This is a clear case of those in position of authority acting as an autonomous group where its authority is absolute, cannot be challenged and answer only to themselves.
--------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: tickbornedisease@hhs.gov, chris.smith@mail.house.gov, pfm0@cdc.gov (Paul F Mead)
Cc: (98 Undisclosed recipients)
Date: July 22, 2019 at 8:57 AM
Subject: Re: Direct Diagnostic Tests for Lyme Disease Published: 11 October 2018
July 22, 2017
Centers for Disease Control and Prevention
3156 Rampart Rd
Fort Collins, CO 80521
Attn: Paul S. Mead, MD, MPH, Chief of the Bacterial Diseases Branch
Dear Dr. Mead,
From the email below dated November 16, 2018:
"What is the CDC’s plan to fast track direct detection laboratory methods for the early detection of Lyme disease i.e.; DNA/Sanger Sequencing, NIST which has been "shown to detect the disease near the time of infection" but has been put on the shelf or PHELIX Phage based PCR?"
It has been eight months since I asked this question (and many others) without a response from your office.
As you well know Dr. Mead, humans do not produce detectable 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.
We have had three decades of this unacceptable testing method sanctioned by the US Centers for Disease Control.
I would like to call attention to the 2015 Wall Street Journal article below:
How to Detect Infectious Diseases Like Ebola Faster
New tools aim to deliver quicker test results—and prevent disease from spreading
https://www.wsj.com/amp/articles/how-to-detect-infectious-diseases-like-ebola-faster-1424145643
Excerpts:
“These tools, which take advantage of improving technology and falling prices for molecular diagnostics and techniques such as genetic sequencing, aim to bring tests to the doctor’s office, clinic or field, and to turn results around while the patient is still there.”
“One of the tools, from a company called BioFire Defense, uses the same kind of machine—polymerase chain reaction, or PCR—as the test that Ms. Meyler underwent. But BioFire’s system automates much of the process, so results are available in about an hour…..”
“Other companies are crafting machines to seek out common diseases. Alere Inc. of Waltham, Mass., has a flu test that delivers results in about 15 minutes, versus about 90 minutes for other tests. The technology, which analyzes samples from a nasal swab, is similar to a PCR test in a lab but requires fewer heating or purification processes.”
“Alere has also introduced new screening tools for HIV. The hope is to catch infection early, when patients are at high risk of transmitting the virus to others, and to get them on drug treatment.”
“Meanwhile, Cepheid , of Sunnyvale, Calif., is tackling drug-resistant tuberculosis. Usually, diagnosing it can take weeks, but Cepheid’s Xpert MTB/RIF molecular diagnostic test can pinpoint one common form of drug resistance in less than two hours.”
Fighting the Plague
“Government agencies are also rushing to develop quick diagnoses. The Centers for Disease Control and Prevention is testing a rapid test for plague—the same Black Death that wiped out millions of people in the Middle Ages.”
Question for Dr. Mead:
Where are the molecular diagnostic tests for Lyme disease?
Direct detection methods for the diagnosis of Lyme disease have the potential to identify persistent infection (chronic Lyme) [1] which would expose Post Treatment Lyme Disease Syndrome as a fabricated medical condition disguising treatment failure.
Is this the real reason why there is no fast track for molecular diagnostics for the early detection of Lyme disease?
A response to this inquiry is required.
Carl Tuttle
Lyme Endemic Hudson, NH
Reference
1 DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4139787/
Faulty/misleading antibody tests landed a sixteen year old male in a psychiatric ward when his lab results did not meet the CDC’s strict criteria for positive results. His Western blot had only four of the required five IgG bands. Subsequent DNA sequencing identified a spirochetemia in this patient’s blood so his psychiatric issues were a result of neurologic Lyme disease misdiagnosed by antiquated/misleading serology. This patient was previously treated with antibiotics.
Current antibody tests for Lyme disease cannot be used to gauge treatment failure or success which makes them the ideal tool for concealing persistent infection.
NOTE: The CDC stopped all communication with Dr. Sin Lee after he published this case of Chronic Lyme Disease.
_____________________________________
The first letter to Dr. Mead can be found here:
Petition Update Nov 16, 2018
Dr. Paul Mead, Acting Branch Chief