Petition update

Medscape: "Lyme Testing Gets Fast and Easy"

Carl Tuttle
Hudson, NH, United States

Sep 17, 2019 — 

Today's letter to Auwaerter with Cc: to the Tick-Borne Disease Working Group......

---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: pauwaert@jhmi.edu
Cc: tickbornedisease@hhs.gov (98 Undisclosed recipients)
Date: September 17, 2019 at 9:04 AM
Subject: Medscape: "Lyme Testing Gets Fast and Easy"

COMMENTARY

Lyme Testing Gets Fast and Easy

Paul G. Auwaerter, MD

https://www.medscape.com/viewarticle/917726

“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

https://jamanetwork.com/journals/jama/fullarticle/2744408

Excerpt:

“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. [1] (No better than a coin toss!)

Serology is inappropriate for a disease that causes death [2] and severe disability [3] as reported by the patient community for the past three decades and exposed in the documentary Under or Skin [4]

Serology however is absolutely essential for concealing persistent infection (chronic Lyme disease) [5] 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?


Carl Tuttle

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.

https://www.ncbi.nlm.nih.gov/pubmed/27920571

2. Wrongful death suit shows pitfalls of IDSA Lyme guidelines

https://www.lymedisease.org/elone-wrongful-death-lawsuit-lyme/

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 

https://academic.oup.com/milmed/advance-article/doi/10.1093/milmed/usz026/5370051?searchresult=1

4. Under Our Skin - Extended Trailer

https://www.youtube.com/watch?v=sxWgS0XLVqw&feature=player_embedded

5. Seronegative Chronic Relapsing Neuroborreliosis.

https://www.ncbi.nlm.nih.gov/pubmed/7796837

Albert Einstein College of Medicine, Published 1995


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