Filed under: General Problems | 2 Comments »

Filed under: General Problems | 2 Comments »

FDA: The Wait for COVID Pills Is Over

https://www.medpagetoday.com/infectiousdisease/covid19/96356

Oral antiviral treatment for COVID-19 is now on the table following FDA’s emergency use authorization (EUA) for nirmatrelvir/ritonavir (Paxlovid), the agency announced on Wednesday.

Paxlovid is authorized for use in adults and pediatric patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe illness. It is administered as three pills (two of nirmatrelvir and one of ritonavir) twice daily for 5 days, for a total of 30 pills, the agency said.

However, the FDA added that the drug is only available by prescription, must be given within 5 days of symptom onset and is not authorized for use longer than 5 days.

Importantly, the FDA said the drug is not meant as a substitute for vaccination for those where vaccines and boosters are indicated, nor is it authorized for pre-exposure or post-exposure prophylaxis.

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research in an FDA statement.

Paxlovid’s problem, however, is insufficient production by manufacturer Pfizer: the company revealed that there are only 180,000 treatment courses available, and another 80 million expected by the end of 2022. The Biden administration has already claimed 10 million courses of the pills.

Experts worried about supplies for the rest of the world are calling for other companies to join in the manufacturing of the drug.

In the EPIC-HR trial, Paxlovid was found to cut COVID hospitalizations and deaths by nearly 90% in high-risk patients in interim results announced in November;

this was confirmed in final data from the phase II/III trial released in mid-December. The trial of more than 2,200 people saw no deaths in the Paxlovid arm and 12 in the placebo arm through day 28.

Side effects of Paxlovid include sense of taste, diarrhea, high blood pressure and muscle aches, and the FDA added that it may cause interactions with other drugs and HIV drug resistance among people living with undiagnosed or uncontrolled HIV.

Because ritonavir may cause liver damage, the agency urged caution when administering the drug to those with pre-existing liver diseases, liver abnormalities or liver inflammation.

The drug is contraindicated for patients already taking drugs that either are “highly dependent” on the enzymes Paxlovid inhibits “for metabolism and for which elevated concentrations of certain drugs are associated with serious and/or life-threatening reactions,” and those taking drugs that induce the same enzymes as Paxlovid inhibits, the FDA said.

Paxlovid is not recommended for those with severe liver or kidney impairment, the agency added, and a healthcare provider should be consulted prior to use.

The FDA did not convene its Antimicrobial Drugs Advisory Committee (AMDAC) prior to this EUA, the way they did for molnupiravir in late November. That drug was ultimately recommended by a divided committee by a vote of 13-10, but has yet to be authorized.

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To me, this is a very interesting read,  you could replace a few words in this article and it would read and apply to those in the chronic pain community.. referring to all the deaths, suffering of substance abusers and their families. I also find it interesting the political party that those sponsoring this bill belong to. The same political party in the majority of Congress that brought us the Harrison Narcotic Act 1914 and basically created the “black opiate drug market”. It is also the party in control of Congress that brought us Medicare – WITHOUT ANY MEDICATION COVERAGE in 1965 and the same Political party that was strongly opposed to the bill that created Medicare Part D in 2006 that provided medication coverage for Medicare folks.  The same political party that brought us the Controlled Substance Act 1970 – that started the WAR ON DRUGS. And now the same political party is proposing the NO PAIN (medication) Act – that will provide a 20% kick back to prescribers that lowers and or stops prescribing opiates for acute/chronic pain pts.  It is claimed that we have some 30-40 million people addicted to the two drugs ALCOHOL & NICOTINE, but those two drugs have a very healthy “sin tax” revenue stream and contribute to some 550,000/yr deaths…  But perhaps because of all the taxes generated at many bureaucratic levels – those deaths are basically “socially acceptable” and that also means that all those people will stop collecting SS/Medicare benefits and/or never start to collect them, yet contributed to those “locked boxes” during the years that they did work and pay taxes.  Also pay attention to the end of this press release this list View Full List of Endorsements (PDF) of the180 different organizations that are behind/supporting this bill – there are a lot of medical/physician/nursing groups… but of interest there is NO PHARMACY GROUP nor Pharma… there is one with “Pharm” in their name – but they are a addiction/rehab group.  This article states that ONLY 6.5 of substance abusers are able to now get treatment… is that because that is the number that REALLY WANTS TREATMENT ? So this proposed 125 billion dollars is being paid out to “save” substance abusers that really don’t want to be “saved” ?  All the while, it is claimed that the amount of illicit fentanyl that is coming across our SW border … is at least UP THREE FOLD – at least that represents the amount that has been seized… which could only represent about 5%-10% of what actually got to our streets and it has been stated the price of illicit fentanyl on the street is dropping dramatically…  more supply than those that want to buy it ?

Van Hollen, Warren, Baldwin, Maloney Reintroduce Landmark CARE Act to Combat the Substance Use Epidemic

https://www.vanhollen.senate.gov/news/press-releases/van-hollen-warren-baldwin-maloney-reintroduce-landmark-care-act-to-combat-the-substance-use-epidemic

The CARE Act is the most ambitious legislation of its kind in Congress and would allocate $125 billion over 10 years to defeat the substance use crisis

U.S. Senator Chris Van Hollen (D-Md.) joined Senators Elizabeth Warren (D-Mass.) and Tammy Baldwin (D-Wis.) and Representatives Carolyn B. Maloney (D-N.Y.), Ann Kuster (D-N.H.), and David Trone (D-Md.) in reintroducing the Comprehensive Addiction Resources Emergency (CARE) Act, the most ambitious legislation ever introduced in Congress to confront the substance use epidemic. Endorsed by over 175 organizations, the CARE Act would provide state and local governments with $125 billion in federal funding over ten years.

In addition to Senator Van Hollen, the legislation is cosponsored by Senators Bob Casey (D-Pa.), Amy Klobuchar (D-Minn.), Bernard Sanders (I-Vt.), Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), Alex Padilla (D-Calif.), Cory Booker (D-N.J.), Tina Smith (D-Minn.), Sherrod Brown (D-Ohio), Martin Heinrich (D-N.M.), and Jeff Merkley (D-Ore.), and nearly 100 members of the House of Representatives.

Originally introduced in 2018, the updated CARE Act of 2021 addresses the substance use disorder crisis, including, but not limited to, the opioid epidemic.

“The opioid epidemic has wreaked havoc on families across Maryland. The ongoing rise in overdose deaths is a tragedy that hurts communities across our state and our nation and it has only gotten worse, which is why we must address it with an ambitious solution like the CARE Act,” said Senator Van Hollen. “The CARE Act makes historic investments in overdose response, addiction treatment, and recovery-to-employment initiatives, with a focus on the hardest-hit places that need these resources the most. This plan will help us mount a serious response to the extensive scale of this decades-long crisis.”

“For too long state and local leaders, health officials, and first responders in Massachusetts and across the country have been forced to shoulder the burden of the substance use disorder crisis,” said Senator Warren. “It is time for the federal government to address this crisis head on by enacting comprehensive legislation to make sure everyone who needs treatment for a substance use disorder is able to get it—whether they live in the largest cities, in rural or suburban areas, on tribal lands, or anywhere else in the United States.”

“Too many families across this country have been devastated by America’s addiction crisis, which has gotten worse during the coronavirus pandemic.  Now more than ever, the federal government must step up and provide our communities with the sustained funding they need to expand treatment access and turn the tide on this epidemic,” said House Committee on Oversight and Reform Chairwoman Maloney. “This critical legislation will deliver essential resources to those on the front lines of this crisis, in order to prevent future tragedies and save lives.”

“The opioid epidemic and substance abuse crisis continues to touch every community across Wisconsin and the country, and the COVID pandemic has only made it worse,” said Senator Baldwin. “I support taking action with the CARE Act, which will deliver a sustained funding source for our local and state partners to support prevention, treatment and recovery efforts. This is bold action that will help address this public health crisis and save lives.”

“While we have taken tremendous steps forward to address the addiction and substance use epidemic in New Hampshire and throughout the country, this crisis has persisted – especially during the COVID-19 pandemic,” said Rep. Kuster, founder and co-chair of the Bipartisan Addiction and Mental Health Task Force. “That’s why I’m proud to join my colleagues in introducing the CARE Act, ambitious legislation to expand access to treatment and create sustained, targeted funding to finally turn the tide on this crisis.” 

“The opioid epidemic has taken hold of communities in every corner of the country. Even still, the treatment between substance use disorder and other diseases such as cancer couldn’t be more different,” said Congressman Trone, founder and co-chair of the Bipartisan Addiction and Mental Health Task Force. “The CARE Act meets the moment by providing crucial funding to not only treat addiction but also prevent the disease in the first place. We must achieve parity in how we treat addiction in America. This bill is a step in the right direction.

“Every day, families across Minnesota and the country lose loved ones to addiction,” said Senator Klobuchar. “This legislation will give Americans access to vital treatment and recovery services and support research on prevention of substance use disorders. We must continue to address this public health emergency and provide assistance to the millions of Americans and families who are suffering.”

“It is long past time to address the opioid crisis and hold pharmaceutical companies responsible for the destruction they caused,” said Senator Sanders. “In order to take on this crisis, we must focus on treatment and prevention. We cannot continue to treat the people struggling with the disease of addiction as criminals. I’m proud to cosponsor this bill to help with this fight.”

“Too many lives and too many families continue to be upended by the epidemic of opioid overdose deaths and the burden of opioid use disorder. We must make these critical investments in public health and harm reduction efforts that will save lives and help bring healing and hope to people in need,” said Senator Markey. 

“This bill is a historic investment in families and individuals on the front lines of the opioid epidemic,” said Senator Blumenthal. “The public health crisis has claimed 500,000 lives during the last two decades and demands additional resources for behavioral health and substance use disorder services. I’m proud to partner with my colleagues on the CARE Act as we fight the scourge of addiction and help our loved ones on the path to recovery.”     

“The isolation and economic impacts of the COVID-19 pandemic have exacerbated the nation’s opioid epidemic – we must respond to this serious public health emergency with the urgency it demands,” said Senator Padilla. “We can no longer stand by as millions of Americans suffer silently with substance abuse disorders and addiction. I am proud to support this lifesaving legislation that provides funding for proven, evidence-based treatments for our most at-need communities struggling with addiction.”

“We need to address the opioid epidemic with the seriousness and resources it demands,” said Senator Smith. “This bill takes an important step forward in ensuring that Minnesotans from rural areas, to small towns and cities, and Tribal communities can all access the resources they need to address the opioid crisis, as well as other mental and behavioral health crises.”

“COVID hasn’t been the only disease terrorizing American families the last two years,” said Senator Merkley, “addiction is ravaging our communities. The Comprehensive Addiction Resources Emergency Act (CARE) Act will help provide sustained funding to states, territories, tribal nations and local communities disproportionately affected by substance use disorders. This bill is an important step in providing support, funding, and solutions for individuals and families struggling with substance addiction in America.”

Last year, approximately 275 Americans died each day from a drug overdose while the COVID-19 pandemic exacerbated our nation’s mental health and substance use disorder crises. According to recent data from the Centers for Disease Control and Prevention, it is estimated that more than 100,000 people died of drug overdoses between May 2020 and May 2021, an increase of more than 20 percent over the previous year. The Substance Abuse and Mental Health Services Administration’s 2020 National Survey on Drug Use and Health revealed that 40.3 million people reported suffering from substance use disorder in the past year. Despite the critical need for substance use disorder services, only about 6.5% of those in need of specialty treatment for substance use disorders were able to access it in 2020.

This is not the first time we have faced a public health crisis of this scale.  During the 1980s and 1990s, deaths from HIV/AIDS grew rapidly, and the country’s medical system was ill-equipped to provide effective, evidence-based care. In 1990, Congress passed the bipartisan Ryan White Comprehensive AIDS Resources Emergency Act (Ryan White Act) to provide funding to help state and local governments, and community-based organizations, combat this epidemic.  

The CARE Act is modeled directly on the Ryan White Act, supporting local decision-making and programs to expand access to evidence-based treatments and recovery support services. The CARE Act also recognizes the need for expanded mental health supports, early intervention, and harm reduction tactics.  

The CARE Act would provide $125 billion over ten years to fight this crisis, including:

• $4.6 billion per year to states, territories, and tribal governments, including $2.3 billion to states with the highest levels of overdoses and $1.84 billion through competitive grants. 
• $3.3 billion per year to the hardest hit counties and cities, including $1.75 billion to counties and cities with the highest levels of overdoses and $1.22 billion through competitive grants. 
• $2 billion per year for public health surveillance, biomedical research, and improved training for health professionals, including $1 billion for the National Institutes of Health (NIH), $500 million for the Centers for Disease Control and Prevention (CDC) and regional tribal epidemiology centers, and $500 million to train and provide technical assistance to professionals treating substance use disorders;
• $1.6 billion per year to support expanded and innovative service delivery, including $1 billion for public and nonprofit entities, $500 million for projects of national significance that provide treatment, recovery, and harm reduction services, $50 million to help workers with or at risk for substance use disorders maintain and gain employment, and $50 million to expand treatment provider capacity; and
• $1 billion per year to expand access to overdose reversal drugs (Naloxone) and provide this life-saving medicine to states for distribution to first responders, public health departments, and the public.

The legislation has been endorsed by over 175 national, local, and tribal organizations. You can view the full list here.

“We cannot afford to ignore the other pandemic raging in our communities. Drug overdoses have taken over 100,000 lives this year — the most ever,” said AFSCME President Lee Saunders. “The CARE Act will invest critical funding in addiction treatment centers, and it would provide the tools that will allow our essential behavioral health workers to fight this overdose crisis. We urge Congress to pass this important legislation and give our everyday heroes the resources and the voice on the job they need to improve care and save lives.”

“This Act will provide the opportunity to change the lives of those living with substance use disorder, increase peoples’ ability to enter treatment, reach our communities hardest hit by the pandemic, and provide meaningful access to the treatment and resources they need and deserve. It is for the reasons listed above that LIFT adamantly supports the CARE Act, and strongly encourage everyone to support this landmark legislation,” wrote Nicole Bell, Survivor, and Founder and Chief Executive Officer of Living in Freedom Together (LIFT). Full letter can be found here. 

“These drug overdoses are tragic and preventable. The CARE Act contains many provisions to implement solutions we know work to prevent these unnecessary deaths. Expanding access to Naloxone reduces overdose fatalities.2 Providing funding directly to the communities most impacted by this epidemic, especially our tribal communities, is important to ensure solutions are tailored to address community-specific issues. NSC also supports increasing funding for research into substance use disorders (SUD), public health surveillance and improved training of health care providers treating individuals with SUDs,” wrote Lorraine M. Martin, President and CEO of The National Safety Council (NSC). Full letter can be found here.  

“Substance use by expecting moms can have an adverse effect on the baby and can lead to a condition known as neonatal abstinence syndrome (NAS), which usually results in babies having withdrawal symptoms from drugs (including prescribed opioids) after birth. In addition, substance use during pregnancy, even if it’s a prescription, can lead to miscarriages, preterm births, and birth defects. That is why March of Dimes proudly supports your legislation, as it would provide critical investments to the most affected families and communities, as well as increase access to life-saving surveillance, training, treatment and recovery programs, and overdose reversal drugs. It would also incentivize states to use Medicaid funding to cover the costs of treatment, and create a new grant program to support at-risk parents struggling with addiction to maintain or find employment while they are in treatment and recovery,” wrote Stacey Y. Brayboy, Sr. Vice President of the March of Dimes. Full letter can be found here.  

“This legislation offers increased access to treatment and will improve care for individuals with substance use disorders (SUDs). The demand for access for mental health and addiction services has increased dramatically since the COVID-19 pandemic and has reached the level of a public health crisis. The CARE Act delivers significant funding and resources to state and local governments efforts to combat SUDs as well as advance federal research and programs to expand access to evidence-based treatments and recovery support services. We appreciate your leadership on this issue and applaud your efforts,” wrote George Abraham, President American College of Physicians (ACP). Full letter can be found here.  

“The passage of the Opioid Crisis Response Act of 2018 was an important first step to creating necessary substance abuse programs and begin addressing prevention and trauma from the opioid overdose crisis. Now, more action is needed to ensure those affected by trauma and substance abuse have the support they need. At a time when the opioid overdose epidemic poses a serious threat to the stability and wellbeing of families and communities across the country, the CARE Act can provide much needed resources to those that have been impacted by this crisis, and continue the journey to ending the epidemic,” wrote Nia West-Bey, Director of Youth Policy, and Isha Weerasinghe, Senior Policy Analyst, of the Center for Law and Social Policy (CLASP). Full letter can be found here.  

View Full List of Endorsements (PDF)

 Bill Text (PDF)  | Section-by-Section (PDF)

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I read where the prime minister of UK … had a break-thru COVID-19 infection and he got the AstraZeneca  vaccine… the one that our FDA did not approve, but one that the Feds ordered 300 million doses and “shared ” them with other countries – one was India or Pakistan when there was a break out.  Apparently the UK approved this vaccine.   https://www.gov.uk/guidance/countries-with-approved-covid-19-vaccination-programmes-and-proof-of-vaccination#approved-vaccines

Study: Double-Jabbed Dying at 6x Higher Rate Than the Unvaxxed

https://www.technocracy.news/study-double-jabbed-dying-at-6x-higher-rate-than-the-unvaxxed/

STORY AT-A-GLANCE–

While recent data from the U.K. Office of National Statistics (ONS) reveal people who have been double jabbed against COVID-19 are dying from all causes at a rate six times higher than the unvaccinated,¹ the U.S. Centers for Disease Control and Prevention is propping up the official narrative with a “study”² that came to the remarkable conclusion that the COVID shot unbelievably reduces your risk of dying from all causes, which includes accidents (but excluding COVID-19-related deaths). As reported by CNN Health, October 22, 2021:³

“The research team was trying to demonstrate that the three authorized Covid-19 vaccines are safe and they say their findings clearly demonstrate that. ‘Recipients of the Pfizer-BioNTech, Moderna, or Janssen vaccines had lower non-COVID-19 mortality risk than did the unvaccinated comparison groups,’ the researchers wrote in the weekly report⁴ of the U.S. Centers for Disease Control and Prevention.

The team studied 6.4 million people who had been vaccinated against Covid-19 and compared them to 4.6 million people who had received flu shots in recent years but who had not been vaccinated against coronavirus.

They filtered out anyone who had died from Covid-19 or after a recent positive coronavirus test … People who got two doses of Pfizer vaccines were 34% as likely to die of non-coronavirus causes in the following months as unvaccinated people, the study found.

People who got two doses of Moderna vaccine were 31% as likely to die as unvaccinated people, and those who got Johnson & Johnson’s Janssen vaccine were 54% as likely to die …”

Two key takeaways from those paragraphs are 1) the researchers admit they intended to demonstrate that the shots are safe and effective, and stats can be manipulated to find what you want to find, and 2) people who got the Janssen shot did in fact have a higher death rate than the unvaccinated (54% likelihood, compared to the unvaxxed).

Are the Shots Reducing All-Cause Mortality?

The researchers hypothesize that people who get the COVID jab may be healthier overall than those who abstain, and have healthier lifestyles. In my view, this is classic Orwellian doublespeak, as most of the brainwashed don’t understand the fundamentals of healthy behavior.

I suspect their new propaganda has more to do with the fact that they only looked at data through May 31, 2021. By mid-April, an estimated 31% of American adults had received one or more shots.⁵ As of June 15, 48.7% were fully “vaccinated.”⁶ So, we can assume that by the end of May, somewhere in the neighborhood of 45% of eligible Americans were double jabbed, give or take a couple of percentage points.

The reason I suspect statistical tomfoolery is because this is precisely how the CDC invented the “pandemic of the unvaccinated” myth, where they claimed 99% of COVID-19 deaths and 95% of COVID-related hospitalizations were occurring among the unvaccinated.⁷

To achieve those statistics, the CDC included hospitalization and mortality data from January through June 2021, a timeframe during which the vaccinated were still in a minority.

Here, we again see them use a seven-month span of time when vaccination rates were low. More importantly, however, is that the chosen cutoff date also obscures a rapid rise in vaccine-related deaths reported to the U.S. Vaccine Adverse Events Reporting System (VAERS).

Look at the graph below, obtained from OpenVAERS mortality reports page.⁸ As you can see, reports of deaths following the COVID jab peaked right at the beginning of April 2021, then dropped down again during the month of April. Interestingly enough, the study notes that the daily vaccination rate has declined by 78% since April 13, 2021.

However, while the daily vaccination rate has plummeted since April, reported deaths have remained high and relatively steady. Could this be a hint that people are dying from shots they received earlier in the year?

As of January 1, 2021, only 0.5% of the U.S. population had received a COVID shot, so comparing death rates of the vaxxed and unvaxxed in December 2020 and January 2021 may not be all that fruitful. Why not include July, August and September in the analysis instead?

As you can see, reported deaths were significantly elevated during these months, compared to December and January. And, while not shown in that graph, between September 3, 2021, and October 22, 2021, the total cumulative reported death toll shot up from 7,662^9,10 to 17,619.¹¹ In other words, it more than doubled in about seven weeks — a timeframe that was not included in the CDC’s analysis.

What’s more, while the study was large and sociodemographically diverse, the authors admit that “the findings might not be applicable to the general population.”

Also, recall they changed the definition of “vaccinated” to include someone who is two weeks past their second dose (for two dose regimens). This would obfuscate the truth as there were tens of millions that received one jab or more but were not considered “vaccinated.”

Why Is All-Cause Mortality Higher in 2021?

According to all-cause mortality statistics,¹² the number of Americans who died between January 2021 and August 2021 is 16% higher than 2018, the pre-COVID year with the highest all-cause mortality, and 18% higher than the average death rate between 2015 and 2019. Adjusted for population growth of about 0.6% annually, the mortality rate in 2021 is 16% above the average and 14% above the 2018 rate.

The obvious question is, why did more people die in 2021 (January through August) despite the rollout of COVID shots in December 2020? Did COVID-19 raise the death toll despite mass vaccination, or are people dying at increased rates because of the COVID jabs?

In a two-part series,¹³ Matthew Crawford of the Rounding the Earth Newsletter examined mortality statistics before and after the rollout of the COVID shots. In Part 1,¹⁴ he revealed the shots killed an estimated 1,018 people per million doses administered (note, this is doses, not the number of individuals vaccinated) during the first 30 days of the European vaccination campaign.

After adjusting for deaths categorized as COVID-19 deaths, he came up with an estimate of 200 to 500 deaths per million doses administered. With 4 billion doses having been administered around the world, that means 800,000 to 2 million so-called “COVID-19 deaths” may in fact be vaccine-induced deaths. As explained by Crawford:¹⁵

“This does not even include vaccine-induced deaths that have not been recorded as COVID cases, though I suspect that latter number is smaller since the only good way to hide the vaccine mortality signal is to smuggle deaths through the already-established COVID death toll.”

Corroborating Crawford’s calculations are data from Norway, where 23 deaths were reported following the COVID jab at a time when only 40,000 Norwegians had received the shot. That gives us a mortality rate of 575 deaths per million doses administered. What’s more, after conducting autopsies on 13 of those deaths, all 13 were determined to be linked to the COVID jab.¹⁶

Is the COVID Jab Responsible for Excess Deaths?

Crawford goes on to look at data from countries that have substantial vaccine uptake while simultaneously having very low rates of COVID-19. This way, you can get a better idea as to whether the COVID jabs might be responsible for the excess deaths, as opposed to the infection itself.

He identified 23 countries that fit these criteria, accounting for 1.88 billion individuals, roughly one-quarter of the global population. Before the COVID jabs rolled out, these nations reported a total of 103.2 COVID-related deaths per million residents. Five nations had more than 200 COVID deaths per million while seven had fewer than 10 deaths per million.

As of August 1, 2021, 25.35% of inhabitants in these 23 nations had received a COVID jab and 10.36% were considered fully vaccinated. In all, 673 million doses had been administered. Based on these data, Crawford estimates the excess death rate per million vaccine doses is 411, well within the window of the 200 to 500 range he calculated in Part 1.

Another interesting data dive was performed by Steve Kirsch, executive director of the COVID-19 Early Treatment Fund. In the video “Vaccine Secrets: COVID Crisis,”¹⁷ he argues that VAERS can be used to determine causality, and shows how the VAERS data indicate more than 300,000 Americans have likely been killed by the COVID shots.¹⁸ Anywhere from 2 million to 5 million have also been injured by them in some way.

What Do the VAERS Data Tell Us?

In a September 18, 2021, interview with The Covexit podcast, Jessica Rose, Ph.D., who holds degrees in applied mathematics, immunology, computational biology, molecular biology and biochemistry, also discussed what the VAERS data tell us about the safety of the COVID shots.

Rose covers issues such as the magnitude of the side effects compared to other vaccination programs, the problem of under-reporting, and how causality can be assessed using the Bradford Hill Criteria. You can find a PDF of the slide show that Rose presents here.¹⁹ Here’s a summary of some of the key points made in this interview:

• Between 2011 and 2020, the number of VAERS reports ranged between 25,408 and 49,412 for all vaccines. In 2021, with the rollout of the COVID shots, the number of VAERS reports shot up to 521,667, as of September 3, 2021, for the COVID shots alone. (Fast-forward to October 22, 2021, and the report tally for COVID-related adverse events has ballooned to 837,593.²⁰)
• Between 2011 and 2020, the total number of deaths reported to VAERS ranged between 120 and 183. In 2021, as of September 3, the reported death toll had shot up to 7,662. As of October 22, 2021, the death toll was 17,619.²¹
• Cardiovascular, neurological and immunological adverse events are all being reported at rates never even remotely seen before.
• The estimated under-reporting factor (URF) is 31. Using this URF, the death toll from COVID shots is calculated to be 205,809 as of August 27, 2021; Bell’s palsy 81,747; herpes zoster infection 149,017; paresthesia 305,660; breakthrough COVID 365,955; myalgia 528,457; life threatening events 230,113; permanent disabilities 212,691; birth defects 7,998.
• The Bradford Hill Criteria for causation are all satisfied. This includes but is not limited to strength of effect size, reproducibility, specificity, temporality, dose-response relationship, plausibility, coherence and reversibility.

CDC Claims COVID Jab Beats Natural Immunity

If you think the CDC’s claim that the COVID jab lowers all-cause mortality is a low point in its irrational vaccine push, prepare to let your expectations sink even lower, with even more egregious Orwellian doublespeak implementation. October 29, 2021, the CDC released yet another study, this one claiming the COVID jab actually offers five times better protection against COVID-19 than natural immunity. As reported by Alex Berenson in an October 30, 2021, Substack article:²²

“Yesterday the Centers for Disease Control, America’s not-at-all-politicized public health agency, released a new study purporting to show that vaccination protects against COVID infection better than natural immunity. Of course, a wave of stories about the benefits of mRNA vaccination followed.

To do this, the CDC used some magic statistical analysis to turn inside raw data that actually showed almost four times as many fully vaccinated people being hospitalized with Covid as those with natural immunity — and FIFTEEN TIMES as many over the summer. I kid you not.

Further, the study runs contrary to a much larger paper from Israeli researchers in August. As my 2-year-old likes to say, How dey do dat? Well, the Israeli study drew on a meaningful dataset in a meaningful way to reach meaningful conclusions.

It counted infections (and hospitalizations) in a large group of previously infected people against an equally large and balanced group of vaccinated people, then made moderate adjustments for clearly defined risk factors.

It found that vaccinated people were 13 times as likely to be infected — and 7 times as likely to be hospitalized — as unvaccinated people with natural immunity. In contrast — how do I put this politely? — the CDC study is meaningless gibberish that would never have been published if the agency did not face huge political pressure to get people vaccinated.”

Data Manipulation Is Apparently a CDC Specialty

Berenson goes on to dissect the study in question, starting with its design, which he calls “bizarre.” The CDC analysts looked at data from 200,000 Americans hospitalized with “COVID-like” illness between January and August 2021 in nine states. Two groups were then compared:

1. Those who had confirmed COVID at least 90 days before and received another COVID test at the time of their hospitalization
2. Those who had been fully vaccinated for at least 90 days, but not more than 180 days, before their admittance and received another COVID test at the time of their hospitalization

Berenson points out what I stressed earlier, which is that choosing certain time or date ranges will allow you to make the shots appear a whole lot better than they actually are. Here, by choosing a 90- to 180-day inclusion range, they’re looking at a best-case scenario, as we now know the shots quit working after a handful of months. So, they’re only looking at that short window during which the COVID shots are at maximum effectiveness.

The 90-day criterion also ends up excluding the vast majority of patients hospitalized with COVID-like illness, both vaccinated and unvaccinated. While Berenson doesn’t address the vaccinated, few if any could have been fully vaccinated for at least 90 days prior to March, so why include January and February? Just about everyone was by definition unvaccinated at that time.

As for those with natural immunity, only 1,020 of the 200,000 patients hospitalized between January and August had a previously documented COVID infection. As noted by Berenson:²³

“Given the fact that at least 20% of Americans, and probably more like 40%, had had COVID by the spring of 2021, this is a strikingly small percentage — and certainly doesn’t suggest long COVID is much of a threat.”

Of the 1,020 with natural immunity, only 89 tested positive for COVID, while 324 of the 6,328 vaccinated patients who met the study criteria tested positive. Of note here is two things:

Hospitalization Rate Among Vaccinated Is Soaring

Berenson continues:²⁴

“And the CDC didn’t have, or didn’t publish, figures on how many people were actually in the two groups … Instead it compared the PERCENTAGE OF POSITIVE TESTS in the two groups. But why would the percentage of positive tests matter, when we don’t know how many people were actually at risk? …

[A]mazingly, the statistical manipulation then got even worse. The natural immunity group had an 8.7% positive test rate. The fully vaccinated group had a 5.1% positive test rate. So the natural immunity group was about 1.7 times as likely to test positive. (1.7x 5.1 = about 8.7.)

With such a small number of people in the natural immunity group, that raw ‘rate ratio’ may well have failed to reach statistical significance. (We don’t know, because the CDC didn’t provide an unadjusted odds ratio with 95% boundaries — something I have never seen before in any paper.)

Instead, the CDC provided only a risk ratio that it had adjusted with a variety of factors, including ‘facility characteristics [and] sociodemographic characteristics.’

And finally, the CDC’s researchers got a number that they could publish — hospitalized people who had previously been infected were five times as likely to have a positive COVID test as people who were fully vaccinated. Never mind that there were actually four times as many people in the second group. Science!

By the way, buried at the bottom of report is some actual data. And it’s bad. The CDC divided the hospitalizations into pre- and post-Delta — January through June and June through August.

Interestingly, the number of hospitalized people with natural immunity actually fell sharply over the summer, as Delta took off. About 14 people per month were hospitalized in the winter and spring, compared to six per month from June through August. (Remember, this is a large sample, with hospitals in nine states.)

But the number of VACCINATED people being hospitalized soared — from about three a month during the spring to more than 100 a month during the Delta period. These vaccinated people still were less than 180 days from their second dose, so they should have been at or near maximum immunity — suggesting that Delta, and not the time effect, played an important role in the loss of protection the vaccine offered.”

Perhaps Rep. Thomas Massie said it best when he tweeted:²⁵

“What do ‘road kill’ and a CDC sponsored COVID paper have in common? By the third day, they’re so picked apart they’re unrecognizable. This CDC Director is shameless for fabricating junk science with findings that stand in stark contrast to every credible academic study.”

Massie goes on to point out some obvious flaws and questions raised by the study, including the following:

• The authors failed to verify recovery among those with previous infection, so any number of these “reinfections” may actually have been long-COVID.
• The fact that more than 6,000 hospitalized for COVID symptoms were vaccinated, compared to just 1,000 with previous infection, counters the claim that 99% of COVID hospitalizations are unvaccinated.
• The number of vaccinated people hospitalized for COVID symptoms correlate negatively with the time since vaccination; 3,625 were hospitalized within 90 to 119 days of vaccination, 2,101 within 120 to 149 days, and 902 within 150 to 179 days of vaccination. “Could initial hospitalizations be due to vaccine adverse effects or due to a temporarily weakened immune system from the vaccine?” Massey asks.²⁶
• The study only considered those with natural immunity who ended up in the hospital, and not the ones who didn’t get sick. “Natural immunity helps prevent hospitalization!” Massey says.²⁷

Massie also notes that this paper, which is only six pages long, has an astounding 50 authors, and at least half a dozen of them disclose Big Pharma conflicts of interest. What’s more, seeing how Congress gave the CDC a cool $1 billion to promote the COVID jab, isn’t working for the CDC a conflict of interest as well?

Martin Kulldorff, Ph.D., professor of medicine at Harvard Medical School and a biostatistician and epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, also critiqued the study in a tweet, saying:²⁸

“This CDC study has a major statistical flaw, and the 5x conclusion is wrong, it implicitly assumes that hospitalized respiratory patients are representative of the population, which they are not. Trying to connect with authors.”

Natural Immunity Is the Best Answer

Try as the CDC might to twist the data, there’s really no question that natural immunity is superior and longer lasting than vaccine-induced immunity. This is also a long-held medical fact that has been tossed aside as too inconvenient to matter in COVID-19.

For some undisclosed reason, the government wants everyone to get the COVID injection, whether medically warranted or not. The sheer lunacy of that is cause enough to be leery and hold off on getting the risky jab. I can tell you one thing, this policy has nothing to do with safeguarding public health, because it’s driving public health in the wrong direction.

It’s quite clear that the way out of this pandemic is through natural herd immunity, and at this point, we know there’s no reason to fear COVID-19. Overall, its lethality is on par with the common flu.^{29,30,31,32,33} Provided you’re not in a nursing home or have multiple comorbidities, your chances of surviving a bout of COVID-19 is 99.74%, on average.³⁴

Additionally, we also know there are several early treatment protocols that are very effective, such as the Frontline COVID-19 Critical Care Alliance I-MASK+³⁵ protocol, the Zelenko protocol,³⁶ and nebulized peroxide, detailed in Dr. David Brownstein’s case paper³⁷ and Dr. Thomas Levy’s free e-book, “Rapid Virus Recovery.” Whichever treatment protocol you use, make sure you begin treatment as soon as possible, ideally at first onset of symptoms.

The reported rate of death from COVID-19 shots in VAERS, on the other hand, exceeds the reported death rate of more than 70 vaccines combined over the past 30 years, and if you are injured by a COVID shot and live in the U.S., your only recourse is to apply for compensation from the Countermeasures Injury Compensation Act (CICP).³⁸

Compensation from CICP is very limited and hard to get. You only qualify if your injury requires hospitalization and results in significant disability and/or death, and even if you meet the eligibility criteria, it requires you to use up your private health insurance before it kicks in to pay the difference.

There’s no reimbursement for pain and suffering, only lost wages and unpaid medical bills. Salary compensation is of limited duration, and capped at $50,000 a year, and the CICP’s decision cannot be appealed.

For a taste of what life is like for those injured by these shots, review some of the cases reported to nomoresilence.world. You can also learn more about the potential mechanisms of harm in Stephanie Seneff’s paper,³⁹ “Worse Than The Disease: Reviewing Some Possible Unintended Consequences of mRNA Vaccines Against COVID-19,” published in the International Journal of Vaccine Theory, Practice and Research in collaboration with Dr. Greg Nigh.

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https://www.foxbusiness.com/technology/meta-facebook-worst-company-2021-survey

BMJ Slams ‘Incompetent’ Facebook Fact-Checking of Vaccine Article

BMJ Slams ‘Incompetent’ Facebook Fact-Check of Vaccine Article (medscape.com)

Editors at The BMJ have released an urgent request to Facebook’s Mark Zuckerberg and parent company Meta regarding a recent “fact-check” on the medical trade journal’s article about questionable Pfizer vaccine trial practices.

 

According to an open letter written by outgoing BMJ editor-in-chief Fiona Godlee and incoming editor-in-chief Kamran Abbasi, Facebook hired a third-party contractor to evaluate the article’s findings. This resulted in “inaccurate, incompetent, and irresponsible” conclusions that “should be of concern to anyone who values and relies on sources such as The BMJ for reliable medical information.”

The article in question investigated data integrity concerns at Pfizer vaccine clinical trial sites. In September 2020, the letter states, a former employee of the research group involved in Pfizer’s main vaccine trials, Ventavia, reached out to The BMJ and “began providing…dozens of internal company documents, photos, audio recordings and emails.” According to the company’s website, Ventavia “played a significant part in [COVID-19 clinical trial] recruitment” and “has received recognition by Pfizer for their contribution to vaccine trials.”

It was previously reported that the whistle-blower is a former regional director who was involved in Pfizer’s vaccine trials in Texas during the fall of 2020. She alleges “the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial.”

The images provided to The BMJ “showed needles discarded in a plastic biohazard bag instead of a sharps container box” and another displayed “vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.”

Despite informing Ventavia, the director’s concerns went unaddressed. She then filed a complaint with the US Food and Drug Administration (FDA) and was subsequently fired the same day. The FDA did not investigate the director’s allegations, say Godlee and Abbasi, even though the evidence “revealed a host of poor clinical trial research practices occurring at Ventavia that could impact data integrity and patient safety.”

Article Labeled as “Hoax,” Without Pointing Out Errors

The BMJ hired an investigative reporter to follow up on the clinical trial claims. The findings were published in an article on November 2, 2021, after the article “went through…the usual high level legal and editorial oversight and peer review,” according to the journal.

However, by November 10, the journal began receiving complaints from readers unable to share the article on social media. Others had their posts flagged with warnings, such as “missing context…independent fact-checkers say this information could mislead people.” Administrators of various Facebook groups were notified that posts containing the article were “partly false.”

Lead Stories states that they “can enter our fact checks into a tool provided by Facebook and Facebook then uses our data to help slow down the spread of false information on its platform.” Although the contractor is compensated, Lead Stories claims they have “no say or influence over what we fact check or what our conclusions are.”

Both editors question the validity of the fact check performed by Lead Stories, as it failed to provide any “assertions of fact” as to what The BMJ got wrong. Moreover, the editors take issue with Lead Stories referring to the journal as a “news blog” and using the phrase “hoax-alert” in the URL when publishing the story on its site.

The BMJ has reached out to Lead Stories and Facebook, says the letter, but Lead Stories refuses to “change anything about their article or actions that have led to Facebook flagging our article.” Requests for Facebook to remove the “fact checking” label and allow “readers to freely share the article on [Facebook’s] platform” have been unfruitful.

Godlee and Abbasi expressed concern that other “high quality information provider[s] have been affected by the incompetence of Meta’s fact checking regime.” Last month, Instagram censored Cochrane, an international provider of independent systematic medical reviews. Instagram, also owned by Meta, prohibited users from tagging Cochrane because the organization “repeatedly posted…false content about COVID-19 or vaccines.” Cochrane refuted the allegations.

While “fact checking has been a staple of good journalism for decades,” say the editors, Meta has “apparently delegated responsibility to people incompetent in carrying out this crucial task.” They urge the company to reconsider its fact-checking strategy and review the issues that contributed to the error.

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Swedish company showcases microchip that can download COVID-19 passport status

https://www.foxbusiness.com/technology/swedish-company-showcases-microchip-download-covid-19-passport-status

A microchip technology introduced in recent years by the Stockholm-based startup Epicenter is being presented as a means to store one’s COVID-19 vaccine passport under the skin, according to a video from the South China Post that went viral Friday.

The firm has showcased an implant capable of storing a COVID passport that can then be read by any device using the near-field communication (NFC) protocol, according to the video.

The video featured Hannes Sjöblad, founder of the Swedish Association of Biohackers, adviser and speaker on human augmentation, and ambassador for Sweden at the Singularity Universe.

ARE YOU READY FOR A CHIP IMPLANT?

Sjöblad demonstrated how Epicenter’s rice-sized microchip, which has been adapted as a COVID-19 passport, is implanted under the skin either in the arm on between the thumb and forefinger.

Three Square Market, a Wisconsin-based technology company, became the first company in the U.S. to offer its employees similar free microchip implants in August 2017. The chip gives employees access to locked rooms and the ability to pay for food and drinks in the break room.

The microchips were provided to Three Square Market (32M) at the time by Biohax, which was run by Jowan Österlund, a Swedish tattooist and body piercing specialist, according to The Guardian.

“Eventually, this technology will become standardized allowing you to use this as your passport, public transit, all purchasing opportunities, etc.,” said Todd Westby, the 32M CEO at the time.

The technology the company uses is called RFID (Radio-Frequency Identification), which uses electromagnetic fields to identify electronically stored information. The chips also use near-field communications (NFC), the same type of technology that is used in most contactless credit cards and mobile payments.

Westby said at the time that these microchips have already become very popular in many European countries and that the companies intended to be ahead of the curve in bringing it to the U.S. Now they could become COVID passports. 

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FDA denies approval of life-saving medicine for Tooele County girl

https://www.fox13now.com/news/local-news/fda-denies-approval-of-life-saving-medicine-for-tooele-county-girl

Filed under: General Problems | 6 Comments »

When I taught ethics at a university, I brought this topic up with my class, and was horrified to discover that virtually every student who worked in a pharmacy believed that they had an unlimited right to deny pain medications to anyone who “could be an addict.” When I asked how they knew, one answer was, “You can just tell,” and the other was, “It’s in the computer.” Well, how did they know that was accurate? It didn’t seem to matter. What mattered was the tiny bit of power they were wielding and the enormous bit of good they thought they were doing. They had no understanding whatsoever of the underlying medical or physiological issues. It was a sobering experience, and it repeated itself every semester for years.

It was impossible for one person to fight all of that dogmatism. I never knew how well I got through to them, or to how many. The sad thing is that many of the nursing students got the same message in their nursing classes. There’s just an extraordinary amount of indoctrination on the subject, much of it driven by the DEA, law enforcement generally, and the media.

Filed under: General Problems | 3 Comments »