Archive for the ‘Testing’ Category

Lyme Times Open Assess For May – Lyme Awareness Month

https://www.lymedisease.org/members/lyme-times/2023-summer-lymetimes/#articles

In honor of Lyme Disease Awareness Month, the latest issue of the Lyme Times is open-access–freely available to all.

This special issue offers articles from 10 prominent Lyme-treating physicians on such topics as:
  • New treatments for chronic Lyme
  • An overview of Lyme testing
  • Lyme carditis
  • Brain inflammation
  • Lyme in young children

COVID Outbreak at CDC Conference: Yet More Proof CDC Guidance is Worthless

https://arstechnica.com/science/2023/05/disease-detectives-gathered-at-cdc-event-a-covid-outbreak-erupted/

Disease detectives gathered at CDC event—a COVID outbreak erupted

Some attendees reportedly did not mask, distance, or take other precautions.
Huge facade for CDC headquarters against a beautiful sky.

Disease detectives with the Centers for Disease Control and Prevention are on the case of a new COVID-19 outbreak—the one at their very own conference, which has sickened around 35 attendees as of Tuesday.

Last week, the CDC hosted the 2023 Epidemic Intelligence Service (EIS) Conference in Atlanta, the first time the conference has been held in person since 2019. The annual event, which dates back seven decades, was fully virtual last year and was canceled entirely in 2020 and 2021 while EIS officers were immersed in the pandemic response.

“The COVID-19 pandemic has been hard on everyone and especially for our public health workforce. … We are thankful you are back with us at the EIS conference,” EIS leaders wrote in the preface of this year’s conference agenda, celebrating the return of the in-person gathering.

But signs of trouble turned up quickly. Several attendees reportedly tested positive during the conference, which spanned Monday, April 24 to Thursday, April 27, and drew about 2,000 participants. Some told The Washington Post that moderators at the conference warned several times about positive cases. CDC spokesperson Kristen Nordlund told Ars in an email that EIS leaders noted the cases during the closing session of the conference. The conference leaders also canceled an in-person training, emailed all officers with current CDC guidance, and offered to extend the hotel stays of sick attendees who needed to isolate, according to the Post. (See link for article)

_________________

**Comment**

The irony here is palpable.

The CDC, NIH, HHS, and FDA need to be disbanded forever.

Study: SOT Potential Treatment For Viruses & Lyme Disease

https://pubmed.ncbi.nlm.nih.gov/36412742/

Supportive Oligonucleotide Therapy (SOT) as a Potential Treatment for Viral Infections and Lyme Disease: Preliminary Results

Free PMC article

Abstract

Antisense therapy is widely used as an alternative therapeutic option for various diseases. RNA interference might be effective in infections, through the degradation of messenger RNA and, therefore, translation process. Hence, proteins essential for microorganisms and viruses’ proliferation and metabolism are inhibited, leading to their elimination. The present study aimed to evaluate the use of oligonucleotide in patients infected by Epstein-Barr (EBV) or Herpes Simplex Viruses 1/2 or with Lyme Disease caused by Borrelia burgdorferi. Blood samples were collected from 115 patients and the different species were characterized using molecular biology techniques. Then, SOT molecules (Supportive Oligonucleotide Therapy), which are specific small interfering RNA (siRNA), were designed, produced, and evaluated, for each specific strain. Oligonucleotides were administered intravenously to patients and then a quantitative Polymerase Chain Reaction was used to evaluate the effectiveness of SOT. This study revealed that for Lyme Disease, one or two SOT administrations can lead to a statistically significant decrease in DNA copies, while for viruses, two or three administrations are required to achieve a statistically significant reduction in the genetic material. These preliminary results indicate that antisense SOT therapy can be considered a potential treatment for viral as well as Lyme diseases.

For more:

The challenge with Lyme is correctly identifying the patient’s infections as they are typically coinfected with many. Further, it’s all based on using PCR to detect the DNA of various bacteria which is known to find Lyme only 30% of the time.  Further, many of the organisms with Lyme/MSIDS aren’t found in the blood so trying to detect it there is futile (another reason this is so hard to test, diagnose, and treat.)

Using genetic code for a treatment for this is like trying to catch a greased pig.  Lyme in particular changes its outer surface protein which means what goes into you isn’t what comes out of you as the organism mutates to survive.  Yet another reason it’s difficult treating this and why there has never and will never be a Lyme vaccine worth its weight in salt.  You can’t pin something down that changes.

Personally, all this work on treatments using genetics scares the bajeebers out of me.  Hopefully the past three years have caused all of us to pause and consider the implications of using genes and their ability to alter genetic code.  Also, what works in a petri dish often doesn’t work in reality.

Of course, at the end of the day, we are all big boys and girls and have to make our own decisions.  What works for one often doesn’t work for another and if you do your reading, are convinced of its merits, and want to try this, then by all means do it.  If you have success, or if you don’t, please let me know.  Often the best way we move forward is by educating one another on various treatments and health changes.

CPAC Warns: Lyme Risk Higher Than Ever

https://www.lymedisease.org/capc-parasite-forecast-2023/

CAPC warns that Lyme disease risk is higher than ever

April 20, 2023

The nonprofit Companion Animal Parasite Council (CAPC) — the nation’s leading source on parasitic diseases that threaten the health of pets and people — is warning that the risk of Lyme disease is higher than ever.

In its 2023 Parasite Forecast, CAPC documents how the blacklegged ticks that spread Lyme disease are expanding into new geographical areas. This increases the risk of Lyme disease outside of historically endemic places like the Northeast and Upper Midwest.

Parasite infections are real and can be harmful and even deadly to pets and people. Lyme disease is a predominant One Health issue, an approach calling for the collaborative efforts of multiple disciplines working to attain optimal health for animals, people and the environment.

11 years of forecasts

“Because of the zoonotic potential of pathogens like Lyme disease, we started providing annual forecasts eleven years ago to alert communities about the risks they pose to people and pets,” says Dr. Christopher Carpenter, DVM, and Chief Executive Officer of CAPC.

“Lyme disease, in particular, is an important One Health pathogen that occurs in both veterinary and human medical settings. CAPC’s Pet Parasite Forecast is critical to alerting pet owners, veterinarians and physicians to the risks this year and reinforcing CAPC’s recommendation that all pets need to be annually tested and protected year-round.”

In its 2023 annual forecast, CAPC reports the risk of acquiring Lyme disease in 2023 is elevated due to the expansive nature of the blacklegged tick vector (Ixodes scapularis).

This increase in Lyme prevalence can be attributed to land use, human population growth, urbanization, and changes in wildlife host density and location. Risks have also increased due to rehoming of pets, as well as changes in:

  • Distribution and prevalence of vector (tick) populations
  • Shifting wildlife populations and their infiltration into newly developed and reclaimed areas
  • Short- and long-term changes in climatic conditions
  • Changes in habitat due to natural or human-induced processes

Lyme Disease Forecast

For 2023, CAPC predicts Lyme disease is a high threat and continues to expand southward and westward outside of the historically high-risk areas in the Northeast and Upper Midwest, including Wisconsin, Minnesota and the upper peninsula of Michigan.

There is a higher-than-average seroprevalence predicted in northeastern Tennessee, western Michigan and Ohio, with high-risk “hot spots” expected in northwestern and southwestern Michigan, and southern and northeastern Ohio.

A higher-than-normal risk is also expected in North Dakota, northeastern South Dakota, Iowa, Illinois, and eastern Kentucky. The southward movement of Lyme is evident in the increasing risk in the Carolinas and Tennessee.

In addition, CAPC reports a northern expansion into Canada, including southern regions of Ontario, Quebec and Manitoba, as well as on New Brunswick and Nova Scotia, due to increased Lyme detection in Canadian dogs. Pets living in or traveling to these areas are considered at high risk.

Testing and Prevention Strategies

The 2023 forecasts – supported by ongoing research by parasitologists and statisticians in leading academic institutions across the United States – highlight areas where more should be done to lower the risk of companion animals’ exposure to disease vectors, such as ticks.

The foundation of these prevention strategies are recommendations that veterinarians and pet owners test their pets annually for disease and protect their pets with products that kill or repel ticks year-round.

A vaccination for Lyme disease should always be considered for pets in high-risk areas. Lyme disease, in particular, is an important One Health pathogen that impacts the health of both pets and people.

Veterinarians play an important role in preventing zoonotic disease in pets, as well as people, by implementing effective parasite control programs. In regions with historically high prevalence and in forecasted regions of increased risk, veterinarians should reinforce their recommendations of aggressive tick control.

CAPC One Health Study

Research conducted by CAPC underscores the value of CAPC’s prevalence maps and emphasizes the importance of a One Health approach to tick-borne diseases. In 2019, a CAPC study confirmed dogs safeguard humans serving as sentinels to alert humans where they are at greatest risk for tick-borne Lyme disease.

“With dogs being tested annually for exposure to the pathogen that causes Lyme disease, we were able to study over seven years of nationwide canine diagnostic data, representing more than 16 million data points — something difficult to achieve when studying ticks and the environment directly. And unlike the challenges with access to human medical records, anonymous veterinary data does not have these privacy concerns,” said Dr. Michael Yabsley, a CAPC Board Member and professor in the Department of Population Health, College of Veterinary Medicine and Warnell School of Forestry and Natural Resources at the University of Georgia.

Results from the study – “Quantifying the relationship between human Lyme disease and Borrelia burgdorferi exposure in domestic dogs” – published in the prestigious, peer-reviewed Geospatial Health quantified the relationship between incidences of tick exposure in domestic dogs to human Lyme disease. The model established in this research broke new ground by giving residents, travelers and health care providers a county-level map to help them identify areas of high Lyme risk across the country.

“By combining sophisticated statistical modeling with this invaluable canine data, we’re enabling veterinary medicine to benefit human medicine,” said Dr. Stella Self, assistant professor in the Department of Epidemiology and Biostatistics at University of South Carolina. “This research represents the first step on the long road to developing a forecast for human Lyme disease.”

30-Day Forecast Maps for Pet Owners

Pet owners who want to monitor the activity in their county throughout the year have access to 30-Day Parasite Forecast Maps at http://www.petdiseasealerts.org. These maps, developed exclusively by CAPC, provide a local forecast for every county in the continental United States on a monthly basis. This free service helps to remind pet owners of the continuous risk in their area and the importance of annual parasite testing and year-round protection.

“Because tick-borne diseases like Lyme are ever-changing, the 30-Day Pet Parasite forecasts at http://www.petdiseasealerts.org are an invaluable tool to protect both pets and people with monthly updates that show the risk for Lyme disease in their area,” said Dr. Rick Marrinson, Past President/Board Member for CAPC and owner of Longwood Veterinary Clinic in Longwood, Florida.

Other Parasite Spread in 2023

In addition to Lyme disease, CAPC forecasts that heartworm disease, which is transmitted by mosquitoes, and tick-borne diseases ehrlichiosis and anaplasmosis, continue to spread throughout the United States in 2023. Veterinarians and pet owners are encouraged to discuss how to effectively address the increased prevalence. Annual testing and year-round use of preventive products remains the best means of providing comprehensive parasite control and disease prevention.

How the Forecasts are Created

The annual CAPC Pet Parasite Forecasts are a collaborative effort between parasitologists and statisticians in leading academic institutions across the United States. These scientists engage in ongoing research and data interpretation to better understand and monitor vector-borne disease agent transmission and changing life cycles of parasites. The forecasts are based on many factors, including temperature, precipitation, and population density.

About the Companion Animal Parasite Council

The Companion Animal Parasite Council is an independent not-for-profit foundation comprised of parasitologists, veterinarians, as well as medical, public health and other professionals, who provide information for the optimal control of internal and external parasites that threaten the health of pets and people.

Formed in 2002, CAPC works to help veterinary professionals and pet owners develop the best practices in parasite management that protect pets from parasitic infections and reduce the risk of zoonotic parasite transmission.

SOURCE OF PRESS RELEASE: The Companion Animal Parasite Council 

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