Medscape: "Lyme Testing Gets Fast and Easy"
Sep 17, 2019 —
Today's letter to Auwaerter with Cc: to the Tick-Borne Disease Working Group......
---------- Original Message ----------
From: CARL TUTTLE <email@example.com>
Cc: firstname.lastname@example.org (98 Undisclosed recipients)
Date: September 17, 2019 at 9:04 AM
Subject: Medscape: "Lyme Testing Gets Fast and Easy"
Lyme Testing Gets Fast and Easy
Paul G. Auwaerter, MD
“When the test was examined for both early Lyme disease and later noncutaneous Lyme disease, it performed as well—if not a bit better—in detecting identifiable antibodies against Borrelia burgdorferi, the causative agent of Lyme disease.[2,3]”
Sept 17, 2019
The IDSA Foundation
1300 Wilson Boulevard Suite 300
Arlington, VA 22209
Attn: Paul Auwaerter, vice chair of the IDSA Foundation
Dear Dr. Auwaerter,
I recommend reading the following JAMA article:
Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices
Rita F. Redberg, MD, MSc1,2,3 ; Sanket S. Dhruva, MD, MHS1,4
JAMA. 2019;322(10):927-928. doi:10.1001/jama.2019.10191
“Recent Kaiser Health News stories reported that more than 1 million medical device adverse event reports had been sealed from public view by the US Food and Drug Administration (FDA).1 The New York Times recently called for reforms in device regulation in an editorial entitled “80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.”2
You did not mention the fact that humans do not produce antibodies to Lyme disease for 4-6 weeks after a tick bite; by the time serology tests are positive, the spirochetes have already invaded various deep tissues, like those in syphilis, and are hard to eradicate with antibiotics.
Half the tests come back negative when the patient is actually infected.  (No better than a coin toss!)
Serology is inappropriate for a disease that causes death  and severe disability  as reported by the patient community for the past three decades and exposed in the documentary Under or Skin 
Serology however is absolutely essential for concealing persistent infection (chronic Lyme disease)  as the test cannot be used to gauge treatment failure or success.
Where is the escalation process to develop direct detection methods and find new treatment approaches for a disease that is destroying lives, ending careers while leaving its victim in financial ruin?
Lyme Endemic Hudson, NH
Cc: Medscape Editorial Staff
REFERENCES (Please read them!)
1. Commercial test kits for detection of Lyme borreliosis: a meta-analysis of test accuracy.
2. Wrongful death suit shows pitfalls of IDSA Lyme guidelines
17 year-old Joseph Elone did not develop a bulls-eye rash and had a negative antibody test for Lyme disease.
3. Latent Lyme Disease Resulting in Chronic Arthritis and Early Career Termination in a United States Army Officer
4. Under Our Skin - Extended Trailer
5. Seronegative Chronic Relapsing Neuroborreliosis.
Albert Einstein College of Medicine, Published 1995
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