Author Archive

FDA Waives Clinical Trials for Boosters Ensuring a Perpetual Pandemic. Policy of Shots First, Questions Later, Is Not Informed Consent

Yes, you read that right.  No trials.  I mean, why bother?  Science is now simply done by press release.

**UPDATE  July, 2022**

Now we learn that the WHO is helping the FDA through “Future Framework” skip further COVID shot clinical trials and that the Bill & Melinda Gates Foundation is the biggest voluntary contributor to the WHO, so Gates is likely directing the play.

Important points:

  • Moderna, Pfizer and Novavax are developing reformulated COVID-19 shots to target the original Omicron strain (BA.1) which has been replaced by newer variants.
  • They know that the FDA is not going to look at health outcomes so they are going to great lengths to jack up the antibody response.
  • Pfizer tested a double-strength dose (60 mcg of mRNA instead of 30 mcg) even though they had previously ruled out a higher dose because of safety concerns. So the antibody levels are through the roof.
  • VRBPAC admitted that there are no known correlates of protection (antibody levels do not tell you who will be immune) so antibody measures are medically meaningless.
  • Turbo charging the immune response may also turbo charge adverse events. But the “Future Framework” allows pharmaceutical companies to skip clinical trials altogether.
  • The FDA is not looking out for worst case scenarios.

https://childrenshealthdefense.org/defender/fda-future-framework-covid-vaccines

FDA Panel Votes to Waive Clinical Trials for New COVID Boosters

The U.S. Food and Drug Administration’s vaccine advisory panel voted 19 to 2 on Tuesday to add an Omicron component to COVID-19 boosters this fall, over objections by panel members and despite a lack of data.
fda future framework covid vaccines feature

The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel on Tuesday voted 19 to 2 to recommend new COVID-19 booster shots that include the Omicron variant this fall.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not issue guidance on whether additional data would be needed to recommend an updated composition of the primary-series vaccines authorized for emergency use in the U.S., or whether it would be appropriate to continue to use a primary-series vaccine as a booster.

It is the first time VRBPAC has suggested vaccine makers modify their vaccines to target a different variant, according to CNBC, which also reported the FDA will likely accept the committee’s recommendation.

If so, the FDA would be authorizing a vaccine change without requiring additional data showing a bivalent vaccine — containing both the original 2019 Wuhan variant and one of the Omicron variants — is safe and effective for those age groups that are already authorized to receive a booster dose.

(See link for article)

__________________

**Comment*

Even Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, and Dr. Hank Bernstein, professor of pediatrics at Zucker School of Medicine broke from the panel to vote against the initiative.

You know it’s bad when Offit finally puts his food down.  He’s as pro-vaccine as you can get.

Two other little flies in the ointment are that by the time a subsequent booster is approved, it will contain outdated strains, as well as the fact they admit there’s no established correlate of protection, and that while antibody data is important so are the T-cells, which they simply don’t understand yet and which are “difficult to study.”

But problems & unknowns be damned and full-steam ahead!

Dr. Nass brings up yet another sticky point: the fact they will likely keep the current version and add another — which might double the amount of mRNA.  Nobody seems to know.

Dr. Brian Hooker states this FDA action will:

“increase the harm to the U.S. public to unprecedented levels, as this action will further circumvent necessary clinical trials even beyond the slapdash testing of COVID-19 vaccines under Emergency Use Authorization.”

“This adds to a foundation of lies used to authorize the original COVID-19 vaccines without anywhere near proper testing.”

Dr. Dustin Bryce, with Interest of Justice, said the FDA, CDC WHO are:

“usurping Congress’ definition of a vaccine — which is any substance designed for the prevention of one or more disease.”

“FDA actually classifies mRNA as gene therapy, which they say is to treat or cure an existing disease by modifying your genes.” “Gene therapies are still being studied and are experimental at this time.”

Bryce went on to state that gene therapy, unlike a vaccine, is so inherently unsafe the FDA requires 15 years of research to follow up on safety due to known risks of antibody-dependent enhancement, alteration of DNA and delayed adverse effects, such as cancer.

Bryce states we require due process, forbid the FDA from authorizing the proposed changes and demand that EUA is promptly revoked due to unreasonable risks in gene therapy products as evidenced by the large numbers of adverse events reports.  He also states COVID-19 vaccines fail to meet the requirements of EUA because not a single mRNA vaccine has been found to be effective for the prevention or treatment of an existing disease.

Some other sticky points:

“A thousand peer-reviewed studies question the safety of COVID-19 vaccines. Doesn’t anyone see the safety signals? Is there anyone here who will stand up?” he asked. “Some of you know this, you need to stand up and you need to help us.”

Another important quote:

“We have shown correlations between vaccination and all-cause mortality. FDA says VAERS is under- and misreported. A FOIA disclosure reveals that CDC has not conducted safety signal analyses, which we have provided to FDA. Neurologic adverse events are finally being acknowledged [but there are] still no cancer studies.”

“A Stanford study in [the journal] Cell showed vaccine message and antigen persisting for at least eight weeks. Does spike accumulate? Is this why myocarditis rates after boosting match or best primary series rates for some ages?

“Does spike persistence contribute to immune suppression, imprinting and negative efficacy? What is the toxicity of multiple doses? How will sameness of the manufacturing process be defined? Are the guidelines talking about monovalents or bivalents?” ~ Dr. David Wiseman, research scientist with a background in pharmacy, pharmacology and experimental pathology

____________________

**Comment**

Well this way they won’t have to deny and/or ignore those who pick apart the science, because now there simply isn’t any to pick apart.

BTW: the mantra the ‘powers that be’ continue to regurgitate is that these injections keep you from a severe case of COVID.  Now, a another study decimates this notion.

____________________

https://popularrationalism.substack.com/p/a-perpetual-pandemic-is-on-the-way

A Perpetual Pandemic is On the Way Thanks to Planned New COVID-19 Vaccines and FDA’s Insanity

FDA will allow Moderna & Pfizer to update the variants targeted by their mRNA injections and require no new studies. What’s even more insane? Their “updates” will ensure a Perpetual Pandemic.

James Lyons-Weiler

 

Did you know that in their insane new framework, US FDA will allow them to change variants w/no new science?

Also – the new vaccines will include mRNA encoding the original, extinct Wuhan-1 spike protein – ensuring a forever pandemic.

(See link for article)

For more: 

https://standforhealthfreedom.com/federal/public-comment/

The FDA’s policy of shots first, questions later, does not allow for informed consent

On June 28, 2022, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to vote on COVID strain replacement in the shots. Stand for Health Freedom was selected to make oral public comment at the meeting. We took this opportunity to remind the federal government of American’s fundamental right to informed consent in medical decisions. This right does not disappear when a pandemic is declared. Listen and read below for full text of the comment made, with references.

Go here to listen to 3 Min. statement:  https://odysee.com/FDA_SHF_comment:56ddc5ccee578dd3558613d87fcff614a5405207?src=embed

Written prepared statement:

Thank you for this opportunity to comment. My name is Valerie Borek, I am Policy Analyst for Stand for Health Freedom, a national grassroots organization of over a half million Americans who are advocates for informed consent and no medical mandates.

Americans have a Constitutional right to informed consent. I urge you to uphold your mission to ensure safety and efficacy of COVID shots before voting on strain replacement without FDA-reviewed clinical trials.

Informed consent requires disclosure of risks, benefits, and alternatives, in terms a patient or guardian can understand – they must be able to ask questions and get answers from providers who have the information they need to answer those questions.

The FDA claims Americans aren’t entitled to informed consent for EUA products, but this is not true. Health professionals have a duty to their patients, including informed consent. EUA products are not fully approved by the FDA and are therefore experimental, requiring informed consent under US law.

In one of the first US Supreme Court Cases addressing COVID policy the Court affirmed that, quote, “We don’t cut the Constitution loose in a pandemic.” Chief Justice Roberts wrote, “As more medical and scientific evidence becomes available…courts should expect policies that more carefully account for constitutional rights.”[i] End quote.

Over the last two years the FDA has lowered their standards. Using antibody response instead of effectiveness when you do “not have the clinical data that we’d all love to have,” to quote Dr. Rubin in the April VRBPAC meeting[ii], is not legally, medically, or scientifically sound. Regarding waning immunity and boosters, Dr. Weir admitted, quote, “there’s just an awful lot we don’t know.” Dr. Meissner asked why SARS-CoV-2 mutates more than other viruses, and was told the spike protein in the shots is “driving the rate of evolution,” in other words, the shots made the mutations–yet the FDA has not investigated this. In CDC’s ACIP meeting on June 23, members asked about the difference between the Pfizer and Moderna formulations for our babies and toddlers, but no one could answer. This is not informed consent.

The FDA has not explored known potential risks, which is required for an EUA, and therefore cannot legally authorize any shots. The FDA is ignoring massive safety signals from VAERS, and reports of injury or death from shots, made in advisory committee meetings, in congressional hearings, and in the federal register. The shots were rushed at “Warp Speed,” with expedited FDA review, and clinical trials are ongoing through 2024. There is no long-term safety data for this novel mRNA technology.

The FDA has not addressed data fraud allegations made by Dr. Peter Doshi[iii], or Pfizer employee Brook Jackson[iv], nor has it answered US lawmaker concerns about authorization of shots for babies and toddlers. Studies were unblinded, confusing data, and eliminating controls. VRBPAC and ACIP members continually say they need more information about natural immunity and safety. How can the FDA tell parents or doctors that benefits outweigh the risks when you do not know the risks?

Even less is known about strain replacements for COVID shots. Americans need this missing data to make informed medical decisions. The more trustworthy your data, the more confidence Americans can have in your advice.

It is illegal for the FDA to authorize COVID shots without adequate safety or efficacy data. The FDA’s policy of shots first, questions later, does not allow for informed consent. On behalf of Stand for Health Freedom, I thank you for your time.

The advisory panel voted 19-2 to update the COVID boosters with the omicron strain genetic sequence. Check out the this Toby Rogers interview on CHD’s “Good Morning CHD” for a detailed recap of the meeting.

Take Action

Step One: Tell your governor to protect your family’s constitutional rights by standing up to federal overreach through public health agencies. The people can overrule the FDA and CDC!​

Take Action

Step Two: We can stop medical tyranny by voting people into office who will stand for health freedom! To have good candidates on the ballot in November, we must vote now in the primaries. Check out where your candidates stand using our Vote for Health Freedom Guide for your state! Go to our Vote for Health Freedom page, or Text the letters VHF to 52886, to learn about candidates in your area!

Go to Vote for Health Freedom

Step Three: If you appreciate the work we are doing here, please support us. We are 100% donor funded, by health freedom loving advocates like you.

Donate

References & Sources

[i] Roman Catholic 591 US ___2020, Dissenting opinion.

[ii] https://www.fda.gov/media/158030/download

[iii] https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-we-need-more-details-and-the-raw-data/

[iv] https://www.bmj.com/content/375/bmj.n2635

Category:

Activism, vaccines, Viruses

Relapsing Babesia Treated Successfully With Tafenoquine & A Real Reason For Antibiotic Resistance: Livestock Farming

The following case report is an update from an earlier version.  The reason I include it is found in the comment section.

https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciac473/6605069

Broad antimicrobial resistance in a case of relapsing babesiosis successfully treated with tafenoquine  

Ralph Rogers, Peter J. Krause, Ashlyn M. Norris, Michelle H. Ting, Ellen H. Nagami, Brian Cilley, Edouard Vannier
Clinical Infectious Diseases, ciac473, https://doi.org/10.1093/cid/ciac473
Published:  10 June 2022

Abstract

We describe a case of relapsing babesiosis in an immunocompromised patient. A point mutation in the Babesia microti 23S rRNA gene predicted resistance to azithromycin and clindamycin whereas an amino acid change in the parasite cytochrome b predicted resistance to atovaquone. Following initiation of tafenoquine, symptoms and parasitemia resolved.

___________________

**Comment**

A wonderful example of how mutations can affect treatment outcome and the importance that a singular drug can make in a person’s life. This person is truly lucky to have this information to help guide their treatment.  Most patients simply have to struggle forward, shooting in the dark to find answers.

The topic of mutations is rarely is discussed or researched and is clearly an area begging for more work to be done.  How many more patients out there have this problem?

We need treatments, not a supposed magic-cure all injection.

For more:

___________________

Another topic that is rarely discussed or researched is the very real problem with wide-spread use of antibiotics in healthy animals in live-stock farming.

https://www.theepochtimes.com/study-sounds-alarm-over-new-bacteria-increasingly-spreading-among-humans

Study Sounds Alarm Over New Bacteria Increasingly Spreading Among Humans

By Jack Phillips
June 30, 2022

A strain of antibiotic-resistant bacteria discovered in pigs is spreading to people and causing infections, according to a new study released this week.

A strain of livestock-associated methicillin-resistant Staphylococcus aureus (LA-MRSA) is suspected to have merged among European pigs and other livestock in the past several decades because of frequent antibiotic use in farming.

“Historically high levels of antibiotic use” may have led to the cause of this “highly antibiotic-resistant strain of MRSA on pig farms,” said Dr. Gemma Murrayn, who worked on the study released by the University of Cambridge, in a news release. 

“We found that the antibiotic resistance in this livestock-associated MRSA is extremely stable—it has persisted over several decades, and also as the bacteria has spread across different livestock species,” Murrayn added in the news release.

(See link for article)

Category:

Activism, Babesia, research, Treatment

A New Look At Chronic Lyme

https://experiencelife.lifetime.life/article/a-new-look-at-chronic-lyme/

A New Look at Chronic Lyme

Many physicians who treat tick-borne diseases now combine conventional medicine with gentler integrative strategies — and more long-term patients are getting well.
image compilation lyme disease
By Pamela Weintraub | Experience Life May 25, 2022
(See link for article)
SUMMARY:
  • Weintrub highlights Jennifer Crystal’s story which mimics many other patients
  • Unfortunately, the article regurgitates the notion that only up to 20% experience chronic symptoms when the number is more like 60%
  • Weintraub explains that historically LLMD’s used high doses of antibiotics/antimalarials in harsh regimens lasting months or years but due to grueling side effects have adopted a multi-pronged approach that combines the judicious use of drugs which includes natural therapies
  • The article also erroneously blames rising temperatures for tick expansion when independent research has shown this to be false
  • The reason infections are reported in every state but Hawaii and Oklahoma has to do with migrating birds, reptiles, and mammals – including humans.
  • Weintraub explains the difference between the “two types” of Lyme disease: the acute, straight-forward cases, and those who remain sick after standard treatment, who are typically diagnosed late, and who have more than one infection – which research confirms who are as impaired as those with congestive heart failure and sicker than type 2 diabetics, and who have a striking degree of neuro-inflammation
  • Unfortunately, this second group which suffers greatly with chronic infections is still gas-lit by physicians who would rather label them with chronic fatigue or fibromyalgia and give them “scattershot” treatment
  • The article then goes into the big problem with faulty Lyme testing which can not register antibodies for 6 weeks, miss a significant subset of people who will always remain seronegative, that can not register certain strains of borrelia, or pick up the organism which lies dormant within tissues.
  • Despite a CDC disclaimer, many doctors still rely on the faulty CDC surveillance case definition which requires a positive test or the EM rash, when many will never test positive and many never get a rash.
  • I was thankful for Dr. Maloney who states an early course of antibiotics does NOT eliminate the risk for chronic Lyme
  • The article then delves into the fact many patients are infected with way more than just Lyme
  • Researchers that previously doubted that Bartonella could be spread by ticks are changing their position as there is now strong circumstantial evidence
  • The article points out that research has identified “persister cells” which are antibiotic tolerate and generally unresponsive to drugs as well as biofilms which work to protect infectious organisms, also making it hard to eliminate them
  • Stanford researchers have exposed persister forms (in vitro) to more than 4,000 drugs to observe effectiveness which has resulted in the use of disulfiram/Antabuse, an old drug for use for alcoholism but is potent against Lyme disease (but can cause severe side-effects in some)
  • Dr. Zhang has tested lyme-containing biofilms (in vitro) using antibiotics and herbs and has found that Japanese knotweed, black walnut, sweet wormwood, and Ghanaian quinine are all effective against Lyme disease.
  • Dr. Horowitz has found that a 2-month course of dapsone combined with biofilm buster rifampin has helped almost half of his chronically ill patients return to health. One patient accidentally took quadruple the dose for 4 days which put her into full remission – another example of how dosage matters.  A few other patients used this approach with similar success leading Horowitz away from long-term antibiotics to hitting hard for several days 3-4 times a year
  • Dr. Kinderlehrer reports that a formerly straightforward infection has morphed into body-wide instability: extreme sensitivities to foods, mold, chemicals, activation of mast cells, and dangerous allergic reactions, which can trigger brain fog, mood problems, pain syndromes, and profound fatigue.
  • A suppressed immune system can reactivate other infections like EBV
  • Integrative doctor Erica Lehman’s experience has taught her to recognize the different between those with neurologic disease versus illness that hits the gut, endodrine system, joint tissues, etc.
  • Many of the doctors who specialize in chronic Lyme do so because they have gone through it themselves

I highly, highly recommend Weintraub’s 2008 book “Cure Unknown: Inside the Lyme Epidemic.”  Although it was written 14 years ago, it remains one of the most thorough, accurate accounts of the Lyme debacle and clearly demonstrates that little has changed.

She also wrote about Dr. Masters the Rebel for Lyme Patients Who Took on the CDC Single-handedly  and broke it down into four parts in Psychology Today and which I summarize in the link. This history must not be lost. 

We must remember the fraud and corruption behind & in the world of Lyme/MSIDS.

Category:

Activism, Lyme, research, Testing, Treatment

Fauci Gets COVID Yet Again After Taking Paxlovid, Proving the Drug that Cost Taxpayers $10.6 Billion is Worthless

https://childrenshealthdefense.org/defender/fauci-covid-rebound-pfizer-paxlovid-taxpayers

Fauci Gets COVID Again After Taking Pfizer’s Treatment — the Drug That Cost Taxpayers $10.5 Billion

Dr. Anthony Fauci said Tuesday he is experiencing a rebound of COVID-19 symptoms after taking Paxlovid, Pfizer’s COVID-19 antiviral pill. Taxpayers are on the hook for $10.5 billion worth of the experimental treatment, under a deal the White House cut with Pfizer.

Excerpts:
Fauci tested positive for COVID-19 on June 15, despite being quadruple-vaccinated, initially experiencing “mild symptoms,” according to the NIAID.
Summary:
  • Due to his age he was put on a five day treatment of the expensive and rushed to market drug Paxlovid, which experts admit has a track record of causing a rebound of COVID, yet the CDC illogically continues to recommend it. Despite all common sense, logic, and science, the CDC will never in 1,000 years promote HCQ or ivermectin, vitamin C & D, and other effective, safe, cheap medications/supplements, just like they will never promote extended antibiotics for Lyme/MSIDS
  • Despite testing negative (as if that means anything) for three days in a row, Fauci reverted back to positive on the fourth day after treatment
  • His rebound felt worse than the first time he had COVID
  • Please know that while Biden’s “Test to Treat” initiative which supposedly allows Americans who test positive for COVID at a pharmacy to obtain “free” antiviral pills on the spot, these “free” pills have cost the U.S. taxpayer $10.6 BILLION.  
  • Dr. David Gortler, pharmacologist, pharmacist, FDA and healthcare policy oversight fellow and FDA reform advocate at the Ethics and Public Policy Center, questions why the government continues to invest in Paxlovid given it’s lack of performance.  He then rips the Pfizer study to shreds:
    • While Pfizer claims the drug reduces hospitalization and death by nearly 90% in people with mild to moderate infections, nearly everyone who gets the existing COVID mutation will have mild or moderate disease. 
    • Pfizer limited its study to people who were unvaccinated and who faced the greatest risk from the virus
    • An updated more recent analysis from 1,153 patients (out of a possible 2,246) showed a non-significant 51% relative risk reduction.
    • Gortler wants to know why Biden gambled every tax dollar on ONE single drug from ONE single drugmaker, Pfizer, “…when they could have spent almost nothing and promoted the established safety and efficacy of hydroxychloroquine and ivermectin with an established, superior outcome.”

Please see this powerful FLCCC graphic comparing Paxlovid vs ivermectin.

Pfizer stands to make $54 billion in sales in 2022 from its vaccine and Paxlovid, The Defender reported in March.

Category:

Activism, Treatment, vaccines, Viruses

Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after COVID Shot

https://www.preprints.org/manuscript/202206.0308/v1

A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against Covid-19

Michael Mörz
Version 1 : Received: 21 June 2022 / Approved: 22 June 2022 / Online: 22 June 2022 (07:53:57 CEST)

How to cite: Mörz, M. A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against Covid-19. Preprints 2022, 2022060308 (doi: 10.20944/preprints202206.0308.v1). Mörz, M. A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against Covid-19. Preprints 2022, 2022060308 (doi: 10.20944/preprints202206.0308.v1).

Abstract

The current report represents a case of a 77-year-old man with Parkinson’s disease who died three weeks after receiving his third COVID-19 vaccination in January 2022. The patient was first vaccinated in May 2021 with the ChAdOx1 nCov- 19 vector vaccine, followed by two more doses with the BNT162b2 mRNA vaccine in July and December 2021. The family of the deceased requested an autopsy due to the ambivalent clinical features noted before death. The underlying illness (Parkinson’s disease) was confirmed by autopsy. However, no sign of a florid COVID-19 was discovered. Meanwhile, the immunohistochemical staining of the brain and heart revealed previously undiagnosed conditions. The brain, in distinctive, revealed multifocal necrotizing encephalitis with massive inflammatory lymphocyte infiltrates. In addition, the heart showed signs of serious myocarditis. Finally, immunohistochemical staining revealed that the SARS-CoV-2 spike protein was evident in the tissues investigated. Based on these immunohistochemical findings, it appears that the inflammatory changes in the patient’s brain tissues are most likely the result of immunological processes. Concurrently, the absence of SARS-CoV-2 nucleocapsid-protein was evidenced, indicating that the detected spike-protein is unrelated to a SARS-CoV-2 infection. If such an infection was the cause of the spike protein, the SARS-CoV-2 nucleocapsid protein would also be detectable. As a consequence, the confirmed presence of the spike protein had to be attributed to the previous vaccination with the BNT162b2 mRNA vaccine that the deceased patient had received.
___________________
**Comment**
Finally autopsies are being done, despite Fauci telling everyone NOT do autopsies.
This case report is important for  the following reasons:
  1. there is Lyme-associated Parkinsonism
  2. necrotizing encephalitis is also related to tick-borne infections, both viral and bacterial
  3. Inflammation is common with tick-borne illness
  4. Myocarditis is also associated with tick-borne illness
  5. Finding the spike protein in the tissues investigated puts to rest the fact it goes systemically into the body, and not only the injected arm.  This was admitted by a vaccine researcher over a year ago but is still denied/ignored by ‘the powers that be’
    1. It accumulates in ovaries, the liver, spleen, bone marrow, and adrenal glands
    2. It can bind to receptors that are on our platelets & the cells that line our blood vessels
    3. It can cause platelets to clump, leading to clotting, or bleeding which explains the many reports of heart issues after these injections
    4. It crosses the blood, brain barrier and can cause neurological damage
  6. Not having the nucleocapsid-protein ruled COVID infection out, leaving the only reason for the presence of the toxic protein to be due to the injection which led directly to this man’s death

Category:

Heart Issues, research, vaccines, Viruses