Please see the letter below addressed to the Tick Borne Disease Working Group regarding DNA testing for Lyme disease and the New York Department of Health. DNA Sequencing is not approved in the State of NY for the early detection of Lyme disease but performance of Dr. Lee’s lab was comparable to the Wadsworth Center. Anyone wishing to contact the Lyme Disease Working Group can send an email to: tickbornedisease@hhs.gov Letter to the Working Group: ---------- Original Message ---------- From: Carl Tuttle To: Cc: Date: January 8, 2018 at 9:11 AM Subject: State of New York, Department of Health, Wadsworth Center To the TBD Working Group, I am forwarding Dr. Sin Lee’s letter below originally sent to the Working Group on Dec 30th announcing his work with the State of New York, Department of Health, Wadsworth Center. Dr. Lee’s DNA sequencing test for Lyme disease produced no false positives. Before you read Dr. Lee’s letter I would like to point out that DNA testing for Lyme was originally introduced in 1992: Development of polymerase chain reaction primer sets for diagnosis of Lyme disease and for species-specific identification of Lyme disease isolates by 16S rRNA signature nucleotide analysis. [Nov 1992] R T Marconi and C F Garon https://www.ncbi.nlm.nih.gov/pubmed/1280643 ____________________________ A few facts you may not know: “Spirochetes disseminate to the lymph nodes, bone marrow, spleen and brain within a week of infection [1]. Lymph node germinal centers, where B cells are supposed to mature and be assigned an immune system function, are rendered incompetent [2] 1. http://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1002066 2. http://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1004976 Humans may not produce detectable antibodies during the first 4-6 weeks of Lyme disease infection. Current antibody tests for Lyme disease with its life-altering/life-threatening consequences (misclassified as a low-risk and non-urgent health issue through an elaborate racketeering scheme supported by the CDC [3]) is useless for 4-6 weeks after a tick bite and this has not changed for over two decades! 3. https://www.courthousenews.com/wp-content/uploads/2017/11/LymeDisease.pdf Quote from Senator Richard Blumenthal: "Today for me culminates more than a decade of work and probably a decade more, because I've seen firsthand the devastating, absolutely unacceptable damage done by Lyme disease to individual human beings, Connecticut children and residents whose lives have been changed forever as a result of Lyme disease” Source: http://ctmirror.org/2011/07/18/blumenthal-takes-lyme-disease-fight-senate/ Dr. Lee worked with the CDC and uncovered a novel borrelia in the serum of a patient already treated for neurologic Lyme disease which he published in 2014. Another sixteen year old with chronic Lyme was sent to a psychiatric ward when his Western blot (serology) did not have the required five IgG bands for positive test results. Shortly thereafter, the CDC stopped communicating with Dr. Lee. [4] 4. https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/20864023 Dr. Lee’s publication identifying chronic Lyme: DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections. https://www.ncbi.nlm.nih.gov/pubmed/24968274 It is time to fire the CDC and create a Manhattan Project to combat this plague while implementing proficiency testing for molecular diagnostics because as of today, the only way you’ll receive confirmatory DNA testing is through autopsy. Antibody tests cannot gauge treatment failure or success. The Sanger method of DNA sequencing through Milford Molecular Diagnostics can detect early infection with as few as 25 bacteria per mL of blood before antibody production. Source: http://www.dnalymetest.com/faq.html DNA Sequencing can detect multiple strains of Borrelia which are not currently recognized by the antiquated two-tier antibody method; miyamotoi in the Northeast, mayonii in the Midwest, bissettii in the South and any novel species yet to be identified. With a cost of $150, this test is reasonably priced. Manhattan Project: http://www.plospathogens.org/article/info:doi/10.1371/journal.ppat.1003796 I would like to point out that the CDC has had a history of condemning tests that might detect persistent infection which would throw a monkey wrench into the well-established racketeering scheme. For example: Advanced Laboratory Services culture test. Assessment of New Culture Method to Detect Borrelia species in Serum of Lyme Disease Patients Barbara J.B. Johnson, Mark A. Pilgard and Theresa M. Russell http://jcm.asm.org/content/early/2013/08/14/JCM.01674-13.abstract You have to ask the question: “Why didn’t the CDC work with Advanced Laboratory Services to correct any so-called “contamination issues” to perfect the culture method in the detection of Lyme disease???? It is also time to recommend a congressional investigation into the deliberate mishandling of Lyme disease to insure this will never happen again and hold those responsible for this crime against humanity. Sincerely, Carl Tuttle Independent Researcher Lyme Endemic Hudson, NH Cc: Daniel R. Dutko, HANSZEN LAPORTE DR. CHARLES BEN BEARD acting deputy director, Division of Vector-Borne Diseases, CDC Dr. Sin Lee’s letter to the TBD Working Group: ----- Forwarded Message ----- From: Sin Lee To: tickbornedisease@hhs.gov Sent: Saturday, December 30, 2017 10:04 AM Subject: National proficiency test program for tick-borne borreliosis To the Tick-Borne Disease Working Group: (Please put the following comment into public record and documentation for the Tick Borne Disease Working Group) I recently participated in an assessment for the detection of Borrelia burgdorferi in whole human blood samples, a pilot program organized by the State of New York, Department of Health, Wadsworth Center. After the assessment tests were completed and the results reported to the NYS DOH, I received from Ronald J. Limberger, Ph.D. Director, Division of Infectious Diseases NYS Department of Health, Wadsworth Center, an email message on December 29, 2017, as follows: "Hi Dr. Lee – Please see the attached summary of the recent Borrelia PCR blind test. The number of cells spiked into the blood is an approximation. Wadsworth also performed the testing in a blinded fashion using our real time PCR assay. Overall the results between the two labs were quite comparable. I hope you find this information useful and we thank you for your patience and for participating in this assessment. Feel free to contact me with any questions. –Ron" As stated in the public and stakeholder comments, as well as by members of the Working Group on December 11 and 12, 2017 during the public meeting of the Tick-Borne Disease Working Group, there is an urgent need for reliable direct detection tests for the causative agents of tick-borne borreliosis, independent of antibody responses. I hereby recommend that this Working Group partner with the NYS DOH to expand this assessment into a national proficiency test program for the detection of all known species of bacteria which may cause tick borne borreliosis in the United States [1], including Borrelia burgdorferi sensu lato, Borrelia miyamotoi, Borrelia lonestari, Borrelia hermsii and Borrelia mayonii in human blood samples. The Working Group should invite all diagnostic and research laboratories involved in Lyme disease diagnosis to participate for a competitive proficiency test to select the best technologies for patient care. At least, this would be a very inexpensive fact-finding program for the Working Group to gather information for making advisory recommendations. After all, reliable laboratory diagnosis of individual cases is the basis for all other relevant clinical, therapeutic and epidemiologic discussions. Thank you for your consideration. Sin Hang Lee, MD Director Milford Molecular Diagnostics Laboratory 2044 Bridgeport Avenue Milford, CT 06460 Telephone No. 203 878-1438 References [1] Kingry LC, Anacker M, Pritt B, Bjork J, Respicio-Kingry L, Liu G, Sheldon S, Boxrud D, Strain A, Oatman S, Berry J, Sloan L, Mead P, Neitzel D, Kugeler KJ, Petersen JM. Surveillance for and Discovery of Borrelia Species in US Patients Suspected of Tickborne Illness. Clin Infect Dis. 2017 Dec 20. doi: 10.1093/cid/cix1107. [Epub ahead of print]