Friday, December 30, 2022

Cardiologists say there appears to be cumulative harm from the mRNA shots, especially to the heart

According to the Centers for Disease Control and Prevention’s (CDC) V-Safe data, 25 percent of people who took the mRNA vaccine were incapacitated the next day, and 8 percent were hospitalized or went to the emergency room.

“This is the most toxic vaccine by the CDC data that we’ve ever seen in clinical medicine,” McCullough said during a recent dual interview with Malhotra for EpochTV’s “American Thought Leaders” program.

McCullough, one of the most published cardiologists in America and chief scientific officer of The Wellness Company, said he believes those 8 percent who went to the hospital likely had COVID-19 prior to being vaccinated.

“I think all cardiovascular conditions have got worse because of the vaccine, and anything and everything that can go wrong with the heart has gone wrong with the heart as a result of this mRNA vaccine,” added Malhotra, who has written extensively on reversing heart disease through lifestyle changes.

“The part of the virus that causes the heart damage is called the spike protein,” said McCullough.

Myocarditis is one of the more common injuries caused when the patient gets a high dose of spike protein with the shot, the doctors said, so the claim by the mainstream medical establishment that the risk of myocarditis is greater without the vaccine is false.

“There is a risk for traditional cardiovascular events because of this big inflammatory incident the body gets with COVID respiratory illness, but there is a small negligible risk of myocarditis with COVID, the respiratory infection, probably because the body doesn’t get this massive exposure to the spike protein, as it does with the vaccines,” said McCullough.

In addition, there is no evidence to support the claim by the drug industry that mild infection with COVID-19 or the omicron variant is causing sudden death, said Malhotra.

“I think people shouldn’t be distracted by this false narrative that mild COVID may be causing a massive surge in cardiac arrests,” said Malhotra.

It is also not true that there is a higher risk of myocarditis from COVID-19 infection than the vaccine because the mRNA vaccines have caused more injury and death, the doctors said. This is not surprising because other vaccines have also been known to cause Myocarditis, including the smallpox vaccines, McCullough said.

However, many doctors, including cardiologists, are still not aware of the data that show the mRNA vaccine can cause cardiac arrhythmias, atrial fibrillation, heart attacks, myocarditis, and heart failure, but Malhotra has been able to correctly diagnose and treat his vaccine-injured patients, he said.

The rule the regulatory agencies historically have followed is that when a new drug is introduced into the market, if someone is injured or dies within 30 days of any new drug or injection, the injury or death is considered to be caused by the new drug until proven otherwise, said McCullough.

The World Health Organization (WHO) acknowledges that the COVID-19 vaccines can cause myocarditis, and in June 2021, the U.S. Food and Drug Administration (FDA) updated the information on the mRNA vaccines to include the potential for myocarditis, added McCullough.

In addition, there are a growing number of studies that show the link between the mRNA vaccines and myocarditis, said McCullough. He cited one study that showed a direct link between mRNA vaccines and myocarditis deaths.

Malhotra believes there would have been less harm to the general public if mRNA vaccines had not been used.

“These vaccines have had a hugely negative impact on society, on health, and of course, everything that’s gone on with it has eroded trust, as well, in medicine,” he said.

“What was most criminal is telling people who had natural immunity to take the vaccine,” said Malhotra, because some evidence suggested that a person was three times more likely to suffer a serious adverse event from the vaccine if they’d already had COVID-19.

In addition, early treatments for COVID-19 have been proven to prevent severe illness and hospitalization, and in many COVID-19 patients, these should have been used instead of vaccination, said McCullough.

Early on in the pandemic, when the FDA and pharmaceutical companies were registering people for the trials, they excluded anyone who had already been infected with COVID-19 and women who were either pregnant or had the possibility of becoming pregnant, McCullough said.

“When we have exclusion criteria in clinical trials, the exclusions must be justified, and the rationale to justify the exclusion was, they did not have an opportunity for benefit and they had an opportunity for harm,” in the case of those with natural immunity and young women.

This is the “golden rule in medicine,” that once people are excluded from the original randomized trials, they are never immediately given the vaccine, but in the case of the mRNA vaccine, this rule was breached, McCullough said.

“Those are breaches of regulatory science and breaches of medical ethics. They are completely off the rails,” he said.

COVID-19 Safety Data

McCullough and Malhotra agreed that adverse effects were worse for people who received the mRNA vaccines after already acquiring natural immunity from an infection, and a 2022 study in the United Kingdom supports that conclusion. The U.S. Centers for Disease Control and Prevention (CDC) tried to prevent the public from accessing its own adverse event vaccine data in its “V-safe” database, but the agency was forced by a court order to release the information to the Informed Consent Action Network, said McCullough.

The UK’s mRNA vaccine adverse event data is very similar to the CDC’s data, said Malhotra.

“There was no precautionary principle applied, and it still comes back that these regulatory bodies failed in their duty to protect the public from the excesses of manipulations of industry who were there just wanting to mass vaccinate as many people as possible, irrespective of the consequences and irrespective of the harm,” said Malhotra.

McCullough has entered many of his patients’ vaccine adverse reactions to the CDC’s Vaccine Adverse Event Reporting System and found it does not allow for differentiating between being vaccinated after having COVID-19 versus being vaccinated before contracting the virus.

“There’s no checkbox to indicate if they previously had COVID. It is a massive oversight,” said McCullough.

In the current era of the omicron variant of the virus, CDC Director Rochelle Walensky said there are about 300 people dying from COVID-19 each day. However, McCullough said 90 percent of those 300 are labeled COVID-19 deaths but are actually caused by some other factor while testing positive for prior infection.

This brings the true number of people dying from the omicron variant to about 30 per day, said McCullough, compared to 2,000 people dying each day from heart disease. There is no reason for President Joe Biden to continue to declare COVID-19 a public health emergency, he said.

“We’re dealing with a cold,” said Malhotra. “People need to be told the truth. We need to stop scaring people.”

The Real Bias

McCullough and Malhotra have been criticized for spreading “misinformation” about the vaccines and allegedly cherry-picking studies to show the outcomes they want.

Although McCullough is not an infectious disease specialist, he has studied the virus for the last three years and written more than 60 peer-reviewed articles on COVID-19, he said, and the real bias is coming from the medical establishment and governments.

“There is a clear-cut bias in the medical literature coming from the major publishers—Elsevier, Taylor & Francis, and others—all the way down to the editorial offices to promote mass vaccination,” said McCullough, which is why he has to rely on less well-known journals for studies that focus only on the data, not the claims about the vaccines.

McCullough said it is common for doctors to have opposing views about a drug or a treatment, and medical journals normally have a balance of studies for and against a particular medical treatment, except for the case of the mRNA vaccines. He said this shows that “there is a deep-seated bias to only promote the vaccines in the peer-reviewed literature.”

Fellow medical professionals and the media have tried to assassinate the two cardiologists’ character but have not been able to disprove or rebut their statements, Malhotra said.

“We are losing out on dedicating time, resources, and research towards helping people who are genuinely vaccine-injured,” said Malhotra.

Vaccines Must Be Halted

McCullough said only about 10 percent of people in the United States are still getting boosted, and the reason is likely that most people know someone who is vaccine-injured.

The vaccine should have been offered to only a very small, high-risk group, McCullough said, adding that the focus on vaccinating children and infants is out of proportion to their risk for serious illness.

Instead, the U.S. government put billions of dollars into advertising and disseminating the vaccines and collaborating with the medical establishment, the media, and popular culture to promote mass vaccination.

“These injuries and problems don’t stop until the vaccines stop,” said McCullough. “We need this immediate about-face, and understand that the vaccines themselves have caused a public health crisis.”

There is a cumulative effect with the vaccines, leading to both immediate and longer-term injury to patients, including heart inflammation, neurological disorders, immune disorders, and blood clots, said McCullough.

The more doses, the worse off a person is, the doctors said.

The vaccine industry needs to pay the vaccine-injured, much like the tobacco industry had to settle for the damage its products caused, said McCullough, and that money needs to be used to help the vaccine-injured.

“We don’t want to scare people too much, but what we need to tell them is to say ‘no’ right now,” Malhotra said. “It’s all risk and no benefit.”


Dr. Jay Bhattacharya Laments How Little The Medical Establishment Has Learned From China's Covid Disaster

Stanford epidemiologist Dr. Jay Bhattacharya expressed concern Wednesday night that the global and national medical establishment might have learned nothing from China's horrific experience with the Covid-19 pandemic.

Appearing on Wednesday night's "Tucker Carlson Tonight" with guest host Sean Duffy, Bhattacharya worried that the same mistakes China and much of the rest of the world made at various points along the way could "come back" if there is another pandemic.

The segment began with Duffy chronicling China's shift from so-called "zero-Covid" policies, a draconian approach to lockdowns that was never sustainable, to essentially giving up and allowing the virus to run unabated through a population that has little natural immunity.

"The World Health Organization has put containment at the center of its approach to future pandemics," Bhattacharya said. "The Biden Administration has basically, I think, rubber-stamped the same kind of containment idea when there's another pandemic. Unless there's a concerted effort by political leaders to examine the failure of our Covid policies and then put in place plans so that we don’t lock down again, I’m afraid it will come back."

The Stanford professor - who helped craft the Great Barrington Declaration in 2020 that called for focused protection of the vulnerable as an alternative to society-destroying lockdowns - noted that many "public health authorities" wanted something like China's Covid policies in the United States even though indefinitely containing a "highly infectious respiratory disease" like Covid-19 is impossible.

It was inevitable that this virus was going to infect basically everybody. It’s a highly infectious respiratory disease. Our efforts to try the control the spread of it, we don’t have a technology that does that ... Chinese authorities capitulated. The problem is they didn’t protect the elderly population. They’re at high risk. There’s a lot of people that have never been infected before that are really at high risk and their healthcare system is much more easily overwhelmed than ours is. That’s what we’re seeing now. It’s tragic. At this point, there’s not much I can do other than to pray for the people of China because it is absolutely a disaster what they’ve had to go through from their move to zero Covid to essentially letting it rip.




Thursday, December 29, 2022

Ivermectin Is Safe and Effective: The Evidence

The article below is right. What it overlooks is why the establishment rejected Ivermectin: Because Trump recommended it. Leftist childishness knows no bounds

Decades of use with nearly four billion doses to humans preceded recent use with COVID patients. From the chapter ‘Ivermectin sends COVID to lockdown,’ in my book The Defeat Of COVID.

Ivermectin is on the World Health Organization (WHO) List of Essential Medicines and is approved by the US Food and Drug Administration (FDA). This well-tolerated but potent anti-parasitic medicine has been prescribed billions of times in its 36-year history against a wide range of parasites. It is a drug in the avermectin family, so named because those compounds are produced by the soil organism Streptomyces avermitilis. It has also been studied and used against a wide range of viruses especially over the last decade, and there is evidence of potent antiviral effects against Influenza A and over a dozen other viruses tested. [309]

In a meta-analysis of 63 studies of ivermectin versus COVID-19 in humans, 100% of these have shown positive results. Studies were from all continents except Antarctica. Considered individually, 29 of those studies were found to be statistically significant regarding use of ivermectin alone. Over the 63 studies in meta-analysis, pooled effects showed 69% improvement in early treatment, and prophylactic use showed 86% improvement. Of those studies in the meta-analysis that were peer-reviewed, overall improvement in early treatment was found to be 70% (64% in randomized controlled trials), and 86% of those in which ivermectin was used prophylactically showed improvement (84% in randomized controlled trials).

Mortality from COVID-19 over all time periods of delay in treatment was 76% improved over controls (69% in randomized controlled trials), whereas mortality was improved 84% in early treatment of COVID-19 (82% in randomized controlled trials). Forty studies were excluded from the meta-analysis for complicating factors or insufficient detail reported, and these also showed 100% positive results.

It is estimated that the likelihood of an ineffective treatment showing such positive results as the above results in the 63 studies in the meta-analysis to date is exceedingly small. That probability is estimated to be one in one trillion. [310] The overall results of the meta-analysis were not only found to be “overwhelmingly positive,” but also “very consistent, and very insensitive to potential selection criteria, effect extraction rules, and/or bias evaluation.” The data in the meta-analysis are as of date of this article, and are continually updated as new studies are reported.

The first clinical trial of ivermectin in COVID-19 patients was an observational study in four Florida hospitals from March to May 2020. Even in patients with severe pulmonary involvement, mortality was 38.8% in the treatment group vs 80.7% in controls, and this group showed the strongest mortality difference from controls, which raised the possibility of ivermectin also being available as a salvage or rescue treatment. [311]

In a randomized controlled trial, patients given ivermectin were 8 times more likely to be medically released than those in the placebo group. This was even though the average age and number of comorbidities were later found to be somewhat higher in the experimental group than in the control group. [312]

The African continent has had remarkably low incidence of COVID-19, particularly equatorial African countries. It may be helpful to look at African countries where ivermectin has been used commonly for decades against the onchocerciasis that it has been prescribed for, to observe population-wide effects. In this population comparison, risk of COVID-19 death was found to be 88.2% lower and morbidity 85.7% lower in 31 countries where onchocerciasis is endemic and ivermectin is commonly used than in 22 countries where neither is the case, even though the latter group of countries has a higher life expectancy, 66 years vs 61 years. [313]

Ivermectin, for all its power against viruses, is among the safest of medicines that are in long-term and widespread use. [314] There are no known serious drug-related adverse events. [315] Again, it is commonly taken by the populations of 31 African countries for effect against endemic parasites. Dosing has been given as a single annual dose of 150 mcg/kg against filariasis. There have been very few serious adverse events reported over more than 30 years of use. 37 of approximately 14,000 patients treated in Ghana had symptomatic posture hypotension, associated with fainting or sweating or tachycardia. These were treated with corticosteroids. [316] This Lancet study determined its safety in pregnant women, and the risk of fetal damage was not greater than in control women’s fetuses. [317]

However, despite this safety data going back 3 decades, the US FDA has alleged, “Any use of ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established.” The FDA offered no supporting evidence for their claim. [318] One concerning risk is that ivermectin is sold over the counter for veterinary use, and if people feel desperate to use it to ward off COVID-19, they might break off too large a piece from a large horse pill. For this reason, it is much better to consult a healthcare provider for ivermectin use and dosing. To further enhance safety, liposomal ivermectin carriers have been developed. When these were used against Dengue fever, cytotoxicity was reduced up to 5 times, absorption was faster and in vivo efficacy was improved. [319]

Despite the spectacular worldwide effect profile, of excellent effect against COVID-19, with 0.26% observed minor side effects, and its use across several continents, ivermectin is widely shunned and ignored in western Europe and in the US. Here is a brief synopsis of how that came to be.

Ivermectin was invented in Japan in 1975 as an anti-parasitic drug by Satoshi Omura, a Kitasato University professor emeritus, which earned Dr. Omura the Nobel Prize in Biochemistry. Ivermectin turned out to be quite effective against a broad spectrum of parasites. The drug was so effective in eliminating a range of parasitic infections, and at very low cost, about $0.10 US, that 3.7 billion doses have been delivered to much of the world’s population since its invention. [320]

A cell culture study in April 2020 showed a 5000 times reduction in SARS-CoV-2 from one dose over 48 hours, compared to control samples. [321] Several Latin American countries, Egypt and India soon began to use it for COVID-19, and then South Africa and several European countries as well. However, resistance remained strong in the US and western Europe, following the vocal disapproval of The World Health Organization (WHO), The US National Institutes of Health (NIH), the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). These agencies all expressed disapproval of ivermectin for use with COVID-19 patients. Even after more than 20 randomized controlled clinical trials showed promising effect without adverse reactions, many western countries have still not adopted its use.

Social media companies censored ivermectin research. Even when the WHO commissioned and reported a meta-analysis of ivermectin, it was censored by YouTube. Only negative commentaries were permitted in western media. [322]

How does ivermectin send SARS-CoV-2 to lockdown? There are a number of mechanisms by which components of SARS-CoV-2 need to stay mobile and active in order to replicate, and thus to spread throughout the human body. It turns out that ivermectin binds several of these, which inactivates the virus. Let’s look at exactly what happens to bind or to lock down SARS-CoV-2.

RNA-dependent RNA-polymerase (RdRp) is one of the main enzymes used by SARS-CoV-2 to achieve RNA replication. It is required for viral genome replication, and therefore it is helpful if a nutrient or drug can act on it as an obstacle in some way. 173 drugs were tested in this study for their ability to bind RdRp (making it unavailable or inactive), including two examined in this book, hydroxychloroquine and vitamin C, although vitamin C was also found to have relatively high binding energy for RdRp in this study. Of all the drugs tested, ivermectin was found to bind RdRp with higher binding any energy than any other drug. [323]

One strategy against SARS-CoV-2, as well as other endemic and pandemic RNA viruses, has been to interfere with transport of viruses into a host cell’s nucleus. Ivermectin has been shown to accomplish this by binding, destabilizing and inhibiting the protein IMP alpha/beta1. When this protein is inhibited, viruses are unable to enter a cell’s nucleus, and therefore unable to replicate. Decreased infection results. IMP alpha/beta 1 has been inhibited in SARS-CoV-2 entry into nuclei by ivermectin. [324] Previously, it has been observed that ivermectin inhibited that same protein from entry of other RNA viruses, giving it a broad-spectrum antiviral effect. [325] [326] [327]

It turns out that ivermectin not only binds tightly to RdRp on SARSCoV-2, and IMP alpha/beta1; it also strongly binds the spike protein on SARS-CoV-2. This particular spike protein is trimeric, meaning it has 3 subunits which vary in amino acid sequences or other ways. It was observed that ivermectin binds all three of the SARS-CoV-2 subunits, both the structural S2 subunit, as well as both of the two functional S1 subunits. [328] This binding of all 3 subunits of the trimeric spike protein may be considered a trifecta of fortunate results of ivermectin in favor of the human host and in opposition to the SARS-CoV-2 virus.

Ivermectin has different mechanisms against parasites, already a miraculous healing drug for that use alone through much of the world’s population. However, now that we learn of its tremendous effect in binding both RdRp and all three trimers of the spike protein of SARS-CoV-2, we are certainly fortunate to have this medicine in our arsenal against COVID-19. It is inexpensive, and full COVID-19 treatment of an individual, from first dose till last needed can be less than one US dollar. Ivermectin is therefore available to even the poorest communities in the world. Ivermectin is being compared to the discovery of penicillin in its enormous impact, and perhaps was one of the greatest discoveries of the 20th century. [329] The fact that this tremendously effective, safe and low-cost antiviral drug is not as thoroughly known to the world as penicillin is a chasm of inexcusable and deadly ignorance that the COVID era is giving the world an opportunity to correct.


Is the CDC Shortening Americans’ Lives?

It’s one thing when government raises your taxes, suffocates your business with regulations or censors your tweets. It’s far worse when government is to blame for actually shortening your life.

American life expectancy dropped to 76.4 years, the lowest in 25 years, according to new federal data. Americans should be gasping. What could be more important than having the chance to live a long life?

The Centers for Disease Control and Prevention repeatedly has blown its responses to health killers like fentanyl, Covid, and lung cancer. All the while, life expectancy gets shorter and shorter.

In 1980, Americans had one of the best life expectancies in the world. Since then, America has lost ground. People live several years longer in France, Switzerland, Italy, and other highly developed countries, reaching ages 83 or 84 on average.

Residents of the Czech Republic, Chile, and Slovenia can expect longer lives than Americans. Even before Covid, America ranked 29th in life expectancy, according to the Organization for Economic Co-operation and Development.

The virus merely widened an already alarming gap between America and other nations.

Now, life expectancy in these other nations is rebounding from Covid, while American lives continue to be cut short due to other causes.

Start with the failure of our government, especially the CDC, to tackle the leading cause of death among Americans ages 18 to 49: overdosing. Two-thirds of these deaths are from fentanyl.

Nearly 107,000 Americans died of overdoses in 2021, about 50 percent more than just two years earlier.

Where’s the campaign to combat fentanyl deaths? Over the last half-century, American health agencies waged several stunningly successful media campaigns to dissuade Americans from smoking cigarettes. The CDC has done nothing like that to fight this new killer.

Blame the agency’s mission confusion. In September 2021, as overdoses soared and Covid raged, the CDC launched a campaign for “inclusive communication.”

The agency instructed health care workers to avoid stigmatizing words like “illegal immigrant” and substitute “parent” for gender-tainted terms like “mother” and “father.” As if political correctness is more important than preventing deaths.

The CDC’s failed response to Covid further depressed American life expectancy. Agency head Rochelle Walensky said, “To be frank, we are responsible for some pretty dramatic, pretty public mistakes, from testing to data to communications.”

America has had a higher per capita death rate from Covid than other developed countries, including the United Kingdom, France, Spain, and Canada.

As Covid fades, the CDC’s inaction on another front — lung cancer screening — is limiting progress on life expectancy for cancer patients, where America is otherwise a leader.

Lung cancer is the number one cancer killer, taking about 130,000 lives a year. That’s more than breast, prostate and colon cancer deaths combined. Because lung cancer is rarely diagnosed before it spreads, the chances of survival are an abysmal 18 percent.

But when lung cancer is diagnosed early with a CT chest scan, a patient has an 80 percent chance of living another 20 years, reports a radiology expert at New York City’s Mount Sinai Icahn School of Medicine, Claudia Henschke. That sure beats 18 percent.

The scan takes 15 minutes lying flat on a table that glides in and out of the scanning machine. There’s no squeezing like with a mammogram and no yucky preparation like with a colonoscopy.

The technology is widely available, recommended by the U.S. Preventive Services Task Force and covered by insurance, but few doctors know to order it, and few patients know to ask. Blame the CDC for this knowledge gap. Only 15 percent of Americans who need lung screening are getting it.

On December 20, the White House announced a pilot project to “screen and treat” cancer. Oh, sorry, that’s not for America. It’s for women in Botswana. Laughable if it weren’t so tragic.

Ten years ago, Americans were told the biggest health challenge was the uninsured. Congress passed Obamacare. Now only 9 percent of Americans are uninsured, but the whole nation faces the prospect of shorter life expectancy.

For those lost years, you can thank federal health officials, especially the dysfunctional CDC. Call it the Centers for Decline and Confusion.




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.”




Monday, December 26, 2022

Boxing day

I am still in holiday mode so am posting on my personal blog only:

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


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

“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.”




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.


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.


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.


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.”




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.




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.


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.


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.


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.