Please see the letter below sent through the TBD Working Group regarding the recent announcement that serology for the detection of Lyme disease is useless.
Direct detection of the spirochete responsible for causing Lyme disease has been intentionally avoided in order to keep the existing dogma intact. (No chronic Lyme)
I rarely receive a response from these letters because I ask the difficult questions which should be asked through a congressional investigation. My purpose at this point is to expose the deception through the public domain/social media. At some point in time perhaps these efforts will prompt a congressional investigation with subpoena power or the evidence presented will be used in future Lyme litigation.
As of Nov 1, 2018 there was no response from Schutzer.
1st email to Dr. Schutzer:
--------- Original Message ----------
From: Carl Tuttle <runagain@comcast.net>
To: tickbornedisease@hhs.gov, Schutzer@gmail.com, schutzer@njms.rutgers.edu
Cc: mark.dayton@state.mn.us, daniel.tillson@mail.house.gov, kvf1@comcast.net, olx1@cdc.gov, iturko@umd.edu, allen.l.richards.civ@mail.mil, scott.cooper@cms.hhs.gov, ddutko@hanszenlaporte.com, kalachakra108@aol.com, chris.smith@mail.house.gov, adam.durand@mail.house.gov, Anthony.Fauci@nih.hhs.gov, info@smith4nj.com, marisa.kovacs@mail.house.gov, dmartin@tulane.edu, w.robinson@stanford.edu, tamir.elnabarawy@mail.house.gov, matt.hadro@mail.house.gov, collin.peterson@mail.house.gov, smithr@mmc.org, dennis.dixon1@nih.hhs.gov, estella.jones@fda.hhs.gov, monica.herman@mail.house.gov, mary.noonan@mail.house.gov, james.berger@hhs.gov, vanila.singh@hhs.gov, lise.nigrovic@childrens.harvard.edu, sdonta@comcast.net, wendyadams1@gmail.com, ptourad1@jhmi.edu, members@tulane.edu, kbechto1@jhmi.edu, jaucott2@jhmi.edu, cbb0@cdc.gov, Schutzer@gmail.com, RSabatino@LymeSocietyInc.org, NMurawsky@HRMML.com
Date: October 28, 2018 at 9:48 AM
Subject: Re: Direct Diagnostic Tests for Lyme Disease Published: 11 October 2018
Direct Diagnostic Tests for Lyme Disease
Clinical Infectious Diseases, ciy614, https://doi.org/10.1093/cid/ciy614
Correspondence: S. E. Schutzer, Rutgers New Jersey Medical School, 185 South Orange Ave, Newark, NJ 07103 (Schutzer@gmail.com).
Oct 28, 2018
Rutgers New Jersey Medical School
185 South Orange Ave
Newark, NJ 07103
Attn: Steven E. Schutzer, M.D. Professor
Dear Dr. Schutzer,
As corresponding author of the recently published viewpoint on Direct Diagnostic Tests for Lyme Disease, I would like to know what follow-up action you plan to take as a result of recognizing and formally announcing that serology is wholly inadequate for the detection and management of Lyme disease.
Excerpt from your published article:
“These serologic tests cannot distinguish active infection, past infection, or reinfection. Reliable direct-detection methods for active B. burgdorferi infection have been lacking in the past but are needed and appear achievable.”
CONCLUSIONS
The goal of an active-infection diagnostic test is now technically achievable.
Questions:
1. Do you have a fast track project schedule for Direct Diagnostic Tests for Lyme Disease?
2. Have you reached out to Dr. Sin Lee of Milford Molecular Diagnostics who has offered a DNA sequencing test for Lyme disease for a number of years? If not, why not?
3. Who is responsible for coordinating and implementing accurate testing for Lyme; Gary Wormser and the Centers for Disease Control who have vehemently promoted serology for the past two decades?
4. Your viewpoint published in Clinical Infectious Diseases came two years after the September 2016 meeting at the Cold Spring Harbor Laboratory and took six months to publish. Are we going to see another decade of serology use before we finally have accurate diagnostics?
We have a disease that is destroying lives, ending careers while leaving the patient in financial ruin with the inability to accurately detect the infection.
Where is the sense of urgency here which should be equivalent to the Manhattan Project?
A response to this inquiry is requested.
Sincerely,
Carl Tuttle
Lyme Endemic Hudson, NH
Cc: The Honorable Chris Smith and Collin Peterson
_____________________________________________________
2nd email to Dr. Schutzer:
--------- Original Message ----------
From: Carl Tuttle <runagain@comcast.net>
To: tickbornedisease@hhs.gov, Schutzer@gmail.com, schutzer@njms.rutgers.edu, stillman@cshl.edu, witkowsk@cshl.edu
Cc: mark.dayton@state.mn.us, daniel.tillson@mail.house.gov, kvf1@comcast.net, olx1@cdc.gov, iturko@umd.edu, allen.l.richards.civ@mail.mil, scott.cooper@cms.hhs.gov, ddutko@hanszenlaporte.com, kalachakra108@aol.com, chris.smith@mail.house.gov, adam.durand@mail.house.gov, Anthony.Fauci@nih.hhs.gov, info@smith4nj.com, marisa.kovacs@mail.house.gov, dmartin@tulane.edu, w.robinson@stanford.edu, tamir.elnabarawy@mail.house.gov, matt.hadro@mail.house.gov, collin.peterson@mail.house.gov, smithr@mmc.org, dennis.dixon1@nih.hhs.gov, estella.jones@fda.hhs.gov, monica.herman@mail.house.gov, mary.noonan@mail.house.gov, james.berger@hhs.gov, vanila.singh@hhs.gov, lise.nigrovic@childrens.harvard.edu, sdonta@comcast.net, wendyadams1@gmail.com, ptourad1@jhmi.edu, members@tulane.edu, kbechto1@jhmi.edu, jaucott2@jhmi.edu, cbb0@cdc.gov, RSabatino@LymeSocietyInc.org, NMurawsky@HRMML.com
Date: October 30, 2018 at 1:08 PM
Subject: Re: Direct Diagnostic Tests for Lyme Disease Published: 11 October 2018
Dear Dr. Schutzer,
As a follow-up to my previous email, I would like to call attention to the following paragraph found in your recent article regarding sequencing technology.
Excerpt from: “Direct Diagnostic Tests for Lyme Disease”
“The rapidly decreasing cost to perform sequencing may make this a viable and high-throughput (multiple samples characterized at the same time) method for detection in the clinical laboratory when appropriate sensitivity can be established. Challenges remain, however, including our incomplete knowledge of the full breadth of Borrelia genomic diversity, that is, of the genes that might be shared by all isolates (also called the “core genome”) and those that might be unique to specific species (also called the “accessory genome”) [32]. Without this critical knowledge, it would be challenging to determine precisely which genes or antigens should be targeted by a selective diagnostic test.”
I have attached a copy of the M1/M2 primers and alignment of the core genome; anyone willing to spend time to look for them in the GenBank can find this information. Primers as you know are an extension of the original Marconi/Garon segment.
These M1/M2 genus-specific primer pairs were offered to the CDC in 2013 by Dr. Sin Lee of Milford Molecular Diagnostics and were published in 2014.
DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections.
Lee SH1, Vigliotti JS2, Vigliotti VS3, Jones W4, Moorcroft TA5, Lantsman K6.
https://www.ncbi.nlm.nih.gov/pubmed/24968274
Detection of borreliae in archived sera from patients with clinically suspect Lyme disease.
Lee SH1, Vigliotti JS2, Vigliotti VS3, Jones W4, Shearer DM5.
https://www.ncbi.nlm.nih.gov/pubmed/24619223
Excerpt:
The same-nested PCR consisted of a primary PCR and a nested PCR in tandem with one identical pair of M1 and M2 primers for both. The M1 and M2 primers were “genus-specific” primers designed to amplify a highly conserved segment with hypervarable regions of the borrelial16S ribosomal RNA gene DNA (16S rDNA) of all commonly known borrelia species found in the GenBank.
To initiate a primary PCR, 3 µL of the crude DNA extract from the ATCC culture containing 30 copies of borrelial chromosomal DNA, 3 µL of the crude DNA extract from the serum sample or 3 µL water as negative control was mixed with 20 μL of ready-to-use LoTemp® PCR master mix (HiFi DNA Tech, LLC, Trumbull, CT, USA), 1 μL of 10 μmol M1 primer (5'-ACGATGCACACTTGGTGTTAA-3'), and 1 μL of 10 μmol M2 primer (5'-TCCGACTTATCACCGGCAGTC-3') in a total volume of 25 μL per PCR tube.
______________________________
Note: The term genus-specific is superior to “core genome” because core to some people may not be the core to others. Genus is more inclusive, even covering Borrelia recurrentis and any other European borrelial strains as well as those not yet named borrelial species.
Questions:
1. These M1/M2 genus-specific primer pairs were sent directly to Martin E. Schriefer of the CDC who coauthored your article. How can you claim “incomplete knowledge of the full breadth of Borrelia genomic diversity?”
2. It would appear that the CDC purposely withheld this information and not shared at the September 2016 meeting at the Cold Spring Harbor Laboratory otherwise you would not have included the paragraph I pointed out. Am I correct with this assessment?
A response to this inquiry is requested.
Sincerely,
Carl Tuttle
Lyme Endemic Hudson, NH
Cc: The Honorable Chris Smith and Collin Peterson
Bruce Stillman, President and Chief Executive Officer, Cold Spring Harbor Laboratory