This document is part of an archive of postings by John Ray on Dissecting Leftism, a blog hosted by Blogspot who are in turn owned by Google. The index to the archive is available here or here. Indexes to my other blogs can be located here or here. Archives do accompany my original postings but, given the animus towards conservative writing on Google and other internet institutions, their permanence is uncertain. These alternative archives help ensure a more permanent record of what I have written.
This is a backup copy of the original blog
December 30, 2022
Cardiologists say there appears to be cumulative harm from the mRNA shots, especially to the heart
According to the Centers for Disease Control and Prevention’s (CDC) V-Safe data, 25 percent of people who took the mRNA vaccine were incapacitated the next day, and 8 percent were hospitalized or went to the emergency room.
“This is the most toxic vaccine by the CDC data that we’ve ever seen in clinical medicine,” McCullough said during a recent dual interview with Malhotra for EpochTV’s “American Thought Leaders” program.
McCullough, one of the most published cardiologists in America and chief scientific officer of The Wellness Company, said he believes those 8 percent who went to the hospital likely had COVID-19 prior to being vaccinated.
“I think all cardiovascular conditions have got worse because of the vaccine, and anything and everything that can go wrong with the heart has gone wrong with the heart as a result of this mRNA vaccine,” added Malhotra, who has written extensively on reversing heart disease through lifestyle changes.
“The part of the virus that causes the heart damage is called the spike protein,” said McCullough.
Myocarditis is one of the more common injuries caused when the patient gets a high dose of spike protein with the shot, the doctors said, so the claim by the mainstream medical establishment that the risk of myocarditis is greater without the vaccine is false.
“There is a risk for traditional cardiovascular events because of this big inflammatory incident the body gets with COVID respiratory illness, but there is a small negligible risk of myocarditis with COVID, the respiratory infection, probably because the body doesn’t get this massive exposure to the spike protein, as it does with the vaccines,” said McCullough.
In addition, there is no evidence to support the claim by the drug industry that mild infection with COVID-19 or the omicron variant is causing sudden death, said Malhotra.
“I think people shouldn’t be distracted by this false narrative that mild COVID may be causing a massive surge in cardiac arrests,” said Malhotra.
It is also not true that there is a higher risk of myocarditis from COVID-19 infection than the vaccine because the mRNA vaccines have caused more injury and death, the doctors said. This is not surprising because other vaccines have also been known to cause Myocarditis, including the smallpox vaccines, McCullough said.
However, many doctors, including cardiologists, are still not aware of the data that show the mRNA vaccine can cause cardiac arrhythmias, atrial fibrillation, heart attacks, myocarditis, and heart failure, but Malhotra has been able to correctly diagnose and treat his vaccine-injured patients, he said.
The rule the regulatory agencies historically have followed is that when a new drug is introduced into the market, if someone is injured or dies within 30 days of any new drug or injection, the injury or death is considered to be caused by the new drug until proven otherwise, said McCullough.
The World Health Organization (WHO) acknowledges that the COVID-19 vaccines can cause myocarditis, and in June 2021, the U.S. Food and Drug Administration (FDA) updated the information on the mRNA vaccines to include the potential for myocarditis, added McCullough.
In addition, there are a growing number of studies that show the link between the mRNA vaccines and myocarditis, said McCullough. He cited one study that showed a direct link between mRNA vaccines and myocarditis deaths.
Malhotra believes there would have been less harm to the general public if mRNA vaccines had not been used.
“These vaccines have had a hugely negative impact on society, on health, and of course, everything that’s gone on with it has eroded trust, as well, in medicine,” he said.
“What was most criminal is telling people who had natural immunity to take the vaccine,” said Malhotra, because some evidence suggested that a person was three times more likely to suffer a serious adverse event from the vaccine if they’d already had COVID-19.
In addition, early treatments for COVID-19 have been proven to prevent severe illness and hospitalization, and in many COVID-19 patients, these should have been used instead of vaccination, said McCullough.
Early on in the pandemic, when the FDA and pharmaceutical companies were registering people for the trials, they excluded anyone who had already been infected with COVID-19 and women who were either pregnant or had the possibility of becoming pregnant, McCullough said.
“When we have exclusion criteria in clinical trials, the exclusions must be justified, and the rationale to justify the exclusion was, they did not have an opportunity for benefit and they had an opportunity for harm,” in the case of those with natural immunity and young women.
This is the “golden rule in medicine,” that once people are excluded from the original randomized trials, they are never immediately given the vaccine, but in the case of the mRNA vaccine, this rule was breached, McCullough said.
“Those are breaches of regulatory science and breaches of medical ethics. They are completely off the rails,” he said.
COVID-19 Safety Data
McCullough and Malhotra agreed that adverse effects were worse for people who received the mRNA vaccines after already acquiring natural immunity from an infection, and a 2022 study in the United Kingdom supports that conclusion. The U.S. Centers for Disease Control and Prevention (CDC) tried to prevent the public from accessing its own adverse event vaccine data in its “V-safe” database, but the agency was forced by a court order to release the information to the Informed Consent Action Network, said McCullough.
The UK’s mRNA vaccine adverse event data is very similar to the CDC’s data, said Malhotra.
“There was no precautionary principle applied, and it still comes back that these regulatory bodies failed in their duty to protect the public from the excesses of manipulations of industry who were there just wanting to mass vaccinate as many people as possible, irrespective of the consequences and irrespective of the harm,” said Malhotra.
McCullough has entered many of his patients’ vaccine adverse reactions to the CDC’s Vaccine Adverse Event Reporting System and found it does not allow for differentiating between being vaccinated after having COVID-19 versus being vaccinated before contracting the virus.
“There’s no checkbox to indicate if they previously had COVID. It is a massive oversight,” said McCullough.
In the current era of the omicron variant of the virus, CDC Director Rochelle Walensky said there are about 300 people dying from COVID-19 each day. However, McCullough said 90 percent of those 300 are labeled COVID-19 deaths but are actually caused by some other factor while testing positive for prior infection.
This brings the true number of people dying from the omicron variant to about 30 per day, said McCullough, compared to 2,000 people dying each day from heart disease. There is no reason for President Joe Biden to continue to declare COVID-19 a public health emergency, he said.
“We’re dealing with a cold,” said Malhotra. “People need to be told the truth. We need to stop scaring people.”
The Real Bias
McCullough and Malhotra have been criticized for spreading “misinformation” about the vaccines and allegedly cherry-picking studies to show the outcomes they want.
Although McCullough is not an infectious disease specialist, he has studied the virus for the last three years and written more than 60 peer-reviewed articles on COVID-19, he said, and the real bias is coming from the medical establishment and governments.
“There is a clear-cut bias in the medical literature coming from the major publishers—Elsevier, Taylor & Francis, and others—all the way down to the editorial offices to promote mass vaccination,” said McCullough, which is why he has to rely on less well-known journals for studies that focus only on the data, not the claims about the vaccines.
McCullough said it is common for doctors to have opposing views about a drug or a treatment, and medical journals normally have a balance of studies for and against a particular medical treatment, except for the case of the mRNA vaccines. He said this shows that “there is a deep-seated bias to only promote the vaccines in the peer-reviewed literature.”
Fellow medical professionals and the media have tried to assassinate the two cardiologists’ character but have not been able to disprove or rebut their statements, Malhotra said.
“We are losing out on dedicating time, resources, and research towards helping people who are genuinely vaccine-injured,” said Malhotra.
Vaccines Must Be Halted
McCullough said only about 10 percent of people in the United States are still getting boosted, and the reason is likely that most people know someone who is vaccine-injured.
The vaccine should have been offered to only a very small, high-risk group, McCullough said, adding that the focus on vaccinating children and infants is out of proportion to their risk for serious illness.
Instead, the U.S. government put billions of dollars into advertising and disseminating the vaccines and collaborating with the medical establishment, the media, and popular culture to promote mass vaccination.
“These injuries and problems don’t stop until the vaccines stop,” said McCullough. “We need this immediate about-face, and understand that the vaccines themselves have caused a public health crisis.”
There is a cumulative effect with the vaccines, leading to both immediate and longer-term injury to patients, including heart inflammation, neurological disorders, immune disorders, and blood clots, said McCullough.
The more doses, the worse off a person is, the doctors said.
The vaccine industry needs to pay the vaccine-injured, much like the tobacco industry had to settle for the damage its products caused, said McCullough, and that money needs to be used to help the vaccine-injured.
“We don’t want to scare people too much, but what we need to tell them is to say ‘no’ right now,” Malhotra said. “It’s all risk and no benefit.”
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Dr. Jay Bhattacharya Laments How Little The Medical Establishment Has Learned From China's Covid Disaster
Stanford epidemiologist Dr. Jay Bhattacharya expressed concern Wednesday night that the global and national medical establishment might have learned nothing from China's horrific experience with the Covid-19 pandemic.
Appearing on Wednesday night's "Tucker Carlson Tonight" with guest host Sean Duffy, Bhattacharya worried that the same mistakes China and much of the rest of the world made at various points along the way could "come back" if there is another pandemic.
The segment began with Duffy chronicling China's shift from so-called "zero-Covid" policies, a draconian approach to lockdowns that was never sustainable, to essentially giving up and allowing the virus to run unabated through a population that has little natural immunity.
"The World Health Organization has put containment at the center of its approach to future pandemics," Bhattacharya said. "The Biden Administration has basically, I think, rubber-stamped the same kind of containment idea when there's another pandemic. Unless there's a concerted effort by political leaders to examine the failure of our Covid policies and then put in place plans so that we don’t lock down again, I’m afraid it will come back."
The Stanford professor - who helped craft the Great Barrington Declaration in 2020 that called for focused protection of the vulnerable as an alternative to society-destroying lockdowns - noted that many "public health authorities" wanted something like China's Covid policies in the United States even though indefinitely containing a "highly infectious respiratory disease" like Covid-19 is impossible.
It was inevitable that this virus was going to infect basically everybody. It’s a highly infectious respiratory disease. Our efforts to try the control the spread of it, we don’t have a technology that does that ... Chinese authorities capitulated. The problem is they didn’t protect the elderly population. They’re at high risk. There’s a lot of people that have never been infected before that are really at high risk and their healthcare system is much more easily overwhelmed than ours is. That’s what we’re seeing now. It’s tragic. At this point, there’s not much I can do other than to pray for the people of China because it is absolutely a disaster what they’ve had to go through from their move to zero Covid to essentially letting it rip.
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December 29, 2022
Ivermectin Is Safe and Effective: The Evidence
The article below is right. What it overlooks is why the establishment rejected Ivermectin: Because Trump recommended it. Leftist childishness knows no bounds
Decades of use with nearly four billion doses to humans preceded recent use with COVID patients. From the chapter ‘Ivermectin sends COVID to lockdown,’ in my book The Defeat Of COVID.
Ivermectin is on the World Health Organization (WHO) List of Essential Medicines and is approved by the US Food and Drug Administration (FDA). This well-tolerated but potent anti-parasitic medicine has been prescribed billions of times in its 36-year history against a wide range of parasites. It is a drug in the avermectin family, so named because those compounds are produced by the soil organism Streptomyces avermitilis. It has also been studied and used against a wide range of viruses especially over the last decade, and there is evidence of potent antiviral effects against Influenza A and over a dozen other viruses tested. [309]
In a meta-analysis of 63 studies of ivermectin versus COVID-19 in humans, 100% of these have shown positive results. Studies were from all continents except Antarctica. Considered individually, 29 of those studies were found to be statistically significant regarding use of ivermectin alone. Over the 63 studies in meta-analysis, pooled effects showed 69% improvement in early treatment, and prophylactic use showed 86% improvement. Of those studies in the meta-analysis that were peer-reviewed, overall improvement in early treatment was found to be 70% (64% in randomized controlled trials), and 86% of those in which ivermectin was used prophylactically showed improvement (84% in randomized controlled trials).
Mortality from COVID-19 over all time periods of delay in treatment was 76% improved over controls (69% in randomized controlled trials), whereas mortality was improved 84% in early treatment of COVID-19 (82% in randomized controlled trials). Forty studies were excluded from the meta-analysis for complicating factors or insufficient detail reported, and these also showed 100% positive results.
It is estimated that the likelihood of an ineffective treatment showing such positive results as the above results in the 63 studies in the meta-analysis to date is exceedingly small. That probability is estimated to be one in one trillion. [310] The overall results of the meta-analysis were not only found to be “overwhelmingly positive,” but also “very consistent, and very insensitive to potential selection criteria, effect extraction rules, and/or bias evaluation.” The data in the meta-analysis are as of date of this article, and are continually updated as new studies are reported.
The first clinical trial of ivermectin in COVID-19 patients was an observational study in four Florida hospitals from March to May 2020. Even in patients with severe pulmonary involvement, mortality was 38.8% in the treatment group vs 80.7% in controls, and this group showed the strongest mortality difference from controls, which raised the possibility of ivermectin also being available as a salvage or rescue treatment. [311]
In a randomized controlled trial, patients given ivermectin were 8 times more likely to be medically released than those in the placebo group. This was even though the average age and number of comorbidities were later found to be somewhat higher in the experimental group than in the control group. [312]
The African continent has had remarkably low incidence of COVID-19, particularly equatorial African countries. It may be helpful to look at African countries where ivermectin has been used commonly for decades against the onchocerciasis that it has been prescribed for, to observe population-wide effects. In this population comparison, risk of COVID-19 death was found to be 88.2% lower and morbidity 85.7% lower in 31 countries where onchocerciasis is endemic and ivermectin is commonly used than in 22 countries where neither is the case, even though the latter group of countries has a higher life expectancy, 66 years vs 61 years. [313]
Ivermectin, for all its power against viruses, is among the safest of medicines that are in long-term and widespread use. [314] There are no known serious drug-related adverse events. [315] Again, it is commonly taken by the populations of 31 African countries for effect against endemic parasites. Dosing has been given as a single annual dose of 150 mcg/kg against filariasis. There have been very few serious adverse events reported over more than 30 years of use. 37 of approximately 14,000 patients treated in Ghana had symptomatic posture hypotension, associated with fainting or sweating or tachycardia. These were treated with corticosteroids. [316] This Lancet study determined its safety in pregnant women, and the risk of fetal damage was not greater than in control women’s fetuses. [317]
However, despite this safety data going back 3 decades, the US FDA has alleged, “Any use of ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established.” The FDA offered no supporting evidence for their claim. [318] One concerning risk is that ivermectin is sold over the counter for veterinary use, and if people feel desperate to use it to ward off COVID-19, they might break off too large a piece from a large horse pill. For this reason, it is much better to consult a healthcare provider for ivermectin use and dosing. To further enhance safety, liposomal ivermectin carriers have been developed. When these were used against Dengue fever, cytotoxicity was reduced up to 5 times, absorption was faster and in vivo efficacy was improved. [319]
Despite the spectacular worldwide effect profile, of excellent effect against COVID-19, with 0.26% observed minor side effects, and its use across several continents, ivermectin is widely shunned and ignored in western Europe and in the US. Here is a brief synopsis of how that came to be.
Ivermectin was invented in Japan in 1975 as an anti-parasitic drug by Satoshi Omura, a Kitasato University professor emeritus, which earned Dr. Omura the Nobel Prize in Biochemistry. Ivermectin turned out to be quite effective against a broad spectrum of parasites. The drug was so effective in eliminating a range of parasitic infections, and at very low cost, about $0.10 US, that 3.7 billion doses have been delivered to much of the world’s population since its invention. [320]
A cell culture study in April 2020 showed a 5000 times reduction in SARS-CoV-2 from one dose over 48 hours, compared to control samples. [321] Several Latin American countries, Egypt and India soon began to use it for COVID-19, and then South Africa and several European countries as well. However, resistance remained strong in the US and western Europe, following the vocal disapproval of The World Health Organization (WHO), The US National Institutes of Health (NIH), the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). These agencies all expressed disapproval of ivermectin for use with COVID-19 patients. Even after more than 20 randomized controlled clinical trials showed promising effect without adverse reactions, many western countries have still not adopted its use.
Social media companies censored ivermectin research. Even when the WHO commissioned and reported a meta-analysis of ivermectin, it was censored by YouTube. Only negative commentaries were permitted in western media. [322]
How does ivermectin send SARS-CoV-2 to lockdown? There are a number of mechanisms by which components of SARS-CoV-2 need to stay mobile and active in order to replicate, and thus to spread throughout the human body. It turns out that ivermectin binds several of these, which inactivates the virus. Let’s look at exactly what happens to bind or to lock down SARS-CoV-2.
RNA-dependent RNA-polymerase (RdRp) is one of the main enzymes used by SARS-CoV-2 to achieve RNA replication. It is required for viral genome replication, and therefore it is helpful if a nutrient or drug can act on it as an obstacle in some way. 173 drugs were tested in this study for their ability to bind RdRp (making it unavailable or inactive), including two examined in this book, hydroxychloroquine and vitamin C, although vitamin C was also found to have relatively high binding energy for RdRp in this study. Of all the drugs tested, ivermectin was found to bind RdRp with higher binding any energy than any other drug. [323]
One strategy against SARS-CoV-2, as well as other endemic and pandemic RNA viruses, has been to interfere with transport of viruses into a host cell’s nucleus. Ivermectin has been shown to accomplish this by binding, destabilizing and inhibiting the protein IMP alpha/beta1. When this protein is inhibited, viruses are unable to enter a cell’s nucleus, and therefore unable to replicate. Decreased infection results. IMP alpha/beta 1 has been inhibited in SARS-CoV-2 entry into nuclei by ivermectin. [324] Previously, it has been observed that ivermectin inhibited that same protein from entry of other RNA viruses, giving it a broad-spectrum antiviral effect. [325] [326] [327]
It turns out that ivermectin not only binds tightly to RdRp on SARSCoV-2, and IMP alpha/beta1; it also strongly binds the spike protein on SARS-CoV-2. This particular spike protein is trimeric, meaning it has 3 subunits which vary in amino acid sequences or other ways. It was observed that ivermectin binds all three of the SARS-CoV-2 subunits, both the structural S2 subunit, as well as both of the two functional S1 subunits. [328] This binding of all 3 subunits of the trimeric spike protein may be considered a trifecta of fortunate results of ivermectin in favor of the human host and in opposition to the SARS-CoV-2 virus.
Ivermectin has different mechanisms against parasites, already a miraculous healing drug for that use alone through much of the world’s population. However, now that we learn of its tremendous effect in binding both RdRp and all three trimers of the spike protein of SARS-CoV-2, we are certainly fortunate to have this medicine in our arsenal against COVID-19. It is inexpensive, and full COVID-19 treatment of an individual, from first dose till last needed can be less than one US dollar. Ivermectin is therefore available to even the poorest communities in the world. Ivermectin is being compared to the discovery of penicillin in its enormous impact, and perhaps was one of the greatest discoveries of the 20th century. [329] The fact that this tremendously effective, safe and low-cost antiviral drug is not as thoroughly known to the world as penicillin is a chasm of inexcusable and deadly ignorance that the COVID era is giving the world an opportunity to correct.
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Is the CDC Shortening Americans’ Lives?
It’s one thing when government raises your taxes, suffocates your business with regulations or censors your tweets. It’s far worse when government is to blame for actually shortening your life.
American life expectancy dropped to 76.4 years, the lowest in 25 years, according to new federal data. Americans should be gasping. What could be more important than having the chance to live a long life?
The Centers for Disease Control and Prevention repeatedly has blown its responses to health killers like fentanyl, Covid, and lung cancer. All the while, life expectancy gets shorter and shorter.
In 1980, Americans had one of the best life expectancies in the world. Since then, America has lost ground. People live several years longer in France, Switzerland, Italy, and other highly developed countries, reaching ages 83 or 84 on average.
Residents of the Czech Republic, Chile, and Slovenia can expect longer lives than Americans. Even before Covid, America ranked 29th in life expectancy, according to the Organization for Economic Co-operation and Development.
The virus merely widened an already alarming gap between America and other nations.
Now, life expectancy in these other nations is rebounding from Covid, while American lives continue to be cut short due to other causes.
Start with the failure of our government, especially the CDC, to tackle the leading cause of death among Americans ages 18 to 49: overdosing. Two-thirds of these deaths are from fentanyl.
Nearly 107,000 Americans died of overdoses in 2021, about 50 percent more than just two years earlier.
Where’s the campaign to combat fentanyl deaths? Over the last half-century, American health agencies waged several stunningly successful media campaigns to dissuade Americans from smoking cigarettes. The CDC has done nothing like that to fight this new killer.
Blame the agency’s mission confusion. In September 2021, as overdoses soared and Covid raged, the CDC launched a campaign for “inclusive communication.”
The agency instructed health care workers to avoid stigmatizing words like “illegal immigrant” and substitute “parent” for gender-tainted terms like “mother” and “father.” As if political correctness is more important than preventing deaths.
The CDC’s failed response to Covid further depressed American life expectancy. Agency head Rochelle Walensky said, “To be frank, we are responsible for some pretty dramatic, pretty public mistakes, from testing to data to communications.”
America has had a higher per capita death rate from Covid than other developed countries, including the United Kingdom, France, Spain, and Canada.
As Covid fades, the CDC’s inaction on another front — lung cancer screening — is limiting progress on life expectancy for cancer patients, where America is otherwise a leader.
Lung cancer is the number one cancer killer, taking about 130,000 lives a year. That’s more than breast, prostate and colon cancer deaths combined. Because lung cancer is rarely diagnosed before it spreads, the chances of survival are an abysmal 18 percent.
But when lung cancer is diagnosed early with a CT chest scan, a patient has an 80 percent chance of living another 20 years, reports a radiology expert at New York City’s Mount Sinai Icahn School of Medicine, Claudia Henschke. That sure beats 18 percent.
The scan takes 15 minutes lying flat on a table that glides in and out of the scanning machine. There’s no squeezing like with a mammogram and no yucky preparation like with a colonoscopy.
The technology is widely available, recommended by the U.S. Preventive Services Task Force and covered by insurance, but few doctors know to order it, and few patients know to ask. Blame the CDC for this knowledge gap. Only 15 percent of Americans who need lung screening are getting it.
On December 20, the White House announced a pilot project to “screen and treat” cancer. Oh, sorry, that’s not for America. It’s for women in Botswana. Laughable if it weren’t so tragic.
Ten years ago, Americans were told the biggest health challenge was the uninsured. Congress passed Obamacare. Now only 9 percent of Americans are uninsured, but the whole nation faces the prospect of shorter life expectancy.
For those lost years, you can thank federal health officials, especially the dysfunctional CDC. Call it the Centers for Decline and Confusion.
https://www.nysun.com/article/thank-government-for-americans-shorter-lives
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With new pricing law, the Feds can make drug firms offers they really can't refuse
This is an attempt to fix a problem that regulation has created. The best part of it is that most of it seems highly likely to fail under constitutional challege. See the 5th and 8th amendments.
High drug prices are a real problem but the most lasting way of bringing them down would be a great reduction in regulatory barriers on marketing them. Regulatory barriers mean that it can cost bilions to bring a new drug to market. And guess who pays the cost of that in the end? It's Joe citizen. The drugmakers have to cover their costs or there will be no more drugs.
And the companies have to make big profits in good times to finance the big losses they experience when a drug fails to get approval after a lot of expensive trials
The best way to get costs down would be to allow marketing of "experimental" drugs after initial trials under a warning that people take them "at your own risk". Doctors would not prescribe them if there were serious probable risks
President Biden has promised that the $740 billion Inflation Reduction Act, signed into law this August, will “lower the cost of prescription drugs and health care for families” thanks to provisions that allow the Department of Health and Human Services to negotiate the price of some medications directly with pharmaceutical companies.
Critics are decidedly less enthusiastic. They say the IRA’s new drug price provisions are more akin to government price-fixing than negotiation – an unprecedented power grab in health care.
As of Oct. 1, the new law requires drugmakers to pay rebates to Medicare if the costs of certain drugs rise faster than annual inflation. If the government determines that the price of a drug increased 6% and the inflation rate that year was 4% – regardless of how or why the price rose – the manufacturer will be required to pay the government back the 2% difference in the price. The law does not provide an appeals process.
And starting in 2026, the IRA permits the government to “negotiate” a “maximum fair price” for certain prescription drugs purchased by the Medicare program. Under the new law, “negotiation” means the HHS determines the price it wants to pay for a specified medicine. Drug manufacturers can counteroffer, but if HHS doesn’t budge, the pharmaceutical company has no choice but to accept that price. Otherwise, the IRS will be empowered to slap the company with a “noncompliance” excise tax of up to 1,900% of the medicine’s daily U.S. revenue until the manufacturer sells the drug at the price HHS has set or withdraws from the market.
“I don’t believe that’s negotiation,” said Matt Wetzel, a Washington, D.C. lawyer at Goodwin Procter who specializes in health care policy. “This is the opportunity to give one counteroffer and then a price cap is generated.”
Cory Andrews of the Washington Legal Foundation, a free-market advocacy group in Washington, D.C., was even more blunt: “No matter how obscured by a regulatory haze, strong-arm robbery is not a ‘negotiation’ for a ‘fair’ price.”
HHS did not respond to a request for comment on the new drug pricing provisions. Rep. Curt Schrader of Oregon, a Democrat who claimed a central role in the measure's bipartisan passage after his early objections, also declined to comment.
Although the new rules will only cover a relatively small number of high-priced medicines, critics say this new authority could set a far-reaching precedent for Medicare, which purchases more than 30% (roughly $130 billion per year) of all prescription drugs in the United States. While raising constitutional issues, it may also hinder the development of new drugs.
In October, HHS produced a report to promote its new powers to compel rebates for drugs that exceed inflation, emphasizing that more than 1,200 drugs rose faster than the cost of inflation between July 2021 and July 2022, and the average price increase was 31%.
The powerful pharmaceutical industry, whose deep-pocketed lobbyists have a reputation for very rarely suffering legislative defeats, appears to be keeping its powder dry so far. Brian Newell, a spokesman for the drug manufacturer advocacy group Pharmaceutical Research and Manufacturers of America (PhRMA), said that for now the industry is evaluating its legal options.
If a drug manufacturer objects to the price dictated by HHS or thinks the government has unfairly calculated the inflation rebates, it has little legal recourse even if it can be demonstrated that the price the government wants them to accept is below manufacturer cost. The law also contains language prohibiting judicial or administrative review of whether the drug is eligible for negotiation or the price that is set. The IRA also imposes fines of up to $1 million a day if the company fails to provide HHS with any information it demands. And if a drug company is determined to have “knowingly” provided inaccurate information to the government, it can be fined up to $100 million.
The only way a manufacturer can exit a negotiation is if it chooses to withdraw all its products from being purchased by Medicare and Medicaid. Pulling out would be a financially ruinous move since those programs are far and away the largest buyers of prescription drugs in America.
Andrews called the price dictates radical and unprecedented in American history. “Apart from one or two rare wartime exceptions, due process requires that a party deprived of property must have the opportunity to be heard,” he said. “The IRA's bar on administrative or judicial review is an unprecedented deprivation of due process.”
In addition, the law gives Health and Human Services three years’ leeway. “CMS and HHS, for purposes of the statute will issue guidance through program instructions for the first three years and not through Notice of Proposed Rulemaking,” Wetzel said. “In other words, for the first three years, CMS has sort of full latitude to implement the program as it sees fit without public input and without stakeholder input or feedback, as is typically the case when implementing regulations.” Wetzel added that CMS, the Center for Medicare and Medicaid Services, the agency within HHS responsible for administering the law, has already submitted a plan to Congress noting that implementing the law will require adding six new divisions to the agency and 95 new federal employees.
'Price Negotiation' Redefined
Containing rising drug costs has long been a priority for reining in Medicare spending. The program has $103 trillion in unfunded liabilities, more than three times the national debt, according to the Congressional Research Service.
Democrats have long sought to leverage the government’s buying power to drive down drug prices as a way to address both Medicare spending and overall health care costs without having to make structural reforms to a popular social program. According to the Kaiser Family Foundation, prescription drugs “account for 10% of national health spending and nearly 20% of health benefit costs for large employers.”
Government negotiations over Medicare drug prices were legally forbidden until the passage of the IRA. In 2003, Congress passed the “Medicare Prescription Drug, Improvement, and Modernization Act” which created Medicare Part D (Medicare’s prescription drug benefit program). As part of that legislation, Congress included what’s become known as Medicare’s “noninterference” clause which states “the [HHS] Secretary may not interfere with the negotiations between drug manufacturers and pharmacies,” along with forbidding government intervention with other relevant entities that play a role in the drug market. According to PhRMA, the purpose of the noninterference clause was to preserve market competition within the Medicare program which helps drive prices down.
Since then, congressional Democrats had been attempting to repeal the noninterference clause, and it’s long been clear “drug price negotiation” was being redefined to include price controls and other regulatory inducements. Most notably, in 2007 the House passed the “Medicare Prescription Drug Price Negotiation Act of 2007,” but the legislation died after Senate opposition and President George W. Bush’s threatened veto. According to The New York Times, Republicans opposed government drug price negotiations because “private insurers and their agents, known as pharmacy benefit managers, were already negotiating large discounts for Medicare beneficiaries.”
This view was affirmed by the nonpartisan Congressional Budget Office, which concluded that allowing HHS to negotiate the price of drugs would have a “negligible effect” on federal spending. However, in 2007 the CBO told Oregon Senator Ron Wyden, a longtime champion of Medicare drug price negotiation, that coercive tactics might produce the results Democrats wanted to see. “Negotiation is likely to be effective only if it is accompanied by some source of pressure on drug manufacturers to secure price concessions,” said the CBO. “The authority to establish a formulary, set prices administratively, or take other regulatory actions against firms failing to offer price reductions could give the Secretary the ability to obtain significant discounts in negotiations with drug manufacturers.”
Given the statutory language forbidding judicial or administrative review, the pharmaceutical industry’s options are limited if it chooses to fight. Legal experts say the Constitution – which prohibits the government from taking property without just compensation in the Fifth Amendment and from imposing “excessive fines” under the Eighth Amendment – may provide the best grounds for a challenge, especially if HHS uses its new powers aggressively.
Slowing New Drug Development
“Under the IRA, the offense may be no more than a manufacturer’s hesitation to agree to give away its product at far-below-market prices,” Andrews said. “The IRA’s eye-popping, nine-figure fines bear no conceivable connection to any government injury.” A conservative Supreme Court, he said, might be sympathetic to these arguments. In the 2012 case NFIB v. Sebelius, the high court rebuked the government for a similarly punitive legislative scheme. In that instance, the federal government had framed the decision of state governments to expand the Medicaid program as a choice, even though it threatened to withdraw states’ existing Medicaid funding if they did not agree to the costly expansion. Chief Justice John Roberts described that arrangement as a “gun to the head.”
There are also warning signs coming from the pharmaceutical industry that the new law could slow the development of new drugs. In late October, Alnylam, a biotech company based in Cambridge, Massachusetts, announced it was pulling one of its drugs out of a clinical trial because it needed “to evaluate impact of the Inflation Reduction Act.” The snag was that the drug Alnylam was evaluating as a treatment for a rare eye disorder called Stargardt disease was already approved to treat a different condition, amyloidosis. According to the new law, drugs that treat only one rare disease are exempt from being forced into price negotiations. If the drug were found to be effective for two diseases, Alnylam might be forced into selling it for a reduced or unprofitable price.
Alnylam seems unlikely to be the only company to pull a potential cure or treatment off the market in an attempt to avoid price controls. A study published by the University of Chicago in November concluded that the IRA’s price controls will result in the pharmaceutical industry spending $663 billion less on research and development through 2039, which will result in 135 fewer new drugs making it to market. In contrast, the CBO estimates that the decline in research and development spending would result in only five fewer drugs being produced during that time span.
Regardless of how much price controls impact innovation, congressional Democrats have produced reports arguing that pharmaceutical companies have engaged in anticompetitive behavior and blatant price-gouging. The IRA’s price controls seem to be a direct response to this concern. The law specifically caps Medicare insulin prices, which have increased 600% in the last 20 years and are significantly higher in America than anywhere else in the developed world. But despite headline-grabbing examples of rising drug costs, the industry also claims that the government has overstated the problems of rising pharmaceutical costs to justify regulation.
PhRMA argues that focusing on the cost of only 1,200 of the more than 20,000 prescription drugs available in the U.S. doesn’t paint the full picture. “If there's one thing in all the inflation data that hasn't been rising as fast as the rate of inflation, it's actually drug prices,” Newell said. “Overall drug prices have been going up roughly 1% to 2% while the economy has been running hot on inflation.” From June 2021 to June 2022, roughly the same time period covered by the HHS report, the government’s official Consumer Price Index data affirms Newell, noting that drug prices rose somewhere between 0.1 and 2.5%. HHS did not respond to a request for comment on why its study on drug prices rising faster than inflation focuses only on a narrow subset of the prescription drug market.
But big-picture inflation data can also be misleading. Relatively inexpensive, generic medicines account for about 90% of the prescriptions filled, while a small number of expensive specialty drugs – defined as those with a price of at least $830 per month and mostly produced by major pharmaceutical companies – eat up a huge share of government spending. According to a 2019 CRS report, “specialty drugs are about 1% of Part D prescriptions but account for more than 25% of spending, up from 6% in 2007.” The fact that such a small percentage of drugs are disproportionately expensive is one reason why Democrats think giving HHS the power to set prices for as few as 20 widely used and expensive specialty drugs could help lower overall costs.
At the same time, PhRMA spokesperson Newell expresses frustration that the new legislation focuses so narrowly on lowering prices rather than examining the incentives that raise costs for drug companies. While Congress points the finger at pharmaceutical companies, they’re not addressing the fact high drug prices are also created by a heavily regulated pharmaceutical market mandating complex interactions between drug companies, insurers, pharmacies, hospitals, government rebates, and federal drug discount programs.
“We haven't really looked at this insuranc e system that we have today and what's really driving what patients pay at the pharmacy,” says Newell, adding, “There are things in the system today that just aren't working. At the end of day, we haven't fixed the fact that years from now patients with insurance will show up at the pharmacy and get stuck with a bill that they can't afford.”
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December 23, 2022
Unvaccinated Blood Is Now in Very High Demand
It’s unknown whether blood donated by people who’ve received mRNA COVID-19 shots poses a risk to those who receive it. A growing number of people aren’t willing to take any chances, however, and are requesting blood that comes from unvaccinated patients. One high-profile case involves a 4-month-old baby, Will Savage-Reeves, in New Zealand, who needs surgery for a heart valve disorder.
His parents, Samantha and Cole, requested the infant receive blood only from donors who have not received COVID-19 shots. While unvaccinated blood is available, the doctors and hospital refused to grant the request. The case was heard before a New Zealand court, which sided with the doctors and took guardianship of the child to proceed with the surgery using vaccinated blood.1,2
Hospital Refuses Family’s Request for Unvaccinated Blood
The outcome of baby Will’s case may serve as a harbinger of things to come. The hospital argued that the surgery should proceed using vaccinated blood because of the importance of finding a quality match. A large pool of donor blood raises the possibility of finding the highest quality match.
In addition, according to Steve Kirsch, executive director of the Vaccine Safety Research Foundation, another of their arguments is, “If there were a safety signal from using vaccinated blood for transfusions, it would have surfaced by now.” They also want to keep up appearances, and allowing one patient to use unvaccinated blood may open the floodgates to others requesting the same. Kirsch noted:3
“If they agree to use unvaccinated blood, it could be interpreted as an admission that vaccinated blood is not safe and could lead to everyone requesting unvaccinated blood which would then create severe blood shortages for a dubious benefit.”
Further, the New Zealand Blood Service (NZBS) manages blood donations and collections in New Zealand. Only a specialist doctor can request directed donation for the baby to received unvaccinated blood.
But, Kirsch noted, “The clinicians responsible for the surgery determined that there was insufficient evidence to make a special request … The hospital cannot compel the NZBS to do what it says, e.g., even if the doctors agreed with the parents, NZBS can still refuse to supply the blood if it doesn’t think the request is justified.”4
The hospital also claimed mRNA shots “to date remain safe.”5 According to Kirsch, “The court, lacking the legal and technical ability to second guess the doctors, therefore sided with the expert opinion of the doctors.”6
The media, meanwhile, are painting the reasonable request to honor the precautionary principle as a conspiracy theory and disinformation dreamed up by fringe “anti-vaxxers.” Case in point, The New York Times reported:7
“The case, and the family’s flawed scientific arguments, highlight the continuing dangers of online misinformation and conspiracist narratives, experts say. The dispute has ‘become a cause célèbre in the most toxic way,’ prompting a spike in hate speech on fringe platforms where conspiracy theories run rife, said Sanjana Hattotuwa, a researcher at the Disinformation Project, a New Zealand monitoring group.”
Not only did the New Zealand health service refuse the family’s request, but New Zealand’s High Court granted two doctors authority to make medical decisions regarding baby Will.8 It didn’t need to go this far, supporters have stated, since there is ready availability of blood from unvaccinated donors.9
In a similar case in Italy, however, a judge also ruled against parents who requested blood transfusions only from unvaccinated donors be used during their 2-year-old son’s heart surgery.10
Embalmers Find Unusual Clots in Veins Post-Shots
Richard Hirschman, a board-certified embalmer and funeral director with more than 20 years of experience, has come forward stating that, in the time period since COVID-19 shots were rolled out, starting around the middle of 2021, he’s been finding “strange clots” in the bodies of the deceased.
“When I do the embalming, I have to go into the vein. And in order for the embalming process, I have to allow blood to be drained. So I actually pulled this huge, long clot — fibrous looking clot — out prior to an embalming,” Hirschman said.11
The beginning of the clot, which resembles a white, rubbery worm, appears red and like a normal clot. But the majority of the clot is different: It’s composed of a white, fibrous material. “It just isn’t normal,” he said, adding:12
“Typically, a blood clot is smooth; it’s blood that has coagulated together. But when you squeeze it, or touch it or try to pick it up, it generally falls apart … you can almost squeeze it between your fingers and get it back to blood again. But this white fibrous stuff is pretty strong. It’s not weak at all. You can manipulate it, it’s very pliable. It’s not hard … it is not normal. I don’t know how anybody can live with something like this inside of them.”
What’s important to note is embalmers have reported finding unusual clots not only in deceased people who’ve received the shots but also in those who have had a blood transfusion. So while we don’t know what risk there is from receiving blood from someone who’s had COVID-19 shots, “the risk is not zero,” Kirsch said.13
Another case involves a baby, Alexander, who received a vaccinated blood transfusion and developed “an enormous clot that eventually stretched from his left knee, all the way to his heart,” and died.14 According to Kirsch, the hospital then went on to delete all related medical records:15
“Sacred Heart Hospital in Washington State has erased all records of the death of baby Alex who died from a blood clot after receiving a transfusion from a vaccinated patient. So there is no evidence of a problem anymore. They erased it, just like the CDC erased all data linking vaccines and autism. This is how science works nowadays.”
Is the Blood Supply Safe? Nobody Knows
In the U.S., a person is in need of blood every two seconds.16 If you have a medical emergency, getting a blood transfusion can be life-saving. But should patients have the option of choosing to receive blood that hasn’t been exposed to mRNA COVID-19 shots?
The Red Cross states they’re following the U.S. Food and Drug Administration’s blood donation eligibility guidance, which states, “In most cases, there is no deferral time for individuals who received a COVID-19 vaccine as long as they are symptom-free and feeling well at the time of donation.”17
“While the antibodies that are produced by the stimulated immune system in response to vaccination are found throughout the bloodstream, the actual vaccine components are not,” Jessa Merrill, Red Cross director of biomedical communications, told The Daily Beast.18 Further, after speaking to Dr. Peter McCullough, cardiologist, internist and epidemiologist, Kirsch reported:19
“He said he’d take the vaccinated blood because of the critical nature of the matching process. With donor blood, the match quality would not be as good because there is a smaller pool to draw from, and it’s not just blood type that is matched.
Nobody has quantified the risk of using vaccinated blood. He said if the risk were high, it would have been noticed by now (I’m not sure I agree with that; there is a lot of willful blindness for anything associated with the vaccine).”
Many Contracted AIDS Via Tainted Blood Transfusions
Pathologist Dr. Ryan Cole compared the current unknowns regarding “vaccinated blood” with HIV-tainted blood that was used for transfusions in the 1980s:20
“We don’t know. Nobody knows. I have clots from unvaccinated deceased that were transfused and formed large clots post transfusion and died. No blood bank is checking. ‘One cannot find, that for which they do not look.’ This is akin to blood banks and hemophiliacs and HIV in the 1980s. It may not be a problem.
However, it may be. There are assays academically available to check for circulating spike protein. It is criminal negligence to not assure the safety of the blood supply based on bureaucratic declarations without scientific explorations.”
Similarly, in January 1983, after the U.S. Centers for Disease Control and Prevention revealed evidence strongly suggesting blood and blood products transmitted AIDS and the disease was sexually transmitted, it recommended blood banks directly question donors about their sexual behavior and run blood donations through a series of screening tests.21
The blood bank community issued a statement soon after, stating “direct or indirect questions about a donor’s sexual preference are inappropriate” and not recommending any laboratory screening tests.22 As noted by Encyclopedia.com:23
“In fact, in the early years of the disease, many of the people who contracted AIDS were infected through blood transfusions. Because it took more than five years to develop a test to check for AIDS in blood before it was used in a transfusion, many people got the disease in hospitals.
The AIDS epidemic continued to grow in Africa and Asia during the 1990s and even in the early 21st century because many nations were slow to adopt blood testing.”
In the 1980s, increasing fears over tainted transfusions led many people to say they’d refuse donated blood entirely. One man, whose wife died of AIDS contracted through a contaminated transfusion, told the AP in 1985, “You want to play Russian Roulette? Even if it were an emergency — and I had some say in the matter — I wouldn’t take blood out of the pool.”24
Now, decades later, doctors are hearing similar concerns from patients regarding vaccinated blood. Dr. Davinder Sidhu, the division head for transfusion and transplant medicine for southern Alberta, Canada, told CTV News he gets requests for blood from unvaccinated donors “at least once or twice a month over the last several months.”25
Is it Your Right to Receive ‘Unvaccinated’ Blood?
As it stands, blood donation centers may ask about vaccines their donors have received,26 but it’s not guaranteed that this information will be passed on to consumers. The Red Cross also states, “If you’ve received a COVID-19 vaccine, you’ll need to provide the manufacturer name when you come to donate.”27
Still, it’s unlikely that most hospitals will readily divulge this information when it comes to receiving a blood transfusion. So what are your options if you’re looking for blood from a donor that’s hasn’t received a COVID-19 shot? Directed donations, in which a donor donates blood for a specified receiver, are an option, but they’re typically only used in cases where matched blood is unavailable due to extremely rare blood types.28
Autologous donations, or self-donation, is another option, in which you donate blood for your own use, such as before a medical procedure like surgery. In both cases, you’ll need your doctor to submit a Red Cross Special Collections Order form to complete an autologous or directed blood donation.29
A “Safe Blood” donation campaign has also been formed to match blood donors and recipients who have not had COVID-19 shots. For now, they’re acting as a resource to match donors with those in need of blood, but the hope is that an mRNA-free blood bank will be established:30
“There is no blood bank with mRNA-free blood yet, not even with us. And, although we have already asked hundreds of clinics, at the moment — at least in Europe — all of them still refuse to allow the human right of free blood choice with them — or at least do not want to be mentioned, because otherwise they fear reprisals. However, we promise you that we will not give up until we can offer a worldwide network of such clinics.”
As for baby Will, whose parents’ hopes for an mRNA-free blood transfusion have been dashed, Kirsch said:31
“Whatever happened to the precautionary principle of medicine? In my opinion, this isn’t a close call. We can’t know today if the blood supply is safe because nobody wants to even ask the question and do the experiments required to answer it. For that reason, Baby Will’s parents’ request to use unvaccinated blood should be respected.”
https://www.theepochtimes.com/health/unvaccinated-blood-is-now-in-very-high-demand_4934809.html
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Australian scientists could have found the ‘masterswitch’ to kill cancer
As I have benefited greatly from immunotherapy, I am pleased to hear of another immunotherapy advance. Specific substances are needed to energize attacks on specific types of cancer cell. Keytruda worked like a charm on my SCCs
Queensland medical researchers are on the brink of a staggering breakthrough that sees palpable tumours completely melting away, offering hope to sufferers of two of the deadliest types of cancers.
QIMR Berghofer scientists have potentially found the “masterswitch” that turns on the immune system to target disease in patients with triple-negative breast cancer and the most common form of bowel cancer, Micro Satellite Stable (MSS) bowel cancer.
The remarkable research findings could finally provide hope for a new, effective therapy but funding is desperately needed to progress the exciting preclinical results into clinical trials.
Associate Professor Michelle Wykes, group leader of Molecular Immunology at QIMR Berghofer, discovered the potential “masterswitch” that turns on a key type of immune cell called dendritic cells while researching immune responses to malaria.
Dendritic cells act like the generals of the immune system waking up other immune cells such as T cells and telling them what to attack and the weapons to use. However, cancer cells are very good at hiding from the immune system. In preclinical testing, the “masterswitch” antibodies make the cancers visible again, so the dendritic cells can go back to work and ‘organise’ the T cells to kill the cancer.
Associate Professor Wykes said further testing of the “masterswitch” antibodies on cancer patient blood samples produced similar results to the testing in preclinical lab work.
“We’re seeing palpable tumours that completely disappear and melt away. In our preclinical lab models, 80 per cent of both the triple negative breast cancers and colon cancers were cleared and hadn’t grown back after ten months. We’re seeing similar results from our tests on samples taken from patients with colon cancer,” she said.
“These patients urgently need help and I have something that I think could really help them, but we need funding to bring us together with a treatment. We’re appealing to the generosity of Australians this Christmas to help us advance this vital research and bring hope to patients and their loved ones,” Assoc Prof Wykes said.
Brisbane mum Justine Dillon was at peak physical fitness when she was diagnosed with highly aggressive stage four bowel cancer and given 18 months to live.
The researchers are working with clinicians at the Royal Brisbane and Women’s Hospital who collected samples from patients for the researchers to test in the laboratory.
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Scientists say they may have uncovered a new treatment for one of the most common symptoms of Long Covid
Researchers at Yale University managed to lift the “brain fog” of eight patients with the condition who were given a mixture of guanfacine, commonly used for ADHD, and an antioxidant called N-acetylcysteine (NAC), which in the UK is mainly used to treat paracetamol overdose and respiratory illnesses.
So far, the treatment has only been tested on a small number of Long Covid sufferers, who were also mainly women, though researchers said the study looked promising for more extensive clinical trials.
But given the potentially devastating and widespread impact of Long Covid, researchers believe doctors should consider prescribing guanfacine to patients.
“If patients have a physician who can read our paper, we’re hoping that they can access help right now,” neuroscientist Amy Arnsten said.
She and her team believe that the combination of drugs could prove “immediately useful“ to millions of sufferers.
Some 2.3 million people in the UK are estimated to be living with long Covid, official figures show.
According to the NHS, brain fog elicits a similar feeling to the effects of sleep deprivation or stress. It lists common symptoms of brain fog as poor concentration, feeling confused, thinking more slowly than usual, fuzzy thoughts, forgetfulness, lost words and mental fatigue.
It’s not necessarily a symptom of those who were hospitalised with Covid and people usually recover from it.
“There’s a paucity of treatment out there for long Covid brain fog, so when I kept seeing the benefits of this treatment in patients, I felt a sense of urgency to disseminate this information,” neurologist Arman Fesharaki-Zadeh explained.
“You don’t need to wait to be part of a research trial. You can ask your physician – these drugs are affordable and widely available.”
Mr Fesharaki-Zadeh first decided to try the drug combination after considering the inflammatory effects of Covid on the human body.
The team of researchers has since tested the treatment on a dozen other patients suffering from Long Covid. Participants took 600 milligrams of NAC daily and one milligram of guanfacine at bedtime.
After a month, the guanfacine dosage was increased to two milligrams.
All eight participants who finished the trial reported substantial benefits to their memory, organisational skills, and multi-tasking abilities. While some said it cured their brain fog completely, others said they had recovered their sense of self.
The study was published in Neuroimmunology Reports.
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Judge Approves $10 Million Settlement for Health Care Workers Fired Over COVID-19 Vaccine Mandate
A U.S. judge approved a multimillion-dollar settlement on Dec. 19 for workers who were fired by an Illinois health care system for refusing to get a COVID-19 vaccine.
About 500 workers who were terminated or, after seeing their exemption requests denied, got a COVID-19 vaccine, will receive compensation as part of the $10.3 million settlement, a preliminary version of which was first announced in July.
U.S. District Judge John Kness, a Trump appointee overseeing the lawsuit brought by the workers, issued verbal approval for the settlement during a hearing, lawyers for Liberty Counsel and NorthShore University Healthsystem said. Kness plans to release a written judgment in the next week.
In a brief statement emailed to The Epoch Times after Kness’s approval, NorthShore wrote, “We are pleased with the Court’s approval of a supportive resolution to this matter and continue to prioritize the health and safety of our patients and team members.”
Harry Mihet, vice president of legal affairs for Liberty Counsel, said in a statement that the group was “pleased to finally get the court’s final approval of this classwide settlement for these health care workers who were unlawfully discriminated against and denied religious exemptions from the COVID shot mandate.”
“This case should set a precedent for other employers who have violated the law by denying religious exemptions for their employees,” he said.
Liberty Counsel, a legal group that brings cases of alleged religious discrimination, was representing the 13 named plaintiffs in the case. The group successfully won class certification for all workers who were denied religious exemptions, a group that was initially believed to be 499 former and current workers but swelled after the preliminary settlement agreement to at least 519.
As of Dec. 12, 493 class members had submitted claims for a piece of the settlement.
Each worker who was fired stands to receive $24,225. Each worker who remained at the company stands to receive $3,725.
The named plaintiffs are in line to receive an extra $20,000. Those payments, described as service awards, will provide compensation for the plaintiffs helping advise on court filings, gathering documents, and serving as lead plaintiffs “in a sensitive case involving personal health choices and religious beliefs over a matter of intense public debate, even when it was uncertain whether they would have to disclose their identities to the public,” according to a recent filing.
Three workers objected to the settlement, but both parties urged the judge to disregard the objections, which were largely based on pay the trio felt they were owed after being fired.
Marzena Novak, one of the objectors, said her actual losses from being fired and losing pay approached $140,000.
“Although the estimated $25,000 is helpful and will be welcomed, it doesn’t come close to the actual losses suffered by those they treated so poorly,” Novak wrote.
Mandate
Like many health care systems, NorthShore imposed a vaccine mandate on employees in 2021.
NorthShore told workers that they could file a request for a religious exemption using a form that said the worker in question needed to provide “a description of my sincerely held religious principle or practice that guides my objection to receiving the required vaccination.” Northshore explicitly instructed applicants to not fill out lengthy answers.
NorthShore initially approved some of the exemption requests but then reversed the decisions and denied “all or virtually all of them,” according to filings from the plaintiffs. Officials said the employees failed to meet the standard for religious exemptions.
Employees who wanted a second look were told to file an appeal that included their vaccination history since they were 18. NorthShore then said that any religious objections based on “aborted fetal cell lines, stem cells, tissue, or derivative materials” would result in denials because those products were “not in NorthShore administered vaccines.” All of the COVID-19 vaccines available in the United States have links to aborted fetal cell lines.
At one point, one of the plaintiffs said, her manager said that “we are not approving anyone” for exemptions, although at least several were approved.
“Instead of engaging Plaintiffs in good faith, NorthShore denied Plaintiffs’ religious exemption requests en masse, providing nothing more than copy and paste responses, informing them that they lacked ‘evidence-based criteria,’ whatever that means,” one filing reads. “By failing to engage any of the Plaintiffs and its numerous employees with religious objections in good faith, NorthShore had no way to know whether an acceptable accommodation might have been appropriate. The only responses received by Plaintiffs and NorthShore’s employees were one-size-fits-all blanket denials.”
The plaintiffs said the treatment violated the Civil Rights Act, which requires employers to treat workers similarly, and the Illinois Health Care Right of Conscience Act, which forbids discrimination on the basis of “right of conscience.”
NorthShore repeatedly denied that it violated the law.
The system also stated that it was “an undue hardship” to let unvaccinated staff work at NorthShore and that “it initially denied many exemption requests and that on appeal it reconsidered some decisions and chose not to challenge that the requests were made based on sincerely held religious beliefs.”
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December 21, 2022
Australia: Prominent lesbian doctor reveals ‘devastating’ Covid vaccine injury, says doctors have been ‘censored’
Former federal MP Dr Kerryn Phelps has revealed she and her wife both suffered serious and ongoing injures from Covid vaccines, while suggesting the true rate of adverse events is far higher than acknowledged due to underreporting and “threats” from medical regulators.
In an explosive submission to Parliament’s Long Covid inquiry, the former Australian Medical Association (AMA) president has broken her silence about the “devastating” experience — emerging as the most prominent public health figure in the country to speak up about the taboo subject.
“This is an issue that I have witnessed first-hand with my wife who suffered a severe neurological reaction to her first Pfizer vaccine within minutes, including burning face and gums, paraesethesiae, and numb hands and feet, while under observation by myself, another doctor and a registered nurse at the time of immunisation,” the 65-year-old said.
“I continue to observe the devastating effects a year-and-a-half later with the addition of fatigue and additional neurological symptoms including nerve pains, altered sense of smell, visual disturbance and musculoskeletal inflammation. The diagnosis and causation has been confirmed by several specialists who have told me that they have seen ‘a lot’ of patients in a similar situation.”
Dr Phelps married former primary school teacher Jackie Stricker-Phelps in 1998. “Jackie asked me to include her story to raise awareness for others,” she said.
“We did a lot of homework before having the vaccine, particularly about choice of vaccine at the time. In asking about adverse side effects, we were told that ‘the worst thing that could happen would be anaphylaxis’ and that severe reactions such as myocarditis and pericarditis were ‘rare’.”
Dr Phelps revealed she was also diagnosed with a vaccine injury from her second dose of Pfizer in July 2021, “with the diagnosis and causation confirmed by specialist colleagues”.
“I have had CT pulmonary angiogram, ECG, blood tests, cardiac echogram, transthoracic cardiac stress echo, Holter monitor, blood pressure monitoring and autonomic testing,” she wrote.
“In my case the injury resulted in dysautonomia with intermittent fevers and cardiovascular implications including breathlessness, inappropriate sinus tachycardia and blood pressure fluctuations.”
Dr Phelps said both reactions were reported to the Therapeutic Goods Administration (TGA) “but never followed up”.
She revealed she had spoken with other doctors “who have themselves experienced a serious and persistent adverse event” but that “vaccine injury is a subject that few in the medical profession have wanted to talk about”.
“Regulators of the medical profession have censored public discussion about adverse events following immunisation, with threats to doctors not to make any public statements about anything that ‘might undermine the government’s vaccine rollout’ or risk suspension or loss of their registration,” she wrote.
The Australian Health Practitioner Regulation Agency (AHPRA), which oversees Australia’s 800,000 registered practitioners and 193,800 students, last year warned that anyone who sought to “undermine” the national Covid vaccine rollout could face deregistration or even prosecution.
AHPRA’s position statement said that “any promotion of anti-vaccination statements or health advice which contradicts the best available scientific evidence or seeks to actively undermine the national immunisation campaign (including via social media) is not supported by National Boards and may be in breach of the codes of conduct and subject to investigation and possible regulatory action”.
Earlier this year, Australian musician Tyson ‘tyDi’ Illingworth said he had been told privately by doctors that they feared being deregistered if they linked his neurological injury to the Moderna vaccine.
Dr Phelps said she had heard stories of vaccine injury from “patients and other members of the community”.
“They have had to search for answers, find GPs and specialists who are interested and able to help them, spend large amounts of money on medical investigations, isolate from friends and family, reduce work hours, lose work if they are required to attend in person and avoid social and cultural events,” she said.
“Within this group of vaccine injured individuals, there is a diminishing cohort of people who have symptoms following immunisation, many of which are similar to Long Covid (such as fatigue and brain fog), but who have not had a Covid infection. These people would be an important subset or control group for studies looking into the pathophysiology, causes of and treatments for Long Covid. It is possible that there is at least some shared pathophysiology between vaccine injury and Long Covid, possibly due to the effects of spike protein.”
She added that “in trying to convince people in positions of influence to pay attention to the risks of Long Covid and reinfection for people with vaccine injury, I have personally been met with obstruction and resistance to openly discuss this issue”.
“There has been a delay in recognition of vaccine injury, partly because of under-reporting, concerns about vaccine hesitancy in the context of managing a global pandemic, and needing to find the balance between risks and benefits on a population level,” she said.
“Reactions were said to be ‘rare’ without data to confirm how common or otherwise these reactions were. In general practice I was seeing cases, which meant other GPs and specialists were seeing cases too. Without diagnostic tests, we have to rely largely on clinical history.”
In July this year, the independent OzSAGE group of which Dr Phelps is a member issued a position statement calling for better systems and management of Covid vaccine adverse events and “recognition of the impact of vaccine injury”.
Dr Phelps, who was heavily involved in crafting the statement, wrote in her submission that the OzSAGE document “outlines the scope but not the scale of the problem because we do not know the scale of the problem”. “This is partly because of under-reporting and under-recognition,” she said.
According to the TGA’s most recent safety update, there have been a total of 137,141 adverse event reports from nearly 64.4 million doses — a rate of 0.2 per cent.
There have been 819 reports “assessed as likely to be myocarditis” from 49.8 million doses of Pfizer and Moderna. Fourteen deaths have officially been linked to vaccination — 13 after AstraZeneca and one after Pfizer.
But Dr Phelps pointed to data from Germany’s pharmacovigilance body, the Paul Ehrlich Institute (PEI), which has “undertaken ongoing surveys of vaccine recipients … as opposed to the TGA which only accepts passive reports, or AusVaxSafety whose survey stopped at six weeks”.
“They have found that the incidence of serious reactions occurs in 0.3 per 1000 shots (not people),” she said.
“Considering that the majority of Australian adults have now had at least one booster, this suggests that the incidence of serious adverse reactions per vaccinated person could be more than 1-in-1000. PEI admits that under-reporting is a problem, and observers suggest that an order of magnitude of under-reporting is not unreasonable to consider (most estimates put underreporting at much worse than this).”
Dr Phelps said there was concern some adverse events could “cause long-term illness and disability”, but data was limited because the “global focus has been on vaccinating as many people as quickly as possible with a novel vaccine for a novel coronavirus”.
“Because of this, all of the studies that have been published so far are either small, or case studies only,” she said.
“The burden of proof seems to have been placed on the vaccine injured rather than the neutral scientific position of placing suspicion on the vaccine in the absence of any other cause and the temporal correlation with the administration of the vaccine.”
She noted some countries had gathered significant databases of adverse events, ranging from allergy and anaphylaxis to cardiovascular, neurological, haematological and auto-immune reactions.
Despite the recognition of heart inflammation associated with the Pfizer and Moderna mRNA vaccines, Dr Phelps said “even then, there has been a misconception that myocarditis is ‘mild’, ‘transient’ and ‘mostly in young males’, when there are many cases where myocarditis is manifestly not mild, not transient and not confined to the young male demographic”.
Dr Phelps said until there was acknowledgment and recognition of post-vaccination syndrome or vaccine injury, “there can be no progress in developing protocols for diagnosis and treatment and it is difficult to be included in research projects or treatment programs”.
“It has also meant a long and frustrating search for acknowledgment and an attempt at treatment for many individual patients,” she said.
“People who suffer Covid vaccine injury may present with a range of symptoms, and results of standard medical tests often come back normal. And like patients with Long Covid, they too are also asking the medical profession and public health systems for help.”
Earlier this year, Dr Rado Faletic — who previously spoke out about his battle with the TGA — launched Australian advocacy group Coverse to provide support and collect testimony from those suffering vaccine injuries.
AHPRA said in a statement that the regulator had “been clear in all of our guidance about Covid-19 vaccinations that we expect medical practitioners to use their professional judgement and the best available evidence in their practice”.
“This includes keeping up to date with public health advice from Commonwealth, state and territory authorities,” a spokeswoman said.
“Legitimate discussion and debate, based on science is appropriate and necessary to progress our understanding and knowledge. The [March 9, 2021 position] statement does not prevent practitioners from having these discussions.”
She added that as of June 2022, only 11 practitioners had been suspended “in relation to concerns raised about Covid-19”.
“The concerns raised about the practitioners related to the spreading of misinformation about Covid-19 or vaccination advice, including that the Covid-19 pandemic was fake, that the vaccination program was about government led mind control or in some instances representing that patients would develop cancer by having a vaccination administered,” she said.
Dr Phelps, who remains a practising GP, was elected as the first female president of the AMA in 2000.
She was also a City of Sydney councillor from 2016 to 2021, and Deputy Lord Mayor under Clover Moore from 2016 to 2017.
In 2018, Dr Phelps ran as an independent candidate in the by-election for the eastern suburbs seat of Wentworth following the resignation of Prime Minister Malcolm Turnbull, defeating Liberal Dave Sharma.
She spent less than a year in federal parliament, losing to Mr Sharma in a rematch in the May 2019 election.
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December 20, 2022
Should treatment for blood clots be routine in some Covid patients?
My heading above is a plain English version of the first academic heading below. Blood clots can do a lot of harm so are a serious problem. But they can be treated with considerable success by blood thinners such as Warfarin. But Warfarin has its problems too. It can cause bleeding. So, obviously, you use it only when it is clearly needed.
And the BIG question is whether you should use it for prevention. Should you give it to a patient BEFORE they get any symptoms?
Nobody is saying that you should give thinners to ALL Covid patients so the question is whether you should give it to high-risk patients? If so, how do you identify the patients most likely to suffer from blood clots?
So you can see that there is a real problem there. The study from Oxford University below tries to solve that puzzle
And there are some categories of patient who usually ARE high risk. We can identifty some patients as being at risk. So how great does the risk have to be before you give a patient thinners? The article below tries to answer that and concludes that there are some cases that should get preventive treatment.
But the problem is a difficult one so I reproduce below the Abstract from the original Oxford article plus two further comments on it.
A crude summary of the findings is that fat old guys should be given thinners. I am old and a bit overweight so if ever I get Covid, I should probably be given a low dose of thinners
Clinical and Genetic Risk Factors for Acute Incident Venous Thromboembolism in Ambulatory Patients With COVID-19
JunQing Xie et al.
Key Points
Question What is the 30-day acute risk of venous thromboembolism (VTE) among ambulatory patients with COVID-19, and what are the clinical and genetic risk factors predisposing them to developing post–COVID-19 VTE?
Findings In this retrospective cohort study of 18 818 outpatients with COVID-19 and 93 179 propensity score–matched noninfected participants, a higher VTE incidence was observed in the former (hazard ratio, 21.42); however, this risk was considerably attenuated among the fully vaccinated, after breakthrough infection. Older age, male sex, obesity, no vaccination or partial vaccination, and inherited thrombophilia were independent risk factors for COVID-19–associated VTE.
Meaning The results of this study suggest that ambulatory patients with COVID-19, either vaccinated or not, present a clinically relevant increased risk of incident VTE during the acute phase, with the risk pronounced by factors of older age, male sex, obesity, incomplete vaccination, and factor V Leiden thrombophilia.
Abstract
Importance The risk of venous thromboembolism (VTE) in ambulatory COVID-19 is controversial. In addition, the association of vaccination with COVID-19–related VTE and relevant clinical and genetic risk factors remain to be elucidated.
Objective To quantify the association between ambulatory COVID-19 and short-term risk of VTE, study the potential protective role of vaccination, and investigate clinical and genetic risk factors for post–COVID-19 VTE.
Design, Setting, and Participants This population-based cohort study of patients with COVID-19 from UK Biobank included participants with SARS-CoV-2 infection that was confirmed by a positive polymerase chain test reaction result between March 1, 2020, and September 3, 2021, who were then propensity score matched to COVID-19–naive people during the same period. Participants with a history of VTE who used antithrombotic drugs (1 year before index dates) or tested positive in hospital were excluded.
Exposures First infection with SARS-CoV-2, age, sex, ethnicity, socioeconomic status, obesity, vaccination status, and inherited thrombophilia.
Main Outcomes and Measures The primary outcome was a composite VTE, including deep vein thrombosis or pulmonary embolism, which occurred 30 days after the infection. Hazard ratios (HRs) with 95% CIs were calculated using cause-specific Cox models.
Results In 18 818 outpatients with COVID-19 (10 580 women [56.2%]; mean [SD] age, 64.3 [8.0] years) and 93 179 matched uninfected participants (52 177 women [56.0%]; mean [SD] age, 64.3 [7.9] years), the infection was associated with an increased risk of VTE in 30 days (incidence rate of 50.99 and 2.37 per 1000 person-years for infected and uninfected people, respectively; HR, 21.42; 95% CI, 12.63-36.31). However, risk was substantially attenuated among the fully vaccinated (HR, 5.95; 95% CI, 1.82-19.5; interaction P = .02). In patients with COVID-19, older age, male sex, and obesity were independently associated with higher risk, with adjusted HRs of 1.87 (95% CI, 1.50-2.33) per 10 years, 1.69 (95% CI, 1.30-2.19), and 1.83 (95% CI, 1.28-2.61), respectively. Further, inherited thrombophilia was associated with an HR of 2.05 (95% CI, 1.15-3.66) for post–COVID-19 VTE.
Conclusions and Relevance In this population-based cohort study of patients with COVID-19, ambulatory COVID-19 was associated with a substantially increased risk of incident VTE, but this risk was greatly reduced in fully vaccinated people with breakthrough infection. Older age, male sex, and obesity were clinical risk factors for post–COVID-19 VTE; factor V Leiden thrombophilia was additionally associated with double the risk, comparable with the risk of 10-year aging. These findings may reinforce the need for vaccination, inform VTE risk stratification, and call for targeted VTE prophylaxis strategies for unvaccinated outpatients with COVID-19.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2795466
***************************************************Is There a Role for Thromboprophylaxis in Selected Outpatients With COVID-19?
Anastasios Kollias et al.
Mr Xie and colleagues1 provide important information on an understudied topic: incident venous thromboembolism (VTE) in outpatients with COVID-19. The findings of their study are commendable and provide useful conclusions. First, COVID-19 was associated with increased VTE risk, even in the outpatient setting given that a higher VTE incidence was shown among 18 818 outpatients with COVID-19 compared with 93 179 propensity score matched, noninfected participants. Second, patients with specific characteristics (older age, male sex, obesity, no/partial vaccination, and inherited thrombophilia) had higher VTE risk. Third, the VTE risk was high for up to 30 days after diagnosis. These findings are highly important and may advance case management and treatment for outpatients with COVID-19.
At present, the available data are generally against the routine use of pharmacologic thromboprophylaxis in outpatients with COVID-19.2,3 Moreover, current guidelines do not provide specific recommendations.4 However, it is common sense that selected outpatients with VTE risk factors are therefore at higher risk for disease worsening and would benefit from thromboprophylaxis on an individualized basis and after careful assessment of bleeding risk. Indeed, data show that major adverse events tend to occur early in patients hospitalized with COVID-19 who have a high-risk profile; prompt thromboprophylaxis would benefit these patients.5
The study by Mr Xie and colleagues was performed during a period when only 41% of patients with COVID-19 had been fully vaccinated; a percentage that has increased worldwide. Thus, it would be interesting to study VTE risk factors separately among the fully vaccinated group—despite VTE events having been infrequent. Moreover, apart from the patient risk factors, the disease characteristics may play a role. Symptoms that indicate disease activity or severity, ie, the duration of the fever, could be contributing to an increased VTE risk in selected patients. In addition, SARS-CoV-2 variants may exhibit a different risk regarding VTE. If these data are available, they would make for another interesting study.
Although thromboprophylaxis among outpatients with COVID-19 is not generally recommended, the data and findings derived from studies, such as this one by Mr Xie and colleagues,1 show that selected outpatients carry an increased VTE risk. On the other hand, widespread immunization, as well as the availability of the antiviral therapies, may be substantially reducing VTE risk. Whether thromboprophylaxis would benefit high-risk outpatients with COVID-19 is unclear, but it seems reasonable to conclude that an individualized strategy would improve their prognosis.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2799543
****************************************************Is There a Role for Thromboprophylaxis in Selected Outpatients With COVID-19? — Reply
Junqing Xie et al.
In Reply In our recent research article regarding clinical and genetic determinants associated with venous thromboembolism (VTE) among community-dwelling patients with COVID-19,1 we reported a marked increase of 30-day VTE and identified older age, male sex, obesity, no or partial vaccination, and inherited thrombophilia as key risk factors. We appreciate the insightful comments from Prof Kollias and colleagues and their support of our call for targeted VTE thromboprophylaxis for outpatients with COVID-19.
Hospitalization is the recommended indicator for initiating antithrombotic therapy for patients with COVID-19. However, we argue that the likelihood of post−COVID-19 VTE should be conceptually seen as a continuum, with some outpatients treated for COVID-19 at an even higher risk of VTE than some hospitalized patients. Also, given that VTE hazard peaks substantially and shortly after SARS-COV-2 infection,2 individuals with COVID-19 would likely benefit from earlier interventions for primary prophylaxis. Our study1 identified several independent risk factors that can be used to stratify patients with different risk profiles for post−COVID-19 VTE. We should highlight that although existing trials (eg, ETHIC, ACTIV-4B) did not generally support routine pharmacologic thromboprophylaxis for outpatients with COVID-19, the results should be interpreted as inconclusive given the great statistical uncertainty and underrepresentation of older patients, and consequently, the low event rates. Therefore, the results do not preclude the use of thromboprophylaxis in selected outpatient subpopulations, particularly among those with a high baseline risk of VTE.3 Further trials targeting high-risk infected outpatients and more real-world studies with larger sample sizes and longer follow-up are warranted to supplement the existing evidence.4
Admittedly, the net benefits of antithrombotic therapy should always be weighed against potential harms5—eg, for those at high risk of VTE, risk of bleeding should be considered when prescribing antithrombotic therapy.6 Of note, genetic risk owing to monogenic thrombophilia or polygenic risk score, as evidenced in our study,1 was exclusively associated with venous but not arterial thromboembolism, which may be promising for identifying individuals susceptible to VTE but resistant to bleeding. Finally, we agree with the proposal from Prof Kollias and colleagues to investigate whether the risk factors persist in fully vaccinated people and what potential value disease symptoms may have for VTE prediction. However, our available data are insufficient for answering this question given the limited sample size: only 6 VTE events among the breakthrough infection cohort.
As the number of COVID-19 outpatient cases continues to increase, personalized prophylactic anticoagulation in this large population may prevent a substantial number of individuals with COVID-19 from developing severe thrombotic complications that require hospitalization and/or intensive care. The clinical and genetic risk factors identified by our study should inform the identification of participants for new research to bridge the knowledge gaps on the risk vs benefit of pharmacologic thromboprophylaxis.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2799542
**************************************************19 December, 2022
The Bible
I have done a bit more writing about Bible topics. My latest is about Methuselah. See here
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FDA’s Peter Marks Starts Recognizing the Failures of the COVID-19 Vaccines
A controversial figure of late, Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has been front and center in the regulatory agency’s aggressive greenlights associated with the COVID-19 vaccines during the pandemic.
Among other things, the agency has been criticized for dropping its rigorous standards during the COVID-19 Public Health Emergency at least, when applied to the mRNA vaccines targeting SARS-CoV-2.
Interestingly, Dr. Marks has now gone on the record in a piece published in JAMA Network titled “Urgent Need for Next Generation COVID-19 Vaccines” in a clear recognition that the current “version 1.0”, first generation COVID-19 vaccines are no longer viable to protect the American public. This media has labeled the COVID-19 vaccines as novel, version 1.0 since the late spring of 2021, when it became very apparent that vaccine durability challenges coupled with a mutating virus (which was called out by critical scientists from the start) represented a challenge for vaccine durability.
While TrialSite maintains the COVID-19 vaccines partially blunted the sharp edge of the pandemic, initially they did so at a severe cost. The vaccines were bundled in a program precluding any serious embrace of early care with repurposed drugs, orchestrated government censorship of media and social tech, and harassment of doctors that dared question any moves by Washington DC or industry all representing perhaps, one of the greatest public health failures in modern history. More people died in America from SARS-CoV-2 than any other nation despite the vast trillions, sophisticated technologies and supposed state-of-the-art vaccines.
From the start influencers such as the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control and Prevention, not to mention academic medicine, big hospital administration, and industry all bought in hook, line, and sinker into the scheme that mass COVID-19 vaccination would control and eradicate SARS-CoV-2, the virus behind COVID-19.
In fact, the World Health Organization (WHO) specifically established the 70% vaccination rate as a target threshold to achieve herd immunity. But from near the start this media, and a minority of independent, critical scientists questioned aloud that logic. Could a dynamic RNA virus that mutates like say, HIV or influenza, be controlled by a novel mass vaccination scheme? Has the flu been controlled out of existence?
This seemed a crap shoot at best, yet the U.S. federal government and its health agencies along with other of the world’s richest most sophisticated economies bet the proverbial farm on novel technology in a way that was guaranteed to not work as intended. Was this a totally desperate move or part of some orchestrated response to advance a biomedical platform?
While the vaccines worked to induce antibodies for short bursts, they did save lives, especially earlier on. But within months (Delta appeared by spring of 2021) of the mass vaccination program it was apparent that they failed to control the spread of the pathogen, exhibited poor durability, and were associated with a disturbing safety signal in the Vaccine Adverse Event Reporting System.
While by the summer of 2021 the whole program should have been under investigation President Biden ordered mandates across the board by September 2021. Now two years later since they were first released on the market Peter Marks initiates a dialogue paving the way to sunset these products, thinking ahead for a next generation of more effective, safety COVID-19 vaccine. But that’s not enough.
Now on the record, that while issues of “vaccines access and hesitancy present throughout the pandemic are partially responsible,” the relentless, or in his words “ceaseless progression of increasingly transmissible variants, recently including BF.7 and BQ.1.1 presents a major challenge to medical interventions, particularly vaccines.”
TrialSite recently showcased a couple studies that indicate real trouble when it comes to the recently authorized bivalent Omicron BA.4/BA.5 vaccine booster effectiveness against subvariants such as BQ.1.1. Put simply, these vaccines don’t work very well against a continuously evolving virus.
To date, the original primary series (2 dose) regimen (mRNA vaccines from Pfizer-BioNTech and Moderna) was introduced by December 2020, followed by two additional booster doses due to waning effectiveness. Then by September, the FDA cleared on an emergency basis without clinical data the bivalent Omicron BA.4/BA/5 booster vaccine in a response to mutated subvariants that evade vaccine-induced antibodies with ease. The FDA sought to respond to the ongoing genetic evolution of SARS-CoV-2 seemingly, the best way it could with the latest booster doses from both Pfizer-BioNTech and Moderna.
The market demand has been very weak for the bivalent booster products and yet the FDA has continued to evidence questionable behavior, such as ongoing promotional campaigns that attempt to create tension among family members who aren’t yet boosted. See “FDA Uses Little Girl to Market Moderna and Pfizer Bivalent Jabs—Crosses a Line Yet Again.”
With no definitive clinical data, Marks continues to promote the current products, declaring in his piece that the bivalent boosters may not only reduce morbidity and mortality but also “may also reduce the amount of symptomatic disease and associated health care use.” But he conveys throughout the article that the time has come to move on from these current products.
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COVID Report Raises Further Questions About Confidence in Virus Origins, and Intelligence Community
On Wednesday night, as Sarah covered, Fox News revealed a report from Republicans on the House Intelligence Committee looking into the origins of the COVID-19 virus. The report was released by minority staff members of the House Permanent Select Committee on Intelligence. In a press call held Thursday afternoon, Rep. Brad Wenstrup, (R-OH), a doctor who is a member of the committee, declared that such a report is "just the beginning."
A particularly memorable finding is that the virus may have origins through a Chinese bio weapons program. It becomes even more memorable in that Rep. Wenstrup mentioned during the call that a report from the intelligence community claims there is supposedly agreement that the virus was not developed as such a weapon.
The congressman is especially interested in knowing who came up to what he referred to as this "broad agreement," and as to what level of confidence there was. The certainty of that level of confidence was not included in the report, though, nor was the basis for why the report indicated as much.
Wenstrup spoke further about this supposed "broad agreement" when taking a question from Townhall, confirming that there is an expectation to just take the report's word for it, though he does hope to get to the bottom of that basis. "Where's the accountability for who's making those comments," the congressman wondered. While he agreed that those putting out such a report should have to answer for it, he confirmed that they haven't done so.
When asked during a follow-up about what such lofty and entitled expectations mean for trust in the intelligence community, the congressman acknowledged trust becomes a problem and "is greatly diminished." This acknowledgment comes from both sides of the aisle, with Democratic members indicating as much as well, the congressman confirmed.
"The way you develop trust and confidence is through transparency," Wenstrup offered. When it comes to entitlement, if anyone is entitled, it ought to be the members of this select committee. "There's nothing they should be keeping from us," the congressman insisted, a point he would make throughout the call, especially when it comes to fulfilling their duties. "It's our job to ask these questions and have that type of understanding," the congressman would say during the call as well. Findings about COVID origins are "something I think we're entitled to understand" he said.
When it comes to that trust, the congressman also shared that they have a responsibility of oversight on the committee. "When we're not getting our questions answered, there is a breakdown of trust," something the committee hopes to dispel.
As to other theories for COVID origins, Wenstrup mentioned that, other than the article hypothesizing as much, he hasn't seen evidence that the virus came from nature. One such theory propagated, to the point that those who dare to mention a lab leak or bio weapon have been ostracized, is that it originated at a wet market. While the congressman noted that the wet market could have been the first super spreader, that doesn't mean that's where the virus came from. While the origin of a virus usually can be found within the animal world, that was not the case when it comes to the animals that were tested for this virus.
Transparency, Wenstrup spoke to, is also crucial when it comes to America being prepared for any future viruses and pandemics. We can do that "by learning what is going on and what our adversaries are doing," especially if it comes to China having a bio weapon and/or developing their own virus along with their own vaccine. This is a matter of national security as well.
The press call was billed to be about sharing bombshells, and the stunning lack of transparency from the intelligence community report was not the only revelation. For instance, China having its own vaccine is not merely a hypothetical, as they looked to have a vaccine patent so quickly after the virus was unleashed, something Wenstrup mentioned was not all too common and "you scratch your head over."
A lack of transparency was, unfortunately, a theme and point of concern throughout the call. On the ever-pressing issue of gain-of-function and taxpayer funding of it through the grants involved, Wenstrup lamented that they "haven't had the right people in front of us" to answer questions.
Other pressing issues and potentially damning revelations lie with China's accountability. In answering a question from a reporter as to if the Chinese Communist Party (CCP) appears to be emboldened by the lack of accountability, Wenstrup believes that they likely have, especially since it appears they can get away with it. A lack of accountability "would embolden anybody who is in this situation," he offered. If China did in fact create the virus, Wenstrup pointed out, they would have something to lose on the world stage.
"If there was negligence, we certainly should hold someone accountable," the congressman offered.
When it comes to the lack of accountability, and how the CCP is indeed feeling emboldened by this, the mainstream media deserves some of the blame too, in insisting on the theory that occurred in nature, for instance. Who can forget how ostracized Sen. Tom Cotton (R-AR) was for daring to suggest early on that the virus may have been manufactured in a lab? The New York Times in February 2020 declared it to be "a fringe theory," for instance.
"If our own media is saying you can't tell the other story, that's a problem," Wenstrup mentioned. Thus, China becomes further emboldened if "they feel America can't do anything about this."
There may even be issues for President Joe Biden, as brought up by a reporter on the call, especially when it comes to transparency issues and how the president has (or has not been) discussing COVID with Xi Jinping. Despite how much Biden has touted his relationship with the Chinese leader, the president appears to have failed to discuss the virus' origins of the virus, as Katie highlighted at the time about the two leaders meeting last month.
While the congressman wished to stick to how he was looking "into the science of" the virus as a physician, there was an acknowledgment that transparency concerns with Biden "might be part of a bigger picture."
Wenstrup also sought to emphasize that there is a bipartisan quest for truth on this. Even those who want to find out the origins of the virus without getting into the blame game yet, with Wenstrup mentioning being part of those group of people, there is nevertheless "a lot of evidence that raises eyebrows."
The congressman told reporters he hopes for the classified report to ultimately be declassified.
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December 18, 2022
Harrowing moment parents who refused to give their newborn vaccinated blood ahead of urgent surgery have the baby 'ripped away' from them by authorities
Dramatic video has emerged of the moment parents watched their baby taken from them and placed into a doctor's care after they refused to allow him to receive a transfusion with vaccinated blood ahead of urgent heart surgery.
The six-month-old had been in a New Zealand hospital since November to receive surgery for a congenital heart disease that was delayed by several weeks because of the parents' concerns.
A New Zealand High Court decision ruled the baby would be placed into the care of his pediatric heart surgeon and cardiologist until the completion of the surgery and post-operative recovery.
Harrowing footage of the encounter shows the distressed parents frantically trying to speak with authorities as the baby was taken away by hospital staff.
'You guys will be recorded in the annals of history as criminals who take babies from their mothers,' the baby's father can be heard saying to authorities as an administrator informs the mother she can see the baby after surgery.
After the distressing encounter, the baby's father spoke candidly to the camera: 'I dont know where this goes to around the world, but our baby has been medically kidnapped,' he said.
'Thugs have come in wearing police uniforms, and they've ripped the baby out of his bed.
'Let this be a lesson to the entire rest of humanity, the takeover has already started, and it started in a hospital ward with a baby. 'I call on humanity to rise, because you all know what's happening.'
Footage of the incident has circulated around the internet after originally being posted on Rumble.com on December 8.
The parents are represented by lawyer and prominent anti-vax campaigner, Sue Grey, who said 'because they label my clients as conspiracy theorists, [their position] is that anything my clients say can be ignored'.
The hospital planned for the baby to receive the life-saving surgery last week. The parents will prioritise 'peaceful time with their baby until the operation, and to support him through the operation', Ms Grey said in a December 8 Facebook post.
'We have concluded that the government cannot afford anything to go wrong for Baby W as the world is watching. 'He is likely to get the best possible care with the best safest blood.'
Two more parents have requested only unvaccinated blood for their seriously ill toddler this week, NZ Herald reports.
Parents Croydon Hodge and Doreen Rudolph, who have a toddler with hypoplastic left heart syndrome, have refused permission for the hospital to use vaccinated blood for the boy's urgent surgery.
New Zealand's blood service has presented evidence of a 'significant increase in potential blood recipients asking for blood from unvaccinated donors'.
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Can Vaccines 'Prevent Nearly Every Death From COVID'?
As the winter season brings a sickness surge, the Biden administration is back to blathering about the supposed efficacy of the coronavirus vaccine, with one of its top doctors claiming "nearly every" COVID-19 death is preventable with vaccination.
CLAIM: The White House's COVID-19 response coordinator Dr. Ashish Jha claimed at Thursday's press conference, "We know we can prevent nearly every death from COVID if people get their updated vaccines [...] So, we continue to press that message."
FACTS: The White House's "message" is countered by data analysis conducted for the Washington Post's The Health 202, which revealed that 58 percent of COVID-19 fatalities were vaccinated or boosted patients in August. "We can no longer say this is a pandemic of the unvaccinated," Kaiser Family Foundation vice president Cynthia Cox, who conducted the analysis, told The Post.
As Katie covered, the new statistics on COVID-19 deaths debunked the White House's narrative on the vaccine. In late November, when the WaPo report was released, Jha had just made the same claim a day earlier that "if folks get their updated vaccines and they get treated if they have a breakthrough infection, we can prevent essentially every COVID death in America."
Although the findings marked the first time that a majority of Americans dying from the coronavirus had received at least the primary series of the vaccine, it continued an eye-opening pattern where we saw the vaxxed population make up 23 percent of 'Rona deaths in September 2021, and then up to 42 percent of the COVID-19 death toll in January and February of this year.
RATING: The claim that keeping up-to-date with coronavirus vaccinations can "prevent nearly every death from COVID" is FALSE. Even though the president has proclaimed we're facing a so-called "pandemic of the unvaccinated" and threatened that unvaxxed Americans alone would suffer "a winter of severe illness and death," Biden's alarmist language isn't backed by real-world numbers.
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Twitter Censorship Contributed to Destructive Pandemic Policies and Is Criminal, Says Former White House COVID Adviser
The recently revealed censorship that has plagued Twitter in recent years is “criminal,” according to former White House COVID adviser Dr. Scott Atlas, as it allowed “lies to be imposed on the public” during a pandemic that wrought untold damage worldwide.
“When correct science policy is blocked, people die, and people died from the censorship,” Atlas, a special coronavirus adviser during the Trump administration and contributor to The Epoch Times, said in an interview.
Atlas was speaking days after Elon Musk, the new owner of Twitter, released troves of internal files showing how the previous Twitter team built a blacklist to limit disfavored tweets’ visibility without the knowledge of those using the platform. Among those flagged was Dr. Jay Bhattacharya of Stanford, whose tweet criticizing pandemic lockdowns shortly after joining the platform last August got him on the “trends blacklist” preventing the amplification of his tweets.
But such revelations, Atlas said, are “only the tip of the iceberg.”
“There’s a far larger story here that we need to hear,” he said, which he considers “far more nefarious and more systemic than isolated tweets being pulled down.”
“This seems to be criminal behavior, and I think it needs to be investigated in the courts,” he said.
The Censorship of 2020
Atlas wants to direct attention back to 2020, when health officials followed in the Chinese Communist Party’s footsteps to implement blanket COVID-19 lockdowns.
In November of that year, while Atlas was still on the White House’s coronavirus task force, Twitter took down his post that argued mask-wearing was not effective in curbing the spread of the virus—a decision celebrated by some proponents of the measures, including fellow task force member Dr. Deborah Birx.
“One would think that the American public should hear what the adviser to the president is saying during the pandemic of 2020. Yet Twitter decided to simply block that discussion from the public,” he said.
Both Twitter and Facebook that August also removed a video from President Donald Trump in which he said children are “almost immune” to COVID-19. That same month, Facebook said it had deleted 7 million pieces of content it deemed to be COVID-19 misinformation over the second quarter of 2020.
Despite most states having a mask mandate until early this year, a number of studies found children and teenagers to be at a far lower risk of getting or dying from COVID-19, even with the emergence of new variants. But the “censorship of 2020,” be it deleting individual tweets, suspending accounts, or blocking the amplification of posts, had done its damage.
“When decisions were being made in 2020 and imposed upon the public, that’s when censorship counted the most,” Atlas said.
The absence of alternative viewpoints manipulated not only the public, but government officials as well, Atlas said.
“It created this illusion that there was a consensus among science and public health policy experts that lockdowns should be imposed; it created and perpetrated lies that if you were opposed to lockdowns, you were choosing the economy over lives, and that if you were opposed to lockdowns, you were somehow calling for letting the infection spread without any mitigation whatsoever,” he said.
“They absolutely contributed to policies that killed massive numbers of people and destroyed children and low-income people, who are the most vulnerable. That’s why it’s criminal.”
Atlas has been a vocal critic of COVID-19 lockdowns since early on in the pandemic, saying that “targeted protection was the logical, safer, and ethical way to manage the pandemic.” In May 2020, he wrote an article for the Hill warning about the “millions of years of life” such policies would cost Americans.
Learning loss aside, the pandemic restrictions led to an explosion of child abuse, drug overdoses, mental health issues, and obesity among youth, who were deprived of normal social interaction and forced to continue schooling through remote learning.
Collectively, America’s social media and legacy media, “coupled with incompetent bureaucrats running the policy and ignorant university professors have left a sinful legacy of damage,” said Atlas—the reason for the massive loss of trust in public health agencies that people depend for guidance in future crises.
Former Twitter CEO Jack Dorsey recently said his “biggest mistake” while at the company was to “invest in building tools for us to manage the public conversation, versus building tools for the people using Twitter to easily manage it for themselves,” a decision he said has “burdened the company with too much power.”
Late last month, Musk announced an end to the COVID-19 “misleading information” policy, which has resulted in 100,000 pieces of content cut from the platform and more than 11,000 account suspensions.
Atlas welcomed the gesture but thought that more individuals need to “rise up”—his term for speaking up, for real change.
“There should be a public outrage that is massive,” he said.
He believes those the American public elected to represent them haven’t done their part. “Where are our elected officials in this, where are they?” he asked. “If they can’t act, simply for ensuring free speech, they should all step down.”
‘Distortion’ Around Vaccine Mandates
A recent study published in Nature of over 15,000 citizens across 21 countries shows that people who have received COVID-19 vaccines are far more likely to be prejudiced against the unvaccinated than the other way around, which Atlas saw as yet another illustration of how social media censorship has shaped public opinion through suppressing critical information.
More than 5.47 billion people worldwide have received at least one dose of one of the COVID-19 vaccines, accounting for roughly 70 percent of the world population, despite lacking a “thorough, detailed understanding of efficacy and side effects from the vaccines,” Atlas noted.
But because of the lockdown mandates, which he called “pseudo-scientific,” throngs of workers in healthcare, education, and the military lost their jobs and hospitals suffered staffing shortages, causing backlogs of patients needing vital treatment for other non-COVID-19 diseases.
In perpetrating a “false narrative,” social media platforms have deviated from their promised role as a digital town hall and a visible source of information, and instead allowed themselves to be a tool for harm, said Atlas.
“We are living in an Orwellian society if this sort of censorship is allowed to keep going.”
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December 20, 2022
Should treatment for blood clots be routine in some Covid patients?
My heading above is a plain English version of the first academic heading below. Blood clots can do a lot of harm so are a serious problem. But they can be treated with considerable success by blood thinners such as Warfarin. But Warfarin has its problems too. It can cause bleeding. So, obviously, you use it only when it is clearly needed.
And the BIG question is whether you should use it for prevention. Should you give it to a patient BEFORE they get any symptoms?
Nobody is saying that you should give thinners to ALL Covid patients so the question is whether you should give it to high-risk patients? If so, how do you identify the patients most likely to suffer from blood clots?
So you can see that there is a real problem there. The study from Oxford University below tries to solve that puzzle
And there are some categories of patient who usually ARE high risk. We can identifty some patients as being at risk. So how great does the risk have to be before you give a patient thinners? The article below tries to answer that and concludes that there are some cases that should get preventive treatment.
But the problem is a difficult one so I reproduce below the Abstract from the original Oxford article plus two further comments on it.
A crude summary of the findings is that fat old guys should be given thinners. I am old and a bit overweight so if ever I get Covid, I should probably be given a low dose of thinners
Clinical and Genetic Risk Factors for Acute Incident Venous Thromboembolism in Ambulatory Patients With COVID-19
JunQing Xie et al.
Key Points
Question What is the 30-day acute risk of venous thromboembolism (VTE) among ambulatory patients with COVID-19, and what are the clinical and genetic risk factors predisposing them to developing post–COVID-19 VTE?
Findings In this retrospective cohort study of 18 818 outpatients with COVID-19 and 93 179 propensity score–matched noninfected participants, a higher VTE incidence was observed in the former (hazard ratio, 21.42); however, this risk was considerably attenuated among the fully vaccinated, after breakthrough infection. Older age, male sex, obesity, no vaccination or partial vaccination, and inherited thrombophilia were independent risk factors for COVID-19–associated VTE.
Meaning The results of this study suggest that ambulatory patients with COVID-19, either vaccinated or not, present a clinically relevant increased risk of incident VTE during the acute phase, with the risk pronounced by factors of older age, male sex, obesity, incomplete vaccination, and factor V Leiden thrombophilia.
Abstract
Importance The risk of venous thromboembolism (VTE) in ambulatory COVID-19 is controversial. In addition, the association of vaccination with COVID-19–related VTE and relevant clinical and genetic risk factors remain to be elucidated.
Objective To quantify the association between ambulatory COVID-19 and short-term risk of VTE, study the potential protective role of vaccination, and investigate clinical and genetic risk factors for post–COVID-19 VTE.
Design, Setting, and Participants This population-based cohort study of patients with COVID-19 from UK Biobank included participants with SARS-CoV-2 infection that was confirmed by a positive polymerase chain test reaction result between March 1, 2020, and September 3, 2021, who were then propensity score matched to COVID-19–naive people during the same period. Participants with a history of VTE who used antithrombotic drugs (1 year before index dates) or tested positive in hospital were excluded.
Exposures First infection with SARS-CoV-2, age, sex, ethnicity, socioeconomic status, obesity, vaccination status, and inherited thrombophilia.
Main Outcomes and Measures The primary outcome was a composite VTE, including deep vein thrombosis or pulmonary embolism, which occurred 30 days after the infection. Hazard ratios (HRs) with 95% CIs were calculated using cause-specific Cox models.
Results In 18 818 outpatients with COVID-19 (10 580 women [56.2%]; mean [SD] age, 64.3 [8.0] years) and 93 179 matched uninfected participants (52 177 women [56.0%]; mean [SD] age, 64.3 [7.9] years), the infection was associated with an increased risk of VTE in 30 days (incidence rate of 50.99 and 2.37 per 1000 person-years for infected and uninfected people, respectively; HR, 21.42; 95% CI, 12.63-36.31). However, risk was substantially attenuated among the fully vaccinated (HR, 5.95; 95% CI, 1.82-19.5; interaction P = .02). In patients with COVID-19, older age, male sex, and obesity were independently associated with higher risk, with adjusted HRs of 1.87 (95% CI, 1.50-2.33) per 10 years, 1.69 (95% CI, 1.30-2.19), and 1.83 (95% CI, 1.28-2.61), respectively. Further, inherited thrombophilia was associated with an HR of 2.05 (95% CI, 1.15-3.66) for post–COVID-19 VTE.
Conclusions and Relevance In this population-based cohort study of patients with COVID-19, ambulatory COVID-19 was associated with a substantially increased risk of incident VTE, but this risk was greatly reduced in fully vaccinated people with breakthrough infection. Older age, male sex, and obesity were clinical risk factors for post–COVID-19 VTE; factor V Leiden thrombophilia was additionally associated with double the risk, comparable with the risk of 10-year aging. These findings may reinforce the need for vaccination, inform VTE risk stratification, and call for targeted VTE prophylaxis strategies for unvaccinated outpatients with COVID-19.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2795466
***************************************************Is There a Role for Thromboprophylaxis in Selected Outpatients With COVID-19?
Anastasios Kollias et al.
Mr Xie and colleagues1 provide important information on an understudied topic: incident venous thromboembolism (VTE) in outpatients with COVID-19. The findings of their study are commendable and provide useful conclusions. First, COVID-19 was associated with increased VTE risk, even in the outpatient setting given that a higher VTE incidence was shown among 18 818 outpatients with COVID-19 compared with 93 179 propensity score matched, noninfected participants. Second, patients with specific characteristics (older age, male sex, obesity, no/partial vaccination, and inherited thrombophilia) had higher VTE risk. Third, the VTE risk was high for up to 30 days after diagnosis. These findings are highly important and may advance case management and treatment for outpatients with COVID-19.
At present, the available data are generally against the routine use of pharmacologic thromboprophylaxis in outpatients with COVID-19.2,3 Moreover, current guidelines do not provide specific recommendations.4 However, it is common sense that selected outpatients with VTE risk factors are therefore at higher risk for disease worsening and would benefit from thromboprophylaxis on an individualized basis and after careful assessment of bleeding risk. Indeed, data show that major adverse events tend to occur early in patients hospitalized with COVID-19 who have a high-risk profile; prompt thromboprophylaxis would benefit these patients.5
The study by Mr Xie and colleagues was performed during a period when only 41% of patients with COVID-19 had been fully vaccinated; a percentage that has increased worldwide. Thus, it would be interesting to study VTE risk factors separately among the fully vaccinated group—despite VTE events having been infrequent. Moreover, apart from the patient risk factors, the disease characteristics may play a role. Symptoms that indicate disease activity or severity, ie, the duration of the fever, could be contributing to an increased VTE risk in selected patients. In addition, SARS-CoV-2 variants may exhibit a different risk regarding VTE. If these data are available, they would make for another interesting study.
Although thromboprophylaxis among outpatients with COVID-19 is not generally recommended, the data and findings derived from studies, such as this one by Mr Xie and colleagues,1 show that selected outpatients carry an increased VTE risk. On the other hand, widespread immunization, as well as the availability of the antiviral therapies, may be substantially reducing VTE risk. Whether thromboprophylaxis would benefit high-risk outpatients with COVID-19 is unclear, but it seems reasonable to conclude that an individualized strategy would improve their prognosis.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2799543
****************************************************Is There a Role for Thromboprophylaxis in Selected Outpatients With COVID-19? — Reply
Junqing Xie et al.
In Reply In our recent research article regarding clinical and genetic determinants associated with venous thromboembolism (VTE) among community-dwelling patients with COVID-19,1 we reported a marked increase of 30-day VTE and identified older age, male sex, obesity, no or partial vaccination, and inherited thrombophilia as key risk factors. We appreciate the insightful comments from Prof Kollias and colleagues and their support of our call for targeted VTE thromboprophylaxis for outpatients with COVID-19.
Hospitalization is the recommended indicator for initiating antithrombotic therapy for patients with COVID-19. However, we argue that the likelihood of post−COVID-19 VTE should be conceptually seen as a continuum, with some outpatients treated for COVID-19 at an even higher risk of VTE than some hospitalized patients. Also, given that VTE hazard peaks substantially and shortly after SARS-COV-2 infection,2 individuals with COVID-19 would likely benefit from earlier interventions for primary prophylaxis. Our study1 identified several independent risk factors that can be used to stratify patients with different risk profiles for post−COVID-19 VTE. We should highlight that although existing trials (eg, ETHIC, ACTIV-4B) did not generally support routine pharmacologic thromboprophylaxis for outpatients with COVID-19, the results should be interpreted as inconclusive given the great statistical uncertainty and underrepresentation of older patients, and consequently, the low event rates. Therefore, the results do not preclude the use of thromboprophylaxis in selected outpatient subpopulations, particularly among those with a high baseline risk of VTE.3 Further trials targeting high-risk infected outpatients and more real-world studies with larger sample sizes and longer follow-up are warranted to supplement the existing evidence.4
Admittedly, the net benefits of antithrombotic therapy should always be weighed against potential harms5—eg, for those at high risk of VTE, risk of bleeding should be considered when prescribing antithrombotic therapy.6 Of note, genetic risk owing to monogenic thrombophilia or polygenic risk score, as evidenced in our study,1 was exclusively associated with venous but not arterial thromboembolism, which may be promising for identifying individuals susceptible to VTE but resistant to bleeding. Finally, we agree with the proposal from Prof Kollias and colleagues to investigate whether the risk factors persist in fully vaccinated people and what potential value disease symptoms may have for VTE prediction. However, our available data are insufficient for answering this question given the limited sample size: only 6 VTE events among the breakthrough infection cohort.
As the number of COVID-19 outpatient cases continues to increase, personalized prophylactic anticoagulation in this large population may prevent a substantial number of individuals with COVID-19 from developing severe thrombotic complications that require hospitalization and/or intensive care. The clinical and genetic risk factors identified by our study should inform the identification of participants for new research to bridge the knowledge gaps on the risk vs benefit of pharmacologic thromboprophylaxis.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2799542
**************************************************19 December, 2022
The Bible
I have done a bit more writing about Bible topics. My latest is about Methuselah. See here
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FDA’s Peter Marks Starts Recognizing the Failures of the COVID-19 Vaccines
A controversial figure of late, Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has been front and center in the regulatory agency’s aggressive greenlights associated with the COVID-19 vaccines during the pandemic.
Among other things, the agency has been criticized for dropping its rigorous standards during the COVID-19 Public Health Emergency at least, when applied to the mRNA vaccines targeting SARS-CoV-2.
Interestingly, Dr. Marks has now gone on the record in a piece published in JAMA Network titled “Urgent Need for Next Generation COVID-19 Vaccines” in a clear recognition that the current “version 1.0”, first generation COVID-19 vaccines are no longer viable to protect the American public. This media has labeled the COVID-19 vaccines as novel, version 1.0 since the late spring of 2021, when it became very apparent that vaccine durability challenges coupled with a mutating virus (which was called out by critical scientists from the start) represented a challenge for vaccine durability.
While TrialSite maintains the COVID-19 vaccines partially blunted the sharp edge of the pandemic, initially they did so at a severe cost. The vaccines were bundled in a program precluding any serious embrace of early care with repurposed drugs, orchestrated government censorship of media and social tech, and harassment of doctors that dared question any moves by Washington DC or industry all representing perhaps, one of the greatest public health failures in modern history. More people died in America from SARS-CoV-2 than any other nation despite the vast trillions, sophisticated technologies and supposed state-of-the-art vaccines.
From the start influencers such as the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control and Prevention, not to mention academic medicine, big hospital administration, and industry all bought in hook, line, and sinker into the scheme that mass COVID-19 vaccination would control and eradicate SARS-CoV-2, the virus behind COVID-19.
In fact, the World Health Organization (WHO) specifically established the 70% vaccination rate as a target threshold to achieve herd immunity. But from near the start this media, and a minority of independent, critical scientists questioned aloud that logic. Could a dynamic RNA virus that mutates like say, HIV or influenza, be controlled by a novel mass vaccination scheme? Has the flu been controlled out of existence?
This seemed a crap shoot at best, yet the U.S. federal government and its health agencies along with other of the world’s richest most sophisticated economies bet the proverbial farm on novel technology in a way that was guaranteed to not work as intended. Was this a totally desperate move or part of some orchestrated response to advance a biomedical platform?
While the vaccines worked to induce antibodies for short bursts, they did save lives, especially earlier on. But within months (Delta appeared by spring of 2021) of the mass vaccination program it was apparent that they failed to control the spread of the pathogen, exhibited poor durability, and were associated with a disturbing safety signal in the Vaccine Adverse Event Reporting System.
While by the summer of 2021 the whole program should have been under investigation President Biden ordered mandates across the board by September 2021. Now two years later since they were first released on the market Peter Marks initiates a dialogue paving the way to sunset these products, thinking ahead for a next generation of more effective, safety COVID-19 vaccine. But that’s not enough.
Now on the record, that while issues of “vaccines access and hesitancy present throughout the pandemic are partially responsible,” the relentless, or in his words “ceaseless progression of increasingly transmissible variants, recently including BF.7 and BQ.1.1 presents a major challenge to medical interventions, particularly vaccines.”
TrialSite recently showcased a couple studies that indicate real trouble when it comes to the recently authorized bivalent Omicron BA.4/BA.5 vaccine booster effectiveness against subvariants such as BQ.1.1. Put simply, these vaccines don’t work very well against a continuously evolving virus.
To date, the original primary series (2 dose) regimen (mRNA vaccines from Pfizer-BioNTech and Moderna) was introduced by December 2020, followed by two additional booster doses due to waning effectiveness. Then by September, the FDA cleared on an emergency basis without clinical data the bivalent Omicron BA.4/BA/5 booster vaccine in a response to mutated subvariants that evade vaccine-induced antibodies with ease. The FDA sought to respond to the ongoing genetic evolution of SARS-CoV-2 seemingly, the best way it could with the latest booster doses from both Pfizer-BioNTech and Moderna.
The market demand has been very weak for the bivalent booster products and yet the FDA has continued to evidence questionable behavior, such as ongoing promotional campaigns that attempt to create tension among family members who aren’t yet boosted. See “FDA Uses Little Girl to Market Moderna and Pfizer Bivalent Jabs—Crosses a Line Yet Again.”
With no definitive clinical data, Marks continues to promote the current products, declaring in his piece that the bivalent boosters may not only reduce morbidity and mortality but also “may also reduce the amount of symptomatic disease and associated health care use.” But he conveys throughout the article that the time has come to move on from these current products.
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COVID Report Raises Further Questions About Confidence in Virus Origins, and Intelligence Community
On Wednesday night, as Sarah covered, Fox News revealed a report from Republicans on the House Intelligence Committee looking into the origins of the COVID-19 virus. The report was released by minority staff members of the House Permanent Select Committee on Intelligence. In a press call held Thursday afternoon, Rep. Brad Wenstrup, (R-OH), a doctor who is a member of the committee, declared that such a report is "just the beginning."
A particularly memorable finding is that the virus may have origins through a Chinese bio weapons program. It becomes even more memorable in that Rep. Wenstrup mentioned during the call that a report from the intelligence community claims there is supposedly agreement that the virus was not developed as such a weapon.
The congressman is especially interested in knowing who came up to what he referred to as this "broad agreement," and as to what level of confidence there was. The certainty of that level of confidence was not included in the report, though, nor was the basis for why the report indicated as much.
Wenstrup spoke further about this supposed "broad agreement" when taking a question from Townhall, confirming that there is an expectation to just take the report's word for it, though he does hope to get to the bottom of that basis. "Where's the accountability for who's making those comments," the congressman wondered. While he agreed that those putting out such a report should have to answer for it, he confirmed that they haven't done so.
When asked during a follow-up about what such lofty and entitled expectations mean for trust in the intelligence community, the congressman acknowledged trust becomes a problem and "is greatly diminished." This acknowledgment comes from both sides of the aisle, with Democratic members indicating as much as well, the congressman confirmed.
"The way you develop trust and confidence is through transparency," Wenstrup offered. When it comes to entitlement, if anyone is entitled, it ought to be the members of this select committee. "There's nothing they should be keeping from us," the congressman insisted, a point he would make throughout the call, especially when it comes to fulfilling their duties. "It's our job to ask these questions and have that type of understanding," the congressman would say during the call as well. Findings about COVID origins are "something I think we're entitled to understand" he said.
When it comes to that trust, the congressman also shared that they have a responsibility of oversight on the committee. "When we're not getting our questions answered, there is a breakdown of trust," something the committee hopes to dispel.
As to other theories for COVID origins, Wenstrup mentioned that, other than the article hypothesizing as much, he hasn't seen evidence that the virus came from nature. One such theory propagated, to the point that those who dare to mention a lab leak or bio weapon have been ostracized, is that it originated at a wet market. While the congressman noted that the wet market could have been the first super spreader, that doesn't mean that's where the virus came from. While the origin of a virus usually can be found within the animal world, that was not the case when it comes to the animals that were tested for this virus.
Transparency, Wenstrup spoke to, is also crucial when it comes to America being prepared for any future viruses and pandemics. We can do that "by learning what is going on and what our adversaries are doing," especially if it comes to China having a bio weapon and/or developing their own virus along with their own vaccine. This is a matter of national security as well.
The press call was billed to be about sharing bombshells, and the stunning lack of transparency from the intelligence community report was not the only revelation. For instance, China having its own vaccine is not merely a hypothetical, as they looked to have a vaccine patent so quickly after the virus was unleashed, something Wenstrup mentioned was not all too common and "you scratch your head over."
A lack of transparency was, unfortunately, a theme and point of concern throughout the call. On the ever-pressing issue of gain-of-function and taxpayer funding of it through the grants involved, Wenstrup lamented that they "haven't had the right people in front of us" to answer questions.
Other pressing issues and potentially damning revelations lie with China's accountability. In answering a question from a reporter as to if the Chinese Communist Party (CCP) appears to be emboldened by the lack of accountability, Wenstrup believes that they likely have, especially since it appears they can get away with it. A lack of accountability "would embolden anybody who is in this situation," he offered. If China did in fact create the virus, Wenstrup pointed out, they would have something to lose on the world stage.
"If there was negligence, we certainly should hold someone accountable," the congressman offered.
When it comes to the lack of accountability, and how the CCP is indeed feeling emboldened by this, the mainstream media deserves some of the blame too, in insisting on the theory that occurred in nature, for instance. Who can forget how ostracized Sen. Tom Cotton (R-AR) was for daring to suggest early on that the virus may have been manufactured in a lab? The New York Times in February 2020 declared it to be "a fringe theory," for instance.
"If our own media is saying you can't tell the other story, that's a problem," Wenstrup mentioned. Thus, China becomes further emboldened if "they feel America can't do anything about this."
There may even be issues for President Joe Biden, as brought up by a reporter on the call, especially when it comes to transparency issues and how the president has (or has not been) discussing COVID with Xi Jinping. Despite how much Biden has touted his relationship with the Chinese leader, the president appears to have failed to discuss the virus' origins of the virus, as Katie highlighted at the time about the two leaders meeting last month.
While the congressman wished to stick to how he was looking "into the science of" the virus as a physician, there was an acknowledgment that transparency concerns with Biden "might be part of a bigger picture."
Wenstrup also sought to emphasize that there is a bipartisan quest for truth on this. Even those who want to find out the origins of the virus without getting into the blame game yet, with Wenstrup mentioning being part of those group of people, there is nevertheless "a lot of evidence that raises eyebrows."
The congressman told reporters he hopes for the classified report to ultimately be declassified.
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December 16, 2022
Researchers Decry Censorship in COVID Policy During Meeting With Gov. DeSantis
Michelle Utter, a health care worker and single mother of grown sons who are active-duty military, said she was in great physical shape—running, working out, and martial arts—until she took the Pfizer vaccine for COVID.
Utter described the ordeal she’s been through for the last two years—physically, trying to do her job and facing resistance and silencing from the Florida hospital that employs her. She’s not allowed to say, “vaccine injury.” She’s been on IV infusions for 17 months.
Another vaccine victim, Steven Ordonia, a retired law enforcement officer and military veteran, talked about his ordeal, which began when he received the Pfizer booster shot in December 2021.
“And from that day on, my life has been turned upside down,” with numerous trips to the emergency room, joint pain, muscle twitching, and convulsions.
“I was convinced at the time I was having a mental breakdown, and that’s what was causing all the symptoms. I contemplated suicide several times.”
As a reminder to all that public health policy has real consequences, the two spoke at a round table on Dec. 13 led by Florida Governor Ron DeSantis.
The governor convened a panel of experts—primarily researchers who had tried to warn about problems with the vaccines—and launched a grand jury investigation into vaccine problems and how they were dealt with or covered up.
The researchers will sit on the state’s new Public Health Integrity Committee.
Researcher after researcher talked about how the public health establishment suppressed information: that the vaccines often don’t pass risk-benefit analysis. How sometimes-fatal myocarditis has emerged as a side effect. How the vaccines’ rates of complications were far higher than those of most approved vaccines. How countries like Denmark, rather than mandating children take the vaccine, now don’t allow them to take it. How lower COVID mortality among vaccine users is often offset by higher mortality from other causes.
They, DeSantis and Florida Surgeon General Joseph Ladapo excoriated a medical establishment that, in DeSantis’ words, “wanted to just cocoon themselves from any criticism, and to try to denigrate anybody that had a different way of thinking.”
‘Largest Blunder in Human History’
“I don’t think it’s an exaggeration to say that all decision-making surrounding COVID amounts to the largest blunder in human history,” said Bret Weinstein, a former evolutionary biology professor at Evergreen State College.
“I think the major problem has been that … people, regular people, scientists, whoever thinks that there’s something really different than the narrative, you’re gonna get destroyed,” said Jay Bhattacharya, a Stanford Medical School public health professor. “That’s happened over and over again, even for very prominent scientists,” he said.
“A lot of the censorship that’s happened of scientific discussion comes from the top.”
Bhattacharya and another round table participant, Martin Kulldorff, were two of the three lead authors of the Great Barrington Declaration, signed by over 60,000 doctors and researchers, plus 870,000 others. Made public in October 2020, signers decried the harm of the lockdown.
They urged, until a vaccine became available, a policy of “Focused Protection”: isolating those at greatest risk while allowing others to go about their lives, acquiring natural and herd immunity.
It called for the resumption of everyday life for most people, said basic hygiene like routine handwashing and staying home when sick were sufficient community measures, and described how the vulnerable, such as the elderly, could be best protected at home and in nursing homes.
The declaration was targeted immediately by the head of the NIH, Francis Collins, with “a devastating takedown of the premises of the declaration,” Bhattacharya said.
“The federal officials were working to suppress what they called misinformation, but actually what they suppress is scientific discussion.”
Emergency Room Physician
Joseph Fraiman, an emergency room physician in what he termed “Cajun country” in Louisiana, said that he and six fellow researchers studied “serious adverse events” associated with the vaccines, events the manufacturers themselves defined.
“And what I mean by serious is that you’re either hospitalized, or you were permanently disabled, or dead,” he said.
They wanted to look at them with “a magnifying glass” because the manufacturers “originally reported that there was no harm, there was no serious harm to the vaccines.”
What they found, Fraiman said, “is that there are more of these types of events in the vaccine group than in the non-vaccine, the placebo group.”
“To our surprise, in the Pfizer trial, the first vaccine to go through it was a 37 percent increase in the number of serious adverse events. That was never reported, not by the FDA, not by Pfizer,” he said.
“In fact, Pfizer says—I may get it wrong verbatim—but they said that the incidence of serious adverse events are similar in the vaccine and placebo groups. Thirty-seven percent is not similar. It’s actually statistically significantly different.”
And, “it turns out in both Pfizer and Moderna, we had a one in 800 risk of serious adverse events” from the list.
Other vaccines, Fraiman said, have a one in one million or one in two million risk. “One in 800 is disastrous, if true.”
Most people, if they contract COVID now, don’t have a one in 800 chance of being hospitalized, he said.
pfizer vaccine
A health care worker prepares a dose of Pfizer BioNTech COVID-19 vaccine in a file image. (Ezra Acayan/Getty Images)
Researchers with different areas of specialty talked about their findings, perspectives, and experiences, trying to publicize what they’d found.
Ladapo discussed a small, preliminary study in Florida comparing all-cause mortality with cardiac mortality after COVID vaccination. They found two remarkable things: a markedly increased risk of cardiac death in young men, specifically in that age and group, and a failure by most public health officials to acknowledge it.
Christine Stabell Benn, a Danish doctor and researcher at the University of Southern Denmark who videoconferenced in, said the vaccines appear to have “nonspecific events”—greater risk of infection by other diseases.
“If we’ve only studied its effect against the target disease, we also need to study its effect against other diseases and its effects on overall mortality and morbidity,” she said.
“I was very concerned when we started recommending vaccines for everybody because I simply didn’t think that the vaccines have been investigated thoroughly enough for nonspecific events. In fact, they haven’t been investigated (at all) for nonspecific events,” she said.
“This means that particularly for children and young people who weren’t at a high risk for COVID-19, I was concerned that nonspecific effects might outweigh or exceed … the benefits achieved from the specific protection against COVID-19.”
Danish public health policy now only recommends booster COVID vaccinations to those over 50 except those at severe risk, and immunization of children has stopped altogether.
As of a few weeks ago, she said, COVID is now regarded in Denmark like any other respiratory disease. “It’s really nice to be here (in Denmark),” she said. “Life goes on as it used to do before COVID. Nobody pays attention to COVID-19 anymore.”
‘Disregarded Basic Principles’
Kulldorff, on leave from Harvard and a fellow at Hillsdale College’s Academy for Science & Freedom, said, “I agree with Dr. Weinstein that our approach to this pandemic is the biggest public health mistake in history … We basically disregarded basic principles of public health.”
He and others who wrote the Great Barrington Declaration argued for a different approach: better-focused protection for high-risk old people while keeping schools open and not locking down the rest of society.
“I think now, over two years later, we have been proven right. Florida and Sweden were two exceptions to the strategy, and both Sweden and Florida have come out on top when it comes to both COVID mortality and, even more importantly, to all-cause mortality,” Kulldorff said.
Sweden has among the lowest rates in Europe. “I think it’s very tragic what we have gone through by mismanaging this pandemic so thoroughly.”
Weinstein discussed the high personal cost of his dissent from COVID orthodoxy.
YouTube shut down his channel, and two videos—one featuring an inventor of mRNA technology and the other with an expert on treating COVID—were removed. “They knocked out more than half of our family income inside of a single hour,” he said.
“There was a radical inversion of the normal medical order of things in this pandemic,” Weinstein said.
“The relationship between doctor and patient is essentially an intimate, sacred relationship. And what happened here is that there was a coup, in which what was swapped in place of that relationship was public health wisdom from bureaucrats,” he said.
“And the problem is that, had we not done anything coordinated with COVID, we would have learned clinically how to treat it. Doctors would have followed hunches. They would have tried things out. They would have discovered what worked and what didn’t. They would have talked to each other, and we would have gotten good at treating COVID.
“Instead, what happened was the policy came down from on high, instantaneously, and fully formed. And then that policy was protected with these draconian censorship measures. With slander.”
The system wasted the narrow window of time when it might have contained the virus’ spread.
“So, at this point, we have millions needlessly dead. We have trillions of dollars of wealth that have been destroyed, and the vital systems that humanity depends on have been stressed to their very limit. But worse than that, we have now made this virus into a permanent fellow traveler of humanity.”
‘Afraid to Speak Up’
Bhattacharya said he had been accused of being a fringe epidemiologist.
“The illusion is that there was a scientific consensus, that everybody, all the smart people, agreed. But actually, that was never true. The censorship was used to create that illusion of consensus,” he said.
He called out U.S. Surgeon General Vivek Murthy, who put in place a policy to identify misinformation online and then gave out instructions for suppressing it to media and social media companies.
“You can’t have good public health policy in this kind of environment,” Bhattacharya said.
“People are afraid to speak up … Even qualified people are afraid to say no because they’re afraid that they’ll also get called ‘fringe.’ They’ll lose their ability to make a living, they’ll lose their reputation, and they stay silent as a result. Scientists always disagree with each other.”
Tracey Hoeg, a physician and epidemiologist at UC San Francisco, talked about how the California Medical Board got a bill through the legislature “telling physicians what they are and aren’t allowed to say to their patients, and that’s specifically related to COVID.”
DeSantis said, “The rule of thumb for us in Florida is whatever they do (in California), we do the opposite.”
His administration plans to move through Florida’s upcoming legislature a bill “that actually protects physicians’ First Amendment rights, and it protects their right to dissent from orthodoxy and from the establishment.”
Loss of Trust
“There’s been a tremendous loss of trust in public health,” said Steven Templeton, an immunology and microbiology professor at Indiana University School of Medicine.
“Fewer people are getting traditional vaccines,” he said. “This isn’t just, you know, anti-vax people. This is people who really lost trust in the system.”
Fraiman interjected that parents listening to the round table should not apply what they heard about the COVID vaccines to most other vaccines, which have nearly no side effects.
DeSantis listed various actions Florida had taken against federal lockdown policy and preserving individual rights.
One event highlighting the system’s corruption for him, he said, happened early on, in the spring of 2020. People were being told to stay home, and Florida, which didn’t follow that policy, had people going to the beach and playing golf.
“If you left your house, you’re almost like a bad person,” DeSantis said of the lockdown rules. “Until you started to have the George Floyd protests. And you had massive numbers of people that are meeting to protest.
“And these public health people wrote a letter, which like hundreds, maybe thousands of them signed, saying, ‘yes, we don’t think you should be leaving your house normally, but we endorse the protest,’ and basically said it was important that people went out even in big groups and protested.”
But they wouldn’t endorse other protests such as those against lockdowns, DeSantis said. “If that just didn’t take the mask off and just show, you know, that this is all a huge political farce,” he said.
“They have totally squandered any type of confidence or goodwill that people would have.”
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December 15, 2022
Twitter Files Confirm Censorship of the Great Barrington Declaration
Users have suspected Twitter of engaging in “shadowbanning” and suppressing the visibility of user accounts for years, even though the social media giant has adamantly denied the practice.
Yesterday (Dec 8 2022), using the information provided by Twitter under direction from new Chief Executive Elon Musk, journalist Bari Weiss, released a Twitter thread confirming these suspicions. Twitter secretly suppressed accounts, operated a “search blacklist,” and blocked certain content from trending, Weiss’ thread confirms. In response, Musk tweeted that Twitter plans to release software that will provide users with more clarity regarding shadowbanning.
Victims of Twitter’s practices include Dr. Jay Bhattacharya, Stanford professor of medicine and co-author of the Great Barrington Declaration (GBD). Weiss’s thread and The Twitter Files confirm what we’ve long suspected. Seeking to prop up Anthony Fauci and the lockdown policies he promoted in response to the COVID-19 pandemic, Twitter (and other Big Tech companies) intentionally blacklisted, censored, suppressed, and targeted the GBD and its signers.
Within Twitter, the Strategic Response Team—Global Escalation Team, or SRT-GET, worked on hundreds of cases daily, actively filtering the visibility of select accounts.
For high-profile accounts, the “Site Integrity Policy, Policy Escalation Support,” team, known as “SIP-PES” would secretly make censorship decisions. The SIP-PES team comprised high-profile executives such as the Head of Legal, Policy, and Trust, Vijaya Gadde, Global Head of Trust & Safety, Yoel Roth, and former CEOs Jack Dorsey and Parag Agrawal.
In addition to Weiss, Twitter’s new leadership granted journalist Matt Taibbi access to its files. Below, Taibbi illustrates how Twitter deleted tweets at the behest of the Biden Presidential campaign.
Still unfolding in this investigation is the role of government officials in pressuring Twitter to engage in censorship over the COVID-19 pandemic. As revealed by a lawsuit earlier this year, internal company Slack messages show that Andy Slavitt, a former official on Joe Biden’s pandemic task force, met with Twitter officials and pressured them to restrict the account of COVID gadfly Alex Berenson. Slavitt also , delivered an ominous warning to executives at Facebook that the company would find itself in the White House’s crosshairs if it did not step up its efforts to restrict what the task force deemed to be “COVID misinformation.”
We now have conclusive evidence that public officials pressure private companies to do the dirty work of censorship. We have yet to discover, and may never know, how far the political involvement in social media censorship went, and which officials were given the power to silence. An ongoing lawsuit by the Attorneys General of Missouri and Louisiana is currently seeking to get to the bottom of those questions. Just two weeks ago, they obtained a court-ordered deposition from Anthony Fauci, in which they grilled him over similar suppressive tactics. Fauci proved evasive, invoking the “I don’t recall” line 174 times, but was caught in a lie about his direct personal involvement in the National Institutes of Health’s (NIH) efforts to smear and discredit the GBD’s authors as “fringe epidemiologists.”
GBD co-author Jay Bhattacharya was slapped with a secret “Trends Blacklist” tag by Twitter executives at some point after his account was created in September 2021, Weiss’s thread confirms. The blacklist tag effectively suppressed Bhattacharya’s tweets by preventing them from going viral or being picked up by Twitter’s trends algorithm. By all appearances, one or more persons on the company’s SIP-PES team made the decision to suppress scientifically grounded dissent against lockdowns.
Given the history surrounding social media giants, government officials, and the GBD, Battacharya’s shadowbanning is not surprising. Unfortunately, neither Weiss nor Taibii’s thread indicates why Twitter took such actions against Dr. Battacharya, a respected Stanford Professor.
What we do know is that Twitter’s actions are consistent with other social media censorship of the declaration, its authors, and supporters. Posts referencing the GBD were removed from popular Reddit threads such as r/COVID-19 and r/Coronavirus, and large online communities with millions of members. Google also played a role. In the week after the GBD’s release in October 2020, Google’s news site search algorithms suppressed mainstream coverage of the document by outlets such as Fox News and the Wall Street Journal.
Instead, it steered news searches for “Great Barrington Declaration” toward anti-GBD hit pieces in fringe venues such as the Byline Times, a blog featuring 9/11 conspiracy theorist Nafeez Ahmed. Google algorithms reportedly prioritized an anti-GBD political editorial in Wired Magazine that Anthony Fauci also mined for his own anti-GBD talking points in the press.
These acts of censorship occurred at a time when government officials were working hard behind the scenes to discredit the GBD and its authors. Most notably, NIAID director Anthony Fauci and NIH director Francis Collins collaborated to wage a “devastating published take down” campaign against the GBD, labeling it “nonsense” or “misinformation.”
Fauci and Collins’ actions are public information in emails first discovered through a Freedom of Information Act inquiry from AIER last winter. The Fauci-Collins emails made national news and became the subject of a Senate hearing in January 2021, where Senator Rand Paul grilled the White House’s COVID advisor over his involvement in the “take down” order.
Last week, Anthony Fauci denied any involvement in coordinating attacks on the GBD under deposition by the Missouri Attorney General. He claims that he was too busy to do so. His emails reveal a different story, though. Fauci expressed his agreement with Collins’ directive, and colluded with Deborah Birx to preempt discussion of the GBD at a White House COVID task force meeting. At some point, Fauci even directed his Chief of Staff Greg Folkers to assemble a list of anti-GBD political editorials, evidently to be parrotted back to the news media during interviews about the GBD. We still don’t know the full extent of Fauci’s efforts, because the NIH heavily redacted several pages of the requested records. But his involvement in the “take down” is undeniable.
Given the nature of Fauci’s smears, lies, and demeanor towards those who question his policy prescriptions, it is time to fully open up the public record at the NIH. It is time to scrutinize the decisions they made during COVID-19, including decisions to politicize science and suppress dissenting viewpoints.
We know that Twitter worked with the Biden campaign to suppress tweets. We know that top Biden administration officials pressured Twitter, Facebook, and presumably other companies to penalize dissenting viewpoints on COVID-19 policy, including lockdowns. We also know that Fauci, former White House Chief Medical Advisor, will leverage the media to undermine his perceived opponents and lie about it under oath. We know.
Private companies are free to censor user speech on their platforms, but when top government officials pressure them to take these actions, that crosses a different line.
Thanks to Musk releasing the Twitter files to Weiss and Taibbi, we have more insight into Twitter’s internal censorship policies. Unfortunately, until the NIH releases more information, the Twitter Files raise more questions than answers.
https://www.independent.org/news/article.asp?id=14366&omhide=true&trk=title
****************************************************With Passenger Mask Mandate Gone, Flight Turbulence Stats Improve Markedly
The friendly skies too often resembled “season’s beatings” shopping brawls during the pandemic, as the number of arguments and even fistfights surged on-board. Viral videos of the flight-and-fight mayhem frequently had a common denominator – the federal government’s mask requirement.
So it may come as little surprise that disruptions on commercial domestic flights have plummeted by 74% since the Biden administration’s mask mandate was overturned by a federal judge in April. The current rate is 1.7 unruly passengers per 10,000 flights, down from 6.4 per 10,000 in February.
But laws and rules created during the pandemic continue to spur federal investigations of passengers, while the federal government has spent untold sums in a legal battle to re-establish its authority, including the power to once again impose mask mandates.
Unions, meanwhile, are seeking stricter measures to give flight attendants more power on the plane.
To date this year, there have been 2,178 reports of unruly passengers, according to the FAA, compared with 87 over roughly the same period in 2019.
Incidents under investigation, which jumped from 183 in 2020 to 1,099 in 2021, have dropped by nearly 40% since a federal judge found the mandate exceeded the rule-making authority of the Centers for Disease Control and Prevention.
The U.S. Department of Justice, however, continues to challenge the ruling of U.S. District Judge Kathryn Kimball Mizell, a Trump nominee. A hearing in the Atlanta-based 11th Circuit U.S. Court of Appeals is scheduled for January.
Leslie Manookian, president of the Health Freedom Defense Fund, which filed the lawsuit that overturned the CDC’s mask mandate, sees authoritarian impulses driving the continuing litigation.
“Most administrations of the last 10 to 20 years have sought this kind of power,” she said, likening COVID-era measures to the Patriot Act passed after the 9/11 attacks, which vastly increased the ability of government to surveil the public.
“It’s not just the Biden administration,” Manookian said. “It’s about increasing the power of the federal government as well as people who are not elected, and it’s not a partisan issue. They all want more power and are getting it through these emergencies.”
The CDC asked the DOJ, which represents government agencies, to appeal the travel mask decision shortly after it was handed down. The FAA and the DOJ did not respond to questions from RealClearInvestigations.
The legal struggle proceeds as a new peer-reviewed study adds to skepticism about the effectiveness of mask use in general. (In any case, passenger planes are required to have advanced air filtration.)
In a recent deposition in state-led litigation against alleged federal censorship, Dr. Anthony Fauci, retiring director of the National Institute of Allergy and Infectious Diseases, couldn't name any studies showing mask effectiveness, according to Missouri Attorney General Eric Schmitt.
The CDC issued the directive on orders from President Biden on his first day in office in January 2021. The rule was a formal extension of what airlines imposed in 2020 under pressure from flight attendant unions.
Within six months of the federal mask mandate, 85% of all alleged transgressions in the air were related to mask-wearing, with the federal government and a spokesman for the union-backed American Airlines flight attendants declaring that the policy they insisted on had created a situation “out of control.”
The mask ruling on appeal now has 34 amicus filings, or statements from parties who claim an interest in the outcome of the case. Among those filing in support of the federal government are the American Medical Association and a group of 251 public health and legal officials and various professional public health associations, many of whom have been public about the importance of government’s role in controlling the pandemic.
Filing in support of Manookian’s group are the Association of American Physicians and Surgeons and a group of 338 flight attendants, pilots, and other airline workers from every major airline and most budget airlines. Several of the pilots in the filing are part of a group that sued the CDC in March, also noting that the mandate overstepped the CDC’s authority.
During the pandemic, the airlines became ground zero for the battle between individuals who sought to determine their own safety measures and the dictating model that was imposed by the government. The result was a series of highly publicized confrontations.
The mandate was so vastly unpopular that many flight attendants again began taking self-defense courses in preparation of doing battle with passengers. Flight attendant unions urged that voluntary training implemented in the wake of 9/11, including measures to thwart a terrorist-style assault, be made compulsory.
In March 2021, the FAA declared a “zero tolerance” policy for alleged disorderly passengers in a threatening announcement. The agency also imposed a new rule beefing up enforcement of alleged in-air infractions, insisting it would pursue legal action against anyone alleged to have violated the agency’s conduct rules.
“The rule was changed and what you have now is a greater percentage of cases that are making it all the way through to being fined that we never saw before,” said William McGee, who spent seven years in flight operations management and is now a senior fellow for aviation for the American Economic Liberties Project.
McGee said that while there is no room for violent behavior by passengers, there are “fundamental rights that include innocent until proven guilty. Some rules now are more like being on the high seas.”
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December 14, 2022
DeSantis Announces Major Move Against COVID Vaccine Makers
Florida Republican Governor Ron DeSantis announced on Tuesday that he was seeking a grand jury investigation into the way COVID-19 vaccines were marketed and promoted and whether wrongdoing occurred.
"It is against the law to mislead and to misrepresent, particularly when you're talking about the efficacy of a drug," DeSantis said on Tuesday.
"Just recently, Florida got $3.2 billion through legal action against those responsible for the opioid crisis," he noted of previous legal action to hold drugmakers and drug sellers accountable. "It's not like this is something that is unprecedented," DeSantis said of his efforts to probe COVID-19 vaccines and the way they were presented to Floridians.
"Today, I'm announcing a petition with the Supreme Court of Florida to impanel a statewide grand jury to investigate any and all wrongdoing in Florida with respect to COVID-19 vaccines," DeSantis said.
"We anticipate that we will get the approval for that," DeSantis explained of his petition. The grand jury, DeSantis expects, "will be something that will be impaneled mostly likely in the Tampa Bay area."
DeSantis added that the grand jury "will come with legal processes that will be able to get more information" about any wrongdoing, and will "bring legal accountability for those who committed misconduct," he said.
The announcement on Tuesday is a follow-through on a promise Governor DeSantis made earlier in December when he pledged that his administration would "work to hold these manufacturers accountable for this mRNA [vaccine] because they said there was no side effects and we know that there have been a lot," DeSantis said of his plan to "bring some accountability" for COVID-19 vaccine makers, namely Pfizer and Moderna who produced the mRNA vaccines.
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Top Doctor: Long COVID is Being Exaggerated to Extort Taxpayers
John's Hopkins Medical School Professor Dr. Marty Makary, who also serves as a health advisor for Virginia Governor Glenn Youngkin, is warning "long COVID" is being exaggerated in order to extort American taxpayers for more money.
"Long Covid is real. I have reliable patients who describe lingering symptoms after Covid infection. But public-health officials have massively exaggerated long Covid to scare low-risk Americans as our government gives more than $1 billion to a long Covid medical-industrial complex," Makary writes in the Wall Street Journal.
"The National Institutes for Health has been intensely focused on studying long Covid, spending nearly $1.2 billion on the condition. To date, the return on investment has been zero for the people suffering with it. But it’s been terrific for MRI centers, lab testing companies and hospitals that set up long Covid clinics," he continues. "I’ve talked to the staff at some of these clinics and it’s unclear what they are actually offering to people beyond a myriad of tests."
The White House continues to demand endless funding as Dr. Anthony Fauci claims the U.S. is still "in the middle" of a pandemic.
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Michigan Medicine Prof. of Biologic Nanotechnology investigates Adverse Reactions Associated with COVID-19 mRNA Vaccines
The founding Director of the Mary H. Weiser Food Allergy Center, and Ruth Dow Doan Professor at Michigan Medicine not to mention an exceptional allergy and clinical immunology specialist, Dr. James Baker Jr., spearheads a 200-patient interventional study titled “Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction.” Launched in the spring, this single-group assignment open-label study runs till December 2024. In the study, the participant receives a dose of Pfizer-BioNTech (Comirnaty) or Moderna (Spikevax), both mRNA COVID-19 vaccines. The goal? Determine primary and secondary endpoints associated with safety of the mRNA-based vaccines. Specifically, the study team hypothesizes that the individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
While the U.S. Food and Drug Administration (FDA) has deemed the mRNA COVID-19 vaccines safe and effective, various side effects and adverse events have been identified, including in the regulatory package insert. For example, a cardiovascular signal has been identified in the form of myocarditis and pericarditis in young persons.
Can persons that had an adverse reaction to the first or second dose of either mRNA -based COVID-19 vaccine (Pfizer-BioNTech or Moderna) safely tolerate an additional dose if they have a personal history of allergic reaction who declined COVID-19 vaccination administration can safely tolerate an initial dose?
In this study funded by both the University of Michigan and the Wallace Foundation, Dr. Baker along with Dr. Charles Schuler IV, seek 200 eligible to receive an initial or additional dose of either Comirnaty or Spikevax.
Participants in this study will also be required to have 1-2 in person visits along with phone call follow up visits.
The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose, and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
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Pathological Syncytia Formation with mRNA Vaccines
One of the curious findings from the original randomized trials of mRNA vaccines was an explosive rate of early infection after the first injection as compared with placebo. In a recent paper from Sfera et al., the description of pathological syncytia or fusion between immune cells is described: “The LNP technology, to put it simply, mimics viral envelopes with externalized phosphatidylserine (ePS), a universal “eat me” signal, that directs immune cells to engulf the particle.
However, as ePS is also a potential “fuse me” signal, LNP may inadvertently facilitate the formation of pathological syncytia. Moreover, ePS may activate a disintegrin and metalloprotease 10 and 17 (ADAM10) (ADAM 17), master regulators of syncytia formation, contributing further to the unintended consequence of cell-cell fusion…As mRNA vaccines are based on pre-fusion epitopes, the fusion pathology may be undeterred, allowing viral infection by syncytia formation to continue unabated.
This is significant, as it could account for the reoccurrence of COVID-19 symptoms in fully vaccinated individuals. The authors point out that SARS-CoV-2 utilizes more than just the ACE2 receptor to gain entry into the fused cells and by overlooking this possibility, vaccine developers have made a blunder.
This is further complicated by the choice of lipid nanoparticles and polyethylene glycol which facilitate entry into organs were syncytia as well as Spike protein will incite inflammation and immune system regulation. Sfera also considers pregnancy: “Several studies demonstrated that SARS-CoV-2 can activate HERV-W, an ancestral gene that encodes for the physiological placental fusogen syncytin-1 responsible for the merger of trophoblasts during the early pregnancy. This suggests that the reproductive post-vaccine events may be triggered by the furin cleavage site pathology.” Such processes could occur in the gravid uterus and compound the bleeding and clotting risks of ill-advised vaccination is this special population.
In summary Sfera et al. point out the following blind spots of well-funded DARPA consultants, BARDA funded academic researchers, and later, by Pfizer and Moderna in mRNA vaccine development: 1) pathologic syncytia formation, 2) use of lipid nanoparticles with PEG, 3) failure to consider SARS-CoV-2 could use alternative points of cell entry other than ACE2 (metalloprotease pathway, antibody dependent enhancement, cell penetrating peptides, viroporins).
With billions of people rushed into indiscriminate mRNA vaccination, virologists and immunologists will be picking up the pieces of a failed vaccine campaign that has left so many at risk for more SARS-CoV-2 infections and progressive complications over the months and years to come.
https://www.trialsitenews.com/a/pathological-syncytia-formation-with-mrna-vaccines-482b8930
**************************************************December 13, 2022
Danish Study Published in Nature Reveals the Prejudice Unvaccinated Individuals Face in Most Countries
The results of a global study from Denmark’s Aarhus University, reveal that across the globe people show prejudice and discriminatory attitudes towards individuals not vaccinated against COVID-19. The findings have been published in the journal Nature.
The study is part of the research project How Democracies Cope with COVID-19: A Data-Driven Approach (HOPE), https://hope-project.dk/#/about supported by the Carlsberg Foundation. It was made in cooperation with the Centre for the Experimental-Philosophical Study of Discrimination, supported by the Danish National Research Foundation.
The researchers set out to assess whether people express discriminatory attitudes in family and political settings across groups defined by COVID-19 vaccination status. Specifically, the sought to quantify discriminatory attitudes between vaccinated and unvaccinated citizens in 21 countries, covering a diverse set of cultures across the world.
Across three conjoint experimental studies (N=15,233), researchers demonstrated that vaccinated people express discriminatory attitudes towards the unvaccinated, often as high as the discriminatory attitudes often seen in common targets including immigrants, drug-addicts and ex-convicts. In contrast, there was little evidence that unvaccinated individuals display discriminatory attitudes towards vaccinated people.
Many vaccinated people do not want close relatives to marry an unvaccinated person. They are also inclined to think that the unvaccinated are incompetent as well as untrustworthy, and they generally feel antipathy against them.
Discriminatory attitudes are more strongly expressed in cultures with stronger cooperative norms. According to the researchers, the reason for this appears to be that the vaccinated perceive the unvaccinated as free riders. The findings suggest that contributors to the public good of epidemic control (i.e., the vaccinated) react with discriminatory attitudes against perceived free-riders (i.e., the unvaccinated).
Part of the overall study looking solely in the United States showed that not only do vaccinated people harbor prejudice against the unvaccinated, but they also think they should be denied fundamental rights. For instance, the unvaccinated should not be allowed to move into the neighborhood or express their political views on social media freely, without fear of censorship.
“It is likely that we will encounter similar support for the restriction of rights in other countries, seeing as the prejudice and antipathy can be found across continents and cultures,” said co-author Michael Bang Petersen, who is a professor of political science at Aarhus University.
With low vaccine uptake still a challenge to pandemic management, the researchers warn authorities against employing a rhetoric of moral condemnation in their attempt increase vaccination rates.
“Moral condemnation may strengthen the cleavages and further feelings of exclusion that have led many unvaccinated to refuse the vaccine in the first place. Our prior research has shown that transparent communication about the safety and effectiveness of vaccines is a more viable public-health strategy for increasing vaccine uptake in the long term,” said Michael Bang Petersen.
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Molecular Changes linked to to Long COVID
One of the first studies of its kind, researchers at Mount Sinai in New York City associate long COVID symptoms with changes in gene expression during acute COVID-19. Specifically, researchers employed with this prestigious academic center in Manhattan are the first to publish a study associating changes in the blood gene expression during COVID-19 with post-acute sequelae of SARS-CoV-2 infection (long COVID) in patients over a year post hospitalization for severe COVID-19. Published in Nature Medicine on December 8, the team highlights the need for greater attention at the infection stage for improved understanding of how the processes that commence eventually turn into long COVID. The hope is that this research can help scientists better understand how the processes that start with SARS-CoV-2 infection led to long COVID. The goal? Develop prevention strategies and treatment options for COVID-19 survivors experiencing ongoing long COVID problems.
What did the Mount Sinai team discover?
Among other things, the New York City-based team found two molecularly distinct subsets of long COVID symptoms with opposing gene expression patterns during acute COVID-19 in plasma cells, the immune system’s antibody-producing cells.
In patients who went on to develop lung problems, antibody production genes were less abundant. However, for patients with other symptoms such as the loss of smell or taste and sleep disruptions, the same antibody production genes were more abundant instead.
Mount Sinai researchers led by co-corresponding author Noam D. Beckmann, Ph.D., Assistant Professor of Medicine (Data Driven and Digital Medicine) and Associate Director of Data Science Strategy at The Charles Bronfman Institute for Personalized Medicine at the Icahn School of Medicine at Mount Sinai wrote that these opposing patterns observed in the same cells, as well as additional unique patterns observed in other cell types. They point to the existence of multiple independent processes leading to different long COVID symptoms; importantly, these processes are already present during acute infection.
Principal Investigator's Point of View
Dr. Beckmann went on the record “Our findings show that molecular processes leading to long COVID are already detectable during COVID-19 infection,” which of course has implications for future care regimens. The Mount Sinai professor continued, “Furthermore, we see the start of multiple molecularly distinct paths leading to long COVID, providing a unique viewpoint into differences between long-term symptoms.”
Study Data Sources
Using the Mount Sinai COVID-19 Biobank, the researchers examined gene expression data in blood samples from more than 500 patients hospitalized with COVID-19 between April and June 2020. More than 160 of these patients provided self-reported assessments of symptoms still present six months or more after hospitalization. The team tested each gene expressed in the blood for association with each long COVID symptom, accounting for ICU admission, COVID-19 severity during hospitalization, sex, age, and other variables. The team then tested for associations specific to each of 13 different types of immune cells, including plasma cells. Finally, these associations were categorized by whether they matched up with changes in patients’ levels of antibodies specific to the virus.
“For long COVID symptoms, like smell or taste problems, connecting antibody gene expression in plasma cells with the actual levels of antibodies against the SARS-CoV-2 spike protein demonstrates a direct link to the body’s response to the virus,” said lead author Ryan C. Thompson, Ph.D., Data Science Analyst at The Charles Bronfman Institute for Personalized Medicine. “On the other hand, the gene expression pattern for lung problems does not match up with SARS-CoV-2-specific antibody levels, highlighting the different immune processes leading to long COVID that are triggered by COVID-19.”
Long COVID Poorly Defined
The reality is that long COVID still remains poorly defined and future studies should take the initial stage of infection into account to characterize the molecular processes of long COVID more comprehensively and identify biomarkers that can help predict, treat, and prevent prolonged symptoms.
“Our findings show there is the potential to use data from the infection stage to predict what might happen to the patient months later,” said co-corresponding author Alexander W. Charney, MD, Ph.D., Associate Professor of Genetics and Genomic Sciences, and Co-Director of The Charles Bronfman Institute for Personalized Medicine. “We should not ignore the infection phase in research on long COVID—this is clearly a critical window of time where the body’s response to SARS-CoV-2 might be setting the stage for what is to come.”
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Exaggerated COVID-19 Death Rates used as Fright Factors
What did Emergency Use Authorizations (EUAs) do to lower the absolute risk of dying from COVID-19?
The phrases "fully vaccinated" and "fully antibody protected" mean different things, obviously. There is not a causation graph that proves that being "fully vaccinated" (a protocol of two shots, that is no longer a measure of efficacy or protection against newer SARS-CoV-2 variants) is any indication of Absolute Risk Reduction (ARR) from the risk of death from SARS-CoV-2. Since the original EUA products have diminishing benefits, the COVID-19 vaccination booster and bivalent booster rates are the only vaccination rates that should be considered to determine the ARR of deaths as a result of the COVID-19 variants of today. Even the nonvaccinated-person (as variable as this "group" is) COVID-19 death rates have changed.
There are hidden reasons for stories to come out the way they do. The recent stories that are being now told -- of achieving a universal saturation in humans of natural and injection-assisted antibodies to the variants of SARS-CoV-2 -- have many tangents. With these data from stories (clinical data are also the basis of "storytelling"), statisticians try to come up with one or two figures that represent statistics to comfort themselves with knowledge, such as how many individuals have died from COVID-19 -- 6,657,680 human deaths is a number that was published yesterday. But what do the statisticians' collective knowledge, represented by one figure, mean?
It means, for one thing, that only those official deaths, that were counted by official counters and recorded by official record keepers, that are the basis for COVID-19 policies and actions -- are not revealing everything we need to know. COVID-19 "death rates" are calculated for as many nations and geographic regions as can be officially monitored, but it is not now reasonable to call these numbers absolutely accurate figures.
Another confounding thing is that the number of deaths of individuals who were sometime-in-the-last-three-years infected with SARS-CoV-2 virus -- "had COVID-19" -- but were not only sick with COVID-19 (they were interfered with) -- having other added reasons that they died.
Yet another confounding factor to the official count is the number of deaths that occurred while attempting to mitigate the COVID-19 infections and contagion scope, with such actions "inadvertently leading to deaths of more individuals" than were in the death-by-COVID-19 designation (think: evasive tactics such as taking medications, receiving vaccinations, trying activities to avoid death from the virus, deaths at the hands of hospital staff, suicides, depression and personal abuses, etc.).
There are also the numbers of individuals that have not been revealed to the officials, those who have neither reported their SARS-CoV-2 infections, nor their recoveries, nor have their determined causes of deaths been clearly confirmed, nor has there been, or will be, a clear inventory of their virus-sharing contacts.
All these are confounding factors. This latter category -- 'contacts' -- is a juicy morsel of human geographical information, with absolute accuracy out of the reach of those demanding to convert us to that theory that the world surveillance of the human population would lower death rates.
But such a strained definition of correlation (of officials having knowledge of where we all are, what we own, what we spend, who we associate with -- correlated to our personal safety through submission to official policy) is a false authority attempt and an untenable conspiracy* that is yet currently being attempted by some so as to become centrally global in scope(if that ever made sense) -- just convince people to waive their own rights temporarily for "the sake of all". The COVID-19 death figure is to be your motivation to serve others in the way the government has found to be approved. Obey the mandates, lower the death rate -- is the mantra.
During this current COVID-19 disease period of changing variants, there is a current single figure representing the death rate from the disease called COVID-19, using one figure. This is supposed to scare us into giving our wills to a central organization that is planning to eradicate the disease COVID-19. We can admit that the figure is indicative of a large number of deaths, roughly calculated at 853.8 deaths of individual human beings -- per million population. With the starting point of "a nearly accurate population estimate" for the world of 8,002,627,404 live humans (the Current World Population from the Worldometers website at 0815 hours Mountain Standard Time on 12-10-2022), we can divide 6,657,680 (current official COVID-19 deaths) by 8,002,627,404 and then worry about how to stop that number from becoming a larger number:
It is not reasonable for the World Health Organization to consider being the One that is skilled and powerful -- so much so that it can attempt to persuade and/or mandate us all to a single-source treatment policy. It is advisory only, and advice can be and will be, in many cases in this vast world --- unuseable when that advice is also untenable.
The current conspiracy (or the milder tone of "collusion") to surveil and control our healthcare through the central organization WHO is untenable. The plans to convince us are dependent on waiving rights of masses of human populations in various and diverse countries.
There are 0.083194% of the World's Human Population that have officially died from COVID-19. Or for more clarity, the decimal fraction of the world's humans that have died from COVID-19, officially, is 0.000831937
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December 12, 2022
Pharmaceutical Trials: When Left’s Obsession With Race Kills
One of the last things Francis Collins, then-director of the National Institutes of Health, did before retiring was to pressure Moderna into delaying the release of its COVID-19 vaccine because he wanted more minorities in its clinical trials.
Moderna’s CEO, Stephane Bancel, was happy to oblige him, saying that diversity “matters more to us than speed.”
That decision was not based on science, and it likely cost lives. A new study by law professor Michael Conklin, and a new book by another law professor, David Bernstein, explain why.
The race labels that we are all familiar with—black, white, Asian, Hispanic, etc.—are not scientific. Quite the contrary, Bernstein traces their origins to “a combination of amateur anthropology and sociology, interest-group lobbying, incompetence, inertia, lack of public oversight, and happenstance.” They have no basis in biology, tell us nothing about genetics, and are therefore useless to medical research.
For that reason, when the federal government standardized our race labels in 1977, it said that they “should not be interpreted as being scientific or anthropological in nature.” Since then, scores of scholars and researchers have warned that our arbitrary labels should never be used in medical research.
But the bureaucrats at the Food and Drug Administration and National Institutes of Health, and the leadership of at least one of our major pharmaceutical companies, ignored them.
Conklin explains that “there is no statute or regulation that explicitly mandates pharmaceutical trials reach any racial quota among their study participants,” but the FDA requires companies to gather such data and “recommends” that they submit it when seeking approval for new medicines.
The FDA claims that “[e]nsuring people from diverse backgrounds join clinical trials is key to advancing health equity.” But, as any doctor or medical researcher who isn’t blinded by ideology will tell you, it isn’t.
Ideology, however, trumps science for many on the left.
Take Harvard Medical School professor Farrah Mateen, for example. In a 2021 paper, she called for racial quotas in medical trials to advance “health equity” even while admitting that “[r]ace is a social construct, a poorly defined marker of genetic diversity, and an imprecise proxy for the relationship between genetics and ancestry.”
In truth, our arbitrary race labels are utterly useless to the science of medicine, which needs to understand how drugs will react to biological and genetic traits.
To give an example of how useless race labels are for medical research, consider the category “black.” According to U.S. law, “black” is anyone descended from one of the black tribes of Africa. The race-obsessed, like Collins, Bancel, or Mateen, might think that this category tracks at least somewhat reliably with biological and genetic traits. After all, they might say, all these people trace their origin to one continent and share a skin color.
But the truth is that there is more genetic diversity among Africans than between other geographically organized people groups. In fact, there is more diversity among Africans than there is between Africans and Eurasians.
Genetic diversity is a lot more than skin color. Not that the race-obsessed care.
If our medical experts, bureaucrats, and drug manufacturers were interested in science, they wouldn’t use our arbitrary race labels in medical research. And if they cared about saving lives, they wouldn’t have delayed the rollout of a COVID-19 vaccine so that they could increase the color diversity of clinical trials.
But they weren’t interested in science, and they didn’t care about saving lives. At least, they didn’t care as much about those things as they cared about signaling their obedience to ideology.
People likely died because of Moderna’s decision to delay its vaccine. We’ll never know how many. But even if we did, it wouldn’t change these people’s behavior. Reality finds no purchase in the minds of the race-obsessed.
https://www.dailysignal.com/2022/12/08/pharmaceutical-trials-when-lefts-obsession-with-race-kills
**************************************************Elon Musk Annihilates Two Leftist Shibboleths With A Single Five Word Tweet, And They Are Big Mad
It's no secret that billionaire Elon Musk has done nearly everything possible to rile up the political left since his purchase of Twitter finalized a month and a half ago, from freeing formerly frozen conservative accounts to releasing the Twitter Files detailing how previous management put their thumb on the scales to censor the right. However, a simple five-word tweet on Sunday morning may have finally driven them all insane permanently.
"My pronouns are Prosecute/Fauci," Musk wrote at 5:58 a.m. eastern time Sunday. So yeah, it was much earlier in Texas or California where Musk was likely located, because when has sleep - which the guy never does anyway - ever gotten in the way of an opportunity to massively troll the left?
If you're counting, that's two leftist shibboleths destroyed by Musk, a self-identified political centrist who believes in free speech. First, pronouns. Leftists love them some pronouns, especially ones that describe something different from someone's actual biological sex or are made up out of thin air. So, as actress Gina Carano found out the hard way, they get big mad when someone pokes fun at their new religion.
The other leftist shibboleth is, of course, America's Doctor Himself, Dr. Anthony Fauci, long may his name be blessed. While anyone with half a brain is at least questioning Fauci's approach to lockdowns, school closures, alternative Covid treatments, masks, and vaccine mandates as policies that resulted in massive suffering and death, leftists still revere the guy because he's one of them and they naturally agree with his totalitarian approach to tackling the pandemic.
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China’s dangerous zero-Covid retreat
China’s scrapping of strict Covid controls represents not so much a shift in gear, as a screeching hand-break turn. It is abrupt and haphazard and comes at a particularly risky time. Hundreds of millions of people will soon be on the move for Chinese New Year, which is next month, and the spread of the virus, already fast, will accelerate rapidly. The transition to living with Covid has not been easy for any country but will be particularly difficult for China – and dangerous for the communist party.
After almost three years of instilling fear – with brutal lockdowns, mass testing, sweeping quarantine and claustrophobic surveillance – the virus is suddenly being portrayed as quite benign
Only last month Xi Jinping was being portrayed as the commander in chief of a ‘people’s war’ against the virus. There was to be no turning back until it was defeated. In his address to the communist party congress Xi did not even note the enormous economic costs, the social toll and the mental stress he was imposing on China – and those brave enough to point them out were quickly silenced.
Now the very term ‘zero Covid’, used as a demonstration of party virility and a measure of superiority over bungling western democracies, has been eradicated from party propaganda. After almost three years of instilling fear – three years of at times brutal lockdowns, mass testing, sweeping quarantine and claustrophobic surveillance – the virus is suddenly being portrayed as quite benign. ‘Everyone should treat it with a normal heart – there is no need to be nervous or even fearful,’ declared Wang Guiqiang, director of the infectious diseases department at Peking University First Hospital.
In a review this week of China’s three-year fight against Covid, Xinhua, the state news agency, not only avoided any mention of contentious lockdowns, such as the two-month long shutdown of Shanghai earlier this year, but also made no mention of zero Covid – as if the policy had never existed. It was a rewriting of history, remarkable even by communist party standards. Thanks to party leadership, China had ‘survived the most difficult moment’, it insisted. Hysteric alarmism was replaced by what seems a remarkable complacency, given the challenges China still faces.
When China’s National Health Commission said this week that it was dropping many of its quarantine and mass testing measures, and that it would reduce the use of lockdowns, it presented the change as a logical response to the changing nature of the threat. But the party does not do logical. Its principal concerns will have been the mounting damage to the economy and the wave of unrest that has swept China.
It has been reported that Xi was swayed by a letter sent by Terry Gou, the head of Foxconn, which assembles most of the world’s iPhones for Apple. Its vast factory complex in Zhengzhou was the scene last month of large-scale rioting. Gou warned Xi that strict Covid controls threatened China’s central position in global supply chains. That may well have had some influence, but more likely the trigger for easing restrictions was the often-violent protests against zero Covid that swept across China. They shook the party leadership because they were so geographically widespread and involved a broad range of social groups from migrant and factory workers to students and the urban elite. It was not so easy to blame the unrest on the usual foreign ‘dark hand’ or other ‘bad elements’ – it was an expression of popular anger and frustration, and it targeted Xi and the party.
The party does not do admissions of failure, although that is what its easing of controls amounts to. The country is ill-prepared for the sudden switch away from Xi’s zero-Covid dogmatism. A vast bureaucracy and industry has been built to impose Xi’s will and to fight his fight – as represented by the massed ranks of white hazmat-suited enforcers. But they have not put in place the basic tools needed to live with the virus. Only two thirds of those aged 80 and over, the most vulnerable to serious illness or death, have received the initial course of vaccination, usually two shots, and only two-fifths of this age group have had a booster. Chinese vaccines are less effective than their western counterparts, especially against the latest Omicron variants, and Xi has stubbornly refused to allow the import of foreign jabs. There is also little natural immunity, since most people have until now been shielded from the virus. According to government statistics, China has 3.6 intensive care beds per 100,000 people, compared to 29.4 in the United States and a little over seven in the UK.
The healthcare system could be quickly overwhelmed, and modelling of the likely impact does not make for comfortable reading for healthcare workers – or the party. Up to a million people are at risk of dying in a ‘winter wave’ of Covid, according to projections reported by the Financial Times. Figures from Wigram Capital Advisors, which provided modelling to governments during the pandemic, suggest the number of deaths could reach 20,000 a day by mid-March, with the demand for critical care beds peaking at ten times capacity.
Chinese New Year falls on 22 January – the year of the Rabbit. In any usual year the annual holiday sees the world’s largest migration of people, with perhaps 400 million on the move. This time could be even busier with considerable pent-up demand for travel and a hunger to see loved ones after years of restrictions. Not only does it stand to be a ‘super-spreader’ event, but inadequately prepared rural areas could be overwhelmed by the virus.
After their initial euphoria, financial markets have become much more cautious. The economy is unlikely to quickly bounce back. Few people are ruling out an abrupt reversal by the party, imposing travel restrictions or even more severe lockdowns if there is an explosion in the number of cases. But the rapid return of the zero-Covid straight-jacket could in turn trigger more unrest among a population emboldened by what is seen widely as the success of their protests in forcing rare concessions from the party.
https://www.spectator.com.au/2022/12/chinas-dangerous-zero-covid-retreat
**************************************************December 11, 2022
FDA Says Ivermectin Doesn’t Work Against COVID-19 but Points to Studies That Show It Does
The FDA’s website states, “Currently available data do not show ivermectin is effective against COVID-19.”
But half of the studies to which the FDA points support using ivermectin against COVID-19, according to the review.
The papers cut against the drug agency’s repeated exhortations for people not to take ivermectin for COVID-19. In Twitter posts, public statements, and emails, FDA officials have repeatedly warned against ivermectin. Some of those statements triggered a lawsuit from doctors who say the agency’s role is to approve drugs, not to issue recommendations. The suit was dismissed this week.
Dr. Pierre Kory, who frequently prescribes ivermectin for COVID-19 and co-authored a meta-analysis that concluded the drug is effective against the illness, told The Epoch Times that the government’s position on ivermectin “is one of the most glaring examples of the corruption of modern evidence based medicine.”
“There’s one message they want everyone to understand. And that message is that ivermectin doesn’t work,” Kory said. “That’s not a scientific conclusion, that’s theirs. That’s their perverted and distorted interpretation of the data.”
The FDA’s media office did not respond to a request for comment.
Dr. Janet Woodcock, a top official at the agency who was its commissioner from January 2021 to February 2022, told The Epoch Times via email that “ivermectin has been shown to be ineffective against COVID in large randomized trials.”
Studies
The FDA’s website points to a U.S. National Library of Medicine database of studies analyzing ivermectin against COVID-19. There are 88 studies listed in the database.
Out of studies that are listed, have been completed, and have results reported, half show or indicate ivermectin effectively combats or prevents COVID-19, according to the review by The Epoch Times.
They include papers reporting on results from randomized, controlled trials, which are often offered as the highest level of evidence by U.S. government officials. Such trials feature a group that receives a placebo and a group that receives the drug, randomization into groups, and blinding, or shielding operators and/or patients from the knowledge of which participants are receiving ivermectin.
Among the papers is a randomized, blinded, controlled trial that found people who received ivermectin and doxycycline, an antibiotic, recovered faster from COVID-19 than those who received a placebo.
Bangladeshi researchers reported the results from the trial of 363 participants on May 13, 2021, in the Journal of International Medical Research.
“Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative by RT-PCR on day 14,” they said. PCR has been used to test for COVID-19.
Another paper, published on July 7, 2022, in the International Journal of Infectious Diseases, found that that ivermectin decreased the level of COVID-19 and its viability. Israeli researchers in the randomized, controlled, open label trial compared 47 patients who received ivermectin against 42 who received placebos and said that “ivermectin significantly reduced the time of viral shedding and affected viral viability when initiated in the first week after evidence of infection.”
“There were lower viral loads and less viable cultures in the ivermectin group, which shows its anti-SARS-CoV-2 activity,” the researchers said. SARS-CoV-2 is a name for the virus that causes COVID-19.
A third paper concluded that a regimen of ivermectin and carrageenan works as a prophylaxis, or preventative medicine. Argentinian researchers found in the observational trial involving 229 health care workers that ivermectin helped prevent COVID-19 infection. A followup study involving nearly 1,200 workers confirmed the results. Both sets were reported in the Journal of Clinical and Biomedical Investigation on Nov. 17, 2020.
Ivermectin “could have saved so many lives,” Héctor Carvallo, one of the researchers, told The Epoch Times via email, adding that “it’s been a crime against mankind to prevent its prescription.”
Some other studies, including the largest ones, either found indications that ivermectin works against COVID-19 but did not achieve statistical significance or found no evidence that ivermectin is effective.
That includes a randomized, controlled, double-blind 2021 study by Mexican researchers that found ivermectin did not significantly impact hospitalization duration or mortality, and a randomized, controlled, double-blind 2022 trial by U.S. researchers that concluded ivermectin did not prevent hypoxemia, hospitalization, or death.
FDA Intervention
Scientists in Australia in April 2020 found that ivermectin worked well against the COVID-19 virus in cell culture, prompting doctors in multiple countries, including Peru and the United States, to start using it against the new illness.
Ivermectin is approved by the FDA to treat parasites. One version is used on horses and other animals.
The FDA quickly warned against using the animal form and said that people should “not take any form of ivermectin unless it has been prescribed to them by a licensed health care provider and is obtained through a legitimate source.”
Studies later in the year suggested ivermectin worked well in humans who had COVID-19, including halting the progression of disease (pdf), helping patients improve faster, and preventing COVID-19 infection, though other studies returned results that did not support ivermectin as a treatment.
The FDA maintained its stance against COVID-19, and created a new web page on March 5, 2021. It initially said, “The FDA has not reviewed data to support use of ivermectin in COVID-19 patients to treat or to prevent COVID-19; however, some initial research is underway.”
In August 2021, the FDA urged people against using ivermectin by telling them that “you are not a horse.” It linked to the page, which was updated the following month with the language it now contains about data not showing ivermectin is effective.
American doctors are allowed to prescribe drugs approved for one use for a different use, a practice known as off-label. But doctors who prescribed ivermectin soon found that many pharmacies stopped filling prescriptions, citing advice from the FDA and other U.S. government bodies.
Half of Studies Supportive
The FDA does not cite studies on its website to support its statement that data “do not show ivermectin is effective against COVID-19.”
“Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing,” the agency adds, providing a link to the U.S. National Library of Medicine’s database.
Of the 88 studies listed there, 56 fall under one of three categories: have not been completed, were completed but results have not been reported, or were completed and have since been retracted or otherwise withdrawn.
Of the remaining 32, 16 found or indicate ivermectin is effective as a COVID-19 treatment or prophylactic, according to the Epoch Times review.
Two of the trials were randomized, controlled, and blinded. Nine others were randomized and controlled but were not blinded at all. Most of the rest were observational, meaning they analyzed data from real-world settings like hospitals, or used observational data to create what’s known as a synthetic control group.
The set of papers includes results of a randomized, controlled, open label observational trial (pdf) that found ivermectin combined with doxycycline, an antibiotic, reduced the time to recovery and the mortality rate, and a randomized, controlled, double-blinded trial that found ivermectin and doxycycline quickened recovery and patients were less likely to see their disease progress.
Of the 16 other studies, six reported mixed results. For instance, Spanish researchers reported in The Lancet in February 2021 that ivermectin did not have an impact on testing results, but that there was “a marked reduction” of self-reported symptoms such as loss of smell and cough, and lower levels of viral loads. The result “warrants assessment in larger trials,” the researchers said.
The remaining 10 studies returned results that did not favor ivermectin or did not achieve statistical significance.
U.S. researchers, for example, found that ivermectin probably worked better than a placebo, but that the results did not achieve statistical significance, prompting them to say in October that “this study adds to the growing evidence that there is not a clinically relevant treatment effect of ivermectin at this dose and duration.”
The FDA did not respond to a request for comment on the revelation that half of the studies it points to support using ivermectin (IVM) against COVID-19.
Woodcock, the FDA’s principal deputy commissioner, reviewed the studies. She was unimpressed.
The Bangladeshi trial, for instance, was criticized for primarily including young persons, and having a higher number of dropouts in the placebo arm. Woodcock said the Israeli study did not report “clinical outcomes” and noted many of the other papers had small numbers of participants.
“There are only a couple studies here that really look at the effects of IVM and see a positive clinical effect and they are much smaller than the negative studies,” Woodcock told The Epoch Times in an email.
The trials in favor of ivermectin are on the smaller side, and more likely to be observational. But that doesn’t necessarily mean they are inferior, Kory said. He cited research that found there was little difference between observational studies and randomized-controlled trials, as well as a paper that said “study design is only one factor that determines study quality.”
The FDA isn’t the only government group opposed to using ivermectin to treat COVID-19. The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel recommends against it, citing several of the larger trials that found little or no benefit for ivermectin. The panel cites none of the papers that found a positive effect.
Criticism of Design
Many of those studies have been criticized over their design. One major factor, critics say, is participants not receiving ivermectin soon after a positive test or the start of symptoms.
In one trial, researchers acknowledged that more than 4 out of 10 participants did not receive the dosage level that was listed as the “goal dose.” Further, the median time from the start of symptoms to treatment was six days, and the treatment duration was just three days. The trial, called ACTIV-6, was backed by the NIH.
The corresponding author for the trial did not return a request for comment. The authors said that “there was no evidence of a differential treatment effect based on the median time of symptom onset to receipt of study drug.”
In another trial that reported little difference between the treatment and control groups, the treatment group received ivermectin days after starting to show symptoms.
Ivermectin works best when applied within 24 hours of symptom manifestation, according to a meta regression of ivermectin studies performed by by an unnamed group of researchers.
“They literally try to treat as late into the disease as they can, for a short duration as they can, at the lowest dose that they can. And they also try to find as healthy and mild patients as you can,” Kory said.
“And yet, when they conduct those kinds of trials, it’s on the front page of a high-impact journal and the conclusion states, ‘this shows there’s no role for ivermectin in treatments.’ Absolutely absurd. And so it’s it’s really just corruption of these trials.”
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December 09, 2022
Covid jab resisters are seen as 'incompetent, untrustworthy' and not marriage material - study reveals
I don't share that view. I reluctantly had two shots but I am perfectly happy that my girlfriend is an ardent anti-vaxxer
A huge global study has revealed the emergence of Covid vaccine snobbery, with vaccinated people seeing the unvaccinated as 'incompetent, untrustworthy' and even poor marriage material.
The study of 15,233 people from 21 countries, including Australia, found vaccinated people were more discriminatory about the unvaccinated than they were towards ex-criminals and drug addicts.
The study, led by Denmark's Aarhus University, also showed the vaccinated generally hold more strongly negative attitudes towards unvaccinated individuals than the other way around.
Its authors claim vaccinated people were 'motivated to exclude the unvaccinated from family relationships and even protected political rights'.
They did however note the reaction was understandable because of the importance of widespread vaccination.
But they also advised governments to take urgent steps to heal the wounds caused by discrimination on the basis of vaccination status during the pandemic.
The study did not include any findings on attitudes about the effectiveness of vaccines, which were estimated to have saved millions of lives.
In June 2022, the highly respected Lancet medical journal estimated that vaccinations prevented up to 20 million deaths from Covid in 185 countries between December 2020 and December 2021.
But the new study's results cast previously unpopular defences of the unvaccinated in a completely new light.
Those include Scott Morrison's call in November 2021 that the unvaccinated should be allowed to order a cup of coffee if they want one - which was criticised by Queensland premier Annastacia Palaszczuk.
The survey also appears to at least partly support claims by fringe politicians and protest groups that discrimination against unvaccinated people was a real thing in Australia.
One Nation leader Pauline Hanson's efforts to introduce her controversial Covid-19 Vaccination Status (Prevention of Discrimination) Bill in November 2021 to federal parliament were defeated.
Covid vaccinations commenced in Australia in February 2021.
As of December 7, 2022, more than 64 million doses of Covid vaccines have been administered in Australia, and 96 per cent of Australians have had at least two doses.
An estimated 500,000 Australians remain unvaccinated, with their reasons a mix of fears about potential health impacts and a personal stand against vaccine mandates.
The 'discrimination' against unvaccinated people worldwide is so serious that study's authors 'urge authorities across the world to heal the cleavages in society left by the Covid-19 pandemic'.
'The study shows that prejudice towards the unvaccinated is as high or higher than prejudice directed towards other common and diverse targets of prejudice, including immigrants, drug-addicts and ex-convicts,' the authors wrote.
'In contrast, researchers find that the unvaccinated display almost no discriminatory attitudes towards the vaccinated.'
The findings directly contradict a public perception that 'anti-vax' and so-called 'freedom' protesters were antagonistic towards vaccinated people.
They also further strengthen the claims that Australian state governments overreached with tough Covid public health orders - such as thousands of fines, which were recently ruled invalid.
The study, titled Discriminatory Attitudes Against the Unvaccinated During a Global Pandemic, was authored by post-doctorate student Alexander Bor and Michael Bang Petersen, a professor of political science.
The data was collected from 21 countries - including Australia - between December 3, 2021 and January 28, 2022.
The global study involved picking 500 respondents each from Australia, Brazil, Denmark, France, Germany, Italy, Mexico, Russia, Spain, Britain, and the United States.
At the time, Sydney and Melbourne were in the grips of an Omicron outbreak, interrupting Christmas plans for millions of frustrated people who had taken up vaccinations.
Queensland's case numbers were just beginning to take off.
The study revealed attitudes 'in all inhabited continents' towards the unvaccinated were so extreme that many vaccinated people 'do not want close relatives to marry an unvaccinated person'.
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Military background of the Covid vaccines explains a lot
Like blurry shapes in a swirling kaleidoscope that suddenly stops, three critical pieces of the pandemic puzzle came into focus this week.
First is the publication on 6 December of an explosive account of The Truth about Wuhan by Dr Andrew Huff, former vice president, from 2014 to 2016, of the EcoHealth Alliance (EA), the dodgy New York-based not-for-profit that funnelled millions of dollars from the US Department of Defense and Dr Fauci’s National Institute of Allergies and Infectious Diseases to the Wuhan Institute of Virology (WIV).
Huff is a highly credentialed whistleblower, who served in Iraq, has a Masters in security technology, and a doctorate in bioterrorism. He was shocked when he saw that the EcoHealth Alliance was transferring gain-of-function techniques to Chinese scientists at the WIV allowing them to make dangerous viruses more infectious and says Sars-CoV-2 was developed during his time at the organisation.
This is supported by Peter Daszak, founder of the EA who boasted in 2016 in a speech to the New York Academy of Medicine presciently titled ‘History and Future of Pandemics’, that he and his colleagues at the WIV had sequenced the spike protein of Sars-like bat coronaviruses and inserted them into pseudo particles to ‘see if they bind to human cells’, observing that with each step they moved closer and closer to a virus that could ‘really become pathogenic in people’.
Amongst those who attended Daszak’s speech was Ian Lipkin, professor of epidemiology at Columbia University and one of the authors of the infamous paper, ‘The Proximal Origin of Sars-CoV-2’. Unredacted emails released in the last fortnight show that the paper was written at the behest of Fauci to rubbish the idea that the virus could have been created in a lab and smear anyone who said otherwise as a crackpot conspiracy theorist. Yet the emails show all the authors knew that the virus could be made more infectious in a lab. Despite – or perhaps because – Daszak refuses to disclose the specific virus that the WIV enhanced, Fauci has continued to fund the EA during the pandemic to the tune of nearly $7 million.
Huff says he sounded the alarm over biosecurity risks at the WIV because of its lax lab management and resigned in 2016 because of ethical concerns with the organisation. But in late 2019 he was offered a job at the US Defense Advanced Research Projects Agency (DARPA). He thinks DARPA already knew about the lab leak and wanted him inside the tent to make sure he couldn’t speak out as they embarked on a massive cover-up of their role in funding the creation of Sars-CoV-2. When he spoke out, he says he was subjected to extraordinary harassment including being stalked by military-grade drones. While China can be expected to lie about the pandemic, Huff’s account explains why Fauci and the Department of Defense would be so keen to cover up what happened in Wuhan.
The third piece of the puzzle to emerge in the last week is provided by Sasha Latypova, a pharmaceutical insider who worked in clinical trials for 25 years. She brings an insider’s focus to a key feature of the response to the pandemic that was hiding in plain sight. The development of the Covid vaccines was undertaken within the framework of the US government’s bioterrorism program under the aegis of the National Security Council.
The diabolical predicament in which we find ourselves is that Operation Warp Speed and its successor under President Biden, was run, at the highest levels, by the military not by vaccine developers, and the products are deemed to be military medical countermeasures. As a result, those in charge of producing them are also charged with regulating their safety and efficacy which they are not required to prove to anyone. They do this under the Emergency Use Authorisation Act (1997) which allows the Department of Health and Human Services (HHS) to dispense with normal safety and efficacy regulations in a public health emergency, if no other effective treatment exists. This provides an important incentive to disregard existing medication to treat Covid or to damn it as ineffective. It also explains why the more than 32,500 deaths and 1.47 million injuries which have been reported to the US database of Covid Vaccine Adverse Events through to 25 November, more than for any vaccine in history, can be ignored when other vaccine rollouts have been halted after 50 deaths.
HHS is also empowered under the Other Transactions Authority Act (2015) to order undisclosed medical countermeasures from pharmaceutical companies without being subject to any scrutiny. Likewise, the companies are not obliged to share the intellectual property developed with taxpayer funds with the government. Millions of dollars can be channelled to companies who can reward government officials with well-remunerated jobs in the private sector in a constant revolving door. It also means pharmaceutical companies have not had to detail to regulators the content of, for example, their proprietary lipid nanoparticles, or tests to prove what they are, what they do, and how they can be consistently manufactured. Indeed, the failure of contractors to comply with standard good manufacturing practices has been disregarded.
Finally, under the PREP Act the Public Health Emergency Declaration of 2020 exempts anyone acting within the framework of the Act from any liability for any injury or death for as long as their is a ‘public health emergency’, which no doubt explains why President Biden recently renewed the emergency declaration.
Without anyone to hold anyone to account, the US government and the vast majority of governments around the world, including ours, have showered billions of dollars on the manufacturers of the most lethal vaccines ever created. Big Pharma hasn’t captured the regulator, the Department of Defense has captured Big Pharma in a mutually rewarding deadly embrace.
For us, however, like Pandora, there is no way out of our dilemma. All that we have left is hope that those who, like gods, have been given unlimited power might give it way, a hope which as Friedrich Nietzsche argued may be ‘the most evil of evils because it prolongs man’s torment’.
https://spectator.com.au/2022/12/pandoras-lab/
**************************************************December 08, 2022
Here Is How the FDA Made the RSV Wave More Dangerous
Forget Covid-19 and Monkeypox. Respiratory syncytial virus (often shortened to RSV) may be the biggest public health threat this season. RSV is a virus that often results in mild cold-like symptoms for many infected adults. However, it can be deadly for children. RSV is estimated to be responsible for 1 out of 50 children’s deaths globally and 1 out of 56 deaths for children in developed countries.
RSV is rapidly spreading across the US and threatens our youth. The Center for Infectious Disease Research and Policy at the University of Minnesota reports the highest hospitalization rates for flu (including RSV) in a decade—with children and seniors most affected. California recently reported its first RSV complications-related death for a child. Fearing the worst is yet to come, Colorado Governor Jared Polis signed an order extending the Covid-19 emergency declaration to include RSV and other respiratory viruses. Governors in other states could follow his lead.
The younger the patient, the more difficult RSV is to treat. Infants with RSV cannot safely use most medications to treat the virus’s symptoms. Because infants are particularly susceptible to developing bronchitis or pneumonia from RSV, carefully monitoring breathing patterns is vital.
There are very few devices that effectively monitor an infant’s oxygen levels, and many of them are only found in hospitals. There used to be one widely available to parents until the Food and Drug Administration ordered it off the market.
Nearly a year ago, the FDA sent a warning letter to Owlet regarding its Smart Sock—a product that monitored an infant’s pulse and oxygen intake. The letter stated the FDA determined the Smart Sock is a medical device that needed to undergo the agency’s approval process before reaching the market. At the time, Smart Socks had been on the market for five years, boasted a 90 percent accuracy rating according to peer-reviewed research, and helped over 600,000 parents care for their children.
Unable to undergo the time-consuming and expensive process, Owlet released a version of the Smart Sock this January. But the latest version no longer monitors an infant’s heart or lungs. Consequently, the FDA drove parents’ best option to carefully monitor their baby’s vital organ function off the market.
In an article I wrote for the American Institute for Economic Research shortly before the Smart Sock was pulled from store shelves, I warned, “The cost of the agency’s decision is hundreds of thousands of infants going without a highly reliable monitoring device and countless sleepless nights for parents fearing for their children’s health or life.” As RSV sweeps across the country, there will be tragically more of both.
https://blog.independent.org/2022/12/06/rsv-wave/
**************************************************Could COVID hold key to curing cancer? Virus' notorious spike protein kills hard-to-treat lung tumors in lab studies
The virus has claimed the lives of six million people and caused unprecedented global disruption — but Covid might actually hold clues to curing cancer.
In lab studies, a modified version of Covid's spike protein killed the most treatment-resistant and deadliest form of lung cancer.
The spike protein is the unique part of Covid that is used to infect people as it is the structure that binds to human cells in the first instance.
It could also infect and kill lung cancer cells, as when combined with other cells, the protein can set in motion the process of cells dying.
Kalipada Pahan, professor of neurology at RUSH Medical College in Chicago and lead investigator of the study, said: 'If these results are replicated in lung cancer patients, it would uncover a promising avenue of this devastating disease.
'Intranasal spike S1 protein could be used for late-stage lung cancer when there’s no other therapy to stop the progression.'
The researchers said there have been anecdotal cases of people with lung cancer whose conditions improved after being infected with Covid, which bolsters their theory.
In the study, published in the journal Cancers, the team took a cloned version of the spike protein that is available to buy for scientists.
They then exposed it to non-small cell lung cancer cells from humans in a petri dish. They found that when the protein was added, it sparked the death of the cancer cells.
Next they gave the protein to the mice with established lung cancer by spraying it up their nose every other day, and gave another group of mice a saline solution as a control.
After four weeks, they examined the mice's tumors and found that the number and size of tumors had decreased in the group given the Covid spike.
Lung cancer is the main cause of cancer related deaths in the world, and has quite a low five-year survival rate.
Rates have not improved despite a multitude of therapies for lung cancer.
According to the American Cancer Society, there will be around 236,740 new cases of lung cancer in this year alone.
Non-small cell lung cancer makes up around 84 percent of all lung cancers, found a study.
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Sex, Racial, and Ethnic Representation in COVID-19 Clinical Trials. A Systematic Review and Meta-analysis
Hong Xiao et al.
Key Points
Question: Compared with their representation in the US population with COVID-19, are female participants and racial and ethnic minority persons underenrolled in COVID-19 prevention and treatment trials?
Findings: In this systematic review and meta-analysis of 122 US-based COVID-19 clinical trials with 176 654 participants, female participants were underrepresented in treatment trials, Asian and Black participants were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials.
Meaning: These findings show systemwide differences in representation for several key demographic groups in COVID-19 prevention and treatment trials in the US.
Abstract
Importance: Since the onset of the COVID-19 pandemic, there have been calls for COVID-19 clinical trials to be fully representative of all demographic groups. However, limited evidence is available about the sex, racial, and ethnic representation among COVID-19 prevention and treatment trials.
Objective: To investigate whether female participants and racial and ethnic minority individuals are adequately represented in COVID-19 prevention and treatment trials in the US.
Data Sources: Identified studies were registered on ClinicalTrials.gov or published in the PubMed database from October 2019 to February 2022.
Study Selection: Included studies must have provided the number of enrolled participants by sex, race, or ethnicity. Only interventional studies conducted in the US for the primary purpose of the diagnosis, prevention, or treatment of (or supportive care for) COVID-19 conditions were included.
Data Extraction and Synthesis: Data on counts of enrollments by demographic variables (sex, race, and ethnicity) and location (country and state) were abstracted. Studies were broadly categorized by primary purpose as prevention (including vaccine and diagnosis studies) vs treatment (including supportive care studies). A random effects model for single proportions was used. Trial estimates were compared with corresponding estimates of representation in the US population with COVID-19.
Main Outcomes and Measures: Sex, racial, and ethnic representation in COVID-19 clinical trials compared with their representation in the US population with COVID-19.
Results: Overall, 122 US-based COVID-19 clinical trials comprising 176 654 participants were analyzed. Studies were predominantly randomized trials (n = 95) for treatment of COVID-19 (n = 103). Sex, race, and ethnicity were reported in 109 (89.3%), 95 (77.9%), and 87 (71.3%) trials, respectively. Estimated representation in prevention and treatment trials vs the US population with COVID-19 was 48.9% and 44.6% vs 52.4% for female participants; 23.0% and 36.6% vs 17.7% for Hispanic or Latino participants; 7.2% and 16.5% vs 14.1% for Black participants; 3.8% and 4.6% vs 3.7% for Asian participants; 0.2% and 0.9% vs 0.2% for Native Hawaiian or Other Pacific Islander participants; and 1.3% and 1.4% vs 1.1% for American Indian or Alaska Native participants. Compared with expected rates in the COVID-19 reference population, female participants were underrepresented in treatment trials (85.1% of expected; P < .001), Black participants (53.7% of expected; P = .003) and Asian participants (64.4% of expected; P = .003) were underrepresented in prevention trials, and Hispanic or Latino participants were overrepresented in treatment trials (206.8% of expected; P < .001).
Conclusions and Relevance: In this systematic review and meta-analysis, aggregate differences in representation for several demographic groups in COVID-19 prevention and treatment trials in the US were found.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2799224
**************************************************7 December, 2022
Victory for lockdown opponent
Governor Kemp credits consistent, good management for his 8-point victory over his Democratic opponent, Stacey Abrams in their second matchup for the Georgia chief executive office.
In the end, Mr. Kemp was done in neither by the fierce national media criticisms of how he handled Covid, the corporate meltdown over the state’s new voting laws, the massive resources that poured in for Ms. Abrams, nor even by former President Trump’s strident campaign against him in the state’s primary.
“We just had a great record to run on, which obviously I didn’t have last time,” he told the Washington Examiner in an interview. When he ran in 2018, he was only the secretary of state. This time, his record included tax cuts, teacher pay raises and an economy less damaged by Covid than those of many other states.
At a time when Mr. Trump’s word was often golden in so many states’ Republican primaries, Mr. Kemp not only defeated but in fact clobbered his Trump-backed Republican primary opponent, Senator Perdue, by 50 points.
“I told our folks going into the primary, ‘We have a record to run on offensively in this campaign and I don’t ever want to be on the defensive; I want to take the fight to David Perdue and I want to take the fight to Stacey Abrams,’” he explained.
“And that’s what we did. And if you really look back, I think our team did a really good job of keeping them on their heels and keeping things focused on what we were; we never allowed anybody to get us in the weeds on all this other stuff.”
He added: “And we just ignored all the outside noise; stuff she was pushing, stuff the Left was pushing, stuff that President Trump or whoever may have been pushing.”
Mr. Kemp credits how he has handled tough times, both campaigns and outside forces, as moments that paved the way and prepared him for this year. “Ever since I got elected in ‘18, the likelihood of us having a rematch was going to be there,” he said.
“So, we developed our own ground game, our own, really, operation to get the vote out, to go after low propensity voters and swing voters and offered them a message of hope and prosperity that appealed to them.”
Mr. Kemp said he was prepared to be outspent but knew that his team had offered an argument to voters, something for them to vote for and not against, and it served his party well.
“We won every single other constitutional office, and we had a good night with our legislative candidates as well, and we got Herschel (Walker) in a runoff with Warnock,” he said.
“It’s tough beating an incumbent, but anytime you got an incumbent in a runoff in Georgia, there’s an opportunity to knock them off.”
Mr. Kemp went into his first race for governor against Ms. Abrams in 2018 as the underdog, with her as the superstar who ran on becoming the nation’s first black female governor. She failed, but the media favorably covered her high-profile denial of the election result and spurious claims of mass voter disenfranchisement.
Within two years, many outlets were already writing Mr. Kemp's political obituary when he became the target of Mr. Trump’s wrath. Mr. Kemp had enraged Mr. Trump by certifying President Biden’s victorious slate of presidential electors in Georgia.
A few months later, he faced a different form of wrath from Mr. Biden, corporate America and every other news organization in America. They were falsely calling the state’s new voting reform law “Jim Crow 2.0,” even though most of them hadn't even bothered to skim the legislation — they just took Democrats’ word for it.
Major League Baseball went so far as to move the All-Star Game out of the state. As he did then, Mr. Kemp shrugs. “Two of the largest investment companies in the state, Delta Air Lines and Coca-Cola, really were the ones that started that,” he said of the allegations the voting law would somehow suppress minority vote, “and then obviously Major League Baseball piled on.”
He added that “we had a lot we had to stand up to and push through. But I think when we did that, I stayed really focused on what our people wanted, not what the political pressure and a few people wanted.”
He also didn’t cave under political pressure when he was the first to reopen small parts of the economy during the pandemic — after the first wave of “stop the spread” and “flatten the curve” passed.
“Of the governors that were doing that at that time, I took obviously the most grief,” he said. “At one time, every state around us had their state parks closed or some of their beaches closed, and we never did that,” he said.
As a result, Georgia’s tourism industry held up fairly well even during the worst part of the pandemic. Plus, people were actually able to go out and walk on the beach.
“We had some regulations around that, but people could get out there and do some exercise and give their kids something to do,” Mr. Kemp said. “We had people from other states coming and putting in in our boat ramps because they just needed some sanity to get out on the lake and go fishing or do whatever.”
Mr. Kemp said his approach was to strike the right balance and not get paralyzed by the public health experts. “I know they had a job to do,” and the state’s commissioner of public health, Dr. Kathleen Toomey, “did too, but she was one of the best and well-trained epidemiologists in the world who was advising me,” he said.
“We didn’t do mandates on the vaccine or mask, and we pushed hard to get our kids back in the classroom because both Dr. Toomey and I said early on that we got to think about the livelihood effect of people not having economic viability, not having their kids in the classroom, just how hard that is for parents to have to deal with that with no outlet,” he added.
“I took a lot of grief from it just because of my political situation on other things that were going on with the president and just those politics,” he said. Early in the pandemic, people may forget, Mr. Trump himself and several mayors were very critical of Mr. Kemp’s failure to lock down his state.
“It was a tough time to go through,” said Mr. Kemp. And he left the criticism of Mr. Trump at that. “But also, it was just listening to those folks that were worried about losing their business, and they were worried about where their kids were going. ... What was going to happen to their kids? And that’s really who we were fighting for.”
Mr. Kemp has now filed paperwork with the Federal Election Commission to create Hardworking Americans Inc., a federal political action committee that he plans on using to help Republican candidates for federal office in Georgia.
He says standing up for policies and principles is just what he does. He adds he doesn’t do it for personal benefit, though sometimes it works out that way.
“In some ways, us standing up to Major League Baseball after we passed the election bill was one of the really first times that somebody started standing up to the woke cancel culture, if you will,” he said.
“We never backed down from that either, which ended up, looking back, really helped me in the primary and in the general.”
Kemp added that he wanted to help other Republicans stand up in similar fashion going forward.
https://www.nysun.com/article/brian-kemp-beat-trump-stacey-abrams-and-the-corporate-left ?
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Surprise: WSJ Uncovers 'COVID Spending' Scandal
One of the eternal truths of politics is that governments are generally very bad at allocating resources efficiently and effectively, especially under the auspices of "emergency." The bigger the government, the more true this reality generally tends to be. Even – or especially – when government intervention or spending is obviously called for, as was the case during the COVID pandemic, shoveling large sums of money out the door as quickly as possible will inevitably lead to the old cliched triumvirate of waste, fraud, and abuse. This recent emergency binge was no exception, witnessing waste, fraud and abuse on a mind-blowing scale.
The Wall Street Journal has uncovered one example of this phenomenon, revealed in a new investigative report:
When Covid-19 struck, the U.S. government gave hospitals tens of billions of dollars to help them cope with the strains of the pandemic. Many of the hospitals didn’t need it. The aid enriched some well-off systems, while failing to meet the needs of many that were struggling, according to a Wall Street Journal analysis of federal financial-disclosure reports. The mismatch stemmed in part from the way the federal government determined how much a hospital should get. A main factor used to allocate relief was a hospital’s revenue, rather than Covid caseload or financial distress. The idea was that revenue was a good indicator of a hospital’s size.
Among the recipients were large, wealthy hospital owners—including some nonprofits—that reported profits from patient care during the periods they got aid. Some were well off enough to put money into investment funds, while others spent on new facilities and expanded campuses. Hundreds of other hospitals that got federal funding, however, reported losses. Some were forced to lay off nurses and make other cuts, saying they didn’t get enough aid to overcome their strains. Some served areas that had among the highest Covid death rates. The revenue-based award system, especially prevalent in the early days of the pandemic, tended to favor hospitals with higher prices
Some mistakes are unavoidable in an undertaking of this scope and magnitude, along a very accelerated timeline, but the Journal piece painstakingly reviews pieces of how "more than $175 billion in aid to a range of healthcare providers, including hospitals, doctors, dentists, clinics, nursing homes and other facilities," mostly within the window of a year-and-a-half stretch. Meanwhile in Florida – where the state government was remarkably effective in the aftermath of the devastation of Hurricane Ian this fall – Gov. Ron DeSantis has announced additional aid from Tallahassee to homeowners in need, after he said FEMA has declined some requests for assistance:
Gov. Ron DeSantis announced in Southwest Florida, the region of landfall for Hurricane Ian, that Florida will pay $25 million of its own money for emergency relief in light of FEMA denying the state’s request. “Unfortunately, we got word last week that FEMA had denied our request for funding our state-led housing initiatives, citing their quote ‘limited authority.’ But we’re not just gonna sit there and take no for an answer,” he said. FEMA sent a Dec. 2 letter to the DeSantis Administration issuing denial for a request to expand the state’s housing recovery program: "Due to the limited authorities FEMA has to approve and pay for this type of work, as well as our inability to confirm that authorizing this policy expansion would achieve the intended outcomes for disaster survivors, your request is denied."
I suspect we haven't heard the last of this dispute.
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6 December, 2022
Long COVID: How clusters of symptoms have emerged and changed over the pandemic
Since the first COVID "long haulers" were reported in 2020, millions of people have experienced long COVID.
While long COVID has no strict definition, it's generally used to describe an illness following a SARS-CoV-2 infection with symptoms that last at least two to three months.
It can manifest as a whole suite of symptoms ranging from body aches and pains to brain fog, and these can substantially vary between people, says Lou Irving, respiratory physician and head of the Royal Melbourne Hospital's post-COVID clinic.
But under that broad "long COVID" umbrella, clusters of symptoms have emerged, and as the pandemic's worn on, those symptoms have shifted.
Senior respiratory physiotherapist Janet Bondarenko has been working in Melbourne's Alfred Hospital post-COVID clinic since its doors opened two years ago.
Early on, most people referred to the post-COVID clinic had been severely sick and many hospitalised. "We saw a lot of breathlessness in people, and they could only manage walking a few metres at a time," Ms Bondarenko says. "Then we started to see memory and concentration issues."
And while she still sees these symptoms in patients now, she also sees more people with heart-related symptoms. "If they're going from sitting to standing, their heart rate will jump and they'll get palpitations, chest pains, things like that," Ms Bondarenko says.
This is an example of what's known as "autonomic dysfunction", where a part of our nervous system that controls things like blood pressure doesn't work properly.
If a person's blood pressure drops, their heart has to work harder and pump faster to compensate and keep blood moving around the body. This, in turn, produces symptoms such as dizziness and extreme fatigue.
"What's interesting is people now often present with breathlessness, but it's not breathlessness caused by the respiratory disorder," Ms Bondarenko says. "It's breathlessness from fatigue and from this autonomic dysfunction."
New data from Australia's longest-running post-COVID clinic has revealed a high proportion of patients are women in their 40s and 50s, painting a picture of who might be more affected by this emerging condition.
Jason Kovacic, a cardiologist at the Victor Chang Cardiac Research Institute, says it's still the case that a very sick person is more likely to develop long COVID, but now people with an extremely mild case can end up in a bad way.
"I have a couple of notable patients who just can't nail down when they had COVID, but they came to the clinic or to the ER with a full hand of long COVID symptoms," Professor Kovacic says.
"They're dizzy, lightheaded, fatigued, and short of breath, and they get to see me because they've got a resting heart rate of 120 and a blood pressure of 90 over 60."
First, Professor Kovacic runs tests to rule out other causes of low blood pressure and fast heart rate, such as myocarditis. "But this group of people tend to have a normal heart that's beating fast with low blood pressure and palpitations and, understandably, a lot of anxiety as well."
Why the shift in symptoms?
Just as different variants (and subvariants) of the SARS-CoV-2 virus have wreaked various levels of havoc on our body, it appears they impart different lingering after-effects too.
"Different strains of the virus are interacting with immune systems differently and triggering different events," Professor Kovacic says.
"The likelihood of getting long COVID was probably double with Delta than what it is with Omicron.
"I think that really speaks to this interaction of what the specific strain of the virus is doing, and how that interacts with the immune system of each person."
Exactly why long COVID develops in some people and not others is still a mystery, but our genetics likely plays a role, as does our history of previous conditions.
Some studies suggest COVID-19 infection can reactivate the Epstein-Barr virus, which causes glandular fever and is linked to chronic fatigue syndrome.
"They're not the same conditions, but there are parallels between chronic fatigue and long COVID, and some of the immune dysfunction that's related to glandular fever is very similar to what happens with long COVID," Professor Kovacic says.
Professor Irving suspects researchers will eventually discover subtypes of sorts within the broader "long COVID" cohort. "I think we'll find there are groups where the virus can activate autoimmune responses, in some people it can activate autonomic responses, and in others it can bring out mental health issues."
While vaccination may lower our risk of developing long COVID, the only surefire way is to not get infected with COVID-19 in the first place.
Management and recovery
The goal for post-COVID clinics is to get people back to their usual activities while managing symptoms.
Treatment depends on each person's symptoms, but recovery typically involves plenty of rest to start, then taking lots of short breaks as activity slowly builds.
Exercise rehab can be helpful too, Ms Bondarenko says, but not for everyone.
"There's two different clusters: some people respond well to exercise but for other people, it could potentially make them worse."
Some people with severe symptoms such as postural orthostatic tachycardia syndrome, or POTS, a condition where most of your blood remains in your lower body when you stand up, can benefit from medications.
But recovering from long COVID takes time, and for most, that's between six and 12 months, Ms Bondarenko says.
"Often the concentration and brain fog is quite highly linked with fatigue, so once the fatigue starts to get better, all those other symptoms tend to resolve as well. "But it does get better with time, and most people get better."
Professor Irving agrees. "Common roadblocks are frustration, doing too much too soon, which can set you back, and financial worries, because not everyone can afford to take time off.
"But from experience, everybody gets better — it just takes time."
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Mask wearing disrupts decision-making ability, Australian study finds
Mask wearing can seriously disrupt a person’s ability to make decisions, particularly when they feel under pressure, a new Queensland study has found.
Dr David Smerdon of the University of Queensland's School of Economics studied 8500 worldwide chess players aged between 5 and 98, comparing how they played a game of chess both with and without masks on.
After analysing almost three million individual chess moves he found wearing a mask substantially reduced the quality of a player’s decisions.
But the disruption to decision making was also only temporary and players were able to recover from their initial brain fog within four to six hours, before returning to their normal playing capability.
“We found that the early part of the game you’re not playing as well as you usually would,” Dr Smerdon said.
“The data showed masks were more likely to decrease performance in situations where there was a demanding mental task with a high working memory load.
“The decrease in performance was due to the annoyance caused by the masks rather than a physiological mechanism, but people adapted to the distraction over time.
“The results suggest that the effect of masks may depend on the type of task, the duration of the task and working memory load.”
Dr Smerdon said it was important to find out what -if any- kind of effect mask wearing had on the general population, with his initial findings also indicating minimal disruptions to children’s decision making.
“From a methodical point of view, it’s been hard to get evidence on this topic and chess gave us those circumstances as it requires calculation, memory, problem-solving and pattern recognition and has been used extensively in psychology, neuroscience and economics to measure changes in cognitive performance,” he said.
“What surprised me was the level of effect for experts, particularly in very important games, the effect is very large.
“When we looked at just juniors, up to the age of 18 we didn’t find any effects of mask (wearing), and that could be because of the comparison of kids to the overall (study) numbers or maybe because they are just more adaptable.”
Dr Smerdon said understanding the impact of mask wearing could help individuals and organisations, particularly if it becomes mandatory again in future.
“A lot of communities have discussed mask policies since they were introduced,” he said.
“This is something to keep in mind for occupations in the STEM fields of science, technology, engineering and mathematics as well as other professions that demand a high level of working memory such as language interpreters, performers, waiters and teachers.
“For example, education policy makers may need to bear in mind the disruptive effects of masks when designing exam conditions to address concerns about student health and fairness.”
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5 December, 2022
Autopsies Show COVID-19 Vaccination Likely Caused Fatal Heart Inflammation: Study
A serious side effect linked to COVID-19 vaccines can lead to death, according to a new study.
Post-vaccination myocarditis, a form of heart inflammation, was identified in a subset of people who died “unexpectedly” at home within 20 days of receiving a COVID-19 vaccine. Researchers analyzed autopsies that had been performed on the people and conducted additional research, including studying tissue samples.
Researchers started with a group of 35, but excluded 10 from further analysis because other causes of death were identified. Of the remaining 25, researchers identified evidence of myocarditis in five.
All of the five people received a Moderna or Pfizer vaccine within seven days of their death, with a mean of 2.5 days. The median age was 58 years. None of the people had COVID-19 infection prior to being vaccinated and nasal swabs returned negative.
Autopsy findings combined with the lack of evidence of other causes of death and how the vaccination happened shortly before the deaths enabled researchers to say that for three of the cases, vaccination was the “likely cause” of the myocarditis and that the cardiac condition “was the cause of sudden death.”
In one of the other cases, myocarditis was believed to be the cause of death but researchers detected a herpes virus, an alternative explanation for the incidence of heart inflammation. The remaining case did not include an alternative explanation for the myocarditis but the researchers said the impact of the inflammation was “discrete and mainly observed in the pericardial fat.” They classified the two cases as possibly caused by vaccination.
“In general, a causal link between myocarditis and anti-SARS-CoV-2 vaccination is supported by several considerations,” the researchers said, including the “close temporal relation to vaccination”; the “absence of any other significant pre-existing heart disease”; and the negative testing for any “myocarditis-causing infectious agents.”
Limitations included the small cohort size.
The study (pdf) was published by Clinical Research in Cardiology on Nov. 27. The researchers all work for Heidelberg University Hospital. They were funded by German authorities.
Moderna and Pfizer did not respond to requests for comment.
The meticulous ruling out of possible causes apart from vaccination signals that the cases are “the tip of the iceberg,” Dr. Andrew Bostom, a heart expert based in Rhode Island, told The Epoch Times.
“If there’s a seemingly healthy person that dies suddenly in their sleep, essentially, these are typically the cases that are autopsied, and clearly the most common finding is some form of atherosclerotic coronary heart disease. But they basically ruled that out in these cases. And then they came up with the most plausible proximate cause being vaccination,” he said. “And so it suggests that the phenomenon could actually be broader than it’s been suspected to be.”
Myocarditis
Myocarditis is a serious heart condition that can manifest as chest pain and typically leads the sufferer to seek hospital care. Doctors usually advise against all or most physical activity for a period of time. Causes include bacteria, viruses, and fever.
Acute myocarditis resolves in about half of cases in the first two to four weeks, researchers have found, but another quarter feature longer-term problems and many of the rest lead to death or heart transplantation.
The incidence of myocarditis among COVID-19 vaccine recipients was higher than expected, researchers in the United States, Israel, and other countries have found. The highest rates have been detected in young people, particularly young males.
Estimates of the typical myocarditis incidence rates are 0.2 to 2.2 per million persons within seven days. Reports to the Vaccine Adverse Event Reporting System show higher rates for males aged 5 to 49 and females aged 12 to 29. The highest rate was 75.9 per million second doses administered. Reports to the system don’t prove causality but the system suffers from severe underreporting, according to studies, indicating the rates are even higher.
The U.S. Centers for Disease Control and Prevention (CDC) continues to recommend vaccination for virtually all people aged 6 months and older, asserting that the benefits of the vaccines outweigh the risks. Some experts disagree, saying side effects like myocarditis tilt the calculus to the risks being higher in some age groups.
Government officials have repeatedly said that most of the myocarditis cases resolve within weeks, but CDC researchers found in September that many youths who experienced post-vaccination myocarditis still had abnormal MRI results months later.
The incidence has been much lower among older people, according to U.S. authorities, which have refused to make public the autopsy results of people who die after vaccination, and various studies. The new study “suggests we’ve been missing some severe myo[carditis] cases in our studies,” Dr. Tracy Høeg, an epidemiologist who advises the Florida Department of Health, said on Twitter.
Causality
Several vaccines have been linked to myocarditis and a related condition, pericarditis. They are made by Moderna and Pfizer and are the two most widely administered in the United States and Germany.
Both vaccines utilize messenger RNA (mRNA) technology.
Causality means that a vaccine causes a condition.
Top CDC researchers have said (pdf) the current evidence shows a causal link between the mRNA shots and heart inflammation. Other researchers have also reached that conclusion.
The U.S. Food and Drug Administration warns potential vaccine recipients that “postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.”
Bostom said the evidence he’s reviewed shows a causal link.
“It’s as certain as most associations that we say are confirmed in medicine,” he said.
Some studies have identified COVID-19 as another cause of myocarditis and pericarditis, but others have indicated it might not be associated.
Other Autopsy Findings
Before the German study, other researchers around the world had reported findings from autopsies of people who died suddenly after vaccination.
In 2021, U.S. researchers reported two adults developed myocarditis within two weeks of COVID-19 vaccination, and they were unable to find causes other than vaccination.
In 2021, South Korea researchers reported that after examining the death of a 22-year-old man who died five days after receiving the Pfizer vaccine, they determined the primary cause was “myocarditis, causally-associated” with the vaccine.
In January, New Zealand researchers reported that the Pfizer vaccine was probably responsible for sudden myocarditis that led to the death of a 57-year-old woman, writing that “other causes have been discounted with reasonable certainty.”
In February, researchers in several U.S. states reported that two teenage boys who died shortly after receiving Pfizer’s vaccine experienced heart inflammation and that the inflammation was the primary cause of death.
In May, CDC researchers reported that a young boy died after experiencing post-vaccination heart inflammation, with myocarditis being pegged as the cause of death.
In September, a German researcher reported that a 55-year-old who died four months after receiving the Pfizer vaccine died of myocarditis and said “these findings indicate that myocarditis, as well as thrombo-embolic events following injection of spike-inducing gene-based vaccines, are causally associated with a[n] injurious immunological response to the encoded agent.”
And just recently, Japanese researchers reported on results from a 27-year-old man who died 28 days after admission following vaccination.
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UPenn developing ‘multivalent’ flu vaccine that could fight 20 strains
A universal flu shot may be on the horizon. A University of Pennsylvania researcher believes he has created a one-and-done vaccine that could fight against 20 influenza strains and last a patient’s lifetime, the school announced last week.
Dr. Scott Hensley and his team created the “multivalent” vaccine to establish immunity against all known flu strains, but it is not intended to replace the annual flu shots, the researchers explained in their published paper. Yearly shots are tailored to combat the strongest strain that year, but the university’s shot is intended to fight the next massive flu pandemic.
“The idea here is to have a vaccine that will give people a baseline level of immune memory to diverse flu strains, so that there will be far less disease and death when the next flu pandemic occurs,” Hensley said in a statement.
The CDC estimates the flu has caused 52,000 deaths annually between 2010 and 2020.
Researchers created the shot using the same technology Pfizer and Moderna used to make the COVID-19 jab. Rather than providing a “sterilizing” effect on individuals, the universal flu vaccine elicits a “memory immune response that can be quickly recalled and adapted to new pandemic viral strains,” the researchers said.
Hensley and his team have found success testing the jab on mice, even when the animals were exposed to flu strains different from those used in the shots they were given.
The jab could fight 20 influenza strains and last a patient’s lifetime.
The team is planning on testing the universal vaccine on humans soon.
The vaccine is designed for people of all ages, but Hensely told the Philadelphia Inquirer that it would be the most effective when administered to children.
“If the vaccine is given early in childhood, it may provide an initial blessing of induced immunity,” Hensley said.
https://nypost.com/2022/12/03/upenn-developing-multivalent-flu-vaccine-that-could-fight-20-strains/
**************************************************4 December, 2022
Scientist who worked at Wuhan lab says Covid was man-made virus
A scientist who worked closely with a Wuhan lab has claimed Covid was genetically engineered and leaked from the facility.
Dr Andrew Huff, former vice president of EcoHealth Alliance, claims to have had a ringside seat to what he brands one of the greatest cover-ups in history and the “biggest US intelligence failure since 9/11”.
The Wuhan Institute of Virology — a high security lab specialising in coronaviruses — has been in the eye of the storm as questions rage over whether Covid could have escaped from its lab, The Sun reports.
Both China and the lab have furiously denied any allegations, but evidence of a lab leak has been piling up over the last two years as scientists, researchers and governments hunt for answers and step forward with evidence.
Dozens of experts have suggested Covid could have escaped from the Wuhan lab through an infected researcher, improper disposal of waste, or potential breaches in the security at the site.
Even the head of the World Health Organisation reportedly believes Covid did leak from the lab after a “catastrophic accident”.
In his new book — The Truth About Wuhan — whistleblower Dr Huff claims the pandemic was the result of the US government’s funding of dangerous genetic engineering of coronaviruses in China.
The epidemiologist said China’s gain-of-function experiments, carried out with shoddy biosecurity, led to a lab leak at the US-funded Wuhan Institute of Virology.
“EcoHealth Alliance and foreign laboratories did not have the adequate control measures in place for ensuring proper biosafety, biosecurity, and risk management, ultimately resulting in the lab leak at the Wuhan Institute of Virology,” he said in his book, an exclusive prerelease copy of which was provided to The Sun Online.
EcoHealth Alliance had been studying different coronaviruses in bats for more than ten years with funding from the National Institutes of Health and developed close working ties with the Wuhan lab.
Dr Huff, who worked at EcoHealth Alliance from 2014 to 2016 and served as vice president from 2015, worked on the classified side of the research program as a US government scientist.
The army veteran, from Michigan, said the organisation taught the Wuhan lab the “best existing methods to engineer bat coronaviruses to attack other species” for many years.
And he claimed “China knew from day one that this was a genetically engineered agent”.
“The US government is to blame for the transfer of dangerous biotechnology to the Chinese,” he said. “I was terrified by what I saw. We were just handing them bioweapon technology.”
Former intelligence chiefs and diplomats have already claimed Covid was leaked from a Wuhan lab in the “cover-up of the century”.
In 2009, the Wuhan lab started working with the EcoHealth Alliance on a USAID program - called PREDICT - focusing on emerging pandemic threats.
PREDICT was designed to help detect and find zoonotic viruses with pandemic potential - including coronaviruses.
Shi Zhengli - the Wuhan virologist who famously became known as “Batwoman” - hoped the program would create an early-warning system for pandemics.
But in 2014, Dr Huff was asked to review a funding proposal which revealed that gain of function work was being carried out to create SARS-CoV-2 - which causes Covid.
Gain of function work sees viruses souped up to more easily infect humans to help researchers test scientific theories, develop new technologies and find treatments for infectious diseases.
But the risky research method can pose safety and security concerns - and it’s banned in many countries.
It was originally banned in the US in 2014 — but was reintroduced by the NIH in 2017.
Dr Huff realised the EcoHealth Alliance was working closely with the Wuhan lab on gain of function research, with the support of USAID - a US government department.
He soon realised the virus would never occur in nature and had been developed into a much more powerful pathogen in the lab.
Dr Huff believes Covid was genetically engineered in Wuhan through gain of function research funded by the US government - and poor biosafety led to a lab leak.
“EcoHealth Alliance developed SARS-CoV-2 and was responsible for the development of the agent SARS-CoV-2 during my employment at the organisation,” he said.
Although he pointed out he has seen no evidence China deliberately released the virus.
Dr Huff believes the US-funded project was “mostly a global fishing expedition for coronaviruses” to carry out gain of function work or for intelligence collection - rather than preventing future pandemics.
“At the time, I felt like the project seemed more like intelligence collection than scientific research and development,” he said in his book.
The scientist said the PREDICT program wasn’t collecting the data is should have been - and he told The Sun Online it appeared to be a “giant intelligence operation”.
He alleges the US were using the project to assess the bioweapon capabilities of foreign labs - including the Wuhan Institute of Virology.
During a meeting with top executives in 2015 and 2016, Dr Huff said he sounded the alarm over biosafety and biosecurity risks in contract laboratories.
“I was concerned that EcoHealth Alliance did not have enough visibility or first-hand knowledge of what was happening at foreign laboratories contracted and managed by EcoHealth Alliance,” he said.
Dr Huff said US government officials again issued warnings in January 2018 about the Wuhan lab - including the major shortage of experts needed to safely manage research on deadly coronaviruses.
“It could be reasonably argued that EcoHealth Alliance set up China to fail,” he said.
And when Covid emerged in late 2019, he said China “and some of their US government collaborators at the Department of State, USAID, and the Department of Defence went into full cover-up mode”.
Dr Huff said he “has good reason to believe that the US government was alerted to the outbreak in August or October 2019”.
He quit EcoHealth Alliance in 2016 “due to a large number of ethical concerns with the scientific work and EcoHealth Alliance as a whole”.
But in late 2019, he was suddenly offered a position at Defence Advanced Research Projects Agency (DARPA) - and was told he would need top security clearance and a polygraph for the job.
Dr Huff now believes he was approached for the role to keep him quiet about the origins of Covid.
“It is my belief that people working within the US government potentially identified me as a risk to knowing first-hand that the SARS-CoV-2 disease emergence event was a consequence of the US government’s sponsorship of the genetic engineering of SARS-CoV-2 domestically and abroad,” he said in his book.
“If I would have accepted the position, then I suspect that DARPA would have disclosed restricted information to me, which would have consequently prevented me from discussing any of this information publicly, like I have been and am doing now.”
He added: “About a month after the pandemic began, and I was adamant that SARS-CoV-2 was a man-made agent, I suddenly realised what the potential motivation and persistence for recruiting me were.
“The intelligence community realised that I was the only person in a senior position that had left EHA, and the fact I was working outside the government’s control made me a threat to their agenda.”
Dr Huff believes government officials offered him the role so he could be “sworn into silence for the rest of my life”.
As he began to unravel the alleged extensive cover-up by the US government, he said the authorities launched a massive campaign of harassment against him.
He claimed military-grade drones would often appear at his home, he was stalked at the supermarket, and he was followed by unknown vehicles.
Dr Huff has since filed a lawsuit with Renz Law LLC against EcoHealth Alliance in the state of New York.
The National Institutes of Health previously stated in a letter to Congress the bat viruses EcoHealth Alliance were studying in Wuhan could not have become the virus that causes Covid.
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Supreme Court of Italy: Vaccine against covid is mandatory
The Italian Constitutional Court has made a definitive decision on the mandatory vaccination against covid for health workers, employees in the public sector and over 50 years of age.
The judges declared that the obligation protects the right to health, and from today fines will be sent to two million people who did not comply with the vaccination obligation.
After five courts from Brescia, Catania, Padua, Lombardy and the region of Sicily asked the Constitutional Court to consider the legitimacy of the mandatory vaccine, and the proportionality of the sanctions because many people work from home, as due to questions about the safety of the vaccines themselves.
The Constitutional Court ruled that all their requests are unacceptable and confirmed the decision on the mandatory covid vaccine.
Almost two million people over the age of 50 in Italy have not been vaccinated.
At this moment, a fine of 100 euros will be sent to all Italians who were required to be vaccinated. Those categories include health workers, employees of law enforcement as well as employees of the education system, and everyone over the age of fifty.
Namely, on November 30, the deadline expired in which it was possible to submit justifications related to avoiding vaccination, such as health reasons or because a person fell ill with covid at the time when they should have been vaccinated.
Most fines will be sent to residents of the Friuli Venezia Giulia, Calabria and Abruzzo regions.
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2 December, 2022
Unintended Consequence of COVID-19 Vaccines–Permanent Installation of mRNA Genetic Code
When we heard about Operation Warp Speed there was sense of shock and awe. American greatness was poised to strike the “China Virus” and it was going to be defeated in a matter of weeks.
The Defense Advanced Research Projects Agency (DARPA) created a project many years ago called ADEPT Pandemic Prevention Platform (P3) whose stated goal was to “end pandemics in 60 days with mRNA technology.”[i] Our government has had a love affair with mRNA for over a decade for precisely a time such as the SARS-CoV-2 outbreak.
Hardly a virus from China, we have learned that Dr. Ralph Baric at the University of North Carolina in Chapel Hill has been publishing on coronaviruses since the 1990’s. Baric and his consortium including Harvard and two Swiss labs conceived the projects, wrote the federal grants, and once awarded, did their development work in the Wuhan Institute of Virology biosecurity annex level 4. The laboratory built by Stephane Bancel formerly at BioMérieux and now CEO of Moderna, the NIH partner in the mRNA patent.[ii]
I wonder in all the DARPA and NIH meetings that occurred in the last ten years on mRNA, did they ever consider reverse transcription?
If the mRNA stays long enough in the cytosol and is not dissolved by enzymes, the human cell could find base pairs of nucleic acids and create a mirror image of the genetic code which could be brought into the nucleus of the cell for insertion into the human genome. This is such a giant consideration because genetic code for a damaging and lethal protein installed into our own cells permanently would be passed down to somatic daughter cells and from spermatocytes and oocytes to an embryo.
Forever changing the human genome for future generations must have been a large part of the safety discussion in those DARPA and NIH transcripts—only investigation and release of documents will tell the story. In the meantime, Alden et al have demonstrated integration of the center 444 base pair amplicon or reporter region from the Pfizer vaccine into the human nucleus in a hepatoma cell line.[iii] This paper has not been challenged by any credible authority nor disproven by any other experiments.
Kyriakopoulos et al (including Dr. McCullough) have illustrated what the ramifications would be for those cells that have been permanently installed with Pfizer or Moderna genetic code.[iv] In addition to the nine well recognized effects of the Spike protein in the human body, one of the potential consequences is oncogenesis. By suppression of the natural tumor surveillance system(s) in even one cell, it is conceivable that reverse transcription could lead to cancer with a single ill-advised injection of mRNA if it was delivered to a cancer-prone cell line in a susceptible person.
At this time, it is fair to say reverse transcription of mRNA into the human genome is still theoretical. But it should be clear that more studies by independent laboratories should be funded immediately. The implications given the massive numbers of recipients are simply too large to ignore this long-term safety concern.
So the next time you see your doctor, ask him or her if they took an mRNA vaccine. When they say yes, ask them if they considered reverse transcription when the needle plunged into the arm. Did they ever think they would be changed permanently? When brushed aside with “the CDC says mRNA does not change the human genome” then forward this issue of Courageous Discourse and suggest a life-altering a five-minute read.
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FDA Trying to Rewrite COVID History on Prohibiting Ivermectin, Dr. Atlas Says
Boyden Gray & Associates filed a lawsuit in June on behalf of three doctors who allege that the U.S. Food and Drug Administration (FDA) illegally interfered with their doctor–patient relationships, resulting in harm. They also claim that the FDA broke the law when the agency issued statements prohibiting the use of ivermectin to treat COVID-19.
In response to the lawsuit, lawyers for the FDA claimed that its guidance for people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation; as such, they weren’t mandating against it.
However, in an interview that aired on NTD’s “Newsmakers” on Nov. 23, Dr. Scott Atlas, a senior fellow in health care policy at the Hoover Institution at Stanford University, confirmed that the FDA did, indeed, take an “unprecedented” approach against ivermectin and said that their defense amounts to the FDA trying to rewrite COVID-19 history.
“This is unprecedented, frankly, in my 30 years as a doctor, where the use of an FDA-approved drug was somehow forbidden if you used it for off-label,” Atlas stated. “In the United States, that’s standard of care.”
The standard of care, Atlas explained, is that once the FDA approves a drug, doctors are allowed to use the drug to treat other conditions.
Atlas added that ivermectin was approved by the FDA and was found to be “so safe” that “billions of doses have been given.” He said that ivermectin is available over the counter in many countries without a doctor’s prescription.
“This was really a shocking interference of the ability of a doctor to do his job,” Atlas said.
Rewriting History
When asked why the FDA was attempting to rewrite history by stating that its guidance against ivermectin was a recommendation only, Atlas said that the rewrite on ivermectin is just the beginning.
“What we’re seeing is a complete Orwellian rewrite of all kinds of things during this pandemic,” Atlas told NTD. “Many colleagues of mine were always saying the truth will prevail. And once the truth comes out, that some of these drugs were either useful or safe … there’s a lot of ‘cover your behind.’”
Atlas then alleged that the FDA didn’t just forbid ivermectin. Instead, its language was such that pharmacists and pharmacies refused to fill prescriptions from doctors. Such a stance was “really unprecedented,” Atlas said.
Further, Atlas said, there’s an overall “Orwellian rewrite of what the advice was on a bigger picture.”
He pointed out that Dr. Deborah Birx, former White House COVID-19 response coordinator, claims that she opposed lockdowns, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, claims he opposed school closings.
Circling back to ivermectin, Atlas said the FDA’s prohibiting its off-label use to treat COVID-19 was “one of the bigger failures of the [National Institutes of Health (NIH)].”
“The NIH could have done definitive clinical trials in the Spring of 2020. Instead, they blocked those trials; they made people afraid of those drugs, so that even when trials were attempted, patients were not willing to enter into those trials,” he said.
Atlas then stated unequivocally that the position taken by the NIH and the FDA was an unethical abuse of public health.
Doctors File Suit; FDA Responds
Plaintiffs in the case against the FDA include Dr. Robert Apter, Dr. Mary Talley Bowden, and Dr. Paul Marik. Lawyers for the plaintiffs allege that the FDA violated the Federal Food, Drug, and Cosmetic Act and the Administrative Procedure Act.
The lawyers also noted that if the court doesn’t rule against the FDA violating its statutory lane and unlawful actions, the FDA will continue to interfere with the practice of medicine.
Atlas agreed:
“Depending on the outcome of these, there will either be a real chilling of what doctors can say and do for patients—complete interference, in a doctor’s ability to help a patient! Or, if the lawsuits go the other way, we will hopefully see a restoration of freedom of medical practice.”
Atlas said that doctors are afraid to be honest with their patients because of what the NIH and FDA have done over the past few years.
“The cited statements were not directives. They were not mandatory. They were recommendations,” Isaac Belfer, one of the lawyers for the FDA, said during a Nov. 1 hearing in federal court in Texas. “They said what parties should do.
They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
As further evidence that the FDA didn’t “prohibit” ivermectin’s use, Belfer added, “The plaintiffs, by their own admission, have continued to prescribe ivermectin. So they always had the authority. It may be that patients were not able to fill prescriptions, but the doctors themselves always had the authority.”
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1 December, 2022
Slew of Unusual Adverse Events Becoming More Common After COVID Vaccine Rollout
If we go to a doctor or clinic for a vaccination, be it an influenza shot or a COVID-19 vaccine, we go with the expectation that it is safe.
We usually dismiss mild symptoms, such as headaches, fever, pain, and redness at the injection site, since we are typically informed of them beforehand and expect them to be transient in duration. Thankfully, most of the time, people recover from them and proceed with their lives as before.
However, since the rollout of COVID-19 vaccines, a significant proportion of vaccinated people have experienced many unusual adverse events. Doctors are raising concerns. Public health officials and vaccine manufacturers are also addressing the high incidence of blood clots, myocarditis, pericarditis, and menstrual irregularities.
Yet, there are thousands more documented health conditions reported to the U.S. Vaccine Adverse Event Reporting System (VAERS)—some appearing very frequently—that have not yet been given the same level of attention.
Since their rollout, COVID-19 vaccines have prompted more VAERS adverse event reports than all VAERS reports made in the previous 30 years, comprising over 55 percent of vaccine injury and death reports. These reports have thousands of different adverse event labels.
Although nearly 1.5 million COVID-19 vaccine injury and death reports have been made to VAERS, studies say the true number of adverse reactions is many times higher. The 2005–2009 HHS-funded Harvard Pilgrim study found that less than 1 percent of adverse events following 1.4 million vaccines administered were reported to VAERS; several independent analysts estimate that only 2.5 percent of COVID vaccine adverse reactions are reported to VAERS.
The system is also notorious for its redundancy: injection site swelling, vaccine site swelling, and swelling are recorded as separate events, and a person reporting to the system may select one or all three events.
Another study found that more serious adverse events are more likely to be reported.
This article examines several now-common adverse events following COVID vaccination. The figures are from the most recent update on Nov. 18, 2022
General Adverse Events:
General adverse events following COVID vaccination are the most common. This is reflected in both VAERS reports and Pfizer’s post-market adverse event reports.
Fatigue: Though fatigue is a common side effect for many vaccines, it is concerning and debilitating if prolonged. At least 121,200 cases of chronic fatigue have been reported to VAERS after injection with the COVID-19 vaccine, of which around 40 percent, or more than 49,000 cases, are reported as unrecovered.
Asthenia: Though often used synonymously with fatigue, asthenia defines a sense of weakness and lack of mental and physical energy. More than 34,000 cases have been reported, mostly in adults aged 30 or older, with almost 41 percent reported as unrecovered.
Death: More than 12,000 cases of deaths have been reported to VAERS following COVID-19 vaccinations. Independent researchers point to the varying ingredients and batch inconsistency of these vaccines. They also mention that it may be driven by blood clots and arterial blockages. Research funded by the National Institute of Health (NIH) speculates that anaphylaxis (severe allergic reactions), among other adverse events, may have contributed to such deaths. More than 25 percent of these reported deaths occurred within the first seven days after vaccination.
Night sweats: Night sweats, with 3,100 cases reported, are far less common after vaccination than excessive sweating, with more than 24,000 cases reported. Although night sweats independent of other symptoms are usually benign, this should be paid attention to if they become prolonged, disturb sleep, and come with other symptoms such as fatigue and weight loss.
Immunological Adverse Events
COVID-19: Listed as the ninth most common adverse event, more than 68,000 cases of COVID-19 infection following vaccination have been reported to VAERS. Several studies have indicated that a few months after administration of mRNA vaccines, individuals’ immunity to symptomatic COVID infections fall from positive efficacy—with immune defense present—to negative efficacy (studies 1, 2). Scientists generally understand negative efficacy in vaccines to mean that the vaccine would “induce a greater degree of susceptibility” to the disease in “vaccinated individuals relative to unvaccinated individuals.”
Therefore, negative efficacy indicates that the effects of the shots will not just wane, but also that a vaccinated individual is more susceptible to COVID than an unvaccinated person.
All of the COVID vaccines are designed to expose the body to a spike protein—a distinctive structural feature of the COVID virus that has an essential role in its pathogenesis—and studies have shown that exposure to the protein can cause immune cells to become less reactive and switch off important first-line immune pathways, which may lead to an untimely response in the event of infection (studies 1, 2, 3). Additionally, a new study found that when mice were injected with the lipid nanoparticles used in mRNA vaccines, cell count and immune responses were reduced in their first- and second-line cells, respectively
Herpes zoster virus (VZV): More than 7,700 reports of VZV infection following COVID vaccination have been reported. It is not specified if these cases are new infections or relapses; several studies (1, 2) have documented relapse of the virus in COVID-vaccinated individuals. Relapse of latent viruses such as VZV from vaccinations has previously been quite rare, and often occurs later in life or when the infected individual is frail, and is therefore often seen as a sign of immunosuppression.
Hypersensitivity: More than 4,900 cases of allergic responses have been reported. Allergic responses are mechanistically related to inflammation, causing swelling, redness, itchiness, and, in the cases of anaphylaxis, difficulty breathing. Allergic responses after vaccinations can be triggered by the contents of the vaccines.
Inflammation: Inflammation is a common physical response activated whenever the body experiences an injury or encounters something foreign or toxic. Any disease or condition where a person experiences pain, redness, swelling, and even difficulty breathing is very likely driven by inflammation. Studies on the SARS-CoV-2 spike protein have shown that it is highly inflammatory. This mechanism can therefore provide a cause for many of the symptoms reported after vaccination.
Neurological Symptoms
Changes in sensation: This includes onset of the “pins and needles” sensation (more than 25,500 reports) and loss of sensation (more than 24,300 reports) following COVID-19 vaccination. These can be signs of neural disease, injury, or reduced blood flow to the neurons, leading to neural dysfunction.
Pain: Pain at the injection site is a common adverse event from vaccination. However, pain in the extremities (more than 78,000 reports) and neuralgia—sharp nerve pain—(more than 2,900 reports) can be a sign of neural injury or possibly autoimmunity. Studies have linked neuralgia with mRNA and adenovirus vaccines, although the causes are not well understood (studies 1, 2).
Tinnitus: Overactivity of the auditory nerves can cause ringing in the ears. Tinnitus has rarely been reported following previous vaccinations but is highly prevalent among people who received the COVID-19 vaccines. COVID vaccine-related cases comprise more than 16,000 of the roughly 19,900 vaccine-related tinnitus cases reported to VAERS. An increasing amount of research is being done on vaccine-associated tinnitus.
Insomnia: Sleep problems are a fairly common adverse event, described as due to hyperactivity of the brain, with more than 9,800 cases reported. It is likely that some of these insomnia cases are related to vaccine-associated tinnitus, which can impact sleep.
Tremor: Described as involuntary shaking or movement, tremors associated with COVID vaccines are estimated to affect 0.002–0.02 percent of the vaccinated population. Though tremors themselves usually do not cause health problems, they are commonly associated with other neurological diseases including Parkinson’s disease. Other common post-vaccine symptoms such as muscle spasms and twitches can be confused for tremors, but muscle spasms are involuntary muscle contractions, and muscle twitches are fine movements of a small portion of a large muscle. So far, more than 15,000 cases of tremor have been reported to VAERS.
Anxiety: As a psychiatric symptom reportedly affecting more than 9,000 people after COVID vaccination, anxiety is hypothesized to be due to an imbalance of the emotional control centers in the brain, and has been associated with altered chemical levels.
Brain fog: The VAERS database has over 6,700 cases of vaccinated people reporting confusional states, with over 2,200 reporting memory impairment and over 560 reporting thinking problems. “Brain fog” is a colloquial term that describes a bundle of symptoms often including but not excluded to confusion and dysfunction in thinking, memory, focus, and clarity. A 2020 study on mice published by Nature showed that spike proteins can cross the usually impervious blood-brain barrier. Another study documenting several autopsies on vaccinated individuals found spike proteins in neurons and the blood vessels in the brain.
Changes in taste and smell: After COVID vaccination, many people report a loss of taste (more than 5,500) and smell (more than 4,400), or a change in taste (more than 4,900), and olfactory alterations where something that once smelled pleasant is perceived as smelling foul; these symptoms are similar to those experienced by many individuals infected with COVID. These changes can occur independently and can impact a person’s enjoyment of food, causing possible weight loss. They can also be a sign of neurodegeneration or deterioration.
Bell’s palsy: This is a relatively rare and usually temporary condition where facial muscles become paralyzed or weak, often resulting in a face droop. It is usually associated with viral infections and is caused by inflammation or swelling of the facial nerves. The condition usually affects one side of the face, though in rare cases, both sides can be affected. So far, more than 3,700 cases have been reported to VAERS. A 2022 paper evaluating 17 reports on Bell’s palsy and the COVID-19 vaccine found that affected individuals typically experience paralysis on the left side of their face, which can occur up to 48 days of vaccination. This has also been reported in Pfizer’s post-market adverse event report. The condition is usually harmless and can usually be reversed, though symptoms may return.
Musculoskeletal Conditions
Musculoskeletal symptoms: These are well documented in relation to the COVID-19 vaccines, including weakness and stiffness in the muscles and joints, impaired mobility, and balance problems and falls. A study published in BMJ found that 66 people experienced short-term inflammation in the joints 11 to 13 days after vaccination, despite having no history of previous or related symptoms. The vaccine may also be able to trigger autoimmune musculoskeletal diseases; in one study that followed 1,519 people with musculoskeletal diseases, 5 percent experienced a flare-up and 0.1 percent experienced severe symptoms following vaccination.
Cardiovascular Adverse Events
Heart palpitations: Over 16,300 cases of palpitations, described as faster, louder, or irregular heart pulses, have been reported to VAERS. Complaints of palpitations are common and usually benign. They are often associated with anxiety, but can be a sign of concerning and potentially life-threatening problems including tachycardia and tachyarrhythmia.
Hypertension: Over 7,700 cases of hypertension (high blood pressure), which is associated with and increases the risk of cardiovascular disease, have been reported. A review that analyzed six studies of 357,387 individuals found that 3.2 percent—13,444 patients—reported abnormal or higher blood pressure after COVID vaccines. Another hypertension report found that nine hypertension patients increased blood pressure to stage 3 hypertension—blood pressure higher than 180/110—within minutes after vaccination (pdf).
Tachycardia: This is a concerning condition that occurs when a person’s heart rate increases past 100 beats a minute. It is a strong predictor of hypertension and cardiovascular diseases, with more than 7,000 cases reported to VAERS.
Pallor: Contrary to the effects of high blood pressure, pale facial features indicate reduced blood flow and are warning signs of low blood pressure. This is especially concerning if the pallor is sudden, as the person may faint from a sudden drop in blood pressure, and it could also be a sign of anaphylaxis. Over 6,300 cases of pallor have been reported.
Blood clots: The FDA has mostly focused on the association between the J&J COVID vaccine—which employs a disabled adenovirus rather than mRNA—and increased risk of blood clot formation. VAERS has documented over 5,100 reports of blood clots reported after COVID vaccinations, but blood clots reported after Pfizer and Moderna mRNA vaccine administration take up the majority of these reports, with over 3,900 cases.
mRNA vaccines have been administered much more broadly than adenovirus vaccines. Studies have shown that the mRNA vaccines’ spike protein is able to bind to red blood cells and thus may cause the formation of blood clots (studies 1, 2).
Along with blood clots, more than 3,800 cerebrovascular events, more commonly known as strokes, have also been reported. Strokes are usually caused by clots in the blood vessels supplying the brain.
Myocarditis: Despite many media reports and research on post-COVID-vaccine myocarditis, out of all the cardiovascular adverse events listed in this article, myocarditis had the lowest number of events reported. More than 2,800 cases are reported, with serious cases comprising almost 70 percent of all myocarditis reports. It is likely that many mild myocarditis cases have not been reported or haven’t been diagnosed. According to VAERS data, young males under the age of 40 who have received mRNA vaccines appear to be more affected than any other group. Depending on the seriousness of the case, patients may be able to make a full recovery. Chronic myocarditis, however, is associated with enlargement of the heart and other cardiac problems, all of which may lead to cardiovascular diseases further down the line.
Pulmonary Adverse Events
Pneumonia: More than 5,000 cases of COVID-19 pneumonia and 4,100 cases of pneumonia have been reported following COVID vaccination, both of which are signs of a weak or dysregulated immune system (studies 1, 2), as people with a strong immune system are normally able to clear out a pulmonary infection before it progresses into inflammation and fluid retention in the pulmonary air sacs. COVID vaccines can induce or exacerbate pneumonia (studies 1, 2) and inflame the lungs after vaccination (studies 1, 2). The biopsy of a vaccinated person found spike protein present in the lung cells nine months after the individual was vaccinated. According to the report, the patient had suffered respiratory symptoms since vaccination.
Pulmonary embolism: This is a serious condition where blood clots are formed in the blood vessels in the lungs, which can reduce blood flow to the lungs, cause tissue damage, and therefore impair lung function and reduce blood oxygen levels. Affected individuals may cough frequently and experience difficulty breathing. At least two case studies have documented pulmonary embolisms after COVID-19 vaccinations in the United States (studies 1, 2). Pulmonary embolisms have also been reported after COVID-19 infections, but a study showed that there is very little literature to support the theory that infection greatly increases the risk of this condition. More than 3,700 cases have been reported after vaccination.
Acute respiratory failure: With more than 3,200 reports after vaccination, this life-threatening condition occurs when a person’s lungs cannot meet oxygen demand or are unable to adequately remove carbon dioxide. Depending on the trigger, physicians may be able to reverse the condition.
Endocrine-Related Adverse Events
Menstrual changes: More than 11,500 people have experienced cases of menstrual changes after COVID-19 vaccinations. This includes menstruation that is abnormally heavy, prolonged, more frequent, irregular, inconsistent, or light, and cessation of menstruation. These changes are more commonly observed in menopausal women aged 45–55, and perimenopausal women, usually 40 to 44 years of age. However, these events are also reported in children and adolescents. Alarmingly, several cases include 3-, 4-, and 5-year-olds, women aged 60 to over 80, and, in very rare instances, infants—all of whom are people who should not be menstruating. The menstruation cycle is a carefully orchestrated rise and fall of estrogen and progesterone, and a sudden change can be indicative of endocrine dysfunction, formation of fibroids—muscular tumoral growths in the uterus—or other less common but concerning health problems.
Hot flashes: These sudden sensations of heat in the face, neck, and upper body typically occur in females during menopause, when estrogen and progesterone levels fall. Though far less common, hot flashes (or hot flushes) can also happen during menstrual cycles, mostly affecting women in their 40s who are experiencing perimenopause. VAERS contains 1,241 reports of hot flashes among women and girls of pre-menopausal age, including 31 cases in girls aged 6 to 17. There are also 727 cases reported in men. Studies on men have shown that hot flashes are usually due to reduced testosterone, such as may occur during hormonal-suppressant cancer therapy or because of testicular dysfunction. (studies 1, 2).
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