US vaccine ‘adverse events’ 2021 data is 15x 2020 TrialSite Staff February 14, 2022

The Vaccine Adverse Events Reporting System (VAERS) 2021 dataset is more than 15 times larger than that of 2020, accounting for 35% of all data in the VAERS system. Despite continued assurances of vaccine safety from regulatory and public health agencies, the dataset in the Centers for Disease Control and Prevention (CDC) VAERS database represents a material difference from any previous year in reported serious adverse events. CDC acknowledges serious adverse events (SAE) associated with the COVID-19 vaccines authorized and approved in the United States yet reminds all they are a rare occurrence.  The CDC goes on the record that the serious adverse event reports in VAERS are not necessarily associated with COVID-19.  Moreover, for a truly accurate comparison to previous years the total number of vaccines administered doses must be compared to previous year. For example, starting in 2021 the COVID-19 vaccination program represented the largest such mass vaccination in U.S. history with an unprecedented 547 million doses administered to date. Undoubtedly SAEs would increase with such a vast endeavor. But what’s an acceptable amount of SAEs — given risk-benefit analyses associated with the dangers of SARS-CoV-2—from over 900,000 deaths to anywhere from 10% to 30% experience long COVID?

TrialSite has followed the alarming cases of adverse events including deaths after the rollout of the COVID-19 vaccines. The CDC confirmed increasing reports of deaths in VAERS from COVID-19 vaccine recipients, though causality was not indicated.  Of course, TrialSite reminds the reader of a catastrophic COVID-19 death count with over 5.8 deaths worldwide and over 943,000 in America alone. With growing problems with long COVID (representing anywhere from 10% to 30% of  COVID-19 cases) the government’s risk-benefit calculus weighs far heavier on the benefit side of the equation—across the board even when applied to children.

Now both mRNA-based vaccines (Pfizer-BioNTech and Moderna) are formally approved by the U.S. Food and Drug Administration (FDA), yet the companies enjoy liability shields due to the PREP Act emergency declaration. Although POTUS mandates were mostly rejected by the U.S. Supreme Court, the one associated with Health and Human Services Centers for Medicare and Medicaid Services stands, as do many vaccination rules at the local level such as school district in Los Angeles. 

The Data: High Level Observations

The VAERS system contains data submitted from 1990 to the present. With the release of COVID-19 vaccines in 2020, the VAERS database expanded at an unprecedented rate. Again, this correlates with the unprecedented number of COVID-19 vaccinations totaling 547 million doses and climbing.

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By the end of 2021, the new COVID-19 vaccines rose to the top with the highest number of adverse reports. The number of reported adverse reactions to COVID-19 vaccines exceeded the combined number of reactions to the next 12 vaccines.

TrialSite reviews VAERS data for the years 2020 and 2021 below. 

Events reported in the VAERS 2020 and 2021 database

VAERS 2020VAERS 202120 vaccine manufacturers in VAERS database42 vaccine manufacturers in VAERS database60,224 adverse events reported1,884,520 adverse events reportedCOVID-19 vaccines were 2nd in position of reported adverse events and 6th position in reported deaths.COVID-19 vaccines were 1st in position of all reported adverse events and deaths. They had more reported events than the next seven vaccines combined.

There were 1,884,520 reported events in total across the 95 vaccine products in the 2021 database. Of these, the seven highest-ranking vaccine products accounted for 1,225,371 (65%) events reported. Data for these seven vaccines is displayed below.

Table 1: Vaccine products with highest number of adverse events reported in 2021

Vaccine Products 2021No. of events reported (Total: 1,884,520) Percentage COVID19 VACCINE (COVID-19)754,97151.23%ZOSTER VACCINE (VARZOS)98,6926.70%INFLUENZA VIRUS VACCINE, TRIVALENT (INJECTED) (FLU3(SEASONAL))93,3526.33%VARIVAX-VARICELLA VIRUS LIVE (VARCEL)80,1655.44%MEASLES, MUMPS AND RUBELLA VIRUS VACCINE, LIVE (MMR)77,4825.26%PNEUMOCOCCAL VACCINE, POLYVALENT (PPV)60,9784.14%HEPATITIS B VACCINE (HEP)59,7314.05%

Graph 1: Vaccine Products versus number of events reported 2021 database

The table and graph below show the 2020 VAERS reports of vaccine products and events.

Table 2: Vaccine products and number of events reported in 2020 VAERS database

Vaccine ProductNo. of events reported (Total 60,224)PercentageZOSTER VACCINE (VARZOS)12,77325.44%COVID19 VACCINE (COVID19)*10,90821.73%INFLUENZA VIRUS VACCINE, QUADRIVALENT (INJECTED) (FLU4(SEASONAL))6,56013.07%PNEUMOCOCCAL VACCINE, POLYVALENT (PPV)2,9555.89%INFLUENZA VIRUS VACCINE, NO BRAND NAME (FLUX(SEASONAL))2,3444.67%UNKNOWN VACCINES (UNK)1,8183.62%VARIVAX-VARICELLA VIRUS LIVE (VARCEL)1,6983.38%

The first COVID-19 vaccine authorized for emergency use in the United States, UK and Europe by the end of 2020.  

Graph 2: Vaccine products versus number of events in the 2020 VAERS

Manufacturers and Number of Events

The number of vaccine manufacturers reported in the database more than doubled in one year between 2020 and 2021, from 20 to 42. The three manufacturers with the highest numbers of adverse events in 2021 were Merck, Moderna, and Pfizer-BioNTech.

Table 3: Vaccine manufacturers in 2021 with reported events

Vaccine ManufacturerNo. of events reportedPercentageMERCK & CO. INC.397,28126.96%MODERNA345,58823.45%PFIZER-BIONTECH343,23923.29%SANOFI PASTEUR203,50113.81%GLAXOSMITHKLINE BIOLOGICALS157,48710.69%PFIZER-WYETH116,8467.93%UNKNOWN MANUFACTURER88,9886.04%JANSSEN64,5064.38%NOVARTIS VACCINES AND DIAGNOSTICS33,5582.28%CONNAUGHT LABORATORIES32,8542.23%

Graph 3: Vaccine manufacturers and reported events 2021

The manufacturers with the highest number of events reported in 2020 were GlaxoSmithKline, Merck, and Pfizer-BioNTech. Moderna ranked sixth.

Table 4: Vaccine manufacturers with reported events 2020

Vaccine ManufacturersNo. of events reported 2020PercentageGLAXOSMITHKLINE BIOLOGICALS16,27732.42%MERCK & CO. INC.12,28424.47%PFIZER\BIONTECH7,74315.42%SANOFI PASTEUR7,65315.24%UNKNOWN MANUFACTURER4,9359.83%MODERNA3,1426.26%SEQIRUS, INC.2,8235.62%PFIZER\WYETH2,0434.07%NOVARTIS VACCINES AND DIAGNOSTICS1,2702.53%PROTEIN SCIENCES CORPORATION8541.70%

Graph 4: Vaccine manufacturers and reported events 2020

The database reveals that COVID-19 vaccines are associated with a vast expansion in VAERS data from 2020 to 2021—at least that’s how individuals are entering reports.  However, as TrialSite has cautioned, health authorities, starting with the CDC, continue to declare that the SAE numbers aren’t necessarily linked to the COVID-19 vaccines.  There is no causation and it’s often difficult to prove, especially when applying to individuals with comorbidities. In most of the deaths TrialSite has tracked federal investigators deny any proof of causation or even association.

CDC positions to the public that in relation to the over 547 million doses administered, any actual SAE remains an extremely rare event.  Given the risk-benefit analysis inputs (e.g., risks associated with SARS-CoV-2 infections including growing incidence of long COVID)  the government agency declares not only that the “COVID-19 vaccines are safe and effective” but also that CDC recommends “everyone ages 5 years older get vaccinated as soon as possible to protect against COVID-19 and its potentially severe complications.”

The CDC continues to assure that the vaccines are under rigorous ongoing scrutiny—“the most intense safety monitoring program in U.S. history.  Thus, the national public health agency assures the entire American population that the risks of COVID-19 far outweigh any risks associated with the rare probability of a SAE associated with the COVID-19 vaccines. events.  Some physicians critical of the public narrative worry about the longer term effects of multiple vaccine boosts.  Study data for two doses, let alone three doses are still under way.

South Africa’s Forced Isolation Law for COVID Infected People Echoes 2020 Measure

The South African government announced regulations this month authorizing it to forcibly isolate people who test positive with Covid-19, should they refuse admission into a health facility.

Regulation 6: Refusal of Treatment and Isolation

The February 1 amendment to the controversial Disaster Management Act, known as Regulation 6, holds that “no person who is a confirmed laboratory positive COVID-19 case and is symptomatic, may refuse to be treated or to be admitted to a health establishment for treatment or isolation in order to prevent transmission.” 

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Regulation 6, also establishes that “if a person does not comply with the instruction or order of the enforcement officer that person must be placed in isolation at a health facility for a period not exceeding 48 hours, pending a warrant being issued by a competent Court, on application by an enforcement officer for the purposes of isolation or treatment.”

South Africa’s 2020 Attempt To Force Vaccination Under Threat of Isolation

The legality of the new amendment will likely be challenged in light of an unsuccessful legal action against isolation laws in the High Court of South Africa in 2020.

In another unsuccessful challenge to the government-imposed national state of disaster, High Court Judge Norman Davis opined that the lockdown regime was “irrational” and constitutionally flawed, writing “the clear inference I drew from the evidence is that once the minister had declared a national state of disaster, little or, in fact, no regard was given to the extent of the impact of individual regulations on constitutional rights of people.” 

In both cases, South Africa’s Supreme Court of Appeal rejected challenges to isolation orders and the state of disaster rules and sided with government COVID policies. 

Despite these appellate defeats, late last year the government relaxed its stance on contact tracing.

South African Opposition to Vaccine Mandates

As in other nations like Canada, France, and the United States, some South Africans have protested vaccination mandates, but it remains to be seen how widespread opposition will become.

Citizen lobby group Dear South Africa joined Afriforum, an Afrikaner-focused civil rights organization, in a legal action to End the State of Disaster, which was extended to February 15. As of today, Nearly 25,000 people wrote to the group about the legal action. Afrikaners comprise about three million out of approximately 49 million South Africans.

Malawian immunologist Kondwani Jambo and South Africa vaccinologist Prof. Shabbir Madhi called COVID an endemic disease and said people must learn to live with it.

South Africa’s Opposition to Vaccine Mandates in Context

Critics of South Africa’s handling of COVID-19 public health responses have argued that it failed to adequately explain the rationale behind its most forceful measures. 

South Africa’s recent history has been shaped by popular uprisings against the apartheid state and more recently against the ruling African National Congress over civil rights abuses and persistent inequality. 

Others have argued that the government is not capable of enforcing the mass quarantines it is attempting to impose. South Africans, whose youth suffer 70 percent unemployment, are deeply skeptical of their government and observers note the quarantine rules will only deepen citizens’ distrust.

Despite relatively modest vaccination rates, South Africa’s COVID-19 infection rates have trailed those of many Western nations. Medical professionals like Zimbabwe’s Dr. Jackie Stone have attributed relatively low COVID infection and death rates attributed to the disease to high levels of natural immunity, use of indigenous medicines like artemisia annua, repurposed medicines such as ivermectin, and local experience in treating viruses like HIV. 

Email responses or tips to: Shabnam@TrialsiteNews.com 

Healthy 33 Year Old Dies After Second Pfizer Vaccination Leads to Severe Autoimmune Disorders

A healthy 33-year-old man with a wife and one-year-old daughter died from the second dose of the Pfizer COVID-19 vaccine known as BNT162b2 or “Comirnaty.” Just 48 hours after receiving his second dose at the end of August,  Brandon Pollet became severely ill with a high fever, severe headaches, and a high number of blood clots reports the family’s GoFundMe profile. What appeared as severe autoimmune conditions only worsened by October 21, when Brandon was first admitted to the hospital: he remained there 9 days and returned home on November 2. Yet he remained very ill, as he was unable to lower consistently high body temperature and continuously battled weakness. He finally had to return to the hospital on December 12 undergoing treatment for Still’s Disease and adult-onset HLH disease. Treatments included chemo and steroid treatments as well as daily insulin and infusion of blood products. Huge bills piled up as can be imagined in the American health care system while his wife, Jessica, took FMLA leave to support her husband. As reported by local media, Brandon died on January 28th as physicians there in Louisiana acknowledged a direct relation to the second COVID-19 vaccine dose, reports the family and local media.

While the official stance of most of the medical establishment, from the National Institutes of Health to the U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration to the administrations of the largest health systems is that serious adverse events and death are rare given the sheer magnitude of the COVID-19 mass vaccination program: yet TrialSite suggests that rare still can equal a sizeable number of incidents. 

According to the CDC’s VAERs website, reports of deaths post-vaccination are “rare,” yet in the VAERS database more deaths have been reported in 2021 than in the previous decade combined. Of course, this doesn’t prove that the vaccine was associated with the deaths, but the numbers are truly concerning, and more investigation needs to be done. TrialSite reviews CDC’s point of view on serious adverse events and deaths. In any other normal situation, the number of deaths reported in the CDC adverse event reporting system (VAERS) would have tripped the stop switch.

Serious Adverse Event TypeRelevant Data/CommentsAnaphylaxis, a severe type of allergic reaction5 people per one million vaccinatedThrombosis with thrombocytopenia syndrome (TTS) after J&J vaccine—blood clots in large blood vessels and low platelets57 confirmed reports out of 18 million doses CDC identified 9 deaths that were the result of TTS following J&J vaccination. Women aged 30-49 face greater risk. Thus far 3 confirmed cases associated with ModernaGuillain-Barré Syndrome, Associated with J&J and involves the body’s immune system damaging nerve cells302 reports of GBS; risk after 21 days 21 times higher with J&J than Pfizer or Moderna. After 42 days the risk of GBS is 11 times higher with J&J.Myocarditis/Pericarditis, associated with mRNA vaccines (Pfizer & Moderna); inflammation of the heart muscle (myocarditis) and inflammation of the outer lining of the heart (pericarditis).2,132 reports of both (preliminary) among people aged 30 and below. Note in Nordic countries Moderna was put on hold for people under 30 due to concerns. Through follow-up analysis of medical records 1,233 reports of myocarditis.Deaths11,657 deaths out of 535 million doses administered (0.0022%).

Again, based on what has been an unprecedented mass vaccination, the total number of deaths in VAERS according to this CDC website (11,657) would be considered rare. The CDC includes a statement denoting that just because they are reported doesn’t mean that such deaths relate to the vaccine. TrialSite reminds readers that the COVID-19 pandemic response mass vaccination was done under the protective umbrella of the PREP Act, a questionable FDA approval, and attempted mandates. 

Pfizer secured an unprecedented $33 billion in year one pandemic monetization effort. Despite the benefits of vaccination (the vaccine does reduce the probability of hospitalization and death and over 850,000 people have died during the pandemic) principles of consent, biomedical ethics, and scientific transparency, not to mention patient-centricity drive this media platform and social network to continue reporting on the world of clinical research with a critical eye-raising pressing concerns, information, and insight.

A growing number of researchers, physicians, and health care professionals carefully and quietly express concerns about the vaccines. TrialSite has directly raised concerns ranging from leaked biodistribution and regulatory documents to Sonia Elijah’s piece thanks to a Freedom of Information Act (FOIA) release back in August of 2021 opening access to vaccine documentation the company relied upon to approved the vaccine for individuals aged 16 and above.  More currently the battle to access the regulatory filing documentation continues. The company and FDA sought to delay the entire release for 55 years! Concerns raised are most often summarily dismissed by much of the medical community and of course targeted for what appears to be biased, non-objective so-called fact-checkers. TrialSite suggests that formal investigations are necessary to ensure trust in public health and industry.

Makes the Local News

The family lived in St. Charles Parish (New Orleans area) prior to moving to Ponchatoula to the north, reports Monique Roth writing for the local Herald Guide. Brandon’s wife Jessica was quoted by Ms. Roth’s piece reporting after the last dose “He was worked up for hemophagocytic lymphohistiocytosis, or HLH, but it was ruled out and he was diagnosed with a rare autoimmune disease called Still’s Disease,” Jessica said. “After discharge, Brandon went home for about a month and was then re-hospitalized Dec. 14.”

She continued, “He received the HLH protocol treatment, which included chemotherapy,” she said last week. “Unfortunately, none of the usual treatments have worked. The doctors have agreed that the COVID vaccine caused an immune response that led to the development of the autoimmune disease and HLH.”

Brandon worked at a nearby Shell Oil plant where he was a mechanic, and his wife reports co-workers have been wonderfully supportive to the family along with the community in St. Charles Parish.

Call to Action: TrialSite recommends for those that have the means to help the family out. Follow the link to the family’s GoFundMe. America’s health care system can break families and this young widow, and her baby daughter deserve help.

Nasal Spray Kills COVID-19, Now Approved in India & Israel Bahrain Indonesia & Thailand: No Mention in Big Media

Toward the end of 2021 TrialSite reported to the world that a nasal spray exhibited the ability to kill 99.9% of the SARS-CoV-2 virus. Called the SaNOTize Nitric Oxide Nasal Spray (NONS), this investigational product was designed to kill COVID-19 in the upper airways, in effect inhibiting the virus from incubating and thereby making its way to the host’s lungs.  Developed by Vancouver-based SaNOtize Research and Development Corp, the product was helped along by testing done at the Utah State University Antiviral Research Institute. By the summer of 2021 the investigational product was evidencing positive results in Phase 2 clinical trials.  By the end of 2021 various nations in the Middle East were embracing the drug from Bahrain to Israel. Now one of India’s largest generic drug producers, Glenmark Pharmaceuticals, embraced the nasal spray for distribution in the world’s second most populated nation. Just days ago, India’s regulatory, the Drug Controller General of India  (DCGI) granted market authorization to Glenmark Pharmaceuticals– so now the product is authorized as a medical device targeting COVID-19 in India, Israel, Bahrain, Indonesia and Thailand. TrialSite has asked the question why not in the United States?  Why is there so little news in the mainstream media?  Are major pharmaceutical companies monopolizing the mindshare for vaccines and expensive branded therapies?

The Product

The SaNOtize Nitric Oxide Nasal Spray (NONS) product is designed to kill the SARS-CoV-2 virus in the upper airways, preventing it from incubating and spreading to the lungs. Based on nitric oxide (NO), a natural nanomolecule produced by the human body and proven with anti-microbial properties, evidence of a direct effect on SARS-CoV-2 2.  The pharmacology, toxicity and safety data for no use of the nitric oxide has been well-established for decades, reports the product’s sponsor.  They report that the nitric oxide molecule released from the NONs product is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome in newborn babies, reports the company.

Positive Phase 3 Study Results

TrialSite has chronicled the development of this nasal spray product developed by Vancouver-based SaNOtize.  Just recently the company reported a Phase 3 trial achieve its primary endpoint while demonstrating a reduction in SARS-CoV-2 log viral load in COVID-19 patients by over 94% within 24 hours of treatment.  Within 48 hours the viral load was wiped out by 99%.

Moreover, a greater proportion of people in the high risk group, numbering 218, achieved a combination of clinical and virological cure, based on the WHO Progression Scale. They report a stunning medical time to virological cure at 4 days in the treatment group and eight days in the placebo group (p<0.05).   Moreover, Glenmark Pharmaceuticals  received manufacturing and marketing approval for the Nitric Oxide Nasal Spray (NONS) as part of an accelerated approval process.

Co-Founder and CEO Gilly Regev shared with TrialSite’s Founder Daniel O’Connor, “SaNOtize is excited to have Glenmark as our partner for manufacturing and distribution in India. We share the vision for this product and hoping it will become the first line of treatment and defence against respiratory viral infections.”

Accumulating Evidence Leads to Commercialization in India

The case for NONS becomes more compelling.  From the early testing at Utah State University Antiviral Research Institute to successful Phase 2 study results in the UK—where Ashford and St. Peter’s Hospitals NHS Foundation Trust and Berkshire and Surrey Pathology Services produced a reduction of SARS-CoV-2 of 95% in 24 hours and 99% in 72 hours back in March 2021—with results published in the Journal of Infection in August 2021—to increased use even in pharmacies in the Middle East to the most recent clinical results,  India now has an approved nasal spray for COVID-19.

Regulatory Approval in India against COVID-19

With no mention in Western news, India’s regulatory has made a major move in the war on COVID-19. Mumbai-based Glenmark Pharmaceuticals was granted manufacturing and marketing approval from the Drug Controller General of India (DCGI) for the Nitric Oxide nasal spray (NONS) as part of the accelerated approval process.

Glenmark Pharmaceuticals and Canada-based SaNOtize Research teamed up to commercialize the spay in India. Now called FabiSpray® this is the first easy to administer nasal spray treatment to treat COVID-19 anywhere worldwide.  Their commercialization partnership dates to August 2021.

As part of this commercialization the approval is for the treatment of adult patients with COVID-19 who have a risk of progression of the disease, which includes either persons over the age of 45, non-vaccinated people and/or those with comorbidities. 

Now Glenmark Pharmaceuticals will distribute the product to the following countries as an COVID-19 treatment:

• Malaysia

• Hong Kong

• Singapore

• Taiwan

• Nepal

• Brunei

• Cambodia

• Laos

• Myanmar

• Sri Lanka

• Timor-Leste

• Vietnam

What about Current use?

As TrialSite reported in November, 2021 the product was already in use in pharmacies as it’s received market authorization as a Class I Medical Device in the European Union. The product is approved in Israel, Thailand, Indonesia and Bahrain and sold under the brand name enovid™or VirX. ™

SaNOtize Research

A Vancouver, British Columbia based concern, SaNOtize Research & Development Corp. commercializes the multi-faceted antimicrobial properties of a liquid producing nitric oxide. The company developed the NORS™ product to treat and prevent upper respiratory and topical infections.

Founded in 2017 by Gilly Regev, PhD and Chris Miller, PhD, BA, RT,  the company has made significant progress on minimal cash reserves. According to Crunchbase they have raised just a couple million dollars. Funding has come from a $1.2 million U.S. Department of Defense grant for a Phase 1 clinical trial, $1 million for Crowdfund in Israel and another $400,000 grant.

They currently employ between 10 and 20. Given the approvals and commercialization of NONS the company’s valuation is undoubtedly growing.  Founders Regev and Miller are commendable for their results.

NYC Mayor With Cephalic-Rectal Syndrome Claims Fired Employees Are “Quitting” Dr-Ron-Brown

Get vaxxed or get tested. That is a viable alternative that accommodates people’s ethical beliefs and respects their right to informed consent before complying with a medical treatment. But take away the testing alternative, and what’s left is criminal extortion—get vaxxed or lose your job, salary, or both. The non-alternative version of the vaccine mandate is what is currently demanded of thousands of New York City employees.

According to Megan Redshaw’s report, Lawsuits Challenge NYC’s COVID Vaccine Mandates, the mayor of New York City appears to be in critical need of treatment for cephalic-rectal syndrome—a serious condition in which one’s head must be extracted from one’s anus. How else to explain the mayor’s incomprehensible comment that workers are “quitting,” when clearly workers are being fired without any alternative provided by the current vaccine mandate.

Here’s wishing the mayor a rapid recovery from the extraction procedure, assuming he consents to the treatment. Maybe it will help him see a clearer picture of the situation…but with so many other government administrators, public health authorities, media personnel, politicians, and employers suffering from the same condition, I’m not expecting an immediate change.

Given cephalic-rectal syndrome’s high prevalence within certain segments of the population most responsible for mismanaging public health pandemic responses, perhaps we should change the pandemic name from coronavirus disease 2019 (COVID-19) to cephalic-rectal syndrome 2019 (CRS-19)?

Related

Family Wins Court Battle Over Ivermectin, But It Comes Too Late

The drug ivermectin continues to be a flashpoint among patients, hospitals, governments and doctors. The latest example is the death of a Mississippi man whose family had just won a court battle to allow him to receive the controversial medication.

63-year-old Wayne Doyle died after a weeks-long battle with COVID-19. Doyle was on a ventilator for almost two weeks and North Mississippi Health Services refused to administer ivermectin to him. He was in North Mississippi Medical Center. Doyle’s family went to Lee County Chancery Court to contest the hospital’s decision. In court North Mississippi Health Service and the family agreed to transfer Doyle to another hospital where he would be given ivermectin.  Before he could be transferred, Doyle died.

Because the Food and Drug Administration (FDA) does not recommend ivermectin as a treatment for COVID-19,  most hospitals refuse to administer the drug. It is not unusual for a patient’s family to sue hospitals so the medication can be given to a patient. The FDA is very clear in its opposition to ivermectin which it has repeated labeled as a “horse de-wormer”.  Yet, the onetime “wonder drug” has been credited with curing some cases of COVID-19. Ivermectin, when administered by a knowledgeable physician, has allowed patients to “walk out of the hospital”.

Lots of Studies—Few Taken Seriously

The drug has been extensively studied during the pandemic in humans with 78 studies and counting, with over 85,000 patients as demonstrated in this website that tracks the studies. However the U.S. medical establishment discounts the great majority of these studies as rigorously weak. In fact, a couple of them have resulted in negligible to no real efficacious results.  While one Egyptian study involved allegations of manipulated data.  Most recently a couple prominent meta-analyses are under attack.  In fact, a journal has issued a so-called “expression of concern” regarding a couple meta-analyses showcasing positive ivermectin studies according to the online media Retraction Watch. Ivermectin papers slapped with expressions of concern – Retraction Watch

Several ivermectin-focused studies that initially evidenced positive results, that were thereafter published after rigorous peer review processes have been retracted. Regardless several countries have allowed for emergency use of ivermectin during the pandemic, including India for a period last year.

Why the Resistance?

In many cases, the court’s determination to allow the ivermectin treatment, is a decision of last resort. Many judges conclude that nothing else is working and the controversial drug should be used. The other obstacle has been the refusal of pharmacies to fill prescriptions for the drug.  

There has been conjecture behind the reasoning of the FDA regarding ivermectin. One of the theories is the drug is a cheaper alternative to the cures and vaccines being marketed by the pharmaceutical companies. Accusations of profit over care have been leveled. Regardless, many families who believe in the medication have been left with no alternative but to go to court to get treatment for their stricken loved ones.

Unfortunately, for Wayne Doyle, a court decision arrived too late.

The Pandemic Division is Now in The Forefront

The COVID-19 pandemic opened fault lines in the American medical system. And what seems to be suffering is the doctor, patient relationship as well as the regulations between the government and the medical community. The patient becomes the ultimate victim.

The most glaring chasm appears to be over the controversial drug ivermectin in its use as an off-label treatment for COVID-19. The Food and Drug Administration (FDA) has come out repeatedly with strong statements condemning the use of ivermectin as a “horse de-wormer”. The FDA warns there is a lot of “disinformation” about the medication, and it should never be taken as a treatment for COVID-19, unless in a clinical trial. The statement from the FDA is strong and unambiguous and is contrasted by many states who are rebelling against the restrictions of the FDA concerning the pandemic. The FDA, traditionally considered the Gold Standard regulatory body followed by other comparable national agencies, succumbed to trickery online in a bid to attack the drug as reported by TrialSite.

The Oklahoma Attorney General issued a statement reassuring doctors in his state that they will not be punished for prescribing ivermectin or another controversial medication, hydroxychloroquine, to treat the Covid-19 virus. The pronouncement was issued despite the FDA’s warning against both drugs. Sonia Elijah writing for TrialSite chronicled for example how the FDA’s leadership became involved in the ivermectin disinformation war.

Legislative Protections?

John O’Connor, the attorney general for the state, went further in his news release saying there is no “legal basis” for the state licensing board to prevent a licensed physician from prescribing either drug. Oklahoma isn’t the only state defying the FDA’s guidelines. Several states governments, besides Oklahoma, are trying to advance legislation preventing doctors from being penalized for prescribing ivermectin. This has turned into a split between the federal and state governments, doctors and administrators, doctors and the federal and state health regulators. Thrown into this are pharmacists some of whom are now hesitant to fill prescriptions for ivermectin.

Online Ordering

This has led to many prescriptions being filled online. Because of the COVID pandemic usage of online pharmacies has increased. Not only is ivermectin bought online but, last year, 56% of drugs bought online were narcotics as well as 52% of the purchases were for stimulants.

This is another instance of consumers “self-medicating” to a certain degree as well as relying on prescriptions issued by doctors who prescribe online and not in person. Some doctors who are not licensed in a state are prescribing medication for patients in that state and doing it through “telemedicine”.    Those doctors must navigate a complex myriad of state law and medical society requirements as well as adhere to ethical guidelines.

Perhaps the most blatant use of online pharmacies, besides ivermectin, is the advertisements for buying Viagra discreetly so as not to suffer the “embarrassment” of purchasing the medication in person. Warnings from the Canadian government over the danger of ordering online claim there are many risks.  The warnings include disclaimers involved with not seeing a doctor in person prior to prescription.  This adds to the divide which seems to be inherent and intensifying in the COVID-19 pandemic. Patients who’ve been diagnosed with the virus are going to doctors online seeking a prescription for ivermectin.  In some cases, the drug has seemingly worked but only after it’s been administered by a doctor.  

Definition of a Crisis

The fault lines have been drawn.  There appears to be “disinformation” on both sides as well as no clear governmental oversight and politicians using the pandemic to further their agenda and careers.

Add to the mix are new treatments being introduced yet in short supply. These pharmaceuticals will come with a bigger price tag. In the middle of a world health crisis health authorities and medical leaders lack a consistent messaging while significant numbers of physicians have felt the need to break away and challenge what they suspect is a corrupted system.  During this pandemic crisis an active federal government disrupted common practices, including the local doctor to patient relationship. Any treatment that deviated from vaccination, such as early treatment with repurposed drugs, was considered blasphemous yet that was common practice just the year before.