The following information about “FDA approved” tests is a perfect example of corrupt government agencies doing what they do best: monopolize and control disease for their own purposes – usually financial.
They have restricted doctor and patient choice, care, and access in a number of ways, but one way they cling to like a survivor on a raft is testing. Lyme testing has been fraudulent from the get-go and their suppression of other tests is something that should be made into a movie. In so many ways the CDC and FDA are maniacal evil twins – both doing all within their power to monopolize medicine.
Dr. Sin Hang Lee has sued the CDC for suppressing direct detection tests for Lyme disease, and promoting their own newly patented, unproven metabolomics technology for diagnosis of LD. Current and former CDC representatives receive royalties as a result of working on the approval and promotion/CDC endorsement of a Lyme disease serology test.
Lee has been fighting back with equal tenacity and performed independent research on faulty COVID testing which showed COVID cases will be overstated by a factor of 72%!
Instead of fixing the obvious errors (no positive control sample, no data on false positives, faulty cycle thresholds, and refusal to publish Ct values due to it being “proprietary”,) HHS, FDA, and CDC opted for arbitrary and perpetual diagnosis of COVID.
It’s important the CDC and FDA control testing because then they can completely steer the narrative about any disease – even if the numbers are all based on faulty testing. They’ve been doing this in Lymeland for over 40 years by
“setting arbitrary level of antibodies to diagnose a disease that has not been amenable to Koch’s postulates seems open to question. By the same token, ignoring antibody results unless they meet arbitrary levels seems suspect. The vast majority of patients in this series showed some WB antibody exposure, but many did not meet the arbitrary limits set….in our present state of knowledge, the diagnosis of chronic Lyme disease is a clinical one. Many of the patients in this series have suffered serious ‘hurts’ when they have been told that they could not have LD because their WB did not meet arbitrary limits.” ~ Dr. Burton Waisbren IDSA founder who disagreed with his colleagues. RIP
https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/ Video within link (Approx. 10 Min)
Medscape: New Federal Oversight of Lab Developed Tests
NOV 1, 2023 —
Please see the following inquiry sent to Dr. Paul Auwaerter regarding his commentary (verbal diarrhea) published on Medscape. He has yet to respond to my serious question. Why not email Dr. Auwaerter and demand a response?
Auwaerter’s image was found on his Hopkins profile page:
https://www.hopkinsmedicine.org/profiles/details/paul-auwaerter
———- Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: “pauwaert@jhmi.edu” <pauwaert@jhmi.edu>, “pgauwaerter@gmail.com” <pgauwaerter@gmail.com>
Cc: “aaguilar@webmd.net” <aaguilar@webmd.net>, “DFlapan@Medscape.net” <DFlapan@Medscape.net>, “lkane@medscape.net” <lkane@medscape.net>, “gamiller@medscape.net” <gamiller@medscape.net>, “dolmos@webmd.net” <dolmos@webmd.net>, “sarah.wright@webmd.net” <sarah.wright@webmd.net>, “editor2@webmd.net” <editor2@webmd.net>
Date: 10/25/2023 9:51 AM EDT
Subject: Medscape: New Federal Oversight of Lab Developed Tests
Medscape COMMENTARY
New Federal Oversight of Lab Developed Tests
https://www.medscape.com/viewarticle/997365
Paul G. Auwaerter, MD
Excerpt:
“I often see patients who are concerned they might have Lyme disease, or they’ve been told by other physicians that they have a tickborne or multiple infections. I’ve had patients who claim to have five or six infections: Lyme disease, Babesia, Bartonella, Mycoplasma, or Epstein-Barr virus. They bring LDT results from outside laboratories, which often have a proviso that these tests are only for research or educational purposes. Yet, they purport finding analytes (antibodies or proteins) that suggest the patient has an active infection. These patients may have been treated but are not improving, so they are referred to me.”
Oct 25, 2023
The IDSA Foundation
1300 Wilson Boulevard Suite 300
Arlington, VA 22209
Attn: Paul Auwaerter, vice chair of the IDSA Foundation
Dear Dr. Auwaerter,
As a member of New Hampshire Governor Chris Sununu’s 2020-2021 commission to study diagnostic testing for Lyme disease, I read your commentary with great interest. After a full year of deliberation, study results concluded that the FDA approved two-tier serologic immunoassay for Lyme was not reliable in all stages of disease. (No better than a coin toss)
COMMISSION TO STUDY TESTING FOR LYME AND OTHER TICK-BORNE DISEASES
https://www.gencourt.state.nh.us/statstudcomm/committees/default.aspx?id=1515
“A commission to study the role of clinical diagnosis and the limitations of serological diagnostic tests in determining the presence or absence of Lyme and other tick-borne diseases”
With that conclusion, serology cannot be used to determine who has or does not have Lyme disease.
“FDA approval” (Federal Oversight) has failed miserably in this example.
The CDC has warned the medical community that “surveillance case definitions” (which include the IgM and IgG Western blot serologic bands) are not to be used for making a clinical diagnosis:
From the CDC website:
Lyme Disease (Borrelia burgdorferi)
2022 Case Definition
https://ndc.services.cdc.gov/case-definitions/lyme-disease-2022/
NOTE: A surveillance case definition is a set of uniform criteria used to define a disease for public health surveillance. Surveillance case definitions enable public health officials to classify and count cases consistently across reporting jurisdictions. Surveillance case definitions are not intended to be used by healthcare providers for making a clinical diagnosis or determining how to meet an individual patient’s health needs.
________________________
Recent announcements:
1. “Standard” Lyme testing once again proves fatal
https://www.lymedisease.org/lyme-testing-proves-fatal/
“Lyme disease helped kill our son. A better test might have saved him.”
2. Sensitivity of Two-Tiered Lyme Disease Serology in Children with an Erythema Migrans Lesion
https://doi.org/10.1093/jpids/piad073
Abstract
In our prospective cohort of 192 children with a physician-diagnosed erythema migrans (EM) lesion, two-tier Lyme disease serology had higher sensitivity in children with multiple EM lesions (76.8% multiple lesions vs. 38.1% single EM; difference 38.7%, 95% CI 24.8 to 50.4%). The diagnosis of cutaneous Lyme disease should be based on careful physical examination rather than laboratory testing.
3. Jury awards $6.5M to Maine family for wrongful death, negligent misdiagnosis
https://fox23maine.com/news/local/jury-awards-65m-to-maine-family-for-wrongful-death-negligent-misdiagnosis-mercy-hospital-dr-john-henson-peter-smith-lyme-disease-lyme-carditis-physicians
Court records show Dr. Henson diagnosed smith with a skin disorder and a virus, writing “no sign of Lyme Disease.” Smith died of Lyme carditis.
(I understand that serology was NEGATIVE in this case)
Question:
Dr. Auwaerter… I would like to call attention to the following 2009 tick study conducted here in New Hampshire:
Correlation between Tick Density and Pathogen Endemicity, New Hampshire
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671416/
The study found deer ticks were carrying multiple pathogens (co-infections) that could be transmitted in a single bite.
What FDA approved Tick-Borne Disease Panel are you recommending so as not to miss any of these infections?
A response to this inquiry is requested
Carl Tuttle
Hudson, NH
Cc: MEDSCAPE EDITORIAL STAFF
Additional reference:
“Seronegativity in Lyme borreliosis and Other Spirochetal Infections” 16 September 2003
https://www.dropbox.com/s/3d6m45jzlhhwalu/Seronegativity.pdf?dl=0
“If false results are to be feared, it is the false negative result which holds the greatest peril for the patient.”
Madison Area Lyme Support Group 