Informed Dissent
Medical Dissidents, Agency Capture, and Dr. Mary Talley Bowden’s Battle with the FDA over Ivermectin
BY M.C. ARMSTRONG | HONEST MEDIA | APRIL 18, 2024
Dr. Mary Talley Bowden recently sued the FDA for stepping beyond their charter, defaming Ivermectin prescribers, and, thereby, interfering with the doctor-patient relationship. Last month, Dr. Bowden resolved her suit, receiving a substantial undisclosed settlement from the government agency.
Dr. Pierre Kory has been an early and staunch defender of the use of Ivermectin to treat COVID-19 in humans. Kory believes the FDA settled this case with Bowden because they had likely hired the PR firm Weber Shandwick to create the now infamous “horse dewormer” campaign (detailed below) to smear Ivermectin and its proponents. If true, once Bowden’s lawsuit went into the phase of discovery then this information would have been revealed, but we will never know since the case is now settled. Weber Shandwick lists the CDC, Pfizer, and Moderna as their clients.
Honest Media covered Ivermectin and the “horse dewormer” controversy in a letter sent to the Associated Press documenting the lies the AP published about the drug. We have also recently received a trove of emails between Dr. Bowden and the Arizona Mirror, an outlet that smeared Dr. Bowden and her colleague, Dr. Peter McCullough. After reviewing them, we can say that these documents illustrate the media’s contempt for medical dissidents.
But why this fear of letting dissenting doctors speak? There has been virtually no coverage of Dr. Bowden’s case. Where there is documentation, like with Jen Christensen’s reporting for CNN, nobody gives voice to the victor and victim, Dr. Bowden. Why?
Dr. Bowden, a Stanford-trained ear, nose, and throat doctor from Houston, has treated more than 6,000 patients suffering from COVID. She is a strong and intelligent woman of science speaking truth to power. Here, in Dr. Bowden, is that “gutsy woman” who Americans were told to admire by leaders like Hillary Clinton. But there’s an implicit caveat in the cult of Clinton’s “gutsy woman:” Such women are to be ignored (and even pilloried and censored) if they challenge the orthodoxies of the Democratic Party or the DNC-aligned Big Pharma industry.
For prescribing Ivermectin and dissenting against the dominant COVID narratives, Dr. Bowden was forced to resign from Houston Methodist Hospital. And she wasn’t the only doctor to face such consequences. Dr. Robert Apter and Dr. Paul Marik, two other Ivermectin physician-advocates, joined Dr. Bowden in her suit against the FDA. Marik, for his part, was forced to resign from Eastern Virginia Medical School as well as Sentara Norfolk General.
Last month, Dr. Bowden traveled to the Supreme Court to stand in solidarity with activists as SCOTUS listened to Murthy v. Missouri. The Murthy case concerns the suppression of medical dissidents, specifically, and online censorship, more broadly. Dr. Bowden addressed the crowd of protesters about her four-year battle with the captured government agency:
How many COVID patients did they examine? How many histories did they take? How many prescriptions did they write? Zero. None of them have cared for a single COVID patient, but because they had the full support of Big Pharma, the government, and, most importantly, the media, they became the scientific authority on a novel disease they had zero first-hand experience in treating.
Bowden has a point. The FDA’s campaign against doctors such as herself gained purchase with the public, in part, because the agency’s claims were amplified by a mainstream media that is shaped and funded – captured – by Big Pharma. Due to the massive influx of advertising dollars and the perfect storm of misinformation and disinformation summoned by Russiagate, the 2020 election, and the COVID-19 pandemic, the American public’s trust in the mainstream media has reached record lows. Bowden’s case reveals another example of why the public is justified in its skepticism.
Let the Doctors Speak
I recently spoke with Dr. Bowden about her fight with the government.
“This was a war on Ivermectin,” she said. “But it was also a war on the doctor-patient relationship.”
I asked her what precipitated the suit against the FDA. Dr. Bowden told me that never before in her career had she witnessed interference with the doctor-patient relationship from the FDA or her local pharmacies. When I asked about prescribing a drug that wasn’t FDA-approved, she told me that she’d often prescribed off-label in the past, with no problems, and that she approached Ivermectin, initially, with hesitancy and skepticism. She said she preferred prescribing monoclonal antibodies at the beginning of the pandemic, but sought new options when access to these treatments became restricted.
“I was nervous to start using it,” she said. “Before I started, I looked at the FDA’s website and the toxicity data. Once I was assured that it worked (maybe not as quickly as monoclonal antibodies), I started offering it to patients.”
Not only did Dr. Bowden prescribe Ivermectin to her patients and witness positive results, but she used it herself. She’s had COVID three times. And in every instance of Ivermectin treatment, both with herself and her patients, she observed either efficacy or minimal side effects.
“I haven’t lost one patient due to Ivermectin,” she said.
In 2015, the Nobel Committee for Physiology honored the discovery of Ivermectin with a Nobel Prize. The NIH lauded this “multifaceted drug,” which was largely unknown in American public discourse prior to the outbreak of the COVID-19 pandemic.
Then, suddenly everyone and their grandmother was an expert on the dangers of Ivermectin. Seemingly overnight, the American people absorbed a viral propaganda campaign from the very government agency (the FDA) that they supported with tax dollars. And if you were a doctor or patient seeking this low-cost, award-winning therapeutic treatment, you were suddenly in the crosshairs of the “war on Ivermectin.” This policing of the poor and the independent all started, according to Dr. Bowden, “with the horse tweet.”
On August 8, 2021, the FDA weaponized its social media account to stigmatize physicians like Dr. Bowden and skeptical and underprivileged patients seeking affordable alternative care. The agency issued a tweet with two images: a veterinarian outdoors caring for a horse, coupled with a physician in an office caring for a masked human. The text for the tweet reads: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This tweet, with its careful use of the colloquial and the second person, supplemented with a juvenile binary logic, became the most popular tweet in FDA history.
Hate wins clicks. Fear creates fog. Shortly after the tweet’s publication and viral propagation, Dr. Bowden’s life came undone.
“I never had a pharmacy deny a prescription before,” she said.
Dr. Bowden’s struggle with the pharmacy was just the tip of the iceberg, revealing the stranglehold Big Pharma now has on health care in America. Dr. Bowden suffered (and still suffers) from vicious attacks online, as well as alienation from her peers. She was forced to resign from her workplace, Houston Methodist Hospital. She explained to me that the “war on Ivermectin” was more vitriolic than anything she’d ever seen before in the discourse on public health. And whereas most doctors bent the knee, stayed silent, and complied with government mandates, Dr. Bowden (and others) fought back. Her case represents what one might call a scientific profile in courage.
What does fighting back look like? Well, for starters, perhaps it begins with telling the truth in public and revealing the whole story of Dr. Bowden’s struggle, along with that of fellow medical dissidents like Dr. Kory, Dr. Robert Malone, Dr. Jay Bhattacharya (co-author of the Great Barrington Declaration), and Dr. Peter McCullough.
In Dr. Bowden’s and Dr. McCullough’s recent email exchanges with the Arizona Mirror, one can see, firsthand, a publication that ignores the opportunity to correct factual errors. The Mirror instead willfully litters its reporting on Dr. Bowden and Dr. McCullough with misinformation, ad hominem attacks, bizarre references to Qanon, constant allusions to shadowy conspiracy theories, and the slanderous insinuation that Dr. McCullough is antisemitic.
The Association Fallacy
One of the most recurrent disinformation patterns we have witnessed in studying the defamation of populist voices, broadly, and Dr. Bowden’s case, specifically, is what scholars of rhetoric call the association fallacy. In short, the association fallacy describes claims where even oblique social connection to a stigmatized individual or organization (like QAnon) is used to poison the claims of the targeted speaker. Simply associating the terrifying name of the poisonous organization with the speaker scares the reader and creates an irrational – fallacious – connection.
What’s troubling, in the case of the Arizona Mirror reporting, is that Dr. Bowden and Dr. McCullough have no ties to QAnon. Furthermore, Dr. Bowden and Dr. McCullough both reached out to Jim Small, the paper’s editor, and politely asked that these fallacies be removed from the Mirror’s articles.
For example, Dr. Bowden and Dr. McCullough called attention to the Mirror’s repeated use of the ad hominem “anti-vaxxer” to label Dr. McCullough and associate the doctor with the world of “anti-vaxxers.” In their email exchange, Dr. McCullough confides in Small that he has “accepted dozens of vaccines during the course of my life.”
But the Mirror refused to mirror the truth and remove the slur. The Mirror refused to interview these doctors, refused to correct their reporter’s mistakes when alerted by the victims, and, furthermore, sought to defame the doctors through ad hominem attacks and the association fallacy.
To witness how the association fallacy works, consider the following sentence about Dr. Bowden’s colleague, Dr. McCullough, from the Arizona Mirror’s Jerod Macdonald-Evoy: “McCullough has become a darling to those in both Qanon and the broader conspiracy world, appearing regularly on shows like the one hosted by antisemite Stew Peters, who said the COVID vaccine is a bioweapon.”
In one sentence, the reporter has accused the doctor (without directly accusing him) of antisemitism and conspiracy theory simply by virtue of association with other human beings, mostly unnamed, who populate “the broader conspiracy world.”
What is happening to people like Dr. McCullough and Dr. Bowden rarely happens to those in power. It happens to those who challenge power.
The Arizona Mirror and CNN should be ashamed. They punished informed dissent. They refused to contextualize Dr. Bowden’s struggle as part of a subculture of dignified scientists and physicians. They erased and defamed Dr. Bowden and her colleagues. They published fear porn and called it journalism. They left out this gutsy woman’s voice. Honest Media has chosen a different path. We let the doctor speak.
Fauci’s Inquisition Against Safe and Effective Anti-COVID-19 Drugs
By Richard Gale and Dr. Gary Null | Global Research | April 6, 2024
A question needs to be asked. Were the novel experimental drug treatments for SARS-CoV-2 viral infections that Anthony Fauci, the CDC and FDA advocated for and funded responsible for worsening the contagion and countless deaths?
However, at that time there were plenty of studies confirming there were pre-existing safe, inexpensive medications known to have highly effective antiviral properties to treat Covid-19 patients. Among these were ivermectin and hydroxychloroquine (HCQ).
There were also specific nutrients such as vitamin D and zinc, known to strengthen the immune system against viral infection and yet there was no recommendation from the government about the benefits of proper nutrition. So why did Fauci along with other federal health officials choose to intentionally ignore the scientific evidence and rather condemn these repurposed drugs? In Fauci’s case, over a year and half into the pandemic, he continued to lie outright on CNN that “there is no clinical evidence whatsoever that [ivermectin] works.”[1] And could millions have been saved if these generic medications were prescribed rather than the feds doing nothing but recommending social isolation and quarantines as the world awaited an experimental Covid-19 vaccine to enter the market?
To date, between ivermectin and HCQ alone, there have been 670 published studies, analyses and papers involving over 9,800 scientists and over 682,000 patients supporting the use of these drugs over and beyond those the FDA has approved under Emergency Use Authorization (EUA) statutes. Despite this, four years later, the FDA continues to fiercely deny ivermectin’s and HCQ’s efficacy and safety under proper administration. Why this blatant cover-up?
Every CDC effort to approve a novel drug treatment for SARS-CoV-2 infections has been a dismal failure. Aside from monoclonal antibody therapy, only three anti-Covid-19 drugs have been approved under an EUA in the United States. None met their promised expectations from either the manufacturer or our federal health agencies. With their poor efficacy rates, safety profiles and a black box warning slapped upon Pfizer’s anti-Covid-19 drug Paxlovid, the CDC is scrambling to find new viable alternatives in the pharmaceutical pipeline. Bloomberg amplifies the fake Covid-19 treatment crisis by lamenting that repurposed drugs such as ivermectin are gaining global popularity as “the world needs effective Covid drugs.”[2]
Shortly after the pandemic was formally announced, the FDA recommended the cheap over the counter anti-malarial drug hydroxychloroquine but then quickly reversed its decision after Fauci publicly announced the future arrival of Gilead Sciences’ novel intravenous drug Remdesivir. The FDA’s and European Union’s approvals of Remdesivir baffled many scientists, according to the journal Science, who questioned its therapeutic value and kept a close watch on the drug’s clinical reports about a “disproportionally high number of reports of liver and kidney problems.”[3] Even an earlier Chinese study published in The Lancet found that remdesivir had no impact on the coronavirus. The Science article notes that the “FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues.”[4] Six months before remdesivir received EUA approval, Anthony Fauci had already hailed the drug as a major breakthrough that would establish a new “standard of care” in Covid-19 treatment.[5]
Today, remdesivir is being increasingly recognized as a debacle in antiviral therapeutic care. Even the WHO released a “conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.” An Italian study observed a 416 percent increase in hepatocellular injuries among hospitalized Covid-19 patients treated with Remdesivir.[6] And a smaller Taiwanese study of hospitalized unvaccinated patients reported a 185 percent higher mortality during late remdesivir treatment.[7]
Earlier this year, Pfizer’s novel oral Covid-19 medication Paxlovid was given an FDA black box warning for clinically significant adverse reactions that can potentially be fatal. Because the company does not permit independent random-controlled trials to investigate its drug, other than retrospective studies, we only have Pfizer’s own data to rely upon. Nevertheless, The Lancet published a study by a team of Chinese scientists at Shanghai Jiao Tong School of Medicine that managed to look at Paxlovid’s use among critically ill patients hospitalized with Covid-19. The study reported a 27 percent higher risk of the infection progressing, a 67 percent increased risk in requiring ventilation, and 10 percent longer stays in ICU facilities.[8]
Paxlovid is a combination of a novel SARS-CoV-2 protease inhibitor and the HIV protease inhibitor ritonavir. The FDA approved Paxlovid under a EUA with the claim it was safe. However, on the government’s HIV.gov website for ritonavir it is clearly stated that the drug “can cause serious life-threatening side effects. These include inflammation of the pancreas (pancreatitis), heart rhythm problems, severe skin rash and allergic reactions, liver problems and drug interactions.”[9] Perhaps due to the drug’s serious side effects, it is no longer used solely against HIV, but rather is given in smaller doses as a booster for AZT-related drugs. Being highly toxic, ritonavir is also not recommended for pregnant women and has been shown to interfere with hormone-based birth control efficacy.
Paxlovid only received FDA EUA approval in May 2023. At that time, the agency claimed there was no evidence that patients who were treated with the drug rebounded and came down with Covid. However, shortly thereafter this was determined to be untrue.[10] A Harvard analysis found that 21 percent of Paxlovid recipients will remain contagious and likely succumb to a viral rebound compared to only 1.8 percent who did not take the drug.
Merck’s anti-Covid-19 drug molnupiravir (Lagevrio) also has an FDA black box warning for potential fetal harm when administered to pregnant women. Why the drug was ever approved under an EUA seems to be an enigma. The drug’s antiviral activity is based upon a metabolite known as NHC, which for many years has been known to create havoc in an enzyme crucial for viral replication by inserting errors into the virus’ genetic code. The theory is: produce enough errors and the virus kills itself off. However, molnupiravir can cause hundreds of mutations thereby “supercharging” the manufacturing of new Covid-19 viral strains. Moreover, according to a Forbes article, the drug’s mutagenic powers may also interfere with our own body’s enzymes and DNA.[11] Another Forbes article points out that Merck’s clinical trial only enrolled around 1,500 participants, which is far too “small to pick up on rare mutagenic events.”[12]
Molnupiravir has a poor efficacy rate across the board including viral clearance, recovery, and hospitalizations/death (68 percent).[13] One trial, funded by Merck, concluded the drug had no clinical benefit.[14] More worrisome, the drug also has life-threatening adverse effects including mutagenic risks to human DNA and mitochondria, carcinogenic activity and embryonic death.[15]
Each of these drugs have been outrageous cash cows for their manufacturers. Remdesivir is priced at $3,120 per treatment and earned Gilead $5.6 billion in sales for 2021.
Pfizer’s Paxlovid is priced at $1,390 per treatment. Last year, the company’s revenues for its Covid products—Paxlovid and the Comirnaty vaccine—came in at $12.5 billion, and, according to Fierce Pharma, Pfizer wrote off an additional $4.7 billion on its overstocked Paxlovid inventory.[16] Merck’s molnupiravir’s sales for 2022 cashed in almost $5.7 billion. Despite their profits, none of these drugs have been shown convincingly to have measurably lessened the pandemic nor the spread of SARS-CoV-2.
Despite all the attention and medical hype about novel experimental antiviral drugs to treat Covid-19, Anthony Fauci and other federal officials had full knowledge that other FDA-approved drugs existed that could have been quickly repurposed at minimal expense to effectively treat Covid-19 infections. Repurposing existing drugs to treat illness is a common occurrence. The antiparasitic and antiviral drug Ivermectin best stands out. Its effectiveness was observed to be so remarkable and multifaceted that researchers started to investigate its potential.
The mainstream media, including many liberal news sources who pride themselves on their independence, continue to channel the voices of Anthony Fauci, the CDC and FDA to demonize ivermectin and other generic drugs for treating Covid-19 and to reduce hospitalization and deaths. This propaganda campaign, however, has completely ignored the large body of medical literature that shows ivermectin’s statistically significant efficacy against symptomatic and asymptomatic SARS-2 infections.
Originally developed for veterinarian use, in 1987, the FDA approved ivermectin for treating two parasitic diseases, river blindness and stronglyoidiasis, in humans. Since then an enormous body of medical research has grown showing ivermectin’s effectiveness for treating other diseases. Its broad range of antiviral properties has shown efficacy against many RNA viruses such avian influenza, zika, dengue, HIV, West Nile, yellow fever, chikungunya and earlier severe respiratory coronaviruses. It has also been shown to be effective against DNA viruses such as herpes, polyomavirus, and circovirus-2.[17]
Unsurprisingly, ivermectin’s inventors Drs. William Campbell and Satoshi Omura were awarded the 2015 Nobel Prize in Physiology and Medicine.
It has been prescribed to hundreds of millions of people worldwide. Given its decades’ long record of in vitro efficacy, it should have been self-evident for Fauci’s NIAID, the CDC and the WHO to rapidly conduct in vivo trials to usher ivermectin as a first line of defense for early stage Covid-19 infections and for use as a safe prophylaxis.
For example, if funding were devoted for the rapid development of a micro-based pulmonary delivery system, mortality rates would have been miniscule and the pandemic would have been lessened greatly.[18] Repurposing ivermectin could have been achieved very quickly at a minor expense.[19] However, despite all the medical evidence confirming ivermectin’s strong antiviral properties and its impeccable safety record when administered properly, we instead witnessed a sophisticated government-orchestrated campaign to declare war against ivermectin and another antiviral drug, hydroxychloroquine (HCQ), in favor of far more expensive and EUA approved experimental drugs. Unlike the US, other nations were eager to find older drugs to repurpose against Covid-19 and protect their populations. A Johns Hopkins University analysis offered the theory that a reason why many African countries had very few to near zero Covid-19 fatalities was because of widespread deployment of ivermectin. In February 2020, the National Health Commission of China, for example, was the first to include hydroxychloroquine in its guidelines for treating mild, moderate and severe SARS-2 cases. Eight Latin American nations distribute home Covid-19 treatment kits that include ivermectin.[20] Why did the US and most European countries swayed by the US and the WHO fail to follow suit?
Early in the pandemic, physicians in other nations where treatment was less restricted, such as Spain and Italy, shared data with American physicians about effective treatments against the SARS-2 virus. In addition, there was a large corpus of medical research indicating that older antiviral drugs could be repurposed. Doctors who started to prescribe drugs such as ivermectin and HCQ, along with Vitamin D and zinc supplementation, observed remarkable results. Unlike the dismal recovery and high mortality rates reported in hospitals and large clinics that relied upon strict isolation, quarantine, and ventilator interventions, this small fringe group of physicians reported very few deaths among their large patient loads. Even reported deaths were more often than not compounded by patients’ comorbidities, poor medical facilities and other anomalies.
Very early into the pandemic, medical papers indicated ivermectin was a highly effective drug to treat SARS-2 infections.
In April 2020, less than a month after the WHO declared Covid-19 as a global pandemic, Australian researchers at the Peter Doherty Institute of Infection and Immunity published a paper demonstrating that a single ivermectin dose can control SARS-CoV-2 viral replication within 24-48 hours.[21] Monash University’s Biomedicine Discovery Institute in Australia had also published an early study that ivermectin destroyed SARS-2 infected cell cultures by 99.8 percent within 48 hours. But no American federal health official paid any attention.
As of March 2024, a database for all studies and trials investigating ivermectin against Covid-19 infections records a total of 248 studies, 195 peer-reviewed, and 102 involving controlled groups reporting an average 61 percent improvement for early infections, a 39 percent success rate in treating late infections, and an 85 percent average success rate for use as a preventative prophylaxis.[22] Moreover, prescribing ivermectin reduced mortality by 49 percent, compared to remdesivir’s 4 percent, Pfizer’s Paxlovid’s 31 percent, and molnupiravir’s 22 percent. Even hydroxychloroquine well outperforms these drugs mortality risk for early treatment at 66 percent.
A noteworthy study conducted in Brazil and published in the Cureus Journal of Medical Science prescribed ivermectin in a citywide prophylaxis program in a town of 223,000 residents. 133,000 took ivermectin. The results for a population of this size are indisputable in concluding that ivermectin is a safe first line of defense to confront the pandemic. Covid mortality was reduced 90 percent. There was also a 67 percent lower risk of hospitalization and a 44 percent decrease in Covid cases. Garcia-Aquilar et al reports a Mexican in vitro analysis showing a definitive interaction between ivermectin and the SAR-CoV-2 spike protein, which would account for its high efficacy in Covid-19 cases.[23]
The All India Institute for Medical Science (AIIMS) and the Indian Council of Medical Research (ICMR), two of India’s most prestigious institutions, acted against the WHO and launched an ivermectin treatment campaign in several states. In Uttar Pradesh there was a 95 percent decrease in morality (a decline from 37,944 to 2,014). The Indian capital of New Delhi witnessed a 97 percent reduction. During the same time period, the state of Tamil Nadu, which followed the WHO’s ban on ivermectin, had a 173 percent increase in deaths (from 10,986 to 30,016 deaths).
There have been many concerted efforts to discredit ivermectin and other repurposed drugs’ effectiveness. Most notable is the large TOGETHER Trial Brazil study published in the New England Journal of Medicine (NEJM) that concluded both ivermectin and another repurposed drug fluvoxamine showed no beneficial signs for treating Covid-19 patients. The study was widely reported in the mainstream media. However, a Cato Institute analysis discovered the study in fact showed its benefits and the results were in agreement with 87 percent of other clinical trials investigating ivermectin. The Cato analysis identifies many odd anomalies in how the trial was conducted including an unspecified placebo—although it is suspected it was Vitamin C, which has itself been shown to be mildly effective against the SARS-CoV-2 virus, and protocol changes as the study was underway including inclusion/exclusion criteria. By his own admission the TOGETHER Trial’s principal investigator Dr. Ed Mills at McMaster University in Ontario “designs clinical trials, predominantly for the Bill and Melinda Gates Foundation.”[24] In a McMaster University press release, the Gates foundation is listed as a funder for the study to debunk ivermectin and fluvoxamine.[25] Oddly, Gates is nowhere listed among the several funders in the NEJM study’s disclosure. In addition, TOGETHER Trials is owned by the Canadian for profit startup Purpose Life Sciences, founded by Mills; legal documents showed Mills’ PLS is largely funded and controlled by Sam Bankman Fried’s FTX who invested $53 million into the project. Administrators of FTX’s bankruptcy are suing PLS for fraud.[26]
In short, the ivermectin/fluvoxamine TOGETHER Trial was a complete medical sham and intentionally designed for one single purpose: to fuel media disinformation in order to undermine ivermectin’s superior efficacy and safety profile to Big Pharma’s more profitable designer drugs.
In 2004, the US Congress passed an amendment to the Federal Food, Drug and Cosmetic Act known as Emergency Use Authorization (EUA). This piece of legislature legalized an anti-regulatory pathway to allow experimental medical interventions to be expedited and bypass standard FDA safety evaluations in the event of bioterrorist threats and national health emergencies such as pandemics. At the time, passage of the EUA amendment made sense because it was partially in response to the 2001 anthrax attacks and the US’s entry into an age of international terrorism. However, the amendment raises some serious considerations. Before the Covid-19 pandemic, EUAs had only been authorized on four occasions: the 2005 avian H5N1 and 2009 H1N1 swine flu threats, the 2014 Ebola and the 2016 Zikra viruses. Each of these pathogen scares proved to be false alarms that posed no threat of pandemic proportions to Americans. The fifth time EUAs were invoked was in 2020 during the Covid-19 pandemic, which at the time seemed far more plausible.
Before the government can authorize an EUA to deploy an experimental diagnostic product, drug or vaccine, certain requirements must be fulfilled. First, the Secretary of the Department of Health and Human Services (HHS) must have sufficient proof that the nation is being confronted with a serious life-threatening health emergency. Second, the drug(s) and/or vaccine(s) under consideration must have sufficient scientific evidence to suggest they will likely be effective against the medical threat. The evidence must at least include preclinical and observational data showing the product targets the organism, disease or condition. Third, although the drug or vaccine does not undergo a rigorous evaluation, it must at least show that its potential and known benefits outweigh its potential and known risks. In addition, the product must be manufactured in complete accordance with standard quality control and safety assurances.
When we look back at the government’s many debacles during the Covid-19 pandemic, other EUA requirements warrant the spotlight. On the one hand, an EUA cannot be authorized for any product or intervention if there is an FDA alternative approved product already available, unless the experimental product is clearly proven to have a significant advantage. Moreover, and perhaps more important, EUAs demand informed consent. Every individual who receives the drug or vaccine must be thoroughly informed about its experimental status and its potential risks and benefits. Recipients must also be properly informed about the alternatives to the experimental product and nobody should be forced to take it.
Finally, an EUA requires robust safety monitoring and reporting of adverse events, injuries and deaths potentially due to the drug or vaccine. This is the responsibility not only of the private pharmaceutical manufacturers but also the FDA, physicians, hospitals, clinics and other healthcare professionals.
Obviously important cautions must be considered after approving a medical intervention under the EUA requirements. Foremost are the inherent health risks of any rapid response of experimental medical interventions, especially novel drugs and vaccines. As we observed during the FDA approval process and roll out of Pfizer’s and Moderna’s mRNA Covid-19 jabs, no long-term human trials were conducted to even estimate a reliable baseline of their relative efficacy and safety. The American public has blindly placed its trust in our federal health authorities decision-making. It is expected that under a national health emergency, the authorities would be completely transparent and act only by the highest ethical standards. However our institutions betrayed public trust and either ignored or transgressed cautions underlying EUA approved medical interventions in every conceivable way. Moreover, conflicts of interests have been discovered to have plagued the entire EUA review process.
Although the EUA amendment provides some protections to authorized drug and vaccine manufacturers, it was the Public Readiness and Emergency Preparedness Act (PREP) in 2005 that expanded liability protections. In addition to protecting private corporations, PREP also shields company executives and employees from claims of personal injury or death resulting from the administration of authorized countermeasures. The only exceptions for liability are if the company or its executive offices are proven to have engaged in intentional and/or criminal misconduct with conscious disregard for the rights and safety of those taking their drugs and vaccines.
During the pandemic, the FDA issued widespread EUAs with liability immunity for the PCR diagnostic kits for SARS-2, the mRNA vaccines and the anti-Covid-19 drugs. Curiously, the Secretary of the Department of Health and Human Services invoked the PREP Act on February 4, 2020 giving liability protections; this was over a month before the pandemic was officially announced, which raises serious questions about prior-planning before the viral outbreak in Wuhan, China.
From the pandemic’s outset, Fauci embarked on the media circuit to promise Americans that federal health agencies were doing everything within their means to get a vaccine on the market because there was no available drug to clear the SARS-2 virus. As we have seen with respect to ivermectin alone, this was patently false. Rather the government placed an overriding emphasis on vaccination with a near total disregard for implementing very simple preventative measures to inhibit viral progression. Once mass vaccinations were underway, we were promised that the SARS-2 virus would be defeated and life would return to normal. In retrospect, we can look back and state with a degree of certainty that American health authorities and these products’ corporate manufacturers may have violated almost every EUA requirement. Everything that went wrong with the PCR kits, the experimental mRNA vaccines and novel drugs could have been avoided if the government had diligently repurposed effective and safe measures as pandemic countermeasures. Very likely, hundreds of thousands of lives, perhaps millions, would have been saved.
Similarly the FDA issued a warning statement against the use of ivermectin. Even ivermectin’s manufacturer Merck discredited its own product. Shortly after ridiculing its drug, the Alliance for Natural Health reported, “Merck announced positive results from a clinical trial on a new drug called molnupiravir in eliminating the virus in infected patients.”[27]
And still the FDA considers these novel patented drugs to be superior to ivermectin. Favoring a vaccine regime and government-controlled surveillance measures to track every American’s movements, American health officials blatantly neglected their own pandemic policies’ severe health consequences. Ineffective lockdowns, masks, social isolation, unsound critical care interventions such as relying upon ventilators, and the sole EUA approvals of the costly and insufficiently effective drugs brought about nightmares for tens of millions of adults and children. This was all undertaken under Fauci’s watch and the heads of the US health agencies in direct violation of the EUA requirements to only authorize drugs and medical interventions when no other safe and effective alternative is available. Alternatives were available.
The 4-year history of the pandemic highlights a sharp distinction between dependable medical research and pseudoscientific fraud. The CDC adopted a common Soviet era practice to redefine the very definition of a vaccine and the parameters of vaccine efficacy in order to fit economic and ideological agendas. This explains Washington’s aggressive public relations endeavors to silence medical opponents. According to cardiologist Dr. Michael Goodkin’s private investigations, several of the most cited studies discrediting ivermectin’s antiviral benefits were intentionally manipulated in order to produce “fake” results.[28] These studies were then widely distributed to the AMA, American College of Physicians and across mainstream media to author “hit pieces” to demonize ivermectin and other repurposed drugs. The government’s belligerent and reactive diatribes, brazenly or casually advocating for censorship, were direct violations of scientific and medical integrity and contributed nothing towards developing constructive policies for handling a pandemic with a minimal cost to life. The consequence has been a less informed and grossly naïve public, which was gaslighted into believing lies.
The FDA’s EUAs for the Covid-19 vaccines and novel experimental drugs were in fact an attack on the amendments and PREP directives. Neither the vaccines nor drugs warranted emergency authorization because effective and safe alternatives were readily available. No doubt a Congressional investigation would uncover criminal misconduct and conscious fraud. Moreover, these violations of the PREP Act may have the potential to lead directly into medical crimes against humanity as outlined in the Nuremberg Code.
Although the Nuremberg Code has not been officially adopted in its entirety as law by any nation or major medical association, other international treaties, such as the Universal Declaration of Human Rights, the World Medical Association Declaration of Helsinki (which is not legally binding), the International Covenant on Civil and Political Rights (ICCPR) and the International Ethical Guidelines for Biomedical Research on Human Subjects incorporate some of Nuremberg’s main principles that aim to protect people from unethical and forced medical research. Although the US signed the ICCPR as an intentional party, the US Senate never ratified it. The ICCPR’s Article 7 clearly states, “No one shall be subject to torture or cruel, inhuman or degrading treatment or punishment,” which can legally be interpreted to include forced medical experimentation implied as cruel, inhuman treatment. Other ICCPR articles, 6 and 17, are also applicable to medical experimentation to ensure ethical conduct, obtaining proper informed consent and the right to life and privacy. For a moment, consider the numerous senior citizens in nursing homes and hospitals who were simply administered experimental Covid-19 vaccines without full knowledge about what they were receiving. And now how many children are being coerced by the pseudoscience of health officials’ lies to be vaccinated without any knowledge of these mRNA products’ risk-benefit ratio?
The US is also a signatory to the Helsinki Declaration, which, although not directly aligned with Nuremberg, shares much in common. The Declaration shares some common features with the EUA amendment and PREP Act. These include voluntary informed consent—which is universally accepted, adequate risk and benefit information about medical interventions, and an emphasis on the principle of medical beneficence (promoting well-being and the Hippocratic rule of doing no harm). It also guarantees protections for vulnerable groups, especially pregnant women and children, which the US government and vaccine makers directly violated by conducting trials on these groups with full knowledge about these vaccines’ adverse events in adults. In addition, weighing the scientific evidence to assess the risk-benefit ratios between prescribing ivermectin and HCQ over the new generation of novel experimental drugs conclusively favors the former. This alone directly violates the ethical medical principles noted above.
However, the failure to repurpose life-saving drugs is less criminal than the questionable unethical motivations to usher a new generation of genetically engineered vaccines that have never before been adequately researched in human trials for long term safety. This mass experimentation, which continues to threaten the health and well-being of millions of people, is global and can legally be interpreted as a genocidal attack on humanity.
If the emerging data for increasing injuries and deaths due to the Covid-19 vaccines is reliable—and we believe it is—the handling of the pandemic can be regarded as the largest medical crime in human history. In time, and with shifting political allegiances and public demands to hold our leaders in government and private industry accountable, the architects of this medical war against civilization will be brought to justice.
*
Richard Gale is the Executive Producer of the Progressive Radio Network and a former Senior Research Analyst in the biotechnology and genomic industries.
Dr. Gary Null is host of the nation’s longest running public radio program on alternative and nutritional health and a multi-award-winning documentary film director, including his recent Last Call to Tomorrow.
Notes
[1] https://www.cnn.com/videos/health/2021/08/29/dr-anthony-fauci-ivermectin-covid-19-sotu-vpx.cnn
[4] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
[6] https://www.dldjournalonline.com/article/S1590-8658(21)00923-3/fulltext
[8] https://www.thelancet.com/action/showPdf?pii=S2666-6065%25252823%25252900012-3
[9] https://clinicalinfo.hiv.gov/en/drugs/ritonavir/patient
[10] https://www.yalemedicine.org/news/13-things-to-know-paxlovid-covid-19
[13] https://www.medrxiv.org/content/10.1101/2023.01.20.23284849v1.full.pdf
[14] https://evidence.nejm.org/doi/pdf/10.1056/EVIDoa2100044
[15] https://c19early.org/waters.html
[17] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7290143/
[18] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539925/
[19] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564151/
[21] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7129059/
[22] https://c19ivermectin.com
[23] https://www.mdpi.com/1422-0067/24/22/16392
[25] https://www.eurekalert.org/news-releases/855535
[26] https://c19ivm.org/tallaksen.html
[27] https://anh-usa.org/fda-ensures-pharma-profits-on-covid/
[28] https://www.trialsitenews.com/a/are-major-ivermectin-studies-designed-for-failure
US health agency hushed Covid vax myocarditis warning – media
RT | January 17, 2024
The US Centers for Disease Control never sent an urgent health alert it had drafted in May 2021 regarding a potentially fatal side-effect linked to the Covid-19 vaccinations it was promoting, and continued to push the shots without warning the public, according to a document obtained by Epoch Times on Wednesday.
In an inter-agency email titled “draft alert on myocarditis and mRNA vaccines” obtained by the Times, CDC official Dr. Demetre Daskalakis informed two high-ranking colleagues that he had attached “the most recent draft of an alert as discussed.”
The agency disseminates what it describes as “vital health information” to doctors and public health officials at federal, state and local levels through a system called the Health Alert Network. The warning was reportedly prepared for release via this network; Daskalakis’ email was dated May 21, 2021, but never saw publication.
While the exact text of the warning has not been made public, the CDC had been tracking cases of myocarditis – a potentially deadly heart condition – in individuals vaccinated with Pfizer and Moderna’s mRNA-based Covid-19 vaccines for months, witnessing what it internally acknowledged was an alarming spike in cases, even as it continued to urge all Americans to get vaccinated against the novel coronavirus.
Two days before the email was sent, the CDC told state officials it was “closely monitoring” post-vaccination cases of myocarditis and pericarditis, a similar condition, and acknowledged that such cases “can be serious.” However, the public was not notified until weeks later – and the CDC continued to promote the jabs to all Americans, even after the risk was made public.
Instead of the never-released draft alert, the CDC later chose to inform healthcare providers about the danger in a document headed “clinical considerations” that lacked the forceful language or widespread distribution a Health Alert Network bulletin would have received. While it acknowledged the increased risk of myocarditis, it placed equivalent emphasis on the need to vaccinate everyone over age 11.
Last year, it emerged that both the CDC and the Food and Drug Administration had been made aware of a myocarditis “safety signal” triggered by an unusually large number of adverse event reports as far back as February 2021 – just two months after the mRNA-based vaccines received regulatory approval [emergency use authorizion].
Despite international news reports that vaccination with Pfizer and Moderna’s shots was associated with an elevated risk of myocarditis, the US regulatory agencies did not inform the public about the risk until after the jabs had been approved for patients between 12 and 15 years old – one of the age groups most susceptible to their deadly side effects.
Low RSV Vaccine Acceptance Among Pregnant Women
By Peter A. McCullough, MD, MPH | Courageous Discourse | January 10, 2024
Vaccination during the third trimester of pregnancy is unprecedented and risky, since a vaccine induced fever could precipitate stillbirth or premature delivery of the baby. The CDC and the Bio-Pharmaceutical Complex has told young mothers they should take the risk for theoretical protection of the newborn.
As of August 30, 2023, the CDC recommends: “Vaccination for pregnant people, 1 dose of maternal RSV vaccine during weeks 32 through 36 of pregnancy, administered immediately before or during RSV season. Abrysvo is the only RSV vaccine recommended during pregnancy.” Now the CDC is reporting that only Asian women in the US have topped 10% on the respiratory syncytial virus RSV vaccination rate while African American mothers remain the most conservative with under 5% rates of acceptance. For any mass vaccination campaign, these data would indicate a program failure. The mothers and families have been burned by genetic COVID-19 vaccines and unprecedented rates of injury, disability, and death. There is little appetite for a new vaccine during pregnancy among obstetricians, midwives, and expecting mothers.
These data on the lagging maternal RSV immunization campaign indicate that “vaccine mania” may be cooling in the United States. As a consulting internist and cardiologist, I do not recommend the new RSV vaccine for pregnant women. There are insufficient data on short and longer term safety. Theoretical protection of infants for an easily treatable illness is simply not compelling enough to risk the pregnancy altogether.
CDC study concludes most young children hospitalized for COVID were unvaccinated — after enrolling 7 times as many unvaxed kids in study
By Angelo DePalma, Ph.D. and Karl Jablonowski, Ph.D. | The Defender | January 9, 2024
A U.S. government-sponsored study published late last month in The Pediatric Infectious Disease Journal reported that most young children hospitalized for acute COVID-19 had not received an mRNA COVID-19 vaccination and were sicker to begin with than vaccinated children.
The authors’ conclusions are true on the surface, but their analysis ignored that more than 7 times as many unvaccinated as vaccinated children were enrolled in their study.
Only 4.5% of trial subjects completed primary COVID series
Investigators led by Laura Zambrano, Ph.D., a Centers for Disease Control and Prevention epidemiologist, recruited 597 children ages 8 months through under age 5 hospitalized for COVID-19 at 28 U.S. pediatric hospitals between Sept. 20, 2022, and May 31, 2023.
Unvaccinated subjects outnumbered subjects who had received at least one COVID-19 shot by 528 to 69, a more than 7-fold difference.
Children were grouped by demographic factors such as race, sex and geographic location, vaccination status (no vaccine, incomplete vaccine series or fully vaccinated) and underlying non-COVID-19 illnesses, or comorbidities.
Only 4.5% of the subjects had completed their primary COVID-19 vaccination series and 7% had received at least one dose.
Cases varied widely in severity, with 174 (29.1% of all subjects) admitted to intensive care and 75 progressing to life-threatening illness.
Fifty-one (8.5% of all subjects) required life support via invasive mechanical ventilation, and three required extracorporeal membrane oxygenation, a life-support treatment involving a heart-lung machine.
Based on results from both vaccinated and unvaccinated groups, infants 8 months to under age 2 were more vulnerable to serious outcomes than children ages 2 to 4 years.
For example, the youngest subjects had more life-threatening illnesses and the greatest need for high-level respiratory support involving vasoactive infusions — intravenous treatments to maintain normal blood pressure and heart rate. Yet they also had shorter hospital stays.
Investigators concluded that most children hospitalized for COVID-19, including most children with underlying medical conditions, were unvaccinated. On that basis, they called for “strategies to reduce barriers to vaccine access among young children.”
Researchers tested kids for COVID but not other respiratory infections
Zambrano et al. also compared the Pfizer mRNA shot to the Moderna product. They found that children who took the Moderna product were somewhat more likely to experience a serious outcome, however, the numbers from both groups were small and the authors did not subject them to statistical analysis.
Based on their analysis they also calculated and reported, in their “results” section, that mRNA COVID-19 vaccines were 40% effective in reducing serious outcomes. However, in their discussion (several sections later), they admitted that “vaccine coverage in this population was too low to evaluate vaccine effectiveness.”
There were two notable limitations to the Zambrano study. Even though the researchers recruited children who were only partially vaccinated the study’s design excluded children who had received any vaccination fewer than 14 days before hospital admission. Therefore no short-term post-vaccination adverse events were included.
Another limitation was that children were tested for COVID-19 but not for all possible respiratory infections, meaning “it is possible that RSV [respiratory syncytial virus], human metapneumovirus or other respiratory viral co-detections influenced disease severity.”
Media parroted authors’ conclusions
U.S. media (for example here and here) picked up on the Zambrano paper and repeated its conclusion that most hospitalized COVID-19 pediatric patients were unvaccinated — ignoring that the study included more than 7 times as many unvaccinated as vaccinated subjects.
A deeper dive into the data reveals the extent of this error and the discrepancies between what Zambrano et al. reported and what they saw.
Tables 1 and 2 illustrate what the authors got wrong.
These calculations say nothing about the relative outcomes for vaccinated and unvaccinated children because Zambrano et al. either did not perform the relevant calculation — number of cases in each group divided by the number of subjects — or chose not to report the results it generated.
Instead of presenting the number of subjects experiencing the indicated outcome as a percentage of vaccinated or unvaccinated groups, they reported them as a percentage of all subjects experiencing that outcome. Since there were 7 times as many unvaccinated as vaccinated subjects, this approach all but guaranteed the numbers among the unvaxed would be higher.
Here’s an analogy: In a hypothetical study comparing 10 coffee drinkers to 100 abstainers, five drinkers and 10 abstainers reported feeling nervous. Using Zambrano’s logic, 67% of people feeling nervous were abstainers, and just 33% drank coffee. This “proves,” according to Zambrano’s logic, that not drinking coffee doubles (67% vs. 33%) the risk of getting the jitters.
The correct way to view this data is that 10 in 100 abstainers, or 10%, felt jittery but 5 in 10 (50%) of coffee drinkers felt jittery, and that drinking coffee raises the risk of nervousness fivefold (50% vs. 10%).
Table 2 uses the same raw data as Table 1. But instead of reporting vaccinated and unvaccinated data as a percentage of all data, it first calculates the occurrence of these conditions or outcomes in each group and compares the inter-group differences.
Hospital stays were also on average one day shorter for the unvaccinated. The only area where unvaccinated children faired slightly worse was in underlying cardiac issues, but the authors did not address this small difference in their discussion.
Previous study used same tactic
A study preceding the Zambrano paper by three weeks used the same tactic to arrive at the same conclusion.
Tannis et al. compared many of the same outcomes as Zambrano in 6,337 unvaccinated and 281 vaccinated children ages 6 months to under 5 years.
All subjects had visited emergency departments for acute respiratory illness from July 2022 to September 2023.
By coincidence, Tannis also calculated vaccine effectiveness to be 40%.
Table 3 presents data from Tannis et al. with percentages reported by Tannis (Tannis %) and the actual values (Actual %).
Vaccinated children were also 68.3% more likely to harbor HCoV, an endemic coronavirus, than the unvaccinated. Similar to SARS-CoV-2 (the COVID-19 virus), HCoV can cause serious illness in immunocompromised individuals and the elderly.
Angelo DePalma, Ph.D., is a science reporter/editor for The Defender.
Karl Jablonowski, Ph.D., holds a master’s degree in computer science and a doctorate in biomedical and health informatics. He practices data science by asking questions of databases that can reveal population-based adverse outcomes of medical interventions.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Dr. Mary Kelly Sutton Loses Medical License in New York for Writing Eight Vaccine Exemptions in California
By John-Michael Dumais | The Defender | January 8, 2024
Dr. Mary Kelly Sutton (who goes by “Kelly”) on Oct. 30 lost her license to practice medicine in New York for writing eight vaccine exemptions in California between 2016 and 2018. New York was the third state to enforce this penalty, after Massachusetts and California. Sutton is now no longer able to practice medicine anywhere in the U.S.
Both the New York and Massachusetts medical boards adjudicated Sutton’s case on the basis of “reciprocal discipline,” rubber-stamping the Medical Board of California’s 2021 decision without allowing her to challenge the validity of the original findings.
Reciprocal discipline avoids the time and costs of relitigating. Therefore, like the Massachusetts Board of Medicine hearing last July, the October hearing in New York was just theater and the board never intended to allow Sutton to defend herself.
Instead, the New York board maintained that the purpose of the hearing was limited to determining what penalty should apply to Sutton’s state license in light of the findings already established in California.
Medical Board of California misinterpreted the law
Sutton, an integrative medicine physician practicing since the early 1970s, told The Defender that the Medical Board of California misinterpreted the law when it determined she violated “standards of care” when writing the vaccine exemptions.
Those exemption-specific standards — which came into effect in 2016 via Senate Bill (SB) 277, a California bill that stripped parents of the personal belief exemption for rejecting vaccines for their children — only stated it was up to the physician to decide on a medical exemption based on the needs of the child.
However, in 2019, California passed two more bills — SB 276 and SB 714 — designed to make vaccine exemptions even more difficult to acquire.
Specifically, when a doctor writes more than five medical exemptions per year (as of Jan. 1, 2020) or a school’s immunization rate falls below 95%, the California Department of Public Health (CPDH) has the right to review the medical exemptions.
Physicians since January 2021 are also required to use a standardized electronic exemption form submitted to a statewide database, and CPDH may revoke exemptions that do not conform to vaccination guidelines established by the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP) and by the American Academy of Pediatrics.
Sutton claimed the Medical Board of California applied its own definition of “standards of care,” in direct contravention to the standard established by SB 277.
“In California, any time a standard of care is written into statutory law, it is more preeminent than a community standard of care that is just held among the general opinion of doctors in practice,” she said.
Sutton believes the Medical Board of California was also applying laws derived from SB 276 and SB 714 that went into effect well after the date she wrote the exemptions.
The CDC’s and ACIP’s vaccine recommendations do not constitute mandates or requirements. According to Sutton, during the lobbying phase of SB 277, a doctor called ACIP and asked whether its recommendations should be considered mandates, and was told that they were only guidelines.
The ACIP guidelines do not mention the word “exemption,” according to Sutton, nor were the guidelines mentioned in SB 277.
“That’s the way guidelines have always been used in standards of care,” Sutton said, calling them “indicators, supports, references — but not mandates.”
Sutton said the mood of medicine is shifting away from a doctor exercising his or her own training and experienced judgment towards doing what the standards and guidelines say.
“This is decidedly against the quality of medicine because there’s no freedom to individualize for the patient,” she said.
Dissecting the California case
The California board revoked Sutton’s license for “gross negligence” and “repeated negligent acts” in issuing permanent vaccine exemptions for eight pediatric patients, saying the exemptions did not comply with standards of care and vaccine guidelines at the time.
The board’s sole expert witness, Dr. Deborah Lehman, infectious disease physician at the University of California, Los Angeles, dismissed Sutton’s claim that SB 277 clearly articulated standards of care regarding exemptions, saying those were not the “community standard of care,” Sutton recounted.
Sutton explained:
“SB 277 was brief and direct to the point. It said that if a child who is required to have vaccines receives a note from a physician stating that it is in the child’s best interests to not be vaccinated, then that suffices to fulfill the requirement and the child can go to school without having the required vaccines. The deciding factor is the physician’s discretion.”
The relevant clause from the bill states:
“If the parent or guardian files with the governing authority a written statement by a licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature and probable duration of the medical condition or circumstances, including, but not limited to, family medical history, for which the physician does not recommend immunization, that child shall be exempt from the requirements.”
Lehman said doctors must only grant an exemption when there is a contraindication to a vaccine and at no other time.
Lehman claimed the standard of care was determined by whether another physician would treat the medical issue the same or similarly. However, according to Sutton, she omitted the all-important phrase “in the same community.”
In the integrative medicine community in which Sutton practices, it is common for patients to receive more individualized treatments rather than one-size-fits-all approaches.
“It was kind of a force-of-personality situation that was successful in the setting of the courtroom hearing at the administrative level,” Sutton said. “And the board witness prevailed upon the judge to believe that the law had no meaning and that community opinion was higher.”
The California board also questioned Sutton’s decision not to request patients’ medical files or perform physicals in the cases for which she wrote exemptions.
“If I required a physical exam for every vaccine exemption, I could be accused of ‘padding the bill’ because the physical exam contributes nothing to the decision about the risk for a vaccine injury,” Sutton said.
Instead, Sutton’s process was primarily to review patient histories to understand if the child or a family member had suffered a negative reaction to vaccines.
She said:
“From my understanding and from the group of physicians that I worked with at the time — Physicians for Informed Consent — the risk factors for vaccine injury lie completely in the story of what’s happened to the child when they have had vaccines and what has happened to their blood relatives when those people had vaccines.”
After the passage of SB 277, Sutton said there was “a great deal of conversation” among doctors about how the law could be read and interpreted and how exemptions could be constructed rationally based on the scientific literature.
That literature showed several different areas of concern around vaccinations, including “The aluminum contained in vaccines can trigger neurologic issues and autoimmune disease,” Sutton said, adding, “There is the question of regression after vaccines and neurodevelopmental delays such as autism.”
“There’s also a higher risk of allergies, and then there’s the immediate reactions where a person collapses or has a seizure after a vaccine,” she said.
“A doctor has to make an extra effort in order to understand the historical pattern of vaccine reactions that would indicate risk of vaccine injury, or how to diagnose mitochondrial dysfunction,” Sutton said.
During the California hearing, Sutton shared extensive scientific citations supporting her medical decision-making, including research by Dr. Chris Exley on the dangers of aluminum in vaccines.
She told the board that it was neither intelligent nor humane to force a family to continue to vaccinate after one of their children had already died or been injured by a vaccine, and shared her clinical observation that unvaccinated patients are healthier than those who are vaccinated.
The California board also claimed Sutton neglected to provide informed consent to her patients requesting vaccine exemptions.
Sutton was uncertain exactly what the board meant here but surmised it was saying she did not adequately highlight the diseases that could develop if the parents failed to vaccinate their children.
Deeming the real issue with informed consent to be advising patients about the potential harms of vaccination, Sutton said, “I don’t think I repeated the CDC bylines.” Instead, she believed the parents who came to her for exemptions were already “more than aware” of the risks of childhood diseases.
From her point of view, there was already enough vaccine promotion happening with mainstream media and schools “echoing over and over” how “vastly dangerous chickenpox” and the other childhood diseases were.
The California board’s concern about Sutton not requesting previous medical records is based on the notion of “Don’t trust a single word the patient says,” Sutton said, an attitude that necessitates getting “every documentation” about adverse vaccine reactions before making a decision.
“That’s not the way medicine works,” Sutton said. “But that’s what was expected in terms of a medical exemption interview. It’s like building a legal case instead of a medical case.”
Further wrongdoing was implied by the California board in pointing out that a number of the exemptions Sutton wrote were for patients for whom she was not the primary care provider.
“That is implying that the primary care doctor knows the patient best,” Sutton said. “And that is good in a lot of ways, but it can be a problem for the patient if it’s a large practice that has been forbidden to give vaccine exemptions.”
Sutton said that if a patient’s need cannot be addressed by that group, even if it’s their primary care group, then it is akin to patient abandonment.
SB 277, the law in effect during the period Sutton wrote the exemptions, never had a requirement that exemptions be written by the primary care physician, or even by a pediatrician or pediatric infectious disease expert, according to Sutton.
“So their [Medical Board of California’s] statements were beyond the law and that’s what they were enforcing against doctors,” she said.
Although the board improperly focused on laws that went into effect in 2019 and later, Sutton said, “That very argument could not be persuasively made by the attorneys at the time.”
Board expert: ‘Science has been decided’ on vaccine risks
The Medical Board of California conducted a three-day “trial” for Sutton in June 2021 in an administrative court with a single judge and no right to a jury.
Three experts spoke on behalf of Sutton, while Lehman, the board’s single expert, testified against her.
Lehman lacked basic knowledge of vaccine risks and stated that all doctors should follow the CDC’s vaccine schedule.
When asked to quantify the risk of vaccine injuries, Lehman said, “I don’t need to cite articles in my report, because the science has been decided … If you want answers to these questions, I would refer you to the CDC.”
After denying any knowledge of Dr. Peter Aaby’s more than 400 articles on PubMed analyzing vaccine dangers, Lehman characterized the journal as “low impact” and Aaby as “anti-vax.”
Sutton’s witnesses were Dr. Andrew Zimmerman, pediatric neurologist, Dr. James Neuenschwander, family physician with vaccine expertise and Dr. LeTrinh Hoang, integrative medicine pediatrician.
They skillfully articulated the heterodox perspectives on vaccine dangers and referenced a number of recent studies on vaccine adverse effects, while noting the lack of data on vaccine safety or government studies comparing health outcomes for vaccinated versus unvaccinated individuals.
“And on this very little evidence, people like the board expert are proclaiming to the high heavens these are safe and effective,” Sutton said. “All of these other concerns are irrelevant.”
Administrative court structure promotes ‘raw power’
In Sutton’s interactions with California, Massachusetts and New York, she observed a notable lack of due process when compared with civil and criminal courts.
In the proceedings with the Massachusetts board, one of the documents filed against her did not list any specific complaints, making it difficult for Sutton to defend herself. “I had to intuit what they were complaining about and then make up the answers,” she said.
When she brought this shortcoming to the magistrate’s attention, he confirmed that such detail is not required in administrative courts.
“The structure of the administrative-level courts promotes the raw power that’s exercised by the medical boards,” Sutton said, adding, “It’s not an exercise within the law and it doesn’t benefit the people, but only the administrative state itself.”
Sutton mentioned the Federation of State Medical Boards, which coordinates all of the medical boards in the U.S., sent out warnings to doctors about misinformation, masks, vaccines and exemptions related to COVID-19, she said.
“It’s a private, unelected group that’s been around for over 100 years,” she said. “It’s not visibly related to any government entity.”
Together with its partner agency, the International Association of Medical Regulatory Authorities, it forms an integral part of the administrative state that is undermining the doctor-patient relationship and helping to delicense doctors like Sutton.
Sutton said, “They are both in the same building at the same address in Euless, Texas. So there is a centralized organ to control medical boards around the world, which means controlling doctors around the world.”
“The coordination of COVID happened through organizations like that,” she added.
Doctors incentivized to ignore vaccine injuries
Sutton said the financial incentives to vaccinate everyone within a medical practice discourage doctors from connecting adverse health outcomes to the vaccines.
“The Blue Cross Blue Shield Provider Incentive Program manual of 2016 listed a $400 bonus to the doctor for every two-year-old who was on the CDC vaccine schedule on time,” she said, “as long as 63% of the practice was vaccinated.”
“That’s going to influence how you respond to a parent when they say, ‘Johnny had a seizure after the MMR [measles-mumps-rubella] vaccine,’” Sutton said, adding, “Do you put that in the chart as an MMR vaccine reaction? Or do you say, ‘Oh, it must be something else’?”
If a child has a febrile seizure, the doctor may well chalk it up to normal childhood fever rather than to a recent vaccination, Sutton said. “So we bias our own literature, our own notes, by the things that have been allowed in terms of financial incentives.”
Sutton said financial incentives must be removed from medicine to restore its integrity.
“It’s too much impact on physician judgment and motivations are not angelic,” she said. “We’re humans. So if somebody says ‘If you just get 10 kids vaccinated you’ll get $4000,’ I’m going to be looking for those 10 kids to vaccinate and I’ll be rationalizing to myself why that’s okay.”
Part of the problem, according to Sutton, is the state of the vaccine research literature that keeps doctors in the dark about the reality of adverse events.
“Vaccines have been very poorly studied,” she said. “Some of them were approved, like hepatitis B, after only four days in one case and five days in another brand’s case study — and it was approved for use in every newborn baby.”
Other vaccines have been studied for as long as 42 days, but none long-term, which is necessary to see the development of autoimmune diseases like asthma that don’t show up immediately after vaccination, she said.
“So the board expert could say there’s no evidence that an adverse event is related to vaccines, which is not accurate because the evidence is there — but it’s not in the evidence that the CDC accepts,” Sutton said.
According to Sutton, the CDC “very carefully curates” the articles and studies it puts on its website to support its own policies. If a CDC-sponsored study shows adverse vaccine reactions, it won’t appear on its website, she said.
Sutton shared the story of a former cardiologist at the Mayo Clinic who was training to do heart transplants when her 12-month-old daughter received an MMR vaccine and immediately regressed with severe autism. The woman had to leave the cardiology program and return to her home in Europe to care for her child.
Sutton said this woman claimed the CDC was researching a lot of topics, including that the rubella virus in the MMR vaccine persists in the body for a long time and results in granulomas in the case of immune-deficient children and sometimes immune-competent adults.
“This is not on the CDC website,” Sutton said. “So if we look at the nature of the research supporting our vaccine program, we would be astonished and staggered and ashamed because we’re injecting our children with very little evidence that these vaccines are safe or effective.”
Financial incentives in research and drug approvals are also highly problematic, according to Sutton.
“Medicine is no longer medicine,” she said. “It’s become co-opted as another business. Sickness is more profitable than health and mandates are more profitable than choice.”
“Otherwise, despite the efforts of individual doctors, the profession will be working against humanity and really becomes organized brutality instead of healthcare,” Sutton said.
‘The whole storm is not finished’
Sutton has exhausted or curtailed her administrative appeals with the states that have removed her license to practice medicine.
However, she and several doctors are planning to file a collective action in federal court in the spring. They are being supported by the nonprofit Physicians & Patients Reclaiming Medicine, where Sutton’s story is currently featured.
Meanwhile, Sutton keeps in touch with many of her colleagues who have suffered the same fate.
“They are recouping from the reputational and financial losses after being attacked,” she said. “So people don’t quit, but there is a lot of sadness about medicine.”
Sutton talked about the “diaspora” away from the state of California because of the discrimination that’s happened to families who had a health concern about a vaccine for their child.
“There’s been a lot of pain. So the whole storm is not finished,” she said.
Lacking a medical license, Sutton has turned to offering health education for a small group of clients. They meet monthly over Zoom, and individuals can discuss their concerns privately with her. But she no longer diagnoses, treats or does physical exams.
Sutton is currently preparing a course about integrative medicine to present to a group of acupuncture students.
John-Michael Dumais is a news editor for The Defender. He has been a writer and community organizer on a variety of issues, including the death penalty, war, health freedom and all things related to the COVID-19 pandemic.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Sen. Ron Johnson Accuses Public Health Agencies of ‘Appalling Lack of Transparency’ on COVID Vaccines
By Brenda Baletti, Ph.D. | The Defender | October 27, 2023
Sen. Ron Johnson (R-Wis.) accused federal public health agencies of displaying an “appalling” lack of transparency with the American public during the pandemic, depriving them of “the benefit of informed consent.”
In a letter sent Oct. 25 to the heads of the U.S. Department of Health and Human Services, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, Johnson said that even now, “As new and alarming information continues to come to light, federal health agencies continue to stonewall and gaslight Congress and the public.”
The lawmaker pointed to an FDA-funded study published this month that identified a potential safety signal linking mRNA COVID-19 vaccines to seizures in children ages 2-5.
Johnson questioned whether the CDC was aware of these findings last month when it recommended everyone 6 months of age and older be vaccinated to protect against COVID-19 this fall and winter.
Johnson said the leaders of these agencies — Xavier Becerra, Dr. Robert Califf, Dr. Mandy Cohen, and Lawrence Tabak, D.D.S., Ph.D. — have failed in their duty to be transparent with Americans regarding what they knew about the safety and efficacy of the vaccines.
As a result, they “have not even come close to ensuring that doctors can provide informed consent on a new gene therapy masquerading as a ‘vaccine’ that was rushed to market without adequate safety or efficacy testing,” he said.
The Wisconsin senator has been a vocal critic of the federal COVID-19 response and an outspoken advocate for people injured by the vaccine. In 2022, he led a roundtable discussion with doctors and scientists to shed light on what was known so far about the vaccines.
Johnson has also accused the CDC of colluding with Twitter to censor his own social media posts about the vaccines.
In his letter, the lawmaker wrote that the agencies’ refusal to respond to the “vast majority” of his questions and information requests “only heightens [his] level of suspicion.”
He listed over a dozen letters he sent requesting information on the COVID-19 vaccines that the agencies “have failed to adequately address.”
These included requests for data about vaccine lots linked to high rates of adverse events, information suppression on social media and the Countermeasures Injury Compensation Program.
The CDC and FDA also failed to fulfill Johnson’s requests for their adverse events surveillance data and their analyses of the Vaccine Adverse Event Reporting System, or VAERS, database.
Children’s Health Defense also is suing the FDA to respond to its Freedom of Information Act requests to make that same data available.
Johnson listed 11 other outstanding requests he made regarding the other aspects of the pandemic.
But these make up only a partial list of over 60 public letters Johnson said he has sent to government agencies concerning various aspects of the pandemic.
“It is well past time for U.S public health agencies to be transparent,” he said.
Johnson requested the agencies respond by Nov. 8 to questions about what they knew about the risks COVID-19 vaccines posed to children, when they knew it and how they plan to address those issues.
Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Another Tacit Admission That COVID Mandates Were a Disastrous Mistake
By Ian Miller | Brownstone Institute | October 9, 2023
Pandemic restrictions were an unmitigated failure, and the evidence base against the politicians and “experts” who imposed them and demanded compliance continues to grow.
And it raises some substantial questions about holding those responsible accountable for their actions. Especially as mask mandates return in certain parts of the country, with hints of more on the way.
Recently a new government report from the United Kingdom was released to little fanfare, which not-so-surprisingly mirrors the fanfare resulting from the release of new data from the CDC itself, showing how vaccine efficacy has fallen to zero.
Finally, Rochelle Walensky did acknowledge publicly that the vaccines couldn’t stop transmission. However it was already far too late to matter.
But all along the agency has strongly stated that the mRNA shots were effective at preventing hospitalizations. Or at least that the latest booster was effective, tacitly acknowledging that the original 2=dose series has lost whatever impact it once had.
What The Evidence Says About NPI’s
The UK’s Health Security Agency (HSA) recently posted a lengthy examination on the effectiveness of non-pharmaceutical interventions at preventing or slowing the spread of COVID-19 in the country.
And at the risk of revealing a spoiler alert, it’s not good news for the COVID extremists determined to bring mask mandates back.
The goal of the examination was laid out succinctly; the UK’s HSA intended to use primary studies on NPIs within the community to see how successful or unsuccessful they were at reducing COVID infections.
The purpose of this rapid mapping review was to identify and categorise primary studies that reported on the effectiveness of non-pharmaceutical interventions (NPIs) implemented in community settings to reduce the transmission of coronavirus (COVID-19) in the UK.
Streamlined systematic methods were used, including literature searches (using sources such as Medline, Embase, and medRxiv) and use of systematic reviews as sources to identify relevant primary studies.
Unsurprisingly, they found that the evidence base on COVID interventions was exceptionally weak.
In fact, roughly 67 percent of the identified evidence was essentially useless. In fact two-thirds of the evidence identified was modeling.
Two-thirds of the evidence identified was based on modeling studies (100 out of 151 studies).
There was a lack of experimental studies (2 out of 151 studies) and individual-level observational studies (22 out of 151 studies). Apart from test and release strategies for which 2 randomised controlled trials (RCTs) were identified, the body of evidence available on effectiveness of NPIs in the UK provides weak evidence in terms of study design, as it is mainly based on modelling studies, ecological studies, mixed-methods studies and qualitative studies.
This is a key learning point for future pandemic preparedness: there is a need to strengthen evaluation of interventions and build this into the design and implementation of public health interventions and government policies from the start of any future pandemic or other public health emergency.
Modeling, as we know, is functionally useless, given that it’s hopelessly prone to bias, incorrect assumptions and the ideological needs of its creators.
The two paragraphs which followed are equally as important.
Low quality evidence is not something that should be relied upon for decision making purposes, yet that’s exactly what the UK, US and many other countries did. Fauci, the CDC, and others embraced modeling as fact at the beginning of the pandemic. They then repeatedly referenced shoddy, poor quality work because it confirmed their biases throughout its duration, with unsurprising results.
And this government report concurs; stating simply and devastatingly, “there is a lack of strong evidence on the effectiveness of NPIs to reduce COVID-19 transmission, and for many NPIs the scientific consensus shifted over the course of the pandemic.”
Of course the scientific consensus shifted over the course of the pandemic because, as we learned, it became politically expedient for it to shift.
As their paragraphs on the available evidence show, there was little solid, high-quality data showing that NPI’s were having a significant impact on the spread of the virus, a reality that had been predicted by decades of pandemic planning.
But the consensus shifted towards NPIs and away from something approaching Sweden’s strategy or the Great Barrington Declaration, simply because Fauci, the CDC, and other “experts” demanded it shift to suit their ideological aims.
The few high-quality studies on say, masking, that were conducted during the pandemic showed that there was no benefit from mask wearing at an individual or population level. And that is why the Cochrane review came to its now infamous conclusion.
Instead of acknowledging that they were relying on poor quality evidence, the “experts” operated with an unjustified certainty that their interventions were based on following “The Science™.” At every turn, when criticized or questioned, they would default back to an appeal to authority; that the consensus in the scientific community unequivocally believed that the evidence showed that lockdowns, mandates, travel restrictions, and other NPIs were based on the best available information.
After initially determining that the UK should follow Sweden’s example and incorporate a more hands-off approach that relied on protecting the elderly while allowing immunity to build up amongst the younger, healthy populations, Boris Johnson panicked, at the behest of Neil Ferguson, and terrified expert groups. Tossing out decades of planning out of fear, while claiming publicly to be following science.
Instead, a systemic, detailed review of the evidence base relied on by those same experts has now concluded that there never was any high-quality information suggesting that pandemic policies were justifiable. Only wishful thinking from an incompetent, arrogant, malicious “expert” community, and unthinking, unblinking compliance from terrified politicians using restrictions and mandates without care or concern for adverse effects.
While this new report wasn’t specifically designed to determine how effective NPIs were in reducing transmission, it’s clear and obvious conclusions give away that answer too.
If it were easy to prove that COVID policies and mandates had a positive impact on the spread of the virus, there would be dozens of high-quality studies showing a benefit. And those high-quality studies would be covered in this report, with a strong recommendation to reinstate such mandates in future pandemics.
Instead, there’s nothing.
Just exhortations to do better next time, to follow the actual high-quality evidence and not guesswork.
Based on how little accountability there’s been for the “experts” and politicians who lied about “The Science™,” there’s little doubt that when presented with the next opportunity they’ll be sure to handle it in exactly the same way.
Abandoning evidence in favor of politics.
Ian Miller is the author of “Unmasked: The Global Failure of COVID Mask Mandates.”
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From the Archives
A short history of British torture
ICC | December 2005
When the House of Commons was debating how much to increase the time limit for detention without trial the question of torture came up. Officially this was limited to the nice considerations of whether it was all right to send people to places where torture is used and whether Britain can use information collected by the use of torture in other countries. This discussion gave an impression of democratic Britain as the home of civilised behaviour where the very idea of torture is repugnant to our legislators – unlike, say, the US with its secret CIA jails… In reality, the British state has a long history of using and developing a whole range of torture techniques. … continue
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