Wednesday, December 28, 2022
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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Monday, December 26, 2022
Boxing day
I am still in holiday mode so am posting on my personal blog only: https://memoirsjr.blogspot.com/
Sunday, December 25, 2022
Merry Christmas and a happy new year to all who come by here
I do not intend to post anything (other than this note) on any of my blogs today. I will be busy enjoying a family Christmas instead.
I have in the past often abandoned my pagan ways long enough to go to church on Christmas day. I will not be doing that today but I did go to a service yesterday at a Seventh Day Adventist church. Adventist beliefs seem generally well founded in scripture so I enjoy an SDA service as well as the Presbyterian services I was brought up to.
On this occasion, my girlfriend wanted to go to a specific SDA church so I was happy to accompany her. I thought the sermon was reasonable and I enjoyed belting out the traditional Christmas hymns
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Friday, 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
**************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Thursday, December 22, 2022
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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Wednesday, 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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Tuesday, 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
**************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Google is increasing their attacks on my Tongue-Tied blog (https://snorphty.blogspot.com/)
On 18th I republished there an article from the NY SUN about the definition of a woman. Google (who own blogspot) have put a notice on that post saying that they have unpublished it because it violates their guidelines. They have instructed me to revise the article according to their guidelines
The odd bit is that as far as I can see, the article is still appearing on my blog unaltered. Maybe I am the only one who can now see it. I would be obliged if readers would tell me what they see there when they log on.
The blog has been for some time behind a scare warning if you access it via a cellphone but remains accessible without interruption if you log onto it via computer
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On 18th I republished there an article from the NY SUN about the definition of a woman. Google (who own blogspot) have put a notice on that post saying that they have unpublished it because it violates their guidelines. They have instructed me to revise the article according to their guidelines
The odd bit is that as far as I can see, the article is still appearing on my blog unaltered. Maybe I am the only one who can now see it. I would be obliged if readers would tell me what they see there when they log on.
The blog has been for some time behind a scare warning if you access it via a cellphone but remains accessible without interruption if you log onto it via computer
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Monday, December 19, 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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Sunday, 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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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Friday, December 16, 2022
The Bible
After a gap of about a year, I have just put something up on my scripture blog. It is about love
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