The Promise of a Targeted Drug For Lyme Disease

October 27, 2021

https://www.lymedisease.org/flightpath-targeted-lyme-drug/

TOUCHED BY LYME: The promise of a targeted drug for Lyme disease

An exciting announcement rippled through the Lyme community recently. Well-known Lyme researcher Dr. Kim Lewis of Northeastern University has identified an antibiotic that appears to selectively kill Lyme spirochetes while leaving gut microbes alone.

This is highly significant because there hasn’t been a drug developed specifically to treat Lyme disease in…well, forever.

Let’s walk through what we know about this promising discovery—and what we still need to find out.

Antibiotics from soil

Did you know that most antibiotics are produced in nature by bacteria and fungi in the soil?

Professor Lewis and his research team recently screened soil samples looking for compounds that could be used specifically against Borrelia burgdorferi, the pathogen that causes Lyme disease, but that would not kill a broad array of other important bacteria.

The team identified a substance called hygromycin-A, a naturally formed antibiotic that was originally discovered back in the 1950s but was never studied in humans or brought to market.

Back then, researchers looked for powerful broad-spectrum drugs that could target many kinds of microbes. The more diseases a drug could treat, the more revenue it could generate. This strategy was the hallmark of Big Pharma’s “one-size-fits-all” approach to drug development. Narrow-spectrum antibiotics such as hygromycin-A were dismissed because their profit potential was smaller.

But here’s the deal about broad-spectrum antibiotics and Lyme disease. While the drugs kill Borrelia, they also wipe out a lot of other stuff. This includes “good bacteria” in the body’s sensitive gut microbiome, as well as other important local microbiomes (skin, mouth, reproductive organs, lungs, etc). Reducing the bacterial diversity in these local areas or microbiomes is now known to increase the risk of developing chronic diseases, cause serious symptoms in patients, and contribute to the global antibiotic resistance problem.

Protecting friendly bacteria

The researchers first tested hygromycin-A in a lab dish and found it highly effective against Borrelia and then later against various Treponemes (found in adult and congenital syphilis as well as in periodontal disease). These are all types of spirochetal bacteria, a dangerous category of human pathogen.

They also tested the substance against various friendly bacteria typically found in the gut and demonstrated that it pretty much left them alone. These “symbiont” bacteria are responsible for regulating our metabolism, balancing immune system function and protecting against pathogen invasion. So, we should try to keep them!

Next, Lewis and his collaborators tried hygromycin-A on Lyme-infected mice. Once again, it cleared the Lyme infection in the treated mice, while leaving their gut bacteria intact. They then tested the drug for use in the environmental eradication of Lyme in field mice, with similar results.

Professor Lewis et al recently published these findings in the scientific journal Cell, sparking hope and excitement in the Lyme community. Is this the breakthrough for which we’ve been waiting for decades–a targeted treatment for Lyme disease?

Could be. But we’re not there yet.

What’s the next step?

A scientist who has identified a new antibiotic in soil can’t just hand a patient a cup of dirt and say, “Take this and be well.” A new drug must be developed and tested, first in animal models and then in people. And the regulatory approval process required to bring any human drug to market doesn’t happen overnight.

A small, private biotechnology company named Flightpath Biosciences, Inc., has obtained an exclusive license to develop hygromycin-A into an antibiotic they now call FP-100.

Building on the work of Professor Lewis, who is on Flightpath’s scientific advisory board, the company needs to complete formal animal studies. Thus far, FP-100 looks very promising. Early results in laboratory mice, field mice and rats indicate that the drug is orally bioavailable (can be made into a pill) and does not appear to have any major safety or toxicity concerns. (The latter can bring novel drug development programs to a screeching halt.)

At the completion of these required animal studies, Flightpath will submit an Investigational New Drug (IND) application for FP-100 to the Food and Drug Administration. After approval of the IND application, the company will be ready to initiate a phase I study with healthy volunteers.

What are Phase I, Phase II and Phase III studies?

Determining the true benefit of a drug in a clinical trial is a difficult and lengthy process. Once a drug has been developed, there are three additional phases to obtaining FDA approval of the drug:

  • The phase I study determines the safety of a drug candidate and its “maximum tolerated dose” that does not produce unacceptable side effects. Phase I studies offer little or no benefit to the volunteer subjects, who are typically healthy people who do not have Lyme disease. This phase takes approximately six to nine months to complete.
  • The phase II study involves a drug candidate whose dose and side effects have been established in Phase 1. This phase will determine the drug’s effectiveness. Does it help patients with Lyme disease get better? This phase will offer opportunities for Lyme patients to volunteer to participate if they meet study inclusion criteria. The timeline for this phase is roughly 18-24 months.
  • The phase III study compares the new drug candidate against a commonly used drug, like doxycycline. Some volunteer subjects are given the new drug and some the commonly used drug. This phase will also offer opportunities for eligible Lyme patients to volunteer to participate. The timeline for this phase is roughly 12-24 months including time required for statistical analysis and submission of materials for FDA review.

Flightpath CEO Matt Tindall tells me that, ideally, Phase II studies for FP-100 could begin in two to three years. And if all goes well, he predicts the drug could be approved by 2028.

That’s not the quick turnaround that Lyme patients might wish for. But in the world of drug development, and with no similar products in the pipeline, that’s moving at a pretty good clip.

All oars in the water

“At this point, we have a full-stack team of experienced life sciences drug developers and all our oars in the water,” says Tindall. However, Flightpath’s process of securing funding continues.

He points out that historically, investors were not interested in supporting the development of new Lyme therapeutics. Overall, he says, this was due to poor diagnostic tests and a standard of care which started and ended with cheap, generic, broad-spectrum drugs.

But he tells me that’s starting to change, with the advent of genomic sequencing and a deepening knowledge of long-haul syndromes, thanks to COVID-19.

“We are seeing more interest in novel ways to diagnose acute and chronic Lyme disease, more targeted approaches to treat acute Lyme, and now significant advances in our understanding of what happens to patients in the chronic phase of the disease,” he says.

Another project–the search for a chronic Lyme biomarker

Flightpath has another ongoing project of high interest to our community—the search for a biomarker for chronic Lyme disease. (Biomarkers are objective biological signals related to a particular condition.) Many folks with chronic Lyme have participated in this study, which the company hopes will result in one or more definitive diagnostic tests for chronic Lyme disease. [See: The quest for a chronic Lyme disease diagnostic kicks into high gear.]

If the company verifies the gut microbiome signature, originally shown by Lewis et al in patients with persistent Lyme symptoms, that will open more avenues to help people with chronic Lyme.

Tindall says the company is also committed to developing a first-of-a-kind live biotherapeutic product aimed at repairing the gut microbiome. This could potentially have a positive impact on the immune system in these patients. But, as with FP-100, there’s more work to be done.

FP-100 is exciting because it is the first novel treatment being developed specifically to treat Lyme disease. Flightpath’s initial goal is to determine whether the drug would prevent patients with acute Lyme disease from developing chronic Lyme. If a patient with chronic Lyme has active infection with Borrelia, the drug may prove useful to these patients as well.

But it’s important to remember that the development and timeline for FDA approval of a drug takes years. The process requires playing the long game, one step at a time. Stay tuned.

TOUCHED BY LYME is written by Dorothy Kupcha Leland, LymeDisease.org’s Vice-president and Director of Communications. She is co-author of When Your Child Has Lyme Disease: A Parent’s Survival Guide. Contact her at dleland@lymedisease.org.

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Category:

Lyme, Treatment

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COVID Surge in Waterford, Ireland Where 99.7% of Adults are Fully “Vaccinated.” Taiwan Death From COVID “Vaccination” Exceeds Death From COVID. Heart Attacks up 25% in Scotland Since COVID Jabs Introduced. Why is Nobody Listening?

October 26, 2021

https://citizenfreepress.com/column-3/covid-is-surging-in-waterford-ireland-where-99-7-percent-are-double-vaccinated/

Posted by Kane on October 17, 2021

(See link for article)

________________

**Comment**

Hopefully by now it’s abundantly clear that these dangerous, experimental, fast-tracked injections do not stop transmission or infections and those exposed to the wild virus are more likely to get severe cases which can result in hospitalizations or deaths.  None of this is new and we are warned about it ages ago, but few heeded the warning.

Waterford, where almost every single adult has been double jabbed now has one of the highest infection rates in the country.  Further, the number of “vaccinated” in the ICU is almost as high as the entire number of Covid patients in ICU a year ago.

Refusing to see or admit the truth, the chief clinical officer states it would be worse if it weren’t for the “vaccine.”

________________

https://medicaltrend.org/2021/10/10/taiwan-death-from-covid-19-vaccination-exceeds-death-from-covid-19/

Taiwan death from COVID-19 vaccination exceeds death from COVID-19

Important excerpts:

(Observer Network News) On October 7th, the death toll after vaccination in Taiwan reached 852, while the death toll after the COVID-19 was diagnosed was 844. The number of deaths after vaccination exceeded the number of confirmed deaths for the first time.

On October 6, the Kuomintang “legislator” Yeh,Yu-Lan bluntly stated in a Facebook post that the vaccine given to save lives has also nearly doubled the number of deaths due to the COVID-19, which is indeed very ironic and confusing.  (See link for article)

________________

https://vaccinedamage.news/2021-10-05-heart-attacks-up-25percent-scotland-covid-jabs.html

Heart attacks up 25% in Scotland since covid jabs were introduced, media plays dumb as to why

10/05/2021 / By

The so-called “experts” claim they are baffled by a sudden spike in heart attack cases in Scotland ever since Wuhan coronavirus (Covid-19) “vaccines” were released to the general public.

During the summer, Scotland saw a 25 percent rise in the number of “fully vaccinated” people who had to be rushed to Golden Jubilee National Hospital in Clydebank with partially blocked arteries, a common occurrence among those who get injected.

“Typically the centre, which is the largest of its kind in the UK and treats people from five health board areas, receives 240 patients a month suffering with this form of heart attack, but this rose to more than 300 over May, June and July of this year,” reported The Times of London.  (See link for article)

_________________

**Comment**

Scotland is seeing a surge in seriously ill patients requiring a hospital bed.  The article states most are fully “vaccinated.”

Mainstream media never mentions the jabs as a possible trigger or cause of all the cardiovascular events despite the fact they are causing verifiable blood clots and imposing inflammatory conditions on the cardiovascular system. The spike protein disrupts human cardiac pericytes function and contributes to micro-vascular disease through CD147-receptor-mediated signaling. A cardiologist warns about covid “vaccine” fraud and hyper-inflammatory immune responses caused by the shots. A pathologist warns spike proteins cause damage in multiple organs, including the heart, which is what we are now seeing in those injured by the shots.

Once you have heart damage the heart does not heal itself. The heart is damaged forever.

We’re ruining kids’ hearts for life with these shots. Dr. Cole

The latest news about the injuries and deaths being caused by Chinese Virus injections can be found at ChemicalViolence.com.

_______________

https://childrenshealthdefense.org/defender/safety-signals-covid-vaccines-full-transparency-cdc-fda

Safety Signals for COVID Vaccines Are Loud and Clear. Why Is Nobody Listening?

The public deserves a complete and transparent accounting of the Centers for Disease Control and Prevention’s safety monitoring, including the results of all interim reports and analyses, whether through a Freedom of Information Act request, Congressional order or some other means.
© [9/29/21] Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
Number of Deaths Since 1990.

Summary:

  • There is a disproportionately large number of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from COVID-19 vaccines compared with other vaccines.
  • There are 91x the number of deaths and 276x the number of coagulopathy events reported after COVID-19 vaccination than after flu vaccination.
  • Safety signals were found for 242 adverse events using the Centers for Disease Control and Prevention’s (CDC) methodology.
  • Full transparency of CDC and U.S. Food and Drug Administration (FDA) safety monitoring is urgently needed.

(See link for full article)

Important excerpt:

What this means in practice, however, is that if the CDC investigators do not understand how these novel vaccines — which use gene therapy technology and have had only limited use in humans — might cause a particular type of adverse event, the presumption is that there is no plausible connection.

For example, the CDC has declared after reviewing over 7,000 reports of deaths reported in the U.S. as of Sept. 7, they were not able to determine a plausible causal relationship for any of them, except for three due to thrombotic thrombocytopenic purpura (TTP) from the Janssen vaccine.

But the methods and criteria they use to make these determinations aren’t published anywhere, assuming they even exist. It would be easier to take their word for it if their decision-making process wasn’t hidden behind a veil of secrecy.

 

 

Category:

Activism, vaccines, Viruses

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How the Definition of ‘Fully Vaccinated’ Misleads People on COVID-19 ‘Vaccine’ Safety & Efficacy & New Study Proves the ‘Vaccinated’ Are Dragging Out the Pandemic

https://popularrationalism.substack.com/p/how-the-definition-of-fully-vaccinated

How The Definition of “Fully Vaccinated” Misleads People on COVID-19 Vaccine Safety & Efficacy: An Explanation For CNN’s Drew Griffin

Received one dose only? You’re Unvaccinated. Two doses? Wait another 14 days. If you survive, congratulations. You’re fully vaccinated.
Everywhere I turn I see claims of COVID-19 vaccine efficacy and safety from studies in the US that defy all logic and reason. The results are the opposite of those seen in the UK and Israel. Here, I go through claims made that have led to the belief that the COVID-19 vaccine is safe, and effective, and explore factors that have been carefully manipulated to produce that misperception.
  1. Moderna Vaccine’s 95% Efficacy
  2. “An Epidemic of the Unvaccinated”
  3. “Boosters are Effective”
  4. “Pfizer’s Vaccine >90% Effective (ahem, “Useful”) in Children Aged 5-12”
  5. “Zero deaths and serious adverse events from COVID-19 vaccines”

I recently watched a CNN segment in which Drew Griffin’s beliefs are absolutely contradicted by the facts that CDC defines “Fully Vaccinated” as people who have made it to the second week (14 days) after their second dose. The fact that anyone who experiences adverse events or dies, and anyone who is diagnosed with COVID-19 before 2 weeks have passed after their second dose are not counted as deaths in the “fully vaccinated”. That means that a person who is vaccinating might not be considered “Fully Vaccinated” until five weeks after their first dose.

It is shameful for Griffin to not know this fact, and the impact of this fact on calculations of breakthrough infections vs. re-infections vs. infections in the “unvaccinated”. Therefore, I outline in detail for Dr. Griffin the key information he needs to know.

  1. Moderna Vaccine’s 95% Efficacy. In January 2021, I published an article in Robert F. Kennedy’s online magazine, The Defender. The article, entitled “Discrepancies in Moderna’s FDA Report Demand Answers”, I offered the following analysis:

“In contrast to what Moderna reported to the U.S. Food and Drug Administration (FDA) in the early months of COVID-19, its mRNA vaccine is not an established technology. It is new. As a new, experimental vaccine, it deserves close and objective scrutiny.

Moderna reports 94.5% efficacy. The “efficacy” of vaccines is understood to be a measure of the effectiveness of the vaccine on an ideal population, and differs from “effectiveness,” which is how well a vaccine manages to induce evidence of immunity in the real population upon which it is being used.

Moderna reported to the FDA (Zhang, 2020) efficacy as the ratio of the rate of SARS-CoV-2 infection in the vaccinated (16 infected out of 28,068 vaccinated) to the rate of infection in the placebo group (275 infected out of 27,956 given placebo).

Close inspection of Moderna’s data made public ahead of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBAC) meeting that was scheduled for Dec. 17, 2020, however, reveals that among the vaccinated, an additional 81 participants and 118 among the placebo participants developed a COVID-19 diagnosis between the first and second shots. These participants were determined to be ineligible for the second dose and removed from the study.

By my calculations, these additional cases shift the vaccine efficacy from 94.5% to 75.4%.

If a chemotherapy agent is being tested against another cancer treatment, the deaths that occur between scheduled treatment rounds must be counted. It is misleading not to count these additional cases of COVID-19 in the Moderna vaccine trial — the 94.5% efficacy is not based in clinical reality even for an ideal population.”

“Efficacy” here, and in Moderna’s use, means the ability of the vaccine to prevent a certain condition in an ideal population. They excluded people with health conditions – for example, metabolic syndrome, diabetes, autoimmune disorders.

What does this mean for the rest of us? Well, given that they reported 95% efficacy, when it should have been 74.4%, means that the vaccine coverage needed for herd immunity was going to be way low.

Fauci’s initial 66-67% coverage needed for herd immunity was tied to Moderna’s 95% efficacy. Fauci never should have come in that low, for two reasons. First, Moderna’s 95% efficacy – the performance of the vaccine in an ideal population – was not, as I showed, 95%. Second, that efficacy could not have been expected to translate into effectiveness – the performance of the vaccine in a non-ideal population, the one with people with metabolic disorder, diabetes, and autoimmune conditions.

Even though later trials used the same tactic of excluding people who got COVID-19 before the second dose, the official estimate of vaccine effectiveness in fact took a nose-dive in the 60-70% range in studies on sample groups representative of the full adult population, and yet to this day public health servants still cite the vaccine as “effective as 95% as in the Moderna trial”.

The data from Barnstable, Massachusetts tell a different story. This was an MMWR report that showed that 74% of new cases in Barnstable County were in those who had been exposed to COVID-19 vaccines. The report actually used the term “exposed”, and they also showed that the RT-PCR cycle threshold distribution of the two groups, “exposed” and “unexposed” were not different. This was the report that led CDC Director Rochelle Walensky to warn that people who were vaccinated still needed to wear a mask and to socially distance.

Almost all of the new cases were Delta variants. Using the 74% of cases in the vaccinated number, it is possible to estimate vaccine efficacy against the Delta variant. Assuming an R0 of 2.6, the VE of all vaccines combined in use in Barnstable County for single-dose exposed persons was almost precisely zero. When estimated for persons exposed to two doses, the VE falls to -0.26, or =26%. People in Barnstable County who are “fully vaccinated” have a 26% increased risk of COVID-19 diagnosis.

See: Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021 Weekly / August 6, 2021 / 70(31);1059-1062

It is worth pointing out that because the clinical trials used PCR to determine the case status in the patients considered “vaccinated” and those considered “unvaccinated”, the actual efficacy estimates were likely invalid given they should have been calculated after a certain number of COVID-19 cases had occurred. With false positive rates of PCR ranging from 11% to over 90%, the actual disposition of patients in the vaccinated and unvaccinated arms of the trial is anyone’s guess.

  1. “An Epidemic of the Unvaccinated”

CDC’s Director, Rochelle Walensky, said yesterday that CDC’s definition of “fully vaccinated” might need to be updated due to boosters. This semantic gameplay would back the population into mandated boosters if the OSHA rule comes through. Remember that it was Walensky who overruled the FDA’s decision to not recommend boosters for all. So now, we are facing the confusing situation in which people w/vaccine cards are no longer “fully vaccinated”. As we have seen, the efficacy of the current vaccines against extinct variants might be reasonably high (whatever it is), but the efficacy against extant variants seems to be in question. So, with eternal boosters, perhaps no one will ever be considered “Fully Vaccinated” in the US under CDC’s ever-changing definition.

CDC: When You’ve Been Fully Vaccinated https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html

The accuracy of the claim that the new cases in the US are occurring primarily in the unvaccinated hinges entirely on the CDC’s definition of “Fully Vaccinated”. We know that people who have had two doses are not considered “Fully Vaccinated” until day 14 after their second dose. So, when new cases occur in the partially vaccinated, they do not count toward cases in the vaccinated. There is significant evidence that COVID-19 vaccination may impair the immune system for a short period of time following administration; in particular, the likelihood of a SARS-CoV-2 infection, or an infection by any other respiratory virus or bacterium may be more likely following vaccination. In animal trials on SARS and MERS viruses, close relatives of SARS-CoV-2, and in studies in humans of the RSV virus, this phenomenon was called “disease enhancement”. If disease enhancement is occurring after the first dose, or within two weeks following receipt of the second dose, the CDC’s semantics will bias the case count data and make it appear as if those exposed to vaccines have a lower risk of COVID-19 infection than those who are unvaccinated.

Proof of this type of statistical manipulation in action can be found in a report from the OKLAHOMA COVID-19 WEEKLY REPORT Weekly Epidemiology and Surveillance Report September 19-25, 2021, which, after reporting more new cases in the unvaccinated than in the vaccinated, dropped this fact into a footnote of at table:

“**Vaccine breakthrough cases is (sic) defined as an individual with a COVID-19 positive laboratory results (PCR/Antigen) and documentation of COVID-19 vaccination that meets the definition of fully vaccinated. (Individuals are considered fully vaccinated ≥2 weeks after receiving the last dose in the COVID-19 vaccine series.)”

Due to this sleight-of-statistical-hand, we will need to revisit all of the clinical studies and non-peer reviewed press releases on the safety and efficacy of COVID-19 vaccines as well as the CDC’s non-peer-reviewed MMWR reports and re-estimate vaccine efficacy, breakthrough cases, and vaccine safety.

“Boosters are Effective”

The claims that boosters are effective begs the question: effective at what?

  • Preventing transmission of SARS-CoV-2? No.
  • Reducing deaths due to COVID-19? No.
  • Reducing hospitalization of patients with positive PCR results (true positives + false positives combined)? Yes. However, remember that people are not considered “boosted” until fourteen days after the second dose. Unless COVID-19 cases in those waiting for fourteen days to be counted are included in the calculation of breakthrough cases, we cannot know the true efficacy of boosters.

Pfizer’s Vaccine >90% Effective (ahem, “Useful”) in Children Aged 5-12

News reports tell us that “kid-size doses of Pfizer’s Covid-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds”.

The Phase 2/3 trial had one=month safety follow-up, and yet the same new source touts “The shots could begin early next month — with the first children in line fully protected by Christmas — if regulators give the go-ahead.”

The Pfizer website describes the trial as “the first of a pivotal trial”. The doses were spaced 21 days apart – meaning that children were not considered “vaccinated” until five weeks after their initial exposure.

It is noteworthy that the incidence of COVID-19 in children is so low that the trial had to accrue patients from four countries. It is also noteworthy that the trial did not undergo peer review; in fact, the company published the results in a press release, which included caveats that the release includes “forward-looking statements”, meaning they put a positive spin on the contents of the press release to encourage investors.

Among those forward-looking statements?

“In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses.”

The press release does not specify if the vaccination produced neutralizing antibodies against the initial Wuhan SARS-CoV-2 virus, which is extinct, or the more recent variants, such as the Delta variant.

Their less-than forward-looking statements included:

  1. “There is a remote chance that the vaccine could cause a severe allergic reaction
    • A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
    • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
    • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
  2. Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
    • chest pain
    • shortness of breath
    • feelings of having a fast-beating, fluttering, or pounding heart
  3. Side effects that have been reported with the vaccine include:
    • severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
  4. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.”
    The FDA has determined that the “study” was not large enough to have detected myocarditis – and yet Pfizer has not updated their report to their investors on this fact.

    Pfizer would have use vaccinate 28 million children on one months’ safety data and a study that was not large enough to detect even a well-recognized serious adverse event.

  1. “Zero deaths and serious adverse events from COVID-19 vaccines.

The world knows about myocarditis following COVID-19 vaccination, and we have known about it for some time. In June 2021, Tom Shimabukuro gave a presentation to ACIP, the Advisory Committee on Immunization Practices. This was a key meeting at which ACIP would vote to recommend or not recommend that COVID-19 vaccine for teens.

Shimabukuro reviewed data from the Vaccine Safety Datalink – the VSD – a taxpayer-subsidized resource to which only a handful of people are allowed to have unrestricted access. In those data, he reported zero (0) serious adverse events and zero (0) deaths from the COVID-19 vaccines in the United States.

See: Shimabukuro, T. 2021. COVID-19 Vaccine safety updates Advisory Committee on Immunization Practices (ACIP) June 23, 2021

Shimabukuro’s presentation followed a review of myocarditis and pericarditis by a CDC employee, who, in the Q&A, reported that the signal of increased risk of myocarditis in males relative to females in older children (teens) and also in younger children.

In his presentation, Shimabukuro made a point on one slide to highlight myocarditis:

It will be important to know whether Shimabukuro used the CDC’s twisted definition of “Fully Vaccinated”. If he did, then all of the events following the receipt of the first dose and those following the second dose on days 0-13 did not count as occurring in the vaccinated, which would be absolutely misleading.

Two days later, FDA issued a warning on myocarditis and pericarditis risk in male teens following COVID-19 vaccination in spite of Shimabukuro’s presentation. The signal for myocarditis has been established reproducibly by independent analysts. This demonstrates at the very least that VSD – and Dr. Shimabukuro – do not provide “Pharmacovigilance”.

Throughout his presentation, Shimabukuro uses the euphemism “immunization”, showing a lack of knowledge on the fact that “exposure to vaccine” does not equal “immune”, especially in this setting with a rapidly evolving mRNA virus.

In his discussion of VAERS data, Shimabukuro reminds the attendees that “a report to VAERS does not necessarily mean that the vaccine has caused a health problem”, but he failed to also report that “This caveat does not mean that the vaccine has not caused a health problem”.

Data from Ontario, Canada show an increase in myocarditis over time – increases from baseline – as vaccination increased over time – a population-level dose-dependent response not expected unless causality was in play.

These data show a range of rates of myocarditis trending toward 20 per hundred thousand. Shimabukuro’s reported his rate estimates at 7 per million. I stand by my conclusion that we do not have anything close to vaccine safety monitoring in the United States.

See: mRNA COVID-19 Vaccination and Development of CMR-confirmed Myopericarditis, https://archive.md/pvggn

Shimabukuro’s analysis of myocarditis using VAERS used data up to June 11, 2021. The VAERS analysis separated results following dose 1 and dose 2; the results consistently showed increased risk with the second dose, again, indicative of causality and perhaps pathogenic priming.

Evidently, those reporting to VAERS did not get the memo that those suffering myocarditis following exposure to vaccination should not be considered vaccinated until five weeks after their initial dose.

Conclusions

In the NVICP, causality determination often requires adverse events or deaths following a vaccine to be observed within 8 weeks of the receipt of the vaccine (often using rates beyond 8 weeks as a baseline, which can be higher than the national baseline rates, making that practice also bogus). To delay designation of a vaccinated person as “vaccinated” until up to five weeks after the initial dose is a brazen statistical manipulation to bury perception of adverse events and deaths from COVID-19 vaccination. It is a shameful practice and must not only be stopped: its effects must be reversed.

The public deserves to see efficacy re-calculated, as well as all rates of break-through cases, rates of reinfection cases, and new case rates all reported assuming that the individuals who have been exposed to COVID-19 vaccines, even a single dose, are “vaccinated”. Otherwise, the effect of the vaccine itself is never actually studied, and the relative risk of COVID-19 diagnosis in the vaccine-exposed and the vaccine-unexposed will never be known.

Now that boosters are here, no one may ever be counted as “fully vaccinated”. This sick, twisted perversion of logic and reason does not jive with reality, and people are going to get hurt needlessly. With draconian policies putting people’s jobs on the line, their very livelihood, this is far, far more than risk of vaccine injury or death. The definition of groups being studied must be changed to “vaccine exposed” and “vaccine naive”.

If the negative efficacy estimate from the data from the Barnstable report holds, then new breakthrough cases combined with the expected surge in “cases” due to false positives in the millions who may opt to be tested instead of vaccinating will lead to a fifth surge in COVID-19 that dwarfs the peak of the pandemic. The US will have more new “cases” of COVID-19 than the rest of the world combined… that will be a sure sign that something is truly rotten in the United States of America.

_________________

https://blogs.mercola.com/sites/vitalvotes/archive/2021/10/23/new-study-proves-the-vaccinated-are-dragging-out-the-pandemic.aspx

New Study Proves the Vaccinated Are Dragging Out the Pandemic

October 23, 2021

A leaked Department of Defense slide show presentation that was quickly removed from the internet, but has been preserved in archives and on private websites shows that the shots are not meeting experts’ expectations.

Using hospitalization records from 5.6 million Medicare beneficiaries who were fully “vaccinated”, the researchers found that 148,000 fully “vaccinated” individuals age 65 and older came down with COVID anyway; 30,000 were hospitalized in an intensive care unit and 9,400 were admitted to an intensive care unit. The death rate was 2.2%.

In the slide show, authors point out that the vaccine effectiveness against infection and hospitalization “is lower than reported in smaller studies.” Specifically, using metrics showing that 80% of persons over age 65 as “vaccinated”, “73% of COVID-19 cases occurred in fully vaccinated individuals.”

Not only that, according to Slide 8:

“Breakthrough infection rates five to six months post vaccination are twice as high as three to four months post vaccination.” The waning immunity was observed in both the Pfizer-BioNTech and Moderna shots.

And — contrary to “official” reports in the media — Slide 12 says it was the “VACCINATED” driving the high infection numbers during the summer of 2021, as “61% of COVID-19 of COVID-19 hospitalizations occurred in fully ‘vaccinated’ individuals in the week of July 24 alone.

The study concluded that the jabs are more effective at preventing hospitalization than infection, and that  “prior COVID-19 infection has a major protective effect against breakthrough hospitalization.” The study was done by the Defense Department’s Project Salus.

SOURCES:

Wayback Archives September 21, 2021

Category:

Activism, vaccines, Viruses

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November Lyme Support Group Meeting: Nov. 20, 2021 – NEW LOCATION

November Lyme/MSIDS Support Meeting

NEW LOCATION!

When: November 20, 2021

Time: 2:30

Purpose: Support

Where: The Sparrow’s Nest at the Abbey: https://sparrowsnest-abbey.com/, 17304 Havenwood Road, Sparta, Wisconsin.  Questions about accommodations:  Call Lori or Tom Graber:  (661) 400-2318 or (661) 406-1721  (Map for directions is on the website).  Once you get off the interstate, and are on highway 16, you turn onto Havenwood and just keep driving (maybe 2 miles?) until Havenwood ends.  Park your car, enter the building, and turn left into the hallway.  Going down about half way, on the right is a room connected to the kitchen where we will meet.  There are circular tables and chairs and a restroom close by. 

What: Bring your questions, frustrations, and anything you want to share with the group. Can’t wait to catch up and see how you are all doing!

Category:

Meetings

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Lyme – The Human Torture Chamber

http://truthbetoldx81.blogspot.com/2017/06/human-torture-chamber.html

Human Torture Chamber

Isabella MacLeo

By Kelly Merriman

June 24, 2017 Published by a truth be told

“If you want to torture someone, give them Lyme disease.” — Dr. Sam Donta

Nobody ever imagines getting sick and never recovering, you can’t even begin to imagine never-ending torture until you’re living it, “You don’t get it until you get it” couldn’t be more true. The suffering a Lyme victims go through is barbaric and not just the disease itself, but the atrocious crimes that surrounds it. People are afraid to speak the truth because of the rejection they already face in this world living with such a controversial disease. It’s a worldwide pandemic, people need to know the truth. Everyone says don’t let your illness dictate your life, truth is, Lyme controls every aspect of your life, every waking second, there’s no way around it. 

Victims are told by the establishment and every doctor they see it’s all in their heads. It is, literally. They’re living with a permanent brain infection, encephalopathy, hydrocephalus, demyelination or lesions. Your brain becomes hijacked. Your mind becomes it’s own entity that you don’t even recognize anymore. Progressive cognitive dysfunction and memory loss as if every brain cell is being destroyed one by one. Thoughts disconnected from your speech. Auditory and visual hallucinations as if you’ve been drugged. It will drag you through the deepest darkest levels of hell you’ve never imagined existed. Rage and anxiety out of nowhere, like the incredible Hulk. You cry yourself to sleep, you cry alone staring hopelessly at your 4 walls day in, day out. Begging to be saved or begging just to be put out of the misery. Help me please. Make it stop. Sorrow, defeat, hopelessness. Are you dying or fighting to survive?

It’s as if your body has an internal circuit breaker malfunctioning each circuit one by one. Pain ripping through and ravaging through every organ system. Crushing every bone, mutilating every joint, suffocating every muscle until strangulation, head pressure as if your brain is imploding, sand paper scraping your brain, razor blades ripping through your intestines and stomach, trying to breathe as if something is squeezing your lungs, blood turned to acid, burning you from the inside out like a pressure cooker, railroad spikes into your skeletal system, lesions as if you were burned, pain that throws you to the ground. 

Central nervous system as if it were hooked up to a high voltage power line, like being tortured to death with a slow steady constant electrocution running through every vein, penetrating the brain to insanity. Electrifying, zapping, burning, tingling, stabbing, vibrating like an internal short circuited exposed live wire backfiring, your core is made of an electrical circuit while your outer surface feels dead. As you helplessly you feel seizures coming on or restless leg syndrome spreading throughout your entire body, sudden jerks and spasms. Stiffness or spasticity as if you just woke up from a coma. Passing out or falling as if you’ve become allergic to sitting upright or standing. Balance and coordination circuit has malfunctioned.

Body or limbs disconnected from the brain to paralysis or complete immobility. You’re trying to move through cement or turned to stone, can’t lift your head, your limbs bearing weights, no energy to blink or breathe, as if every cell and organ system is shutting down. A permanent vaccum installed to your cells, slowly sucking every ounce of life. Your hanging on by a threads, every day another thread breaks. Everyday a new weight is added to your bucket. Everything is resistance pulling you the other way. Blood pressure, sugar and heart rate circuit shortage.

Everything makes you sick. Sound, heat, humidity, lights, chemicals, physical and mental exertion, foods. Intense sweating, dehydration, tremors, twitching, vomiting, chills, fever as if you were going into septic shock. Insomnia to hypersomnia are now permanent. You feel drugged, hungover, toxic. A 365 day flu, every year. You cant eat, sleep, talk, think, shower, move, walk, without climbing Mount Everest. Millions bedridden, others wheelchair bound with nowhere to turn.

But wait….there’s no help anywhere? What do you do? Where do you go? How are you supposed to live like this? In a human torture chamber…..

“This is the Worst Historical Medical Holocaust of our Lifetime.” — Karen Bailey, RN (cared & coded the very first Aids baby in the Boston Nicu)

“Lyme disease is absolute torture physically, mentally & emotionally where you scream & scream for help but nobody hears. It is a hell on earth. We live on a different earth, one where no one cares, no one hears, no one helps. It’s like being a toddler in an adult body, you can’t take care of yourself with a broken brain & broken body but there are only doors slammed in your faceat every turn.”— Marcie Evanosky Nichols

“It’s like being undead. You’re too sick to ever participate in life. All things that make life worth living have been stolen from you, leaving you a ghost of your former self, forever doomed to haunt the world, but you can never participate in it. And if you dare try, you are given a payback of such severe pain and a flare up of symptoms that make it never, ever worth trying. Everything you used to enjoy makes you severely physically ill. Everyday is a never ending struggle just to survive the most basic of needs. And sometimes, you can’t even do that. You are stuck in a world you are not well enough to live in. And no one will help you. There is no help coming. There is no future. There is only now, and never ending pain, and disappointment, and a loneliness only the undead can feel. This is the reality of severely advanced Lyme Disease.”  — Julie Carrigon

“Lyme steals Everything. You become a complete and total stranger to your entire family and even to yourself. The physical manifestation is literally the king of all nightmares. You feel so ill, deathly ill, but no one can see it. It’s dark, lonely and evil on every level. Every Dr you see tells you there’s nothing wrong with you and it’s all in your head. Insidious symptoms from skin crawling fire ants burning your brain to bone crushing pain and the feeling that your flesh is being ripped from your bones. While the nervous system is so badly affected you feel electrical shocks through out your body.” -Rachel Brendel

“Chronic Lyme is like every nerve in your body is on fire while someone is pouring acid on your brain. At the same time something is twisting your muscles, then hitting your bones with a hammer.”— Tera Banks

“It’s being too tired to even cry. Starving yourself because you can’t stand up to even make a PB&J. Hurting so bad you can’t force yourself to move your eyes. Being accused of being a drug addict, or that somehow you are bringing your suffering on yourself. Lying to medical professionals about being in pain because you don’t want to lose your credibility as a sick person. I firmly believe a Mother’s love is the most powerful thing this Earth can provide. Having Lyme disease challenges that in a deadly serious way. When you become so despondent that you truly don’t give a shit whether you live or die. Death can seem like the only comfort left in your life, an end point is all you can think about. You just want it to stop”— Jena Blair

“There is not an ounce of cellular energy left after forcing food and chugging fluids like my life depends on it. For what seems like an eternity, I have been stuck, floating, in a bathtub of darkness and urgency, while my children tell me about their lives through the door.”— Heather Scott Hetler

“I’m truly just barely hanging on buy a thread. To have to live in this pain ever second of every minute of every day, week, month, year of 12 years and counting, and for my pride, my vanity, for not letting people, my friends see me like this, then we have my four walls? It’s all I can do to watch everything that I was, everything I love, and now my love of my life leave me. I can count on one thing, more of the same Pain? Buy the Ticket, Take the Ride, I don’t think this is what Hunter S. Thompson meant when he wrote that. I don’t think I can bare to hear another doctor tell me agian, and I Quote, “We can tell you what it isn’t, but we can’t tell you what it is.” And they’re getting paid for this ground breaking news, and oh by the way, send me home in the same shape as I walked in.”-– Nick C. Baker

Meanwhile, the CDC and establishment libels, mocks, slanders, ridicules us over power, greed and profit since commercializing Lyme disease in 1994 by changing the testing to a high antibody concentration and removing the most prominent antigens to deliberately miss all low antibody neurological immunosuppressed victims from testing positive. They have to preserve their biggest medical scandal in history knowing millions are disabled by the very same thing they injected their test subjects with, OspA, the Lymerix vaccine. OspA is a TLR2/1 agonist, a highly toxic post-sepsis causing fungal antigen injected via vaccine or shed off a Borrelia spirochete via tick bite. The vaccine trials are how the CDC knows it’s a disease of post-sepsis leading to neurological immunosuppression, a B-cell AIDS. OspA / Lyme via vaccine or tick bite are the same disease. Their fraudulent test was designed to miss all of these cases, the low to no antibody concentration victims otherwise, it would reveal their vaccine injuries. The same CDC criminals who falsified the case definition and testing own patents on the vaccine and fraudulent test kits.

Exposure to a TLR 2/1, causes immune paralysis and tolerance, the immune cells can no longer recognize or fight other pathogens. Latent viruses and opportunistic viral, bacterial, fungal, and parasitic infections take over creating the perfect stealth infection of permanent immunosuppression, mutated B-cells, encephalopathy, and “The Great Neuro-Degenerative Imitator”: ALS, MS, parkinson’s, lupus, dementia, huntington’s, alzheimer’s, fibromyalgia, chronic fatigue syndrome, cancer, autism, schizophrenia, stroke, etc. What the CDC calls post-Lyme syndrome is really post-sepsis syndrome and is why antibiotics can’t cure Lyme, it’s the immunosuppression and secondary infections doing all the damage.

25 years later, the CDC is still saying there’s no such thing as chronic Lyme disease, while publishing evidence of their crime and the real disease mechanism and outcomes in their own scientific research and patent documents. This past week, the CDC hit an all new low by counter-attacking and slandering chronic Lyme disease victims after Lymerix whistle-blower and TruthCures lobbied in Washington D.C overturning all evidence of the Lyme Cryme to Senators, demanding the USDOJ investigate and prosecute the CDC for their crimes.

http://www.health.com/lyme-disease/chronic-lyme-disease-treatment-is-risky-says-cdc

http://scienceblogs.com/insolence/2017/06/21/deaths-and-complications-due-to-treating-the-fake-disease-known-as-chronic-lyme-disease/

http://www.mvtimes.com/2017/06/21/cdc-study-slams-lyme-disease-treatment-long-term-antibiotics/

And, then we have ILADS, Lyme literate MD’s who only treat you if you’re rich, banking off of desperate half-dead sick people by selling books, their own protocol or supplement lines and those who can actually afford $2000 for an office visit and out of pocket treatments by going bankrupt and losing everything trying to get treatment, that fails in majority anyway by not treating the real disease mechanism by treating immunosuppression, b-cell mutation and re-activated viruses with antibiotics. And, many end up with pharmaceutical injuries, especially the deadly fluoroquinolone antibiotics, just speeding up the disability process if not outright killing you. Where else is anyone supposed to go? There’s no help anywhere for a disease deliberately made not to exist. Then there’s the majority who are too poor to see an LLMD trying to self treat or symptom management with everything under the sun at home, wondering if they’ll ever wake up again. Everyone making money off the severely sick and disabled, while they can’t even afford a roof over their heads or food in their bellies, and spending years fighting for social security disability.

To be so physically ill and disabled, with no help anywhere, to be told you need a psychiatrist, it’s all in your head, stop faking or attention seeking and to be told by the establishment Lyme doesn’t exist. Why would anyone go on years to decades faking a disease that was deliberately commercialized not to exist just to be libeled, slandered, shunned, lose everything and have your entire life ripped out from under you? If you were really going to fake a disease, it would be one that’s validated, not denied. Lyme is very real, the suffering is too real for any human to bare, its barbaric torture, not only the disease itself but the daily abuse by the establishment who have committed the most atrocious crimes to humanity as they leave them to suffer and die with a psychiatric or munchausen diagnosis.

The suicide rate is high among Lyme victims, we just had 2 Lyme suicides. Can you blame them?

Please click here to see how you can help. We are screaming for help as Lyme disease remains the worst medical scandal in history of medicine and, a silent pandemic.

TruthCures

https://www.truthcures.org

Lyme Cryme whistle-blower and activists group on Facebook

https://www.facebook.com/groups/OccupyUSDOJ/

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For more:

The link to mental health shows how crucial appropriate treatment is.  It also shows how important support is.  If you suspect you are infected with Lyme/MSIDS, find a local support group to attend either in person or online.  For a starting point, go to the right side of the website and scroll down until you find the tab called “Lyme Resources.”  Under that is a tab “Find a Lyme Support Group.”  There are also Facebook and other online groups if you can’t attend in person. 

Patients need to be believed and validated.  This goes a long way toward recovery.  On top of this, they learn from others in the support group, which helps their own case.  They can get ideas to implement and just talk to someone who has “been there.” 

While you may feel depressed, hopeless, and in so much pain you want to end it all, DON’T!  Feelings are fickle.  Better days are coming, so chin up and press on.  This rotten, complex illness often takes a long, long time to get on top of and there might even be relapses, but you can wade through it all with the help of experienced practitioners, supportive people, and a mindful “line in the sand” you will not cross no matter how poorly you feel. 

Category:

Activism, Lyme

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