https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/23412818?

Direct Diagnostic Tests for Lyme Disease

Carl Tuttle
Hudson, NH
OCT 13, 2018 —

Latest message to the TBD Working Group:
———- Original Message ———-
From: Carl Tuttle <runagain@comcast.net>
To: jaucott2@jhmi.edu, tickbornedisease@hhs.gov
Cc:
Date: October 12, 2018 at 1:48 PM

Subject: Re: News Release: Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

To the Tick Borne Disease Working Group,

Please see the viewpoint below recently published in Clinical Infectious Diseases regarding direct detection tests for Lyme disease.

I have purposely highlighted coauthor Martin E Schriefer of the Centers for Disease Control because he was one of the CDC officials working directly with Dr. Sin Lee of Milford Molecular Diagnostics regarding “direct detection” of Lyme disease.

All communication from the CDC stopped with Dr. Lee with absolutely no explanation whatsoever prompting the current lawsuit.
And now we see Schriefer’s name on this publication pushing for DNA tests?

It’s time to fire the CDC and take control of this runaway plague as all the evidence indicates deliberate mishandling of a disease that is destroying lives, ending careers while leaving its victims in financial ruin.

Carl Tuttle
Lyme Endemic Hudson, NH

CORRECTED PROOF

Direct Diagnostic Tests for Lyme Disease

Steven E Schutzer, Barbara A Body, Jeff Boyle, Bernard M Branson, Raymond J Dattwyler, Erol Fikrig, Noel J Gerald, Maria Gomes-Solecki, Martin Kintrup, Michel Ledizet, Andrew E Levin, Michael Lewinski, Lance A Liotta, Adriana Marques, Paul S Mead, Emmanuel F Mongodin, Segaran Pillai, Prasad Rao, William H Robinson, Kristian M Roth, MARTIN E SCHRIEFER, Thomas Slezak, Jessica L Snyder, Allen C Steere, Jan Witkowski,Susan J Wong, John A Branda

Clinical Infectious Diseases, ciy614, https://doi.org/10.1093/cid/ciy614

Published: 11 October 2018

Abstract
Borrelia burgdorferi was discovered to be the cause of Lyme disease in 1983, leading to seroassays. The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings. 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. New approaches have effectively been applied to other emerging infections and show promise in direct detection of B. burgdorferi infections.

______________________________

THE FOLLOWING EMAIL WAS PREVIOUSLY SENT TO THE TBD WORKING GROUP AND POSTED AS AN UPDATE HERE: https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/23321574

Subject: Re: News Release: Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

On September 25, 2018 at 11:11 AM Carl Tuttle <runagain@comcast.net> wrote:

To the Tick-Borne Disease Working Group,

Before you read the following press release I would like to point out that Patient #45 from Table 2 of the attached CDC document titled, “Reply to Response to Motion to Dismiss” (page 26) had a bulls-eye rash and a single positive Western blot Band 41 which as you know is the flagellar antigen of Borrelia burgdorferi.

Patient #45 has a case of early Lyme confirmed by the bulls-eye rash but hadn’t yet produced a full set of antibodies to the infection. Dr. Lee’s 16S rRNA gene sequencing was able to accurately detect early infection before antibody production.

The CDC claims the following:

“ with respect to pretreatment patients, he (Dr. Sin Hang Lee) reported B. burgdorferi in a patient whose antibody testing failed to indicate the presence of the disease at all (patient 45). Attachment I at 4287 and 4292. Therefore, Dr. Lee’s tests were not accurate.”

For the record, you will find the following statement from the CDC website:

Diagnosis, Testing, and Treatment

https://www.cdc.gov/lyme/faq/index.html

Excerpt:
As with serologic tests for other infectious diseases, the accuracy of the test depends upon the stage of disease. During the first few weeks of infection, such as when a patient has an erythema migrans rash, the test is expected to be negative.

______________________________________

The CDC is responsible for the current Lyme disease crisis where patients cannot obtain a timely diagnosis through accurate early detection.

This perpetuated outdated dogma of using a restricted pattern of antibody tests for disease definition is now on record disclosing the hidden agenda of the bureaucrats in charge of the Lyme disease policy.

MILFORD MOLECULAR DIAGNOSTICS

2044 Bridgeport Avenue
Milford, CT 06460
http://www.dnalymetest.com

September 25, 2018

Media Contact:
Kevin Moore
203-788-8497

FOR IMMEDIATE RELEASE

In Unprecedented CDC lawsuit, Dr. Sin Hang Lee Accuses CDC of Resorting to Politically Motivated False Science to Cover Up Its Failure to Promote More Exacting Test for Lyme Disease

Milford, Conn. – Dr. Sin Hang Lee, the Connecticut based pathologist who, in May, filed an unprecedented $57.1 million Lyme disease related lawsuit against theUnited States Centers for Disease Control and Prevention (CDC),charged the CDC in a legal filing* this week of employing false, pseudo-scientific theories in order to justify its own anti-consumer actions aimed at perpetuating Lyme disease testing by a flawed technology previously endorsed by the CDC. It is also believed that certain current and former CDC representatives receive personal financial gains (royalties) as a result of their having worked on the approval and promotion/CDC endorsement of a Lyme disease serology test.

According to Dr. Lee, the truth behind the CDC’s inexplicable retreat from supporting a cutting-edge test capable of diagnosing Lyme disease infections with 100% accuracy, came to the surface in the CDC’s lawsuit-related recent filing in theU. S. Court of Federal Claims. For the purpose of suppressing direct detection tests to diagnose early Lyme disease infections, the CDC’s lawyers wrote,

“with respect to pretreatment patients, he (Dr. Sin Hang Lee) reported B. burgdorferi in a patient whose antibody testing failed to indicate the presence of the disease at all (patient 45). Attachment I at 4287 and 4292. Therefore, Dr. Lee’s tests were not accurate.”

Dr. Lee informed the Court through his legal counsel,

“Using Lyme disease serology test results to overrule 16S ribosomal RNA gene sequencing diagnosis of Lyme borreliosis is to practice Lysenkoism in disguise.” It is serious when the CDC allows its policies to be made on the basis of bogus science, said Dr. Lee.

Dr. Sin Hang Lee, a Connecticut pathologist and the plaintiff in the $57.1 million lawsuit against the CDC, said Lyme disease is actually a chronic tick-borne borrelia infection or its sequelae because this bacterial infection has not been diagnosed correctly at the early stage for timely appropriate treatment.

The world’s scientific literature of medicine all agrees that 16S rRNA DNA sequencing of bacterial genes in patient specimens is a tool to reach irrefutable diagnosis of bacterial infections, including those due to Borrelia, even if antibodies to the bacteria in the patient are not measurable.

When a government authority, like the CDC, insists upon using a negative antibody testing result to overrule the 16S rRNA gene sequencing diagnosis of Borrelia burgdorferi infection in official federal court documents, this is concrete evidence that the CDC has resorted to Lysenkoism to perpetuate Lyme disease in the United States, said Dr. Lee through his lawyer*.

Lysenkoism once prevailed in the Soviet Union under Stalin when bogus science was used to suppress true biological and medical sciences and to punish the scientists and medical doctors who did not follow the Party Line. Since the CDC has now, for the first time, officially narrowed the case definition of Lyme disease in a Federal Court case as an illness to be diagnosed by testing the antibodies against a particular strain of Borrelia burgdorferi to the exclusion of all other direct detection diagnostics, including Sanger sequencing, this Party Line must be challenged by evidence-based science in the public eye as well as in Court, said Dr. Lee.

* See document, called Sur-Reply filed on September 20, 2018 at the U.S. Federal Court of Claims in response to the CDC statements previously submitted to the Court on August 27, 2018.
###
Attachments:
1. Lee – Reply to Response to Motion to Dismiss
2. Lee – Sur-Reply re Motion to Dismiss 2018-09-20

Carl Tuttle
Lyme Endemic Hudson, NH

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For more:  

https://madisonarealymesupportgroup.com/2018/10/12/direct-diagnostic-tests-for-lyme-the-closest-thing-to-an-apology-you-are-ever-going-to-get/

Key quote: “These serologic tests cannot distinguish active infection, past infection, or reinfection.”

In plain English, the CDC’s “FDA approved” two-tiered tests don’t show squat.

Direct detection is nothing new. Dr. Sin Hang Lee sued the CDC over their suppression of HIS direct detection test. https://madisonarealymesupportgroup.com/2018/08/15/milford-pathologist-fires-broadside-at-cdc-motion-to-discuss/
Another great article showing how they’ve worked tirelessly to suppress direct detection tests: https://madisonarealymesupportgroup.com/2018/04/03/cdc-deliberately-avoids-direct-detection-testing-methods-for-ld/

https://madisonarealymesupportgroup.com/2018/10/12/paving-the-way-for-better-lyme-diagnostic-tests/  (This article does a great job explaining the tests)

In the comment section I explain how small labs like IGeneX have been poisonously smeared by the CDC.  I actually attended a public meeting at the WI capital where a pediatric doctor quoted right off the CDC website and called the IgeneX Lyme test, “Home-brewed.”

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6315a4.htm
“Often these are laboratory-developed tests (also known as “home brew” tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. 

Patients, the doctors who dare treat them, and these smaller labs specializing in bacteriology and virology have been quaking in their boots for decades due to the antics of the CDC.

The CDC is a bully, plain & simple.