Friday, October 27, 2023

Another Friday Hiatus

Both medical and social matters again

Thursday, October 26, 2023

Children who get Covid shot are infectious for same amount of time as non-vaccinated, study finds

Children vaccinated against Covid are infectious for the same amount of time as their non-vaccinated peers, a new study out of California has found.

Whether or not students had received their bivalent Covid booster made no difference to the length of time they shed pieces of the virus after testing positive.

Both groups of kids aged seven to 18 were infectious for three days on average, according to the results from April to September 2022.

The study adds more doubt about the importance of giving Covid booster shots to children. Until earlier this year, several states including California and Illinois mandated the vaccines in schools.

Experts from Stanford University and the University of California, Los Angeles, who carried out the study: ‘Return-to-school policies may not need to discriminate by vaccine or booster status.’

Crucially, though, lead author Dr Neeraj Sood said the team did not look at the vaccines' abilities to prevent infection in the first place.

The study also took place before Pfizer's original bivalent booster was approved. That vaccine offered better protection against the Omicron subvariants that were circulating at the time. The youngest children in the study likely did not receive a booster but rather the standard two-dose vaccine course.

Levels of immunity and protection have ebbed and flowed with different vaccines and virus variant combinations.

The report was published in the journal JAMA Pediatrics. The 76 children involved in the study were from the Los Angeles-area included in the study ranged in age children seven to 18 years old.

The goal was to measure the impact of the virus on the children's cells to better understand how it behaves and for how long it is contagious.

The researchers studied their level of viral shedding, the number of virus particles that a child emits through coughing, sneezing, or talking that are then spread throughout the environment.

WHO says healthy kids and teens don't need Covid vaccinations
The World Health Organization (WHO) revised its Covid vaccine recommendations and suggested that healthy children and adolescents may not need a shot.

Every child tested positive for the Covid-19 Omicron variant. Of the 76 children, including 41 seven to 12-year-olds, 52 were vaccinated.

Children who had been vaccinated were infectious for three days, the same duration as children who were not vaccinated.

Researchers did not say whether they were surprised by their results. But what they found was similar to a study in adults with the Omicron variant, which also could not find an association between the length of time that a person is contagious and their vaccination status.

The Centers for Disease Control and Prevention recommends that all children, including babies as young as six months, receive a bivalent booster shot containing components of both the original virus strain as well as the omicron variant.

Yet uptake has remained low. A July 2023 study published in the journal Annals of Medicine reported that just 39 percent of children aged five to 11 and 55 percent of teenagers have gotten a booster dose.

Bivalent boosters have been shown to be highly effective at preventing severe enough cases to land a child in the hospital or at an urgent care clinic, but it is not clear to what extent the shots can prevent infection in the first place.

Covid vaccines are highly effective at preventing severe illness in the elderly, but protection against initial infection tends to be much weaker.

And children do not typically get dangerously sick with Covid, which has led many parents to believe there is not enough benefit to justify the shot.

Pandemic fears prompted many state and local officials to shutter schools in 2020 in order to protect children.

However, children are typically not nearly as vulnerable to severe illness as older adults, especially seniors.

This fact has contributed to an overall lack of enthusiasm among parents for pediatric booster shots, as many parents simply do not believe they are worth getting.

There is a tiny risk of heart inflammation in younger people after being vaccinated with the mRNA vaccines, but the majority of cases are mild and subside on their own.

Still, the tiny risk of a severe Covid infection has left many parents wary.

Widespread school closures have been blamed for fomenting a mental health crisis among school-aged children, as well as causing a downward spiral in academic performance overall.

A Brookings Institution study last year found that average fall 2021 math test scores in grades three to eight were 0.20 to 0.27 standard deviations (SDs) lower relative to same-grade peers in fall 2019.

Standard deviations are used to show how much test scores vary from the overall average, and a decrease of 0.20 to 0.27 SDs suggests a major decline in math performance.

At the same time, reading test scores decreased by 0.09 to 0.18 SDs.

Proponents for keeping schools open, which includes about 60 percent of American parents, have cited plummeting academic achievement as a clear indication that in-person instruction is far superior to consigning children to learn via Zoom at home.


Like Pfizer, the Covid Train May Have Run Out of Track for Moderna

It appears the Covid party for big pharma may finally be coming to an end. Last week, TrialSite reported on the fact that Pfizer will be lucky to generate $13 billion for their Covid product line. With a stagnant to declining stock price, sophisticated investors are concerned. The analysts are still generally upbeat (after all, the company is diversified both in product portfolio and R&D pipeline). But an ominous sense, one based on behavior over the past couple of years, brings dark clouds over the company. Cash flow for the pharmaceutical giant for the twelve months ending June 30, 2023, at $51.168 billion represented a 36.44% decline year-over-year. Pfizer's annual cash flow from operating activities for 2022 was $29.267 billion, a 10.17% decline from 2021. In August of this year, TrialSite speculated Pfizer’s Covid train could be out of track. Now, it looks as if the train has pulled out of another station.

Moderna Loses Value

Moderna became famous during the Covid pandemic because of their mRNA vaccine. The company was named after their innovative shot. But now demand for the jab has waned, and the company appears rudderless. Last week, it was reported Moderna erased $6.8 billion in market value after rival shot maker Pfizer slashed its profit outlook the previous Friday, sounding the alarm on dwindling demand for its Covid shots and pills. Moderna’s stock closed at the lowest since November 2020, when the company was still trying to get its Covid serum authorized for use in the United States.

“Covid-19 vaccine revenue concerns should be at all time high right now,” said Hartaj Singh, an analyst at Oppenheimer. “A good third-quarter print should allay some of these fears. And good guidance early next year in 2024 potential revenues could get the stock’s mojo back.”

Moderna’s stock has dropped about 83% from its August 2021 high when the company’s market capitalization was almost $200 billion. This isn’t good for a company which was once compared with Tesla, but this year, Moderna is one of the worst performing S&P 500 companies.

“Too Early to Predict”

According to Moderna’s management, the company still expects between $6 billion to $8 billion from the Covid shots, while cautioning it is still too early to predict US vaccination rates. Wall Street analysts predict Moderna’s Covid sales will be lower based on an updated guidance range from Pfizer. However, Pfizer has recovered a bit recently, gaining 3.6% as the drug maker’s post-pandemic growth strategy was weighed and investors’ expectations were reset, according to some on Wall Street. Similar to Moderna, Pfizer’s stock has dropped, losing about half its value from its pandemic record high. As with Pfizer, the Covid train tracks appear to have run out for Moderna. They better be ready for the next engine.


Increasing Recognition Of Vaccine Injuries

The push to increase vaccination rates comes amid an increasing recognition of vaccine injuries in Australia and overseas.

In Australia, the government operates a vaccine injury compensation scheme that has paid out over $7.3 million (US$4.87 million) to 137 claimants. It has received 3,501 applications and is progressing with 2,263, according to figures obtained by in March this year.
The Department of Social Services has previously estimated the government could be liable for a payout of $77 million (US$49.35 million).

In the UK, the increasing number of vaccine adverse effects had resulted in a lawsuit against vaccine manufacturer AstraZeneca, with families and patients arguing that their loved ones died or suffered severe reactions after taking its vaccine, according to their lawyers.

Meanwhile, multiple doctors and COVID-19 patients have also reported that their discussion of vaccine adverse effects has been labelled as misinformation.

The former president of the peak medical body, the Australian Medical Association, came out in December last year to say that discussion around vaccine injuries is being “censored” despite data confirming COVID-19 vaccines can cause adverse reactions.

Dr. Kerryn Phelps said she herself had suffered from a vaccine injury and that she faced “obstruction and resistance” to openly discuss the issue, according to a submission to the federal Parliament’s inquiry into Long COVID.

She said that while current COVID-19 vaccines may reduce the risk of developing Long COVID by an estimated 15 to 41 percent, recent data shows the risk remains for most people after immunisation, with some adverse events going on to cause “long-term illness and disability.”

Dr. Phelps also revealed in her case, that the vaccine injury resulted in dysautonomia with intermittent fevers and cardiovascular implications including breathlessness, inappropriate sinus tachycardia, and blood pressure fluctuations.

“I have spoken with other doctors who have themselves experienced a serious and persistent adverse event including cardiological, rheumatological, autoimmune reactions and neurological consequences,” she wrote in her submission.

She said while there is higher awareness about the unusual blood clotting from AstraZeneca, “less generally recognised are the reported adverse reactions after mRNA vaccines by Pfizer and Moderna beyond myocarditis and pericarditis.”





Big medical day today so no time for blogging. Should be back tomorrow

Tuesday, October 24, 2023

Skeptical Professor Exonerated After Being Accused of 'Unethical Practices' in Famous COVID Vaccine Study

The vaccine establishment applied irrelevant standards to his work in their zeal to discredit it

A professor from the Michigan State University (MSU) has been exonerated from charges of “unethical practices” related to a study claiming that the COVID-19 vaccines may have resulted in hundreds of thousands of deaths in the United States.

In January, Dr. Mark Skidmore, a professor at the MSU’s Department of Economics with over 90 published papers, published a study in the BMC Infectious Disease, which suggested that the total number of COVID-19 vaccine fatalities in the United States could be “as high as 278,000.”

It soon came under criticism and Dr. Skidmore was accused of using “unethical practices” in the study. Subsequently, the journal retracted the research.

Following a seven-month ethics investigation by the university’s Institutional Review Board (IRB), Dr. Skidmore has now been cleared of any wrongdoing. The board stated that they did not find any “noncompliance” to their protocols by the study, according to an Oct. 17 press release by the Christian ministry Liberty Counsel.

The complaints against Dr. Skidmore alleged he did not follow rigorous oversight procedures that are mandated for clinical studies. If the university were to find him “guilty,” it would have had serious consequences for Dr. Skidmore’s credibility and career.

This is because clinical studies involving human subjects have strict protocols to ensure that no harm comes to the participants. As such, any fault in this regard would be a significant blemish on the reputation of the researchers.

The university’s IRB found that Dr. Skidmore’s study did not involve any clinical work. Instead, it relied only on an online survey, which posed no risk to human participants. The IRB therefore deemed the study to be “exempt” from the protocols of clinical study and cleared it to proceed.

“The allegations against Dr. Mark Skidmore were baseless,” Liberty Counsel Chairman Mat Staver said. “Researchers with integrity like Dr. Skidmore are using rigorous scientific protocols to validate the dangers of the COVID-19 shots.”

“Censoring scientific debate is reprehensible and our researchers need to be free to conduct proper science without fear of later being the subject of an ethics investigation because their findings contradict a certain narrative.”

Top Research Paper

While Dr. Skidmore’s study at the BMC Infectious Disease journal remains retracted, an updated version was recently published in the Science, Public Health Policy & the Law journal.

The study involved an online survey completed by 2,840 participants between Dec. 18 and Dec. 23, 2021, which collected data on COVID-19 health experiences. “The primary aim of this work is to identify factors associated by American citizens with the decision to be vaccinated against COVID-19,” it read.

The survey collected information on why respondents chose to take COVID-19 vaccinations or refused to do so. It also collected details on respondents’ experiences with COVID-19 illnesses and inoculations. With regard to COVID-19 vaccines, the survey found that:

Respondents that knew someone who had experienced a health problem following vaccination were less likely to be vaccinated.

Out of the 2,840 participants, 612 (22 percent) said they knew at least one individual who experienced a health problem after taking a COVID-19 shot.

Dr. Skidmore extrapolated the numbers from the survey to the national level to estimate that COVID-19 vaccine fatalities in America could be as around 289,789. The COVID-19 vaccine fatality number in the revised study published in the Science, Public Health Policy & the Law journal is higher than the original study by 11,789 deaths.

According to the BMC Infectious Diseases journal, Dr. Skidmore’s original study was retracted after “concerns were raised regarding the validity of the conclusions drawn after publication.”

A peer review of the study conducted after publication found that “the methodology was inappropriate as it does not prove causal inference of mortality, and limitations of the study were not adequately described.”

Despite being retracted, the study remains in the top 1 percent of shared research worldwide, according to data science firm Altmetric. The study is ranked number one among all outputs from BMC Infectious Diseases tracked by Altmetric.

In April, Dr. Skidmore claimed that the study at BMC Infectious Diseases journal went viral on social media and reached up to 17 million Twitter users prior to being retracted.

He attributed the vast exposure of the study to two factors. “First, the finding resonated with many who have loved ones who they believe experienced harm from the COVID-19 vaccine. Second, for a variety of reasons, many were angered by the study,” he said.

Other studies have also found links between COVID-19 vaccines and excess deaths. A March report from global macro-investment firm Phinance Technologies calculated that COVID-19 vaccines resulted in around 310,000 excess deaths in the United States.

Some studies have reported otherwise. A study from The Commonwealth Fund estimated that 2 million deaths were prevented in the United States through March 2022 due to COVID-19 vaccination efforts.

Another serious concern regarding the vaccine is the persistence of spike proteins for a prolonged period of time after the vaccination.

Even though the CDC claims that mRNA from COVID-19 vaccines is “broken down within a few days after vaccination and doesn’t last long in the body,” recent research reveals that spike proteins are retained in the biological fluids of people who received an mRNA COVID-19 vaccine six months after vaccination.


More Research Refutes Efficacy of Masks Against COVID-19

As flu—and coronavirus—season approaches, Dr. Anthony Fauci is again saying that wearing face masks protects individuals from spreading the coronavirus.

Some colleges and hospitals are reinstating mask mandates.

Politics and the fear of coronavirus may have held sway the past few years, but common sense and rational science need to prevail now. Masks are ineffective, and mask mandates are unnecessary.

We offer several explanations from our National Association of Scholars report and peer-reviewed study to refute doomsayers’ warnings about the effectiveness of wearing masks.

Viruses Go Around, Through Masks

Coronaviruses are very small, with a size range of 0.06 to 0.16 micron. For perspective, 1,000 microns equals 1 millimeter. Respiratory viruses like the coronavirus are transmitted through secretion fluids during breathing in the form of small aerosols (less than 5 microns in size) or larger droplets (greater than 5 microns in size), rather than isolated viruses.

When viral-infected humans breathe, talk, eat, cough or sneeze, they emit aerosols and droplets containing viruses.

Aerosols emitted from simple breathing are small (size range 0.2 to 0.6 micron), and once emitted can be present in an enclosed setting for several hours. A person showing no symptoms of viral infection does not cough and sneeze, and therefore they do not emit large droplets.

Aerosols less than 0.5 micron are not easily filtered out of air by any physical mechanism. The openings in medical masks range from 0.3 to 10 microns in size. The latter dimension is much larger than small aerosols emitted from an infected person.

Now, there are a couple of ways in which virus-laden aerosols can infect a person wearing a mask when the aerosols are present in their breathing zone. One way is aerosol penetration through the mask during breathing because mask openings are too large.

A second way is breathing air containing aerosols from the side of a mask due to incorrect wear, increased mask resistance, or poor string tension. A mask wearer breathes out moist air, which increases mask resistance by plugging up the openings. Simple breathing has been shown to emit up to 7,200 aerosols per liter of exhaled air. While this can reduce aerosol penetration through a mask, it worsens the problem of inhaling virus-laden aerosols from the side of the mask.

Controlled Trials Show Masks Not Effective

The leading Cochrane Database of Systematic Reviews published a review in 2020 and a reanalysis in 2023 of human controlled trials using masks to slow the spread of respiratory viruses.

Both of these studies concluded that it is uncertain whether wearing masks help to slow the spread of respiratory viruses. Outside of the Cochrane organization’s influence, one of the senior authors of both studies (Jefferson) was more to the point: “There is just no evidence that [masks] make any difference. Full stop.”

Jefferson’s findings are consistent with viral transmission basics. Is he right? To answer this, we independently evaluated his data used in the 2020 review using a novel statistical p-value plot.

A p-value plot is used to visually inspect characteristics of a set of test statistics addressing the same research claim; for example, do masks make any difference? The plot is well-respected, being cited more than 500 times in the literature. The plot examined whether p-values support no association (randomness) or a real association between community mask use and viral infections.

Jefferson’s 2020 review looked at 15 separate community (that is, non-health care worker) controlled trials comparing medical masks to no masks. We took the results from these 15 trials—risk ratios and confidence intervals—and converted them to p-values.

If p-values approximately follow a line with a flat/shallow slope, where most of the p-values are small (less than 0.05), then the set of p-values provides evidence for a real association; that is, masks work.

The p-value plot of the 15 controlled trials clearly shows p-values aligned approximately 45 degrees, indicating randomness. This is consistent with what Jefferson found: Masks don’t work.

A Natural Experiment Shows Ineffectiveness

A final explanation is a natural experiment of World Health Organization-reported daily new COVID-19 deaths in Germany and Sweden during the second wave (October 2020 through July 2021). At the time, Germany had a mask mandate, whereas Sweden did not, as they followed a strategy to let herd immunity develop naturally.

Many factors contribute to mortality risk. Numerous influences may be at play in the airborne respiratory virus-mortality chain across populations; for example, access to health care, health status, lifestyle, standard of living, etc., which complicates efforts to draw conclusions from observational data.

However, Germany and Sweden are members of the European Union with similar national health policies. Both should have had similar capacities to respond to the COVID-19 pandemic. Also, in 2020, Germany and Sweden ranked closely in the top 10 countries of the world with the United Nations Human Development Index: Germany sixth and Sweden seventh. So, comparing the two should control for many factors affecting mortality.

Moreover, mask wearing was very dissimilar in the two countries. Survey data on mask compliance during the pandemic was captured in many countries by the University of Maryland Social Data Science Center and Facebook. Using these data, we observed that monthly average mask compliance in Germany was never less than 80%, whereas in Sweden it was never more than 21%, during the second wave.

Those figures shows that mask use had little or no benefit in preventing COVID-19 deaths in Germany and Sweden during the second wave. Despite similar health care capacities, similar Human Development Index measures, and obvious differences in mask compliance for the two countries, daily COVID-19 deaths per million population were not much different.

Policymakers Should Learn From Experience

It is the obligation of those espousing a theory to provide solid supporting evidence. Undoubtedly, more studies on the medical maskrespiratory virus infection research question, including COVID-19, will be presented in literature in the coming years as those in favor of mask mandates look for empirical support.

However, the evidence to date offers no support for mask mandates.




Monday, October 23, 2023

Yet Another Validation of DNA Contaminants in COVID-19 mRNA Vaccines

TrialSite recently covered the unfolding “plasmidgate” controversy involving DNA contamination found in same of COVID-19 mRNA vaccine product. To date, this media reported on four such studies featuring what some experts are declaring are unacceptable amounts of DNA contamination in the mRNA vaccines, with an emphasis on the Pfizer-BioNTech product.

A new study has been uploaded to OSF Preprints, and one of the authors is a regular TrialSite contributor, David Wiseman, Ph.D., but also includes none other than Kevin McKernan of Medicinal Genomics in Beverly, Massachusetts, the investigator leading the first study verifying that DNA contaminants in the mRNA vaccine vials exceeded the European Medicines Agency 330ng/mg requirement and the Food and Drug Administration (FDA) 10g/dose requirements.

The new study is titled “DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.” While this study is not yet peer reviewed, meaning as a matter of scientific practice the findings should not be cited as evidence, the combination of seriousness, relevance and timeliness of findings merit high level introductory overview in the TrialSite.

Representing the study as corresponding author is Dr. David J. Speicher, Ph.D., DTM, a molecular virologist and clinical epidemiologist whose Ph.D. thesis in 2012, on the detection and characterization of HHV-8 led to the first HHV-8 quantitative PCR assay in Australia. He currently teaches and does research at University of Guelph.

Other authors involved with this study include Jessica Rose, Ph.D. and Maria Gutschi, a research pharmacist and drug assessor in Canada.

The study team acknowledges in their study paper the recent studies covered by TrialSite pointing to significant levels of plasmid DNA in both mRNA COVID-19 vaccine products (Pfizer-BioNTech and Moderna). But the authors acknowledge that the previous study findings were based on output based on a limited number of lots, as well as questions linked to variance and quality of the underlying samples used in those studies.

The Study

In vitro transcription employed to generate nucleoside RNA (modRNA) for SARS-CoV-2 vaccines to date relies on an RNA polymerase transcribing from a DNA template, meaning DNA is required in the mRNA production process.

In this context, as an example, the manufacture of the modRNA used in the original Pfizer randomized clinical trial was based on such PCR-generated DNA template.

In fact, by generating clones into a bacterial plasmid vector for amplification in Escherichia coli before linearization, part of the second process making up this study, the team can expand the size and complexity of possible residual DNA, while bringing sequences not present in the template mentioned above.

Articulating that Moderna’s vaccine, both clinical trials and post authorization mRNA product, is based on a comparable plasmid-based set of processes, the present authors used quantitative polymerase chain reaction (qPCR) and Qubit® fluorometry as part of a process to test the additional 27 vials of mRNA COVID-19 vaccine product obtained in Canada.

With the samples drawn from 12 unique lots including:

5 lots of Moderna child/adult monovalent
1 lot of Moderna adult bivalent BA.4/5
1 lot of Moderna child/adult bivalent BA.1
1 lot of Moderna XBB.1.5 monovalent
3 lots of Pfizer adult monovalent
1 lot of Pfizer adult bivalent BA.4/5

To better understand safety profile, the authors queried the U.S. Vaccine Adverse Event Reporting System (VAERS) database for the number and categorization of adverse events (AEs) reported for each of the lots tested. Using Oxford Nanopore sequencing, this helped the team investigate the content of one of the previously studied Pfizer COVID-19 vaccine vials as part of the quest in this study to determine the size distribution of DNA fragments.

Speicher and team also used the sample to verify if the “residual DNA is packaged in the lipid nanoparticles (LNPs) and thus resistant to DNaseI or if the DNA resides outside of the LNP and is DNaseI labile.”


Based on the dose response model established, Speicher and team conducted an exploratory analysis, finding at least early evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). Could it be that COVID-19 mRNA vaccine safety as reflected in the number of safety incidences could be predicted based on this model?

The study authors report that the Pfizer and Moderna products differed based on size distribution analysis---mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively.

Disturbingly, the study authors write, “The plasmid DNA is likely inside the LNPs and is protected from nucleases.”


Of course, this study output needs to be vetted via peer review, but the authors demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in the studied Pfizer and Moderna mRNA 19 vaccines.

The study team was able to verify using fluorometry that “all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold.”

During this study, Speicher et al. point to the need for methodological clarity and consistency when interpreting quantitative guidelines based on observations for instance, that the qPCR residual DNA content in all vaccines were below established guidelines.

They point out, “The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrant confirmation and further investigation.”

Perhaps most importantly is the overall mounting unease about the COVID-19 mRNA vaccines. This concern is expressed by the present authors:

“Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection.”


Ivermectin/Hydroxychloroquine Lawsuits Continue On

Physicians in Iowa are suing the state’s licensing boards to overturn restrictions associated with repurposed drugs used for COVID-19, including Hydroxychloroquine and Ivermectin. The physician has filed a civil lawsuit seeking a court order to force pharmacies to fill prescriptions for these drugs.

This news was reported by the Des Moines Register and other sources. Why is Iowa doctor David Hartsuch pursuing a lawsuit against the Iowa Board of Medicine and Iowa Board of Pharmacy? He is accusing them of dissuading members against use of hydroxychloroquine and ivermectin as a regimen for COVID-19.

Citing one study published in the Journal of the American Medical Association, the plaintiff points out that despite the fact that the FDA doesn’t authorize the drugs for COVID-19, approximately 1 in 20 U.S. adults are identified as using hydroxychloroquine or ivermectin for COVID-19 treatment.

Briefly authorized as an emergency medicine during COVID-19, Hydroxychloroquine’s status was revoked when ensuing research suggested the potential for harm. Although conflict ensued thereafter over the research, with some studies showing efficacy and others not. Ivermectin was never authorized in the United States although at least a dozen nations, mostly in low-and middle-income countries, authorized ivermectin on an emergency basis against COVID-19.

While some prominent larger studies (TOGETHER, COVID-OUT, ACTIV-6) showed no efficacy, many others have shown promise. For example, a website tracks ongoing studies which now total 99 studies covering 137,255 patients across 28 countries. The takeaway: the drug can statistically lower risk for mortality, ventilation, ICU and other targeted outcomes. But critics in institutions such as the NIH suggest these studies are not trustworthy, with poor design, questionable data, and the like.

Regardless, by 2021, weekly ivermectin prescriptions, according to one study, skyrocketed from 3,000 per week to nearly 90,000 per week!

The FDA joined in on an information war against the drug, labeling it only as an animal drug, when of course hundreds of millions of doses are administered to humans per year.

Iowa Clash

Dr. Hartsuch’s conflict with the Iowa licensing boards emerged in March 2020. While during summer and late 2020 growing ivermectin use across America was generally accommodated, as Biden entered the White House, the conditions changed.

This market demand triggered a massive industry, government and academic medical system response. TrialSite examined how the federal government went after doctors indirectly in December 2021. In “Feds coming after Doctors & Pharmacies that Market Ivermectin as Safe & Effective for COVID-19” for example, the FDA wrote letters to group such as the Federation of State Medical Boards (FSMB) warning state groups to monitor members for espousing misinformation involving ivermectin.

This campaign spooked doctors and pharmacists around the nation. By the fall of 2021, it was becoming harder for doctors such as Hartsuch to prescribe the off-label drug to his patients. Pharmacies were increasingly on alert.

So, a patient of Dr. Hartsuch for example, could not get ivermectin prescriptions filled, which led to investigations by the Board of Medicine into the doctor’s ivermectin prescribing trends.

But the Iowa physician points out in his complaint that warning letters received by the Iowa Board of Medicine were violative of core free speech rights, during his professional brand reputation.

Now seeking the court to expunge the warning letter from his record, he demands an injunction requiring pharmacies to fill prescriptions for the off-label drugs.

The Iowa physician’s point of view: doctors’ rights to consider and prescribe repurposed off-label drugs is a basic physician right, as long as they follow their professional standards (e.g., consent, etc.).

In other states such as Nebraska, the attorney general doesn’t enforce disciplinary measures should physicians prescribe drugs like ivermectin or hydroxychloroquine for COVID-19.

Before COVID-19 physicians routinely would prescribe off label drugs typically with little to no problems.




Sunday, October 22, 2023

The Decline and Near Fall of the COVID Vaccine Makers

The uptake of the latest version of the COVID vaccines, which underwent almost no testing but were rubber-stamped by regulators anyway, has been far lower than expectations. The CDC is not publishing real-time data but what we know so far suggests that it is in the realm of 2 percent.

This is incredibly low. The most pessimistic prediction I had heard was 5 percent. This is a deep failure by any standard. That is precisely why the numbers are not being advertised. The average person has stopped buying what they are selling.

Initially, the excuse was that drug stores faced logistical problems. Then it was widely suggested that they were too expensive. For a few weeks, such diversions dominated the messaging. But in the end, the reality is here: people just don’t want them.

Now we see why the shot pushers were so intent on mandates wherever and however they could. The makers always claimed that the shots were safe and effective but that bypasses a more fundamental question: were they necessary?

The demographics of risk of COVID have been published and unchanged since February 2020, fully a year before the shots became generally available. By that time, millions were already exposed and gained immunity without the shots.

From the beginning, the claims for what they called a vaccine were wildly exaggerated and obviously so. Vast numbers of people had figured this out by the time they were rolled out.

The Biden administration was advised early on that ending the pandemic required 70 percent uptake, which is consistent with the pharmaceutical target for herd immunity. But that goal presumes an absence of natural immunity, which the crowd in charge at the time pretended did not exist or that there was not enough evidence to rely upon it.

When that number failed to stop the spread, the Biden White House kept expanding the goal, from 70 percent to 85 percent to 90 percent to everyone. Finally, they said that the whole reason COVID still existed was due to the unvaccinated, which most every expert knew was false but the needs of industry at that point overrode all science.

The main competitor to the two mRNA shots of Pfizer and Moderna was Johnson & Johnson, which was a more traditional vaccine and required only one shot. But that was withdrawn briefly for safety concerns by the Food and Drug Administration (FDA) in 2021, which wrecked its market share, leaving only two giants to scoop up the fiduciary rewards of public panic.

Keep in mind that these vaccines were developed by tax dollars. The companies enjoyed patent protection. Briefly, the Biden administration toyed with the idea of giving away the formulas so that anyone could make them but that idea faded quickly following panicked industry protests. Then they relied on mandates, which is a form of conscription. Further, they enjoyed indemnification against harms. Finally, they are publicly listed companies so could reap the whirlwind of profits, and they did.

After three years, where does the stock price of Pfizer and Moderna stand? Moderna has lost 74 percent of value in two years, while Pfizer has lost 46 percent. No question that the time to have sold these stocks was two years ago. The layoffs have already started and their valuation will likely crawl back to what it was two years ago.

There is a temptation to cheer when big shots bite the dust, and I share that sense. And yet, nothing about a fallen stock price undoes the tremendously terrible history of these shots: the expense, the coercion, the harms, and the wealth transfer associated with them.

All of which is to say: they will likely get away with the whole thing.

I often think back to what we knew about coronaviruses from the first days. Such viruses are mostly unstable, prone to constant mutation. They are not candidates for viable vaccines. At best, pharmaceuticals can chase down the last variant and provide some therapeutic benefit. They are completely unlike polio, measles, rubella, or smallpox, which are stable viruses against which there have been sterilizing vaccines for a very long time.

Again, this is not wisdom we recently discovered. It was widely known, and has been for many decades. You could find it in any medical textbook. You could even learn about it in 9th grade biology class a generation or two ago.

For some strange reason, by the time 2020 came around, enough people had forgotten or never learned that bad actors were able to manipulate the public into believing that a magic shot could make a respiratory virus go away. There was never any chance that we could vaccinate our way out of this one. Never.

As for safety and efficacy of the shot, I can only quote Tracy H√łeg: “There was thus no informed consent and, as stated, safety and efficacy almost entirely unknown when the vaccine was administered to the public.”
Meanwhile, the FDA had a strong team focused on vaccines, which resigned when they saw what was coming with the first booster and how the manufacturers were essentially buying their way into the approval process. Those who remain, it is widely acknowledged, are entirely in the pay of the industry.

Will they get away with all of this? Certainly the public and the financial markets are now in a punishing mode. It’s about time. As for larger accountability, it’s unclear. We had investigations going and some focus on Capitol Hill but all that might be shelved now in light of the huge attention being paid to war in the Middle East. War tends to do this: put everything else on the back burner.

No question that we urgently need reforms, particularly with the problem of regulatory capture and indemnification against harms. The 1986 act (National Childhood Vaccine Injury Act [NCVIA]) that protects vaccine makers against harms needs an urgent repeal. That will bring an element of reality back to these markets.

And measures need to be taken to restore integrity and science at the FDA. That’s just the beginning.

At the start of this entire mess, thinking and writing not as an expert but as a literate human being, I pretty much assumed that the vaccine would be a great distraction from the need for good protocols for dealing with the sick. It turned out to be far worse than a distraction. Many people have been injured and many have died. The entire fiasco has massively raised public doubt about all vaccines, pharmaceuticals, medical services, and public health generally.

What this means is that even without serious efforts at reform, we could see de facto refusal of the public to go along anymore. Public health in this country and around the world squandered decades of goodwill and built up reputational capital on an unworkable project that was never necessary for the vast majority. Now we are stuck with the consequences.

Given all this, a lowered stock valuation for the main two vaccine distributors is small consolation.


COVID-19 Vaccines and Reports of Deep Vein Thrombosis (DVT)

Reports of deep vein thrombosis (DVT), the formation of blood clots, as an adverse effect associated with COVID-19 vaccines, are increasing. TrialSite has reported before on the blood clot crisis linked to COVID-19 and its vaccines. A compilation of such hematological case reports has been contributed by Aaron Hertzberg. We will summarize some of them here.

Deep vein thrombosis (DVT) is a medical condition where blood clots form in a deep vein; usually in the lower leg, thigh, or pelvis. However, sometimes they can form in the arm.

Case reports of the adverse events following the COVID-19 vaccine administration are appearing after the massive vaccination campaigns to control the pandemic. Studies have been conducted to investigate the link between these vaccines and blood clot formation. Here we present a summary of case reports of DVT, post-COVID-19 vaccination.

Case 1
The first paper mentioned here entitled “Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine” was published in the Internal and Emergency Medicine journal in 2021.

This case involved a 66-year-old female who received two doses of the Pfizer vaccine. Before vaccination, the woman had been completely healthy and did not smoke or have any allergies. She just had a history of left leg neuropathy (damage to peripheral nerves in the leg) after a trauma. A day after receiving her second dose, she had a persistent fever with chills, fatigue, muscle pain, and discomfort. To control these symptoms, she was administered acetaminophen, a drug used for bringing down fever and easing pain. The fever had not resolved by the next day and the patient had also developed acute pain in her right calf in the absence of any trauma. On the third day post vaccine administration, she could not walk and was admitted for investigations. She had mild swelling in her right calf. A diagnosis of DVT was confirmed through a color-doppler ultrasound scan, a non-invasive method to test for deep vein thrombosis. To treat this condition, she was given 10 mg of apixaban, an anticoagulant, for a week. The dose was later reduced to 5 mg and the symptoms resolved rapidly.

Case 2
The second case study was published in the American Journal of Case Reports in 2021. It is titled “A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine”.

It involved a 59-year-old female who reported to a hospital in Oman after suddenly experiencing pain in her left leg. She had a medical history of type 2 diabetes mellitus (T2DM), a condition in which there is a decrease in the insulin secretion to metabolize glucose in the body, osteoarthritis, a degenerative joint disease, and COVID-19 pneumonia. She had been diagnosed with COVID pneumonia in September 2020 for which she had been hospitalized for a week, but the condition had not been complicated. Seven months later, she received the Pfizer BioNTech vaccine, and seven days after that, she developed leg pain with swelling and tenderness. Acute DVT was diagnosed by performing duplex ultrasonography, a test to visualize how blood travels through arteries and veins. The patient experienced tachycardia for which computed pulmonary tomography angiography (CTPA) was performed to look for blood clots within the arteries of the lungs. The test confirmed the presence of blood clots in her pulmonary arteries. For treatment, she was given enoxaparin, an injectable anticoagulant. This was later switched to rivaroxaban – an oral anticoagulant – due to a positive heparin-induced thrombocytopenia test (HIT).

Case 3
The third case report entitled “An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report” was published in 2021 in the Annals of Translational Medicine journal.

It involved a 27-year-old female who had been completely healthy before receiving the second dose of mRNA-1273 (Moderna) COVID-19 vaccine. She had an unremarkable medical history. On the third day after receiving the dose, she reported to the hospital with swelling, redness, and pain with bruising in her upper right arm. (The first dose of this vaccine had been well-tolerated by her with mild soreness at the injection site which had lasted for a few days.) An acute thrombosis in her subclavian and axillary veins was diagnosed using venous duplex ultrasound. For treatment, she was given a heparin infusion to clear the blood clots. After that, she was given rivaroxaban for three months. Her symptoms significantly improved two weeks after being discharged.

Case 4
The fourth case titled “Deep Vein Thrombosis and Pulmonary Thrombosis After BNT162b2 mRNA SARS-CoV2 Vaccination” was published in Circulation Journal in 2022.

This case involved a 14-year-old male who presented at the clinic with pain in his left lower leg 24 hours after receiving the second dose of the Moderna vaccine. He had no family history of juvenile thrombosis or medical history of thrombosis. A contrast-enhanced computed tomography scan revealed multi-organ thrombosis. The patient was administered heparin initially and then shifted to an oral anticoagulant.

The bottom line

While COVID-19 vaccines have been promoted as safe and effective by the World Health Organization (WHO) and public health organizations like the Centers for Disease Control and Prevention (CDC), several adverse events have been associated with them. These include musculoskeletal events, neurological and cardiovascular events as reported in this article.

While some of these adverse events are manageable, several vaccine-injured individuals are yet to recover completely from the effects of these vaccines. This highlights the need for in-depth investigations into the safety profile of these vaccines, as well as the possible link between adverse effects and the vaccines.