Archive for the ‘Lyme’ Category

Lyme Cabalist Develops Test for Pfizer Lyme Vaccine Trials: Yet More Proof of a Conspiracy

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/31520021

To: The FDA… What shenanigans are taking place here?

Carl Tuttle

Hudson, NH, United States

APR 23, 2023 — 

Please see the following inquiry/complaint sent to the FDA.

Dr. Gary Wormser has developed diagnostics for Pfizer’s Lyme vaccine trial?

What shenanigans are taking place here? This is a huge red flag! Controlling the Lyme disease narrative for the past 30yrs and now the outcome of a vaccine trial?

I believe the FDA will refuse to respond to my complaint so PLEASE demand an answer to this citizens complaint by sending an email to  the Center for Biologics Evaluation and Research at ocod@fda.hhs.gov referencing my letter below. Everyone has permission to cut and paste my correspondence.

Complaint sent to the Center for Biologics Evaluation and Research at the FDA:

———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: ocod@fda.hhs.gov
Cc: Brennan, Patti (NIH/NLM) [E], Schor, Nina (NIH/OD) [E], Gregurick, Susan (NIH/OD) [E], michael.lauer@nih.gov, lyric.jorgenson@nih.gov
Date: 04/18/2023 11:34 AM
Subject: Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)
https://clinicaltrials.gov/ct2/show/NCT05477524

Apr 18, 2023

Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Re: ClinicalTrials.gov Identifier: NCT05477524

To whom it may concern,

For the past thirty years there has been a handful of academics controlling the Lyme disease narrative who have a vested interest in bringing an “OspA-Based” Lyme disease vaccine to market. Most of these individuals hold patents on technology that would pay out handsomely in royalties.  It would be a flagrant conflict of interest if these individuals reside on Pfizer’s Endpoint Adjudication Committee deciding who has or does not have Lyme disease.

There is another concern here as discovered through the Open Payments Search Tool.

“The Open Payments Search Tool is used to search payments made by drug and medical device companies to physicians, physician assistants, advanced practice nurses and teaching hospitals.”

Dr. Gary Wormser received $156,000 in 2021 and in one of his recent publications he claims to have developed “Lyme diagnostics for a Lyme vaccine trial” for Pfizer:

Lack of Convincing Evidence that Borrelia burgdorferi Infection Causes Either Alzheimer’s Disease or Lewy Body Dementia
https://doi.org/10.1093/cid/ciab993
Gary P Wormser, Adriana Marques, Charles S Pavia, Ira Schwartz, Henry M Feder, Jr, Andrew R Pachner

COI Statement….

Disclosures: Dr. Wormser reports receiving research grants from the Institute for Systems Biology for exploring biomarkers for outcome of Lyme disease, Pfizer, Inc for developing Lyme diagnostics for a Lyme vaccine trial, NIH/Tufts for Xenodiagnosis to assess persistence of Borrelia, and CSU/NIH. He has been an expert witness in malpractice cases involving Lyme disease and was an expert witness regarding babesiosis; employed by New York Medical College; and is an unpaid board member of the non-profit American Lyme Disease Foundation. He reports no money paid to anyone for U.S. Patent No. 10,669,567 B2 ( HIGH SENSITIVITY METHOD FOR EARLY LYME DISEASE DETECTION Issue Date: June 2, 2020 Inventors: John T. Belisle, Claudia R. Mollins, Gary P. Wormser).

Dr. Marques has a patent US 8,926,989 B2 and 9310367 for compositions and methods for screening for Lyme disease; and is an unpaid Scientific Advisor to the Global Lyme Alliance and to the American Lyme Disease Foundation. Dr. Schwartz has been on the External Advisory Committee for Oklahoma InBRE. Other None

End of COI statement

______________________________

The CDC requires “new tests” to be cleared by the FDA. Is Wormser’s Lyme diagnostics for this clinical trial FDA approved? What behind the scenes shenanigans are going on here?

From the CDC website:

CDC supports the development of new tests
https://www.cdc.gov/lyme/diagnosistesting/index.html

“New tests may be developed as alternatives to one or both steps of the two-step process. Before CDC will recommend new tests, they must be cleared by the Food and Drug Administration (FDA).”

Additional concerns:

There were neurological complications with the previous “OspA-Based” Lyme vaccine (LYMErix) as published in the International Journal of Risk & Safety in Medicine. Reports of cerebral ischemia, transient Ischemic attacks, demyelinating events, optic neuritis, transverse myelitis, and non-specific demyelinating conditions are evaluated in this paper. To my knowledge, there were no studies to determine why LYMErix caused these serious complications.

Neurological complications of vaccination with outer surface protein A (OspA).
Marks DH.
http://www.ncbi.nlm.nih.gov/pubmed/21673416

REPORT ON LYMErix prepared for the 2001 Advisary Committee Meeting:(personal Dropbox storage area)
https://www.dropbox.com/s/sodqs3pdeeesktf/Sheller%20Lymerix.pdf?dl=0

Excerpt

“The people who have contacted us were, prior to vaccination with LYMErix, healthy, active and energetic. Indeed, the very reason they sought the LYMErix vaccine was their desire to preserve their healthy, active lifestyle. However, what they experienced was a dramatic degradation of their health and quality of life. As will be described below, these previously healthy individuals are now afflicted with painful, at times debilitating arthritic symptoms, including joint pain and swelling, as well as extremely severe Lyme-disease-like symptoms which have persisted to this day.”

Below is the link to the Final Judgement and Approval of the class action against SmithKline Beecham as a settlement was awarded to these individuals.

JUDGEMENT, FINAL ORDER AND DECREE GRANTING FINAL APPROVAL OF THE CLASS ACTION SETTLEMENT: (personal Dropbox storage area)
https://www.dropbox.com/s/v3gyw4fv8nst9bz/2003_Vaccine_Judgement_Final_Sttle_Apprvl..pdf?dl=0

Summary of this inquiry:

  1. Who are the individuals residing on the Endpoint Adjudication Committee in North America?
  2. Is Wormser’s “Lyme diagnostics for a Lyme vaccine trial” FDA approved?
  3. Through informed consent have the study participants been advised of Neurological Complications from the previous “OspA-Based” Lyme vaccine and are they made aware of the class action settlement?

Let us not forget that Pfizer paid the largest fine for health care fraud in 2009:

Justice Department Announces Largest Health Care Fraud Settlement in Its History Pfizer to Pay $2.3 Billion for Fraudulent Marketing  https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history

Please provide a prompt reply to this inquiry/complaint and answer all three questions.

Respectfully submitted,

Carl Tuttle
Hudson, NH

Cc: Patricia Flatley Brennan, RN, PhD Director National Library of Medicine

Nina F. Schor, MD, PhD, NIH Deputy Director for Intramural Research
Susan K. Gregurick, PhD, NIH Associate Director for Data Science
Michael Lauer, MD, NIH Deputy Director for Extramural Research
Lyric Jorgenson, PhD, Acting NIH Associate Director for Science Policy

________________

**Comment**

It’s all right here in purple crayon, and is yet more proof the government uses people, social media, mainstream media, and “vaccine” manufacturing companies as subsidiaries for their own nefarious purposes.

For more on Wormser:

  • Immunetics, Inc. (the developer of the insensitive C6 Lyme test, which he promotes).
  • Abbott, Institute for Systems Biology
  • Rarecyte, Inc.
  • Quidel Corporation
  • Insurance companies, by serving as an expert witness in court cases against doctors for treating outside IDSA guidelines
  • NIH: by receiving large shares of grants for Lyme-related research and by being influential in the selection of grant recipients.
  • IDSA – by being chairman of the Lyme guidelines revision panel which is opposed toand biased against chronic/persistent Lyme
Wormser serves the commercial interests of profit-making companies, and trivializes the effects of Lyme on patients as proven by his appearance in Under Our Skin, a documentary on the ravages of chronic Lyme disease

Cast Reports: Orbital Myositis Due to Lyme Disease

https://danielcameronmd.com/case-reports-orbital-myositis-due-to-lyme-disease/

CASE REPORTS: ORBITAL MYOSITIS DUE TO LYME DISEASE

myositis-lyme-disease

In their article “Two Cases of Orbital Myositis as a Rare Feature of Lyme Borreliosis,” Sauer et al. describe two female patients with focal orbital myositis due to Lyme disease. [1]

Orbital myositis is typically caused by systemic disease, such as Grave’s disease, or haematological disorders like lymphomas, the authors explain. In these cases, myositis is often bilateral. It has been reported, as well, as a rare manifestation of Lyme disease.

In these two cases, myositis was confirmed by MRI findings.

Patient #1: 68-year-old female

“The 68-year-old patient had acute and recurrent episodes (lasting from 2 to 4 weeks, 2 to 4 times each year) of right orbital swelling and pain,” the authors wrote.

Each episode resolved spontaneously or with steroids and nonsteroidal anti-inflammatory drugs.

Lyme disease was suspected since the patient was living in a rural area of France, highly endemic for Lyme disease, and she recalled having numerous tick bites and had a history of an erythema migrans rash and arthralgia.

Testing for Lyme disease was positive and the woman began treatment with doxycycline. Within 3 weeks, her symptoms had resolved.

“We reported the cases of two patients who presented with orbital myositis caused by Borrelia infection.”

Patient #2: 13-year-old female

The 13-year-old adolescent complained about unilateral orbital swelling complicated with exophthalmia and horizontal diplopia.

“MRI showed a hyperintense signal of right inferior and medial rectus muscles,” the authors wrote.

The woman was living in an area endemic for Lyme disease and had a recent tick bite followed by an Erythema migrans rash.

Lyme disease testing was positive and she was treated successfully with 4 weeks of doxycycline.

The authors reported, “a resolution of ocular symptoms and a decrease of the MRI signal intensity were observed within 1 month.”

The authors conclude:

  • “Orbital myositis is an unusual manifestation of Lyme disease, although it is likely that the condition is underdiagnosed.”
  • Unexplained muscle swelling occurring in a patient who has had a rash or a recent history of a tick bite in an endemic area for Lyme disease should prompt consideration of this diagnosis.”
References:
  1. Sauer A, Speeg-Schatz C, Hansmann Y. Two cases of orbital myositis as a rare feature of lyme borreliosis. Case Rep Infect Dis. 2011;2011:372470. doi: 10.1155/2011/372470. Epub 2011 Jul 28. PMID: 22567470; PMCID: PMC3336248.

________________

**Comment**

Where to even begin……

  1. Rarely reported is a far different matter than rarely occurs.  Everything about Lyme/MSIDS is downplayed. This most probably happens a lot.
  2. I hesitate to ponder what would have occurred if they hadn’t each tested positive, which is akin to winning the lottery with tests that miss 70% and in this case, 86% of cases.  Current 2-tiered CDC testing also completely omits testing for any coinfections which are quite common.
  3. The second patient had a tick-bite followed by the bullseye rash.  This proves she is infected with Lyme.  No testing required since the rash is diagnostic for Lyme – yet ‘the powers that be’ continue to take the deadly “wait and see” approach and continue to utilize faulty, inadequate testing for diagnosis and treatment.  It seems nothing ever changes.
  4. They continue to treat infected patients with the inadequate and limited mono-therapy of doxycycline, despite research and reality proving this doesn’t work.
  5. Like all other studies, these patients need lengthy follow-up.  IF that occurred, I guarantee that research would prove the current therapy simply doesn’t work.

For more on eye issues with Lyme/MSIDS:

May: Lyme Disease Awareness Resources

May: Lyme Disease Awareness Month Coming Up

Need some resources on Lyme and other tickborne illnesses to share with neighbors and friends?

Go here for downloadable posters and brochures to educate others on this very real 21st century plague.

The posters include everything from tick prevention to symptoms experienced, to a handy chart listing details about coinfections, to a sheet on Lyme facts that defy the commonly touted narrative regurgitated by most doctors.  Very helpful stuff.

For more on tick prevention:   https://madisonarealymesupportgroup.com/2019/04/12/tick-prevention-2019/  Includes a multi-pronged approach covering you, your pets, and your yard.

For more on what to do if you are bitten by a tick:   https://madisonarealymesupportgroup.com/2020/04/21/help-i-got-bit-by-a-tick-what-do-i-do/  Great advice here.  Be prepared and always carry a tick removal device with you at all times.

Remember, ticks have been found in the most unlikely places.

I shared this before but it’s worth repeating: the wind can blow ticks off of trees into your yard.  I had a Lyme advocate tell me that ticks were blowing into her pool, located quite a distance away from all trees.  I experienced this myself last summer when I noticed a tick that suddenly appeared on my beach towel on the deck of my pool where again – trees are some 30 feet away and nothing else is around the pool. It was a particularly windy day.  I also met TV anchor Mike Schneider who relayed in person to me how he was infected at a friend’s garden party on their deck and whose feet never touched the grass.  Schneider believes he was infected by a tick dropping or blowing out of a tree onto his head.  While most researchers deny this phenomenon, I’ve heard it too many times for it to be coincidental.  Birds transporting ticks is a much bigger issue in my opinion than mice, yet mice get all the press coverage and research money.

The Power of Fasting For Health

**DISCLAIMER**

I’m not a doctor.  As with all treatments, always discuss with your doctor.

The Power of Fasting For Health

Recently I saw a book that intrigued me called, “Starving to Heal in Siberia: My Radical Recovery From Late-Stage Lyme Disease and How It Could Help Others.”

While I admit I haven’t read it yet, fasting is as old as time itself, and even Upton Sinclair wrote an article back in 1910 on his experiences with fasting.  He then wrote “The Fasting Cure” which is considered a historical work.

Intermittent fasting or time restrictive eating is all the rage now.  Studies on rats have shown this form of fasting can reduce weight, blood pressure, cholesterol, and improve blood sugars.

The type of fasting utilized by the Lyme patient in the book, however, is called dry fasting which is an extreme version of intermittent fasting which involves restricting both food and water intake.  Researchers at Baylor College of Medicine have found that dry fasting (fasting without food or liquid) from dawn to dusk for four weeks has an anti-atherosclerotic, anti-inflammatory and anti-tumorigenic effect on the proteins in a type of immune cell called a peripheral blood mononuclear cell (PBMC)A previous study found similar results in blood serum.

But Heal Lyme?  My interest is piqued.

The following article may help explain why fasting can also help Lyme/MSIDS patients, and those who are “vaccine” injuried:

https://wmcresearch.substack.com/p/friday-hope-fasting-removing-senescent

Friday Hope: Fasting – Removing Senescent Cells and Reducing ROS

Our greatest weapon against the Spike Protein may just be self-discipline.

MAR 31, 2023

The Spike Protein of SARS-CoV-2 induces two phenomena which drive cells, and ultimately organs, into a state resembling the oldest old. These are Senescence and the induction of ROS (Reactive Oxygen Species).

SARS-CoV-2 Spike Protein Induces Paracrine Senescence and Leukocyte Adhesion in Endothelial Cells
https://pubmed.ncbi.nlm.nih.gov/34160250/

A Preliminary Study about the Role of Reactive Oxygen Species and Inflammatory Process after COVID-19 Vaccination and COVID-19 Disease
https://www.mdpi.com/2039-7283/12/4/63

However, we have a therapeutic which is very effective against both phenomena. It is one that is the free and universally accessible. This is the therapeutic of FASTING.

Far from being a cure-all, I believe the evidence demonstrates that adding fasting to a COVID, Long COVID and Spike Protein Injury protocol will prove very effective. Additionally, fasting will also most likely be proven as a prophylactic against COVID and Spike Protein Injury.

Fasting is extremely effective at preventing and removing Senescent cells.  (See link for article)

______________

**Comment**

Wild animals that are sick stop eating.  This innate intelligence allows their bodies to heal and transfer all the energy spent in digestion toward healing. A lot of energy is used to digest food. This is also a similar tenet of the Gershon Therapy for cancer and other degenerative diseases.  By juicing only organic fresh fruits and vegetables, less energy is required for digestion and more for healing, plus the patient can absorb more nutrients, vitamins, and minerals.

Go here for Autophagy Fasting: Benefits and How To

Briefly, autophagy is the body’s natural way to clean up damaged cells.  My old holistic doc once told me, “The body is like a kitty litter box because crap builds up and needs cleaning out.”

For more:

Persister Cells: The LINK to Lyme Disease

https://holtorfmed.com/articles/lyme-disease/persister-cells-is-there-a-connection-to-lyme-disease?

By Holtorf Medical Group

4/4/23

Persister Cells: A Major Concern in the Fight Against Antibiotic Resistance

Antibiotic resistance is a growing problem in the world today. The overuse and misuse of antibiotics has led to the development of bacteria that are resistant to many of the drugs we use to treat infections. This has made it more difficult to treat bacterial infections and has resulted in increased morbidity and mortality. One factor that contributes to antibiotic resistance is the presence of persister cells.

What are Persister Cells?

Persister cells are a subpopulation of bacteria that have the ability to survive antibiotic treatment. These cells are not resistant to antibiotics, but rather they enter a dormant state that prevents them from being affected by the drugs. This means that even after a course of antibiotics, some bacteria may remain in this dormant state and can continue to cause problems later on.

This is a major concern in the treatment of bacterial infections, as persister cells can contribute to the development of antibiotic resistance and make it difficult to completely eradicate an infection. Researchers are currently working to develop new treatments that can target persister cells and prevent the development of antibiotic resistance.

Connection to Lyme Disease

According to a recent review published by the Global Lyme Alliance persister cells may play a role in the persistence of Lyme disease. These cells can enter a dormant state, similar to the spirochetes that cause Lyme disease, and may contribute to the chronic nature of the disease. Current treatments for Lyme disease, such as antibiotics, may not be effective against these persister cells. Therefore, researchers are investigating new treatments that can target these cells and prevent the recurrence of Lyme disease. This highlights the importance of understanding the role of persister cells in infections and developing new treatments to combat them.

Lyme disease is a tick-borne illness caused by the bacteria Borrelia burgdorferi. The disease is transmitted to humans through the bite of infected black-legged ticks. In addition to the well-known symptoms of Lyme disease, such as fever, fatigue, and joint pain, some people with Lyme disease may experience problems with their vision.

Current treatments for Lyme disease typically involve antibiotics, which are effective in killing the actively growing bacteria. However, persister cells can enter a dormant state and evade the effects of antibiotics, leading to a possible recurrence of the disease.

To combat this problem, researchers are investigating new treatments that can target persister cells and prevent the recurrence of Lyme disease. One approach being studied is the use of drug combinations that can target both the actively growing bacteria and the dormant persister cells. Another approach is the use of drugs that can stimulate the persister cells to become active again, enabling the antibiotics to target and kill them.

Understanding the role of persister cells in Lyme disease is crucial to developing new treatments that can effectively eradicate the bacteria and prevent the recurrence of the disease. It is important to note, however, that the best approach to combating the spread of Lyme disease is through prevention, including avoiding tick bites and seeking treatment early if symptoms develop.

Persisters in Other Chronic Infections

A study published in the journal Nature found that persisters may be responsible for the development of chronic infections in patients with cystic fibrosis. The researchers found that Pseudomonas aeruginosa, a common bacteria associated with cystic fibrosis, was able to form persisters in the lungs of patients with the condition. These persisters were able to survive antibiotic treatment and contribute to the chronic nature of the infection.

Another study published in the Journal of Bacteriology found that persisters may be involved in the development of chronic urinary tract infections. The researchers found that E. coli, the bacteria responsible for most urinary tract infections, was able to form persisters in response to antibiotic treatment. These persisters were then able to re-emerge and cause recurrent infections.

While the role of persisters in chronic infections is still not fully understood, these studies suggest that they may be an important factor in the development and persistence of these infections. Further research is needed to fully understand the mechanisms behind persister formation and develop effective treatments for chronic infections.

Dormancy vs Activation of Persister Cells

One approach being investigated to combat persister cells is the use of drugs that can stimulate the persister cells to become active again. By doing this, the antibiotics can then target and kill the persister cells, instead of just putting them in a dormant state. However, this approach is still in the early stages of research, and it is not yet clear if it will be effective in treating bacterial infections.

Another approach to targeting persister cells is to use a combination of antibiotics that can target both the actively growing bacteria and the dormant persister cells. This approach has shown promising results in vitro and in animal studies, but more research is needed to determine if it will be effective in humans.

It is important to note that targeting persister cells is just one part of the fight against antibiotic resistance. It is also important to use antibiotics responsibly and only when necessary, to prevent the development of new resistant strains of bacteria. Additionally, the development of new vaccines and alternative treatments is also important in reducing the need for antibiotics.

Final Thoughts

Persister cells may contribute to the persistence of Lyme disease, and current treatments may not be effective against them. Researchers are investigating new treatments that can target persister cells and prevent the recurrence of the disease. However, prevention remains the best approach to combating the spread of Lyme disease.

For more: