all drugs—can make the body dependent on the drug rather than working to fix itself.

2. Ivermectin for Early and Acute COVID

Many peer-reviewed studies have found that ivermectin, when used by itself or in conjunction with other therapies in symptomatic patients, reduces ventilation time, time for recovery, and the risk of progressing to severe disease. (pdf 1, pdf 2, pdf 3)

This is likely due to ivermectin’s anti-inflammatory role in multiple pathways, achieved by clearing out the viral particles by immobilizing them, reducing inflammation, and improving mitochondrial action.

Suppose the early viral replication is not controlled and cleared out soon enough by the body’s immune system. In that case, the infection can become severe or even hyperinflammatory, possibly leading to systemic organ failures.

Ivermectin can also directly interact with immune pathways, suppressing inflammation and reducing the chances of developing a cytokine storm. A cytokine storm occurs when the immune system is hyperactive and hyperinflammatory. Though ivermectin can help to clear out the virus and its particles, the inflammatory state of the tissues and the organs can often cause more damage than the virus itself.

Ivermectin also likely improves gut health, which plays an essential role in immunity by preventing bacteria and viruses from infecting people via the gut.

In a published study, Hazan hypothesized that ivermectin helps COVID-19 patients by increasing the levels of Bifidobacteria—a beneficial bacteria—in the gut.

As the CEO and founder of her own genetic sequencing research laboratory, ProgenaBiome, Hazan noticed that the Bifidobacteria levels in her stools would increase after she took ivermectin. Critical COVID patients would have “zero Bifidobacteria,” which can often be a sign of poor health.  

In her peer-reviewed study on hypoxic patients, she observed that COVID patients with low oxygen levels from the cytokine storms in their lungs would improve within hours of administering ivermectin.

“When people die of COVID, they die from the cytokines—they couldn’t breathe anymore. It’s almost like an anaphylactic reaction. So when you give them ivermectin at the moment they’re about to crash, you’re boosting the Bifidobacteria [and increasing their oxygen],” Hazan said.

She explained that ivermectin is a fermented product of Streptomyces bacteria. Streptomyces are within the same group Bifidobacteria are from, which may explain why ivermectin temporarily boosts Bifidobacteria.

Ivermectin also helps with mitochondrial function. During severe COVID-19, patients often experience pulmonary dysfunctions due to lung inflammation, reducing oxygen flow. This can cause stress to the mitochondria, leading to fatigue, and, when severe, may cause cell and tissue death. Ivermectin has been shown to increase energy production, indicating that it is beneficial to the mitochondria.

Furthermore, Ivermectin can bind to the spike protein—a distinctive structural feature of the COVID virus which has a crucial role in its pathogenesis. In systemic disease, the spike protein can enter the bloodstream and bind to red blood cells to form blood clots. Ivermectin can prevent blood clots from forming in the body.

3. Ivermectin for Long COVID and Post-Vaccine Symptoms

The number of studies supporting ivermectin to treat long COVID and post-COVID-19 vaccine symptoms is limited. However, doctors treating these conditions have observed successful results with ivermectin.

An Argentinian study published in March 2021 is the only peer-reviewed study evaluating ivermectin for long COVID.

Researchers found that in patients reporting long COVID symptoms—including coughing, brain fog, headaches, and fatigue—ivermectin alleviated their symptoms.

Mechanistically, ivermectin can improve autophagy. This process is usually switched off during COVID-19 infections. By switching autophagy back on, ivermectin can help cells clear remnant viral proteins out, returning stability to the cell.

Like acute and severe COVID-19, chronic spike protein triggers inflammation, and ivermectin can reduce such responses by suppressing inflammatory pathways and lessening the damage to tissues and blood vessels.

The Changing Public Health Messaging on Ivermectin

The NIH’s stance on ivermectin has changed several times.

Early in the pandemic, there was little information on ivermectin as a potential treatment for the virus.

The first study that mentioned ivermectin as a potential COVID-19 treatment came from Australia in April 2020. Researchers administered ivermectin to SARS-CoV-2-infected monkey kidney cells in the laboratory and found the drug beneficial. However, the researchers concluded that further study was needed. Many health agencies, including the NIH, the CDC, and other global health regulators concluded that ivermectin could kill the virus only at toxic levels.

Even now, NIH’s statement on ivermectin for COVID-19 reads: “Ivermectin has been shown to inhibit replication of SARS-CoV-2 in cell cultures. However, pharmacokinetic and pharmacodynamic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans.”

In October 2020, the first clinical study showing the benefits of ivermectin was published by the journal CHEST. The study found ivermectin to reduce mortality rates in COVID-19 patients and garnered immediate attention.

The study’s lead author, Dr. Jean-Jacques Rajter, is a critical care doctor specializing in pulmonary medicine.

Rajter gave a testimony (pdf) of his findings to the Senate Committee on Homeland Security & Governmental Affairs in December 2020.

The day after he saw the Australian study, one of his COVID patients dramatically deteriorated from breathing normally at room oxygen levels to requiring intubation. The patient’s son pleaded with Rajter to save his mother using whatever options were available. Dr. Rajter recognized that  hydroxychloroquine would be ineffective in the advanced stages of COVID. After much deliberation, Dr. Rajter tried ivermectin.

“The patient deteriorated as expected for about 12 more hours but stabilized by 24 hours and improved by 48 hours. After this, two more patients had similar issues and were treated with the ivermectin-based protocol. Based on experience, these patients should have done poorly, yet they all survived,” the testimony read.

More clinical studies were published, showing the benefits of ivermectin as a prophylactic treatment. (pdf 1, pdf 2).

The findings encouraged the use of ivermectin among doctors desperate to find a cure.

Meanwhile, by October 2020, research into COVID-19 vaccines and the use of remdesivir to treat the virus was already in full swing.

According to the FDA, specific criteria should be met for the EUA (Emergency Use Authorization) to be granted for vaccines and medications, including that there are “no adequate, approved, and available alternatives.”

Some doctors say that if ivermectin’s use for COVID had been approved, it would have made the EUAs for vaccines and remdesivir null and void.

Following the Australian study, the FDA published a statement, “FAQ: COVID-19 and Ivermectin Intended for Animals,” highlighting the use of ivermectin in animals and advising against the use of ivermectin for COVID-19.

The NIH also discouraged the use of ivermectin, albeit briefly. On Jan. 14, 2021, the NIH changed its statement, writing that there was no evidence to recommend or disapprove the use of ivermectin. However, in April 2022, the statement changed to strongly disapproving of using ivermectin.

“We [Marik, Kory, and Dr. Andrew Hill, a virologist and consultant to the WHO] had a conference with NIH in January of 2021. We presented our data, and Andrew Hill presented the data he had done…there were a number of studies at that point, which were very positive,” said Marik.

Health Authority Overreach

Despite the NIH’s neutral statement on ivermectin for most of 2021, the FDA actively campaigned against using ivermectin in COVID-19 patients. On Aug. 26,  2021, the CDC sent an emergency warning against using ivermectin; a few weeks later, the American Medical Association and affiliated associations called for an end to ivermectin use.

Many doctors were thus discouraged from using ivermectin, and pharmacies refused to prescribe it. State health agencies warned against using ivermectin, and medical boards removed the medical licenses of doctors who prescribed ivermectin, alleging misinformation.

Yet using the FDA’s statement against ivermectin to ban its use in COVID-19 cases would be considered an overreach. Since the FDA approved ivermectin in 1996, this made the drug acceptable for off-label use.

“The fact that it’s not FDA approved for COVID is irrelevant because the FDA endorses the use of off-label drugs at the clinician’s discretion,” said Marik.

As an ironic side effect of the messaging on ivermectin, people suddenly found themselves unable to access ivermectin, and some turned to veterinary-grade ivermectin.

Though veterinary ivermectin is the same product as medicinal ivermectin, the manufacturing standard is not the same as it is for human-grade pharmaceuticals.

Contradictory Research and Campaigns

Though the initial research in 2020 showed promising results for ivermectin, published studies reported conflicting findings by the following year.

The NIH has funded many studies on the effectiveness of ivermectin, the most recent being ACTIV-6.

Individuals can participate in the study once they develop COVID by selecting ivermectin from four other drugs. The drug was sent to them via mail. This method means that some people in the study could have recovered by the time they received the ivermectin.

There are some controversies regarding this study.

The first is that the authors changed the primary endpoints during the study, which is heavily frowned upon as it can affect the validity and reliability of the outcome.

Initially, the primary endpoint was the number of deaths, hospitalizations, and symptoms reported at day 14.

This was changed to the number of deaths, hospitalizations, and symptoms by day 28. In the actual published study, there was another change, with the endpoint being duration of COVID-19 symptoms.

A rapid review published by the Massachusetts Institute of Technology (MIT) implied that the endpoints were changed because, by the time the study commenced, there were far fewer events of death and hospitalizations; as a result, there would not be enough data for a reliable comparison.

Indeed, the data at the ACTIV-6 livestream showed that the ivermectin group reported only one death; this death would not be considered relevant to the research because the patient was hospitalized and died before he took ivermectin.

There were also further implementations in the study that could impact the observed effectiveness of the drug.

On average, this study’s participants received treatment six days after first reporting symptoms. Patients needed to report eligible symptoms and test positive for COVID-19 before receiving drugs. Due to this added time, about seven percent of the participants had no symptoms by the time ivermectin arrived.

Despite these negative findings for ivermectin, there is still some evidence that may demonstrate that ivermectin can be useful in treating COVID-19.

In the abstract, the authors concluded that taking ivermectin had “a posterior probability of benefit of .91,” this is another way of writing that ivermectin had a 91 percent probability of being more beneficial than placebo.

The percent of probability is below 95 percent, making the benefit of ivermectin insignificant.

Slides from the ACTIV-6 presentation on a statistically significant secondary endpoint findings.

Another secondary endpoint showed that by day 14, ivermectin already had a statistically significant 27 percent benefit with 98 percent probability of efficacy.

The FDA and NIH did not respond for comments by press time.

The War on Ivermectin

The outcome could have been much different - and many lives saved - if Big Pharma hadn't been so successful at suppressing this generic pharmaceutical that was found to work against COVID-19.