Is Ivermectin Safe in Long-term Pre-Exposure Use?

Tensions mount among physicians seeking to treat COVID-19 with safe doses of ivermectin as they face push-back from medical councils. TrialSite has reported on the success stories around the globe of ivermectin reducing COVID-19 transmission, which are impossible to ignore. However, it remains to be established whether the drug is safe for prolonged use as prophylaxis against COVID-19. With the onset of the pandemic, its safety profile has come under close scrutiny. The drug’s credibility has been challenged as a result. The pressure is mounting to determine its long-term safety profile, so that it may be prescribed as a prophylactic measure for those who are at-risk from adverse effects of vaccination.   

As featured in earlier reports on TrialSiteivermectin has demonstrated a safety profile for over three decades, shown through copious epidemiological studies, expert meta-analyses, and peer-reviewed studies. In a systematic review of more than 500 scholarly works commissioned to an independent reviewer, Dr Jacques Descotes, ivermectin revealed very low percentages of adverse events. These were non-fatal and evanescent. Less than 1% resulted in serious implications.

Analyses on neurological impacts of ivermectin, such as seizure, indicated that 0.000000007% of cases exhibited adverse effects. This was derived from a global pharmacology database search. Out of 4 billion doses issued, only twenty-eight cases had negative neurological effects. Again, these were self-limiting and temporary, disputing warnings issued of ivermectin’s possible neurotoxicity.

The rationale behind ivermectin’s extremely low toxicity is because it does not “cross the blood-brain barrier … (and) displays a 100-fold greater affinity for parasitic Cl– channels compared to the human homologs.” 

To evaluate the potential risks associated with prolonged use of ivermectin or pre-exposure ivermectin, studies involving susceptible groups such as children, pregnant women, and the elderly are investigated. 

Safety profile of off-label ivermectin use in children and infants

Infants and children are the most susceptible groups to any drug implications, so research on this age group can be particularly illuminating. While some non-clinical animal studies caused hypothetical concern around ivermectin toxicity in children, human studies do not support these assertions. 

Studies done from 1980 to 2019 on children weighing less than 15 kilograms (33lbs) were analyzed using systematic review and individual patient data (IPD). From this, 1088 children were included to find interactions with the effects of ivermectin treatment. Only 1.4% of cases (15 out of 1088 children) had any negative experience, and these minor cases were resolved on their own without complications. 

In France, children between 1-64 months of age, (below 33 lbs.) received oral ivermectin for scabies. The study examined data from 170 infants in 28 different centers treated between July 2012 and November 2015. Even though ivermectin is not recommended for infants, the centers used it as an off-label treatment. Out of all the children treated, seven cases from 170 children (4%) reported mild reactions that were self-limiting. 

Safety of ivermectin use in pregnant women

Pregnant women also need to be carefully considered in terms of safety during prolonged dosage, as there are concerns regarding possible teratogenic effects on the fetus after exposure in the womb. 

A meta-analysis conducted in one study showed inconclusive results. Other studies indicate that there is no demonstrable cause for alarm.

To better understand these outcomes, retrospective case studies from years of mass distribution administration (MDA) Merck campaigns were systematically reviewed. The outcomes of interest included: neonatal deaths, stillbirths, congenital abnormalities, low birth weights, congenital anomalies, spontaneous abortions, and maternal morbidities. 

From the seven outcomes examined, there were zero cases of preterm births, low birth weight, maternal morbidities, or neonatal deaths reported. However, it was unclear whether spontaneous abortion, congenital anomalies, and stillbirths resulted from ivermectin exposure. For babies and infants breastfeeding, the concentration in human milk is very low and has shown to be tolerably below the threshold.

Observational studies done with a control group found that out of 500 pregnancies, 12 cases reported birth anomalies (2.4%), while the control of 2666 had 33 congenital abnormalities (1.2%). The results varied widely across different retrospective case studies with conclusions failing to give definitive answers. 

Previously, ivermectin was classified as pregnancy category C by the US Food and Drug Administration (FDA). Pregnancy category C of any drug means that the available data is from animal studies demonstrating teratogenic effects, but no adequate data from controlled human studies. This grouping criteria has since been replaced. The ivermectin animal studies have since been rescinded after finding the lab animals had a defect that gave erroneous results. 

Safety of ivermectin in an elderly cohort

The elderly are another vulnerable group that should be considered when investigating ivermectin’s safety. Interestingly, there was a situation in an elderly residential facility in France which served to shed some light on this. Ivermectin was inadvertently served as pre-exposure prophylaxis to the 69 residents there who averaged 90 years old–they received ivermectin treatment after a case of scabies, which proved to be a blessing in disguise. 

While recovering from scabies, COVID-19 affected the facility along with others in the area. Only seven of the elderly who had taken ivermectin got COVID-19. No fatalities occurred, unlike neighboring facilities which reported 5% fatalities with 23% infections. This situation revealed that ivermectin may have helped the residents while also being well-tolerated. Concomitant drugs, comorbidities, and dosage were not indicated.

Weighing the risks and benefits of ivermectin pre-exposure

Research indicates a few contraindications of ivermectin with other drugs. In patients taking blood thinners such as warfarin, caution is highly recommended. Immunosuppressed individuals and organ transplant patients taking calcineurin inhibitors are also at risk of drug interaction. Studies advise that it is imperative to carefully evaluate the amount of intake in concurrent administration.

There is a clear consensus of data on ivermectin as a safe pre-exposure drug. Combined studies of more than 50, 000 patients have established the overall safety of ivermectin. Doses have varied from 0.15 mg /kg to 12 mg/kg, from infants to the elderly. Similarly, frequency has differed from daily intake to weekly, monthly, and annually. 

Indications for a long-term dosage of ivermectin for pre-exposure prophylaxis 

A central question for ivermectin pre-exposure prophylaxis over long-term use is how to ensure safe dosage, while at the same time making sure it provides adequate protection.

In Dhaka, Bangladesh, participants in a clinical study took 12 mg/ month of ivermectin for four months, while in Argentina health workers took 12 mg every week for four weeks as prophylaxis protocol. Since both cohorts reported comparable significant effectiveness, studies asserted that monthly dosing provided an adequate protective effect. 

The All India Institute of Medical Sciences (AIIMS) implemented their own efficacious ivermectin prophylaxis procedure in healthcare workers of 0.3 mg/kg taken twice, 72-hours apart, every month. The meta-analysis averred that since there has not been a definitive standardized prophylaxis, “studies should be undertaken to better define … the optimal dose and frequency required.” 

The sooner ivermectin’s long-term safety profile is determined, the sooner physicians will be able to use its potential benefits to the advantage of their patients.

Why won’t the CDC or FDA reveal the VAERS URF? Steve Kirsch October 25, 2021

Summary: The VAERS underreporting factor (URF) is required information to be known for any risk-benefit of assessment of a vaccine. The fact that this number was never calculated by the FDA or CDC means that all the safety recommendations to date have been by guessing. This has resulted in the needless loss of life of well over 150,000 Americans.

VAERS is the Vaccine Adverse Event Reporting System. It is the official system relied upon by the FDA and CDC for adverse event tracking. 

For example, if you report an adverse event in V-Safe, the app they told you about when you got vaccinated, you are told to file a VAERS report. It is essentially the mother of all adverse event reporting systems for vaccine events in the US. There is nothing more comprehensive than VAERS.

The most important thing to know about VAERS is that it is always underreported. This is widely known. 

To properly interpret any safety data, you must know the underreporting factor (URF).

For example, the famous Lazarus report estimated the VAERS URF to be over 100:

“Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health.”

The Baker paper, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, showed that “the odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52–95.5).” 

In other words, the VAERS URF was at least 30 (since the system wasn’t perfect, 30 is a lower bound of the URF in that study), but they estimated that it was likely between 9.5 and 95.

The URF is normally calculated for very serious events since these are required to be reported for all vaccines by healthcare workers. That URF can then be applied to less serious events to create a conservative estimate of the true incidence rate (since less serious events would have a higher URF).

The method for calculating the URF is well known.

Sadly, the CDC has erroneously assumed that Vaccine Safety Datalink represents a fully reported comparator. 
This is clearly false as can be seen from slide 13 in ACIP Chair Grace Lee’s presentation delivered on August 30, 2021:

You can clearly see that VSD estimates are below the VAERS estimates.

Therefore, calculating the URF from anaphylaxis data from a prospective targeted study, such as the Blumenthal Mass General Brigham study that was published in JAMA provides a more accurate estimate. There was a second Blumenthal paper published again in JAMA (this time an Editorial rather than a Research Letter) showing an anaphylaxis rate that was 48X lower, but that is just to mislead people into taking the vaccine.

As a Professor of Biology I know wrote:

“You are correct in your analysis. The 2.4/10000 rate is based on all cases of anaphylaxis reported but the 5/1,000,000 is based only on inpatient hospital or emergency department visits.  You can undergo anaphylaxis without being admitted into the hospital going to the emergency room.  I also believe that the 5/1,000,000 applied the Brighton Collaboration criteria much too narrowly.  The second paper is just propaganda to get people vaccinated.”

When we do the math, we find that the URF is 41, well in line with the mean and range described in the Baker paper. It means that over 150,000 people have been killed by the vaccine so far (and we show 8 different ways in that paper, only one of which uses VAERS).

The troubling thing is this: nobody at the CDC, FDA, or on any of the outside committees will admit this. When they are asked, “what is the URF for serious events in VAERS for the COVID vaccine” they are unable to respond. Not even Steven A. Anderson of the FDA can answer that. He said he was the top guy for vaccine safety at the FDA. I heard him say that on a zoom call. 

He won’t talk. He doesn’t respond to emails, he doesn’t respond to voicemails. His staff doesn’t respond either. 

Janet Woodcock won’t tell me the URF. 

The friendly people at covid19vaxsafety@cdc.gov won’t tell me the URF.

Lorrie McNeill of the FDA won’t tell me the URF.

Tom Shimabukuro won’t tell me the URF.

John Su won’t tell me the URF. He pretends in his presentations to ACIP and VRBPAC committees that the URF=1 because he never points out that VAERS is underreported or what the reporting factor is. We have all that on the record.

No member of any of the outside committees of the FDA or CDC would respond to my multiple requests.

I have tried to find someone knowledgeable to interview to ask that question, but no prominent pro-vaccine person would consent to an interview. Eric Topol doesn’t respond. Monica Gandhi doesn’t respond. UCSF Dean of Medicine Bob Wachter won’t talk to me on camera. They are all afraid of being exposed. 

None of the fact checkers I asked would help me out.

Heck,  I couldn’t even get Health Nerd to consent to be interviewed by me. 

I thought it was just me.

To test that, I asked a former NY Times reporter (now working for another newspaper) to ask the question of the FDA and he was stonewalled as well. They refused to answer him. Silence as soon as he asked the question. But his paper won’t let him write a story about it.

Let’s be clear: you cannot do any sort of risk-benefit assessment without knowing the VAERS URF. It is impossible.

The fact that as of October 25, 2021 that nobody knows the URF for VAERS is a sign of mass incompetence and corruption at the FDA, CDC, and their external committees.

There is no other alternative.

This of course is why nobody at the FDA, CDC, or on the external committees wants to talk to me. Because I ask questions that they don’t want to answer. This is why censorship is required to silence people like me.

This is the biggest cover-up in history. CDC, FDA, mainstream media, nearly the entire medical community, and all the major social media companies are pitching in to silence people like me who ask questions we aren’t supposed to ask.

It’s pretty sad that nobody in the mainstream media is asking those questions, isn’t it?

Australian tyrants promise to FLOOD the country with virus-transmitting vaccinated people... global biowar aims to REMOVE humanity before the coming "big event"

AUSTRALIA: Queensland health official Jeannette Young is now promising to flood the country with vaccinated super spreaders who carry covid, claiming on video, "Every single queenslander is going to get exposed to the covid-19 virus and will get infected." She adds, "We will be bringing in virus in vaccinated people..." and then specifically explains she is targeting unvaccinated people with this biowarfare attack by explaining, "But if you're vaccinated, that's not a problem." This unthinkable admission of coordinated criminal activity by the government of Queensland is just the latest assault on humanity being waged by Australian officials who are so corrupt and evil, it's almost like they're competing for an award from Satan himself. Watch this stunning comment in the following video. The text callout was added to the video by someone else and was not in the original broadcast video: Brighteon.com/8d554303-cd88-45d7-b6ad-2020c26075c9Dr. Young is fully aware that vaccines are killing people. She previously warned that blood clot-inducing vaccines shouldn't be given to people under the age of 50, saying, "Wouldn’t it be terrible that our first 18-year-old in Queensland to die from this pandemic died from the vaccine?" Since then, she has been "corrected" by the genocidal medical establishment and anti-human news media that are coordinating their attacks on anyone who questions vaccines. Dr. Young has fallen in line and is now waging actual biological warfare against humanity, bragging that vaccinated people are the super spreaders who will infect everyone. They're not even trying to hide their agenda anymore. Let us all remember the names of these criminals as the international war crimes tribunals commence.

The real threat from Cumbre Vieja / La Palma island volcano

In today's Situation Update, we cover the Queensland attack on humanity, and we also cover the real threat to human civilization posed by the Cumbre Vieja volcano. It's not the tsunami threat to the East Coast that's the real threat here. It's that the volcano might erupt and eject a massive amount of particulate matter into the atmosphere, darkening the sun for an entire year. This would collapse the global food supply and lead to mass starvation around the world, followed by unrelenting disease and economic collapse. Naturally, all solar power would also be heavily impacted, resulting in a catastrophic collapse of "green" energy. A similar event already happened in 1816, known as "The year without a summer," following the 1815 eruption of Mt. Tambora in Indonedia. Following the eruption, a global food collapse commenced, leading to mass famine, die-offs, disease and collapse. As covered by AmusingPlanet.com: The immediate aftermath of the eruption was famine as a result of destruction of crops. This was accompanied by all kinds of disease, especially diarrhea caused by the drinking of polluted water. The famine was so serious that people in Sumbawa were reduced to eating dry leaves and poisonous tubers. Many sold their children just to obtain rice. About 48,000 people were killed on Sumbawa and 44,000 on Lombok. Tens of thousands fled to Java, Bali and South Sulawesi to escape hunger. The effect of the eruption was not limited to Indonesia. Unseasonably cold weather killed trees, rice and animals even as far north as China and Tibet. Floods destroyed many remaining crops. In Taiwan, which has a tropical climate, snow was reported in many cities. In Europe, still recuperating from the Napoleonic Wars, low temperatures and heavy rains resulted in failed harvests across the continent, leading to serious famine in Ireland and Wales. This was followed by major typhus epidemics in parts of Europe, including Ireland, Italy, Switzerland, and Scotland, exacerbated by malnutrition caused by the Year Without a Summer. Temperatures plummeted across North America, especially in the northeastern parts of United States and Canada. Throughout spring and summer, there was a persistent dry fog that reddened and dimmed the sunlight such that sunspots were visible to the naked eye. Frost and snow fell in the upper elevations of New Hampshire, Maine, Vermont, and northern New York in the middle of summer. Cold weather ruined most agricultural crops in North America leading to rising prices. In Canada, Quebec ran out of bread and milk and Nova Scotians found themselves boiling foraged herbs for sustenance. We also know that a loss of photosynthesis would also cause atmospheric oxygen levels to plummet as plant metabolism is shut down. With 7.8 billion human beings still breathing oxygen (plus all the animals, insects, etc.), global oxygen concentrations in the atmosphere would plunge at the same time global food supplies collapsed. What's clear is that globalists are now in a panic to exterminate billions of human beings via vaccines, spike protein bioweapons, economic collapse and food supply chain disruptions, most likely because they need to remove billions of humans before the "big event" arrives. What is that big event? It's anyone's guess at this point, but it's obviously something on a cosmic or planetary scale. Whatever it is, it's big enough to have the globalists panicked into a planetary-scale mass extermination agenda. Find more details in today's Situation Update podcast: Brighteon.com/52af5c5f-d4cd-487f-82d5-d0ab8846d4c1

How Ivermectin became a Target for the ‘Fraud Detectives.’

By Sonia Elijah

From its humble beginnings, derived from an isolated bacterial culture from Japanese soil 46 years ago, to a Nobel prize-winning and anti-parasitic drug, included in the World Health Organisation’s essential list of medicines–ivermectin is one of modern science’s major success stories.

However, from the onset of the pandemic, this cheap generic drug, which for decades has safely cured people of river blindness in 33 countries, with more than 3.7 billion doses administered, has rapidly become public enemy #1 for the fact-checkers when the drug was repurposed as an early treatment and prophylaxis (preventative) for Covid-19.

To date, there have been 31 RCTs (Randomized Controlled Trials), 64 controlled studies, and 7 meta-analyses of the RCTs done on ivermectin. All of them found that ivermectin significantly reduced mortality and hospitalization rates as well as the risk of contracting Covid-19. In Mexico City, over 50,000 patients were treated early with ivermectin, resulting in up to a 75% reduction in hospitalization rates, compared to over 70,000 who were not treated. In Peru, a mass distribution program of ivermectin, led to a 74% drop in excess deaths within a month. Similar success stories were found in Las Pampas and La Misiones regions in Argentina.

In Uttar Pradesh, India, with a population of 241 million as of 10 September 2021, unbelievably only 11 cases and no deaths were recorded. The WHO reported on Uttar Pradesh’s success, attributing it to the aggressive test and treat program, which included the distribution of medicine kits. However, their report failed to include the list of the kits’ contents. Only one article from the mainstream media, an MSN report, revealed that the ‘Uttar Pradesh government has claimed that it was the first state to have introduced a large-scale “prophylactic and therapeutic” use of ivermectin and added that the drug helped the state to maintain a lower fatality and positivity rate as compared to other states.’

A similar success story was experienced in Indonesia after the government authorized the use of ivermectin for Covid-19 patients in July when the Delta variant was ripping through the country.

The number of cases has significantly plummeted since July.

In response to the real-world proven track record of ivermectin as an effective Covid treatment, governmental regulatory bodies, mainstream media, and disinformation agents/fact-checkers have deplored its use and embarked on what can be described as a smear campaign. With headlines running in the Washington Post such as “How those ivermectin conspiracy theories convinced people to buy horse dewormer.”

Even the US Food and Drug Administration (FDA) recently tweeted this post below.

A formulation of ivermectin has long been used in veterinary medicine but for the FDA to be so reductive and defamatory in tone by simply referring to it as a horse dewormer, is misinformation. Especially when ivermectin is approved by the FDA to treat humans with intestinal diseases with a proven forty-year safety record. 

The apparent censorship and smear campaign against ivermectin by Big Tech, Big Media, and Big Pharma has arisen against the backdrop of the Trusted News Initiative, led by the BBC. Its members include Reuters, CBC, Associated Press, Financial Times, Microsoft, Twitter, Facebook, Google/YouTube. It was set up in 2019 with the sole purpose to censor what powerful interest groups consider to be ‘misinformation.’

It’s worth noting, James C. Smith, a Pfizer board member was the former CEO and chairman of Thompson Reuters Corporation until February 2020. In addition, Scott Gottlieb, another Pfizer board member, served as 23rd Commissioner of the US Food and Drug Administration (FDA) until 2019.

This ‘revolving door’ of pharmaceutical execs either coming from or going to work for governmental regulatory bodies, such as the FDA, has given impetus to the argument these agencies have been ‘captured.’

Big Pharma is the colloquial term used to define the top ten pharmaceutical companies in terms of revenue. Major players include Pfizer, Roche, Sanofi, Johnson & Johnson, and Merck. Pfizer has seen a surge in revenues after partnering with BioNTech and winning approval of their Covid vaccine. (Source: investors.pfizer.com)

An example of the merging of Big Tech and Big Pharma can be seen in the purchase of two pharmaceutical companies by Alphabet (the parent company of Google which owns YouTube). Calico, which discovers treatments to overcome aging, and Verily Life Sciences, which partnered with GlaxoSmithKline (GSK) in 2016 to form a new drug company, Galvani Bioelectronics, chaired by GSK’s former chairman of its global vaccine business. It’s interesting to note that Emma Walmsley the CEO of GSK is also on the board of Microsoft, founded by Bill Gates.

The controversy surrounding ivermectin reached a fever pitch in July when the Elgazzar et al RCTs pre-print (led by Dr Ahmed Elgazzar from Benha University in Egypt) was retracted from Research Square on 14 July. It was not retracted by the author but by the server, Research Gate, based solely on the complaints of alleged ‘fraudulent data,’ ‘data manipulation,’ and ‘plagiarism’ by Jack Lawrence, currently studying for his biomedical sciences masters at St George’s, University of London.

Research Square did not give the authors of the Elgazzar study prior notice of the retraction or the right of reply. The retraction, based on ‘ethical concerns’, came a day after Lawrence claimed he alerted them to the fraud. In the Body of Evidence podcast interview, Lawrence states he was given the Elgazzar study to critique by his professor as part of his master’s course. Then, he later states he was studying it, “looking for fraud” (at 13:28 in the timeline). He vividly described his discoveries of “patchwork plagiarism” akin to “a James Bond movie scene.”

The Canadian interviewers, Dr Christopher Labos and Jonathan Jarry, ‘debunkers of pseudoscience’ that ‘tell you what’s solid, what’s iffy, and what’s crapola’, did not attempt to hide their openly biased opinion. Their ill-humored remark that the BIRD group (British Ivermectin Recommendation Development Group) should be renamed was emphasized with a neighing horse sound effect.

“There is a whole ivermectin hype…dominated by a mix of right-wing figures, anti-vaxxers and outright conspiracy theorists” Jack Lawrence stated in the 15 July, Guardian article.

This statement can be viewed as disparaging given its use of derogatory stereotyping against those who support the scientific evidence in favor of ivermectin’s prophylactic and therapeutic effectiveness.

The article was swiftly published only 24 hours after the Elgazzar paper was retracted by Research Square. Melissa Davey, the medical editor of the Guardian, Australia, omitted important information regarding Lawrence. She failed to include details that this master’s student also happens to be a journalist/blogger and founder of the website and discussion forum called, GRFTR, grifters exposed, ‘dedicated to countering online disinformation, misleading stories, and exposing online grifters of all types via debunkings, criticism, analysis, and review.’

It’s worth noting that the Guardian is a recipient of a generous grant by the Bill and Melinda Gates Foundation (BMGF) through their Global Development Fund. The same foundation has given over $17 million in grants to Pfizer, which it has shares in, as well as other pharmaceutical companies, such as BioNTech, Pfizer’s manufacturing partner of its Covid vaccine. The BMGF also heavily finances GAVI, the vaccine alliance, which has posted articles actively advising against the use of ivermectin on its website.

According to the Guardian article, Lawrence ‘found the introduction section of the paper appeared to have been almost entirely plagiarised.’ London-based Lawrence then contacted the chronic disease epidemiologist from the University of Wollongong in Australia, Gideon, currently studying for his PhD and Nick Brown, a data analyst affiliated with Linnaeus University in Sweden, to help him review the report. It’s worth noting the University of Wollongong is the recipient of a substantial grant from the BMGF.

What’s unusual is that Lawrence claims to have accessed the raw data by attempting to guess the passcode, which he claims ended up being “1 2 3 4.”

Whether or not the raw data was accessed and done so by guessing at the password, is yet to be determined. The fact that Lawrence admits to guessing at the password to get into a password protected database could be interpreted as hacking, given the definition is the following ‘the gaining of unauthorized access to data in a system or computer.’ This is concerning, since hacking is as illegal activity under UK law, according to the Computer Misuse Act 1990.

Dr. Ahmed Elgazzar alarmingly stated in an email to a chief investigator of a large meta-analysis on ivermectin, “the data mentioned in the Guardian article is not the actual data of my raw materials.” Furthermore, in an email to Research Square, he accused Lawrence of “taking strange raw material that had been fabricated and added to another website and linked to my research, but after reviewing it I confirmed beyond any doubt that it does not belong to me at all.”

When I asked Lawrence about how he was able to access the raw data file, his response was “the data file has been removed from the file transfer website, I’m afraid. I do not know the reasons for this. The ways these authors shared the data is not normal scientific practice, to say the least. You can find an archived copy of the data here.”

Unusually, this alleged raw data is kept on Nick Brown’s blog casting a shadow over its authenticity, particularly as Elgazzar claims it did not originate from his study.

Furthermore, in Elgazzar’s email he shared the fact that he had contacted Melissa Davey of the Guardian, to refute the claims made by Gideon Meyerowitz-Katz that “the data was just totally faked.” He has strongly asserted defamation and intimated legal action.

In contrast, Davey writes ‘Lawrence and the Guardian sent Elgazzar a comprehensive list of questions about the data but did not receive a reply. The university’s press office also did not respond.’

Since Davey’s article was published exactly one day after the study was retracted by Research Square, perhaps Elgazzar was not able to respond to her within the 24-hour time frame. However, no update to the article has included Elgazzar’s response to date.

In the Body of Evidence podcast, Lawrence reveals that he had been evaluating the Elgazzar paper “for months” and events unfolded very quickly within a 2-week period which led him to alert Research Square in July of the alleged fraud and Melissa Davey of the Guardian. These seemingly coordinated events followed on the heels of the influential Bryant et al meta-analysis systematic review of 24 RCTs (including the Elgazzar RCT) which was published just before in the American Journal of Therapeutics concluding that ‘Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin.’

Turning to Gideon Meyerowitz-Katz (the Australian PhD student quoted in the Guardian article), it’s worth highlighting the articles written by Meyerowitz- Katz prior to the pandemic, all share something in common- the downplaying of any harms caused by chemicals. It could be said that Meyerowitz-Katz, by default, is promoting the interests of the chemical lobby. One of his articles reads, “Alarmist fearmongering over the scary chemicals in your food is all the rage, the reality is far more humdrum”. He then writes how the organic food movement is just a “health fad” and downplays any negative health effects attributed to chemical food additives as simply, “sensationalist science”. Another runs with the headline “Artificial sweeteners aren’t destroying your children’s health.”

Meyerowitz-Katz was also quoted in a Genetic Literacy Project article, known to be a pro chemical lobby publication, challenging the meta-analysis that the weedkiller glyphosate, originally developed by Monsanto in the 1970s and often paired with GM crops, increases cancer risk.

The self-proclaimed fraud detectives, Lawrence, Meyerowitz-Katz and Brown teamed up again but this time alongside Kyle Sheldrick and James Heathers, to write a letter to the editor published in Nature on 22 September. Heathers and Brown have worked together in the past, exposing ‘shoddy and questionable research.’

They explained that ‘several other studies that claim a clinical benefit for ivermectin are similarly fraught and contain impossible numbers in their results.’ Inadvertently, they reveal their own biases in their statement by only discrediting the studies that ‘claim a clinical benefit’ without providing any evidence for it. They remain silent on the ones which are widely considered to be flawed studies, like Roman et al, where 40 physicians signed an open letter, detailing the errors and requested retraction of the study.

When I asked Lawrence why he and his colleagues had not looked for fraud in the Roman et al study, he said “We are reviewing every RCT for ivermectin with over 100 patients for fraud, but not every systematic review which is why we have not focused on Roman et al.”

This can be interpreted as an admission of their selective bias in determining which studies they choose to find flaws in. Perhaps, it was Roman et al conclusion of ivermectin not being a viable option to treat Covid-19, which gave it a free pass.

When I asked him about the Lopez-Medina study, his response was “Lopez-Medina was very forthcoming with his data, and we have looked into it.” His response did not address whether they found flaws in that study. One can be forgiven for presuming that it was given a pass like Roman et al, based on its ‘findings that it did not support the use of ivermectin.’

Even though ‘the fraud detectives’ seemingly found no problems with the Lopez-Medina study, more than 100 physicians did. They signed an open letter concluding that the Lopez-Medina study was fatally flawed.

It’s odd that this group specializing in investigating ivermectin studies for fraud and ‘dodgy science’ failed to find the evident flaws in these previously mentioned studies when so many others did.

The TOGETHER Clinical Trials (one of the largest randomized clinical trials in the world evaluating the effectiveness of repurposed drugs, including ivermectin) is another study with flaws and conflicts of interest. The trial is associated with MMS Holdings. This is the same company that helps pharmaceutical companies get approval by designing the scientific studies that help them get approved. As it happens, one of their clients is Pfizer. It’s not surprising that their results showed no benefit for ivermectin in the treatment for Covid-19.

The co-lead investigator of the TOGETHER trial is Dr Edward Mills, an associate professor in the Department of Health and Research Methods, Evidence, and Impact at McMaster University in Canada. He’s also a clinical trial advisor at the Bill and Melinda Gates Foundation.

The fraud detectives are of the collective opinion that if the Elgazzar study is removed from the meta-analyses – ‘the revision will show no mortality benefit for ivermectin.’ In contrast, scientists with decades of experience disagree, such as Dr Tess Lawrie M.D., Ph.D., Andrew Bryant, and Dr Edmund Fordham. They wrote a letter to the editor of the American Journal of Therapeutics and explained when the Bryant et al. study was re-analyzed to exclude the Elgazzar study, the results showed a ‘49% reduction in mortality in favor of ivermectin.’

Dr Pierre Kory, MD, who won the British Medical Association‘s 2015 President’s Choice award, along with Dr Paul Marik MD, also wrote a letter to the editor of the American Journal of Therapeutics stating ‘we decided to redo the original meta-analyses excluding this study [Elgazzar et al]. The summary point estimates were largely unaffected when the study by Elgazzar et al was removed.’

Another mainstream media report targeting ivermectin is the October 7, BBC article, written by Rachel Schraer and Jack Goodman. It reads: ‘The scientists in the group – Dr Gideon Meyerowitz-Katz, Dr James Heathers, Dr Nick Brown, and Dr Sheldrick – each have a track record of exposing dodgy science.’

Meyerowitz-Katz is a PhD student and not eligible for the ‘Dr’ title. Kyle Sheldrick, is a medical doctor, James Heathers and Nick Brown have PhDs. It’s interesting to note that Sheldrick received almost $1 million in grant money from the Australian government for his bio-tech company, Merunova

Since my report was published on TSN, the BBC article has been revised and the ‘Dr’ title for Meyerowitz-Katz has now been removed.

‘The group of independent scientists examined virtually every randomized controlled trial (RCT) on ivermectin and Covid.’ This is another false statement. As stated earlier, in Lawrence’s response to my question, he admitted that they did not examine every RCT.

The article incorporates commonly used derogatory phrases such as ‘pushing anti-vaccine sentiments,’ ‘hype around ivermectin,’ and ‘conspiracy theories of ivermectin cover-ups’ in referring to those who support the use of ivermectin as a Covid-19 treatment. The referenced scientists who are stated as being ‘pro-ivermectin’ are not described in favorable terms. Dr Pierre Kory is considered by the BBC to have ‘an exaggerated influence’ and Dr Tess Lawrie is accused of making ‘unsubstantiated claims’ regarding the Covid vaccines’ adverse events. Perhaps the BBC is unaware that Covid vaccine adverse events (including deaths) have been recorded on databases such as VAERS and the UK’s Yellow Card scheme, since their rollout.

‘The BBC can reveal that more than a third of 26 major trials of the drug for use on Covid have serious errors or signs of potential fraud.’ This statement not only reveals the BBC’s bias but is overt disinformation. The BBC has not supplied any independently verified evidence to back up its claim. The defamatory accusation that a third of all scientists involved in the 26 major trials are implicated in fraud and erroneous trials, is yet another example of them publishing an unsubstantiated ‘fact’ and pushing “fake news.”

Both the BBC and the Guardian are guilty of publishing articles with the presumption that the Elgazzar study is fraudulent, purely based on the claims of this group and the prima facie retraction of the study. In truth, the Elgazzar study is under current investigation and no verdict has yet been announced. In fact, they have declared someone guilty before the evidence has been independently examined and judgment made–this is shocking. What happened to innocent until proven guilty?

Similar to the Guardian, the BBC has received generous grants from the BMGF via its Global Development Fund. However, it has received significantly more than the Guardian with grants dating back as early as 2006.

When reviewing this very polarized debate over the use of ivermectin as a treatment for Covid-19, the motive has an essential role to play. The question that needs to be asked is what do these scientists have to gain by promoting the use of ivermectin as a treatment?

They are not promoting the use of a patented expensive drug but advocating the use of a cheap generic one. They are putting their well-established careers on the line. They are sticking their heads above the parapet and by doing so exposing themselves to slander or worse. Yet, they continue to do so because they know lives are worth saving.

And why is ivermectin being so negatively targeted by Big Tech and Big Media? One could argue conflict of interest plays a major role, given how intertwined they are with Big Pharma and the far-reaching grasp of the BMGF. A cheap and effective early treatment for Covid-19, like ivermectin, can be seen as a significant threat to the financial interests of those involved with Covid vaccines and expensive anti-viral drugs.

One fact is for certain, the disinformation war surrounding ivermectin shows no signs of abating.

The U.S. Health Feds’ Effort to Purge Ivermectin Use is Working  

Recently, TrialSite reached out to 100 pharmacies in a survey investigating whether ivermectin would be available. Many readers have sent us tips that the supply of the drug was suddenly in very short supply. While ivermectin prescriptions skyrocketed by summer for off-label use driven by COVID-19, there were no pervasive reports of shortage or availability issues then. After reaching out to 100 pharmacies, TrialSite reports nearly 65% of them suddenly have major “supply issues” informing our analysts that the product was out and on backorder. 

Prescriptions for ivermectin absolutely skyrocketed to nearly 90,000 prescriptions per week, reported the New York Times last month even though the drug purportedly didn’t help address early-onset mild-to-moderate COVID-19. By October, TrialSite suggests increasing pressure from pharmacy and physician licensing boards on providers to not prescribe the drug for off-label use led to sweeping changes in access. Of course, the pressure comes from above as the current Biden administration, leadership within the National Institutes of Health and the U.S. Food and Drug Administration (FDA), and the media have vilified the drug when it comes to any off-label use for COVD-19. 

Earlier in the year, this cheap drug was far easier to obtain via physician prescription. But many TrialSite readers called or emailed tips that they are not able to access the drug—even with a physician’s prescription. 

Typically, an easy product to access with a prescription, our survey indicates most pharmacies now will declare that they do not have the product available. Many of the pharmacies that we spoke with reported that even their wholesalers, such as Amerisource and McKesson, reported supply issues. 

We identified some geographic patterns. For example, the 25% of pharmacies that did report some availability of ivermectin were mostly based in the South or the Southwest. Conversely, those pharmacies we surveyed in the Northeast or Midwest, for example, were far more likely to report “out of supply” and in “backorder” status with no foreseeable date to obtain it. Overall, we learned that if the prescription was off-label for COVID-19, it is now far more difficult to get that prescription filled.  

The standard price point for ivermectin, according to Drugs.com, for 20 tablets 3mg ivermectin is $93.97 or $4.70 per unit. During our survey, we found a range of prices much higher than the Drugs.com  average price. Some pharmacies are willing to provide the drug off-label for cash, but of course, this requires a prescription. For example, one pharmacy in Dallas, Texas, offers a 20-pill box for $199 or $9.95 per pill! We found another location in Delaware charging $5.46 per pill. A pharmacy in Louisiana charged $4.50 per tablet, one in Alabama quoted us $5.89 per pill, and a private pharmacy in Phoenix was charging $6 per pill. We found a few more cases where the price per unit headed toward the $9 mark. 

Of note, we discovered that overwhelmingly, large corporate chains have effectively cut off the ivermectin supply, declaring they cannot access the drug. They reported it was on “backorder,” while small, privately-owned pharmacies in the South and Southwest were more likely to carry the product but charge increasingly exorbitant prices.  

FLCCC Pharmacy List 

Recently, the Front Line COVID-19 Critical Care Alliance (FLCCC) shared their ivermectin pharmacy list. Demonstrating the purge that has occurred, only 39 pharmacies made the list out of about 88,000 pharmacies nationwide. 

Undeclared Hazardous Components in Nasopharyngeal Test Swabs Used in COVID-19 PCR Tests

We tested two widely used nasopharyngeal test swabs used for COVID-19 PCR test sample collection by the SEM-EDS method. Scanning electron microscopic (SEM) analysis demonstrated fairly uniform artificial fibers that showed a great degree of heterogeneity in their internal composition. Elemental analysis by electron dispersion spectroscopy (EDS) revealed carbon, oxygen, nitrogen, aluminum, and silicon as main components at highly variable concentrations within the cross-sections of the fibers. In some spots, the concentrations of aluminum and silicon were as high as 7.25% and 14.06%, respectively. The base matrix appeared to be nylon with inorganic ingredients mixed in. Aluminum and silicon can both present health hazards, and this can explain the rapid-onset nasal bleed and strong and lasting adverse reactions reported by the tested individuals.

Introduction

Respiratory specimen collection techniques for the detection of SARS-CoV-2 were defined by the WHO and CDC (1,2) in March 2020, and these have become standard methods worldwide. The most widely used technique is the nasopharyngeal test swab, (3) even though a more effective and less irritating method is available (4).

The swab has a long shaft with a fiber tip made of nylon, rayon or polyester. It was reported that the specimen collection may cause a mild discomfort (3). However, numerous tested persons have reported epistaxis (4) and/or a rapid-onset irritation reaction that may even require medical attention.  In one study, 28% of the swabbed individuals reported significant side-effects (5). Unfortunately, such observations are typically not followed up and often dismissed as insignificant.

However, the rapid onset of these adverse reactions suggest mechanical and/or chemical damage to the nasopharyngeal mucosa. Since the swabbing procedure is administered by trained professionals, we wanted to check out if the swabs themselves could be responsible for the observed reactions. Our test method was SEM-EDS, which allows morphological examination of the fibers and a determination of the main elements present in them. This also allows for the discovery of material heterogeneities in test samples.

Results and discussion

We tested two specimen collection swabs widely used in COVID-19 PCR diagnostic tests. Swab “K” (Figure 1A) was manufactured by Noble Bio Clinical Diagnostics Products, Republic of Korea, lot number NFS-12011-02. This is a sterile flocked nylon swab. The other sterile swab “M” (Figure 1B) provides lot number 20201130 on its packaging, but no manufacturer information is listed. This is in violation of both U.S. and European labeling requirements for diagnostic products.

Figure 1A. Swab “K” packaging

Figure 1B. Swab “M” packaging

The fiber tips of the two swabs were placed into the sample holder of a Zeiss Quant SEM-EDS system, and the fibers analyzed for morphology and elemental composition. Specifically, we were interested in finding out if the fibers have sharp surface features that could account for the reported injuries of the nasal microvasculature. Figure 2 exhibits the images of sample “M” and subsequently the EDS analysis results.

Figure 2. Fibers of sample “M”.

The endpoint of a fiber was analysed at three spots by EDS and the bulk elemental composition and concentrations were recorded. The X-ray spectra are shown in Figure 3.

.Figure 3. Elemental composition of the sample “M” swab nylon fiber.

Table 1. Elemental composition of fibers in sample “M”.

The spectra and tabulated data reveal that the fibers were not in fact made of nylon exclusively, but contained unreported bulk components of aluminum and silicon. This is in violation of prevailing regulations that require the identification of all constituents in diagnostic products. The concentrations of aluminum and silicon were variable, at some spots as high as 1.68% and 14.06%, respectively. The distribution of these inorganic components across the fibers was highly uneven, a factor that could be caused by an uncontrolled manufacturing process.

Swab “K” was tested under the same conditions and the morphology of the fibers was comparable, suggesting that both manufacturers use similar technology. However, the elemental compositions were different, with aluminum being the dominant inorganic component.

Figure 4. Fibers of sample “K”.

Figure 5. Elemental composition of the swab “K” nylon fiber.

Considering the strict manufacturing and quality procedures embodied in Current Good Manufacturing Practices, it is reasonable to suggest that this heterogeneity of the fibers is by design. Silicon is likely present as silicon dioxide (quartz) microparticles, an abrasive that can have sharp edges randomly distributed inside and on the surface of the fibers. Rotating such a fiber tip inside the nasal cavity may injure the microvasculature of the nasal mucosa, leading to the observed nose bleeds.

Table 2. Elemental composition of fibers in sample “K”.

The presence of high levels of aluminum in the fibers is another disturbing finding, particularly in sample “K” (as high as 7.25% aluminum), which is hard to rationalize. These swab fibers contain ingredients that are known health hazards to humans, but this fact is undisclosed by the manufacturers, and apparently missed by the regulatory agencies.

Aluminum is a neurotoxin and can enter the brain viathe nasal cavity. Accumulation of aluminum in the brain leads to encephalopathy-related dementia. Considering the mass (and repeated) COVID-19 PCR testing of healthy individuals, aluminum exposure of the population via swabbing could constitute a health hazard and should be discontinued. Nasal uptake of aluminum is facilitated by mucosal injury, which can be another factor involved in the reported adverse reactions. It is likely that testing more fibers at more spots could reveal even more heterogeneities in the fibers’ compositions.

There is an alternative to swabbing: The nasal rinse procedure, which is more effective in recovering respiratory pathogens and is far less intrusive to the tested individuals (6). In this study, 91% of the test subjects opted for the nasal rinse because it is easier to tolerate. Apparently, the well being of patients is of little concern for the medical industry currently; this is just one more iatrogen effect that is accepted as “normal.”

Our results revealed a disturbing pattern of noncompliance with regulatory requirements, combined with the lack of concern for the well-being of test subjects. It is ironic that the medical establishment that now strives to control human health is incapable of producing a safe and simple product in conformance with current regulatory standards.

Since the COVID-19 PCR technique is standardized, these commonly used test swabs should be reevaluated for regulatory and manufacturing compliance. We have contacted Noble Bio Clinical Diagnostics Products for further safety information on their product, but our inquires have so far gone unanswered. This is unacceptable corporate behavior, and should prompt the regulatory agencies to take action to protect patient health.

The optimal decision would be to promote nasal rinse or oral saliva sampling and discontinue the use of swabs. If viral RNA can be detected from wastewater (7), why can’t COVID-19 diagnostics tests use other sources, e.g., urine samples? These are logical questions that need an answer, and the continued proliferation of COVID-19 testing argues for improved testing protocols. Hopefully, protecting the profits of healthcare providers will not become the overarching issue here. The current atmosphere, in which essential scientific debate about COVID-related issues is discouraged, unfortunately leads to the situation we are reporting in this communication. We urge researchers to be courageous enough to scrutinize the fundamental risks and benefits of COVID-19 testing protocols, and be forthright about bringing these to light.

Acknowledgement

We are indebted to Gregory M. Vogel for his valuable comments and suggestions on the manuscript.

Competing interests

None.

References

1. World Health Organization. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: interim guidance. March 2, 2020.

2. Centers for Disease Control and Prevention. Interim guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus disease 2019 (COVID-19). April 14, 2020, accessed on 08/15/2021.

3. Marty FM, Chen K, and Verrill, KA. How to obtain a nasopharyngeal swab specimen. N Engl J Med 2020; 382:e76

4Gritzfeld JF, Roberts P, Roche L, El Batrawy S, and Gordon SB. Comparison between nasopharyngeal swab and nasal wash, using culture and PCR, in the detection of potential respiratory pathogens. BMC Res Notes 2011; 4:122-122.

5. Healthline, accessed on 08/15/2021.

6. Gupta, K, Bellino, PM and Charness, ME. Adverse effects of nasopharyngeal swabs: Three-dimensional printed versus commercial swabs. Infect Control Hosp Epidemiol. 2020 Jun 11:1.

7. Aizza Corpus MV, Buonerba A, Vigliotta G, et al. Viruses in wastewater: occurrence, abundance and detection methods. Sci Total Environ. 2020; 745:140910.

“October Discontent” is Maine’s New Fall Brew

Update 10/20/21: The ruling on the Maine court case on vaccine mandates is held up on its 6th day with no advisement rule from Justice Murphy; this is leading people to speculate that there are ramifications that are affecting the judge’s decision, which was said to be coming last Friday.   

By Laurie Dobson

With Halloween on its way, front yards in the state are costumed with ghouls and witches intermixing with blaze-colored fallen leaves. The colorfully festive atmosphere belies a state which has endured two years of vexation and anguish, with lost jobs, hopes, and lives as the hits just keep on coming. 

Is Maine a testing ground, and its citizens experimented on, to see how much they can endure? Is this practice for the so-called “build back better” rollout? The latest pressure point is Governor Mill’s vaccine mandates for Maine’s health care workers. Religious exemptions have been shot down and a judge will rule any day on the decision to impose vaccine mandates on healthcare workers in a state that’s already critically short-staffed. 

Economic Indicators Not Good

Poverty is a plague that has become perennial since government policies shut down the mills, and now entrepreneurs have been forced to close doors in drastic numbers during the quarantine of 2020-21.

The state had a feeding frenzy this summer as people, wary of social and political pressures to comply with mandates, fled to Maine to try to leave a less tumultuous life. 

They are moving in droves to a state that boasts it’s the place that offers a lifestyle that’s “the way life should be.” But does Maine’s beauty compensate for the poverty and austerity endured by its poorer population? 

Targets of Pharma?

It does seem to many observers that there is a concerted effort to deliberately draw down the state’s health, wealth, and well-being. Looking to other pitfalls, there is the drug crisis. OxyContin was pushed early in the pain medicine overdose crisis. Maine was a key state targeted by big Pharma due to Maine’s rural working population. 

According to the docudrama “Dopesick” currently showing on Hulu, this is because of the higher likelihood of pain suffered from injuries sustained in dangerous manual labor and factory jobs, which were plentiful at that time in Maine. 

Health Access Challenges

The lockdown has changed the employment landscape, and Maine is still feeling the pain of job losses. Many people are calling this “the great resignation” as mandates across the country are eliminating first responders once treated as heroes.

The population of Maine is the most elderly of all the states. Nursing home deaths are high, especially right after the “vax,” according to a nurse who spoke on personal authority. Residents are further plagued by difficulties getting to hospitals in emergencies due to distances traveled to care centers, only to be turned away. Some hospitals are now announcing they will be transferring those needing critical care due to staff shortages. EMTs are in short supply and seem targeted for further discouragement for trying to stay with their jobs. 

Growing Anger at POTUS

Biden’s various policies, especially his vaccine mandate pressure policy, are getting comical pushback- “LGB” and “FJB” chants move in wave formation across public events, making it impossible to ignore. 

The President’s approval is tanking and commentary regarding his dementia has become a matter of common discussion in the media and everyday conversation in the US and worldwide. An “FJB” rap chant just hit number one in the music charts.

https://rumble.com/vnxkjy-lets-go-brandon-loza-alexander-politician-dance-remix.html

Medical Liberty Battleground

The chant could well turn into a call to action. If Maine is a testing ground for fighting or complying with further odious pressures, will Mainers decide to turn desperation into decisive action, and fight back? 

There was another call to arms that is “fixed” into Mainers’ history. “Fix bayonets” was the famous battle cry at Gettysburg when Maine’s General Joshua Chamberlain fought against all odds to win with no ammo left. It is considered the turning point in the Civil War.

Do not think you can predict what will happen. It’s an unpredictable state. This is possibly why Judge Murphy is taking her sweet time deciding about imposing health care mandates in the delayed ruling on the court case being closely watched and covered by TrialSite News

A Difficult Group to Break

Behind the scenes, various factors are weighed. Because Maine has shown itself to have a character of endurance, the state may be punished further. Decency and maturity are not playing to their benefit right now. 

Maine’s people are the least likely to declare bankruptcy. There is an honor code alive in the state, and the proud independence of New Englanders runs deep. They suffer and don’t like making issues, or federal cases, out of minor causes. 

Fighting is the last resort in a state that is determined to enjoy life on life’s terms. But the tide always turns, and sometimes it turns red when conditions are polluted and untenable. Lobster wars (cutting traps and other forms of recrimination) do break out, especially when government intrusion forces confrontation. 

‘As Maine Goes, so does the Nation’

The Gulf of Maine, with the Bay of Fundy, has the deepest tides in the country. Coastal workers know how to use the tide to good effect, and “taking the tide at its crest” has been decisive in past battles. 

“As Maine goes, so goes the nation,” it’s been often said, and overly quoted! 

Maine may be at the point where its depleted resources force a population reluctant to complain to finally realize its desperately depleted state and may help its citizens band together to resist its government. 

But perhaps not yet?  Perhaps Mainers will decide to hunker down and wait for the foul weather to hopefully pass. Winter is coming on with snow already expected this week. Or enough may be enough. Maine’s discontented may take the tide at its crest and decide it’s high time to push back. 

If Maine has had enough, beware!