Madison Area Lyme Support Group

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:

• https://madisonarealymesupportgroup.com/2019/02/10/wormsers-worthless-study-waste-of-taxpayer-money/
• https://madisonarealymesupportgroup.com/2017/05/22/the-21st-century-do-it-yourself-plague/
• https://madisonarealymesupportgroup.com/2022/01/05/study-association-of-pathogens-biofilms-with-alzheimers-disease-but-wormser-repeats-no-evidence-mantra/
• https://madisonarealymesupportgroup.com/2019/11/22/wormsers-junk-science-deliberate-avoidance-of-chronically-ill-patients-a-letter-him-asking-why/
• https://madisonarealymesupportgroup.com/2017/11/30/wormser-wrong-choice-for-lyme-panel-send-letters-now/  Wormer’s conflicts of interest:

• https://madisonarealymesupportgroup.com/2017/12/05/christmas-came-early-gary-wormser-off-lyme-panel/