Please see the letter below sent to the Tick-Borne Disease Working Group as the IDSA is determined to hide chronic Lyme disease.
---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: tickbornedisease@hhs.gov, chris.smith@mail.house.gov, pfm0@cdc.gov
Cc: csears@jhmi.edu, PracticeGuidelines@idsociety.org, (88 Undisclosed recipients)
Date: August 22, 2019 at 7:34 AM
Subject: Draft Lyme Disease Guidelines Public Comment from Dr. Sin Lee
To the Tick-Borne Disease Working Group,
In reference to the IDSA's Draft Guidelines, please see Dr. Sin Lee’s comments below…..
Dr. Lee is the Director of Milford Molecular Diagnostics providing DNA Sequencing tests for Lyme disease. When Dr. Lee identified a case of persistent infection (chronic Lyme) in blind coded serum samples from the CDC’s serum repository and published those results, the CDC abruptly stopped communicating ending his agreement to complete proficiency testing.
Lyme disease is a life-altering/life-threatening infection that can leave the patient disabled if not treated immediately and adequately as Duke University Cancer researcher Neil Spector required a heart transplant after his Lyme disease went four years undiagnosed.
Source:
https://www.dukehealth.org/blog/doctor-hopes-his-medical-journey-inspires-others
There are two statements from Dr. Lee’s comments pointing out that the IDSA is determined to keep persistent infection well-hidden as serology is the ideal tool for concealing chronic Lyme disease.
-Clinging onto proven inaccurate antibody tests developed more than 30 years ago in writing the 2019 Lyme disease Guidelines is not right.
-The current Lyme disease crisis is the result of suppression of direct detection tests for the diagnosis of Lyme disease at the early stage of infection by the rheumatologists until arthritis occurs for pain management.
Dr. Lee’s comments:
Line 223-228
General principles
Diagnostic Testing for Lyme Disease
Based on performance characteristics and practical considerations, antibody tests are first-line the laboratory diagnosis of Lyme disease. Serum antibody (serologic) testing is highly sensitive in patients with non-cutaneous manifestations of the infection, as these manifestations typically develop after weeks to months of infection [14, 15].
Comment: This statement is seriously flawed for the following reasons:
1. Lyme disease is a systemic bacterial infectious disease. It is generally believed that at the early stage of infection this disease can be treated successfully with a proper course of antibiotics, but within days to weeks certain species of Borrelia may disseminate from the site of the tick bite to other regions of the body if not properly treated [1]. If antibody tests are used as the first-line laboratory diagnostic tool, appropriate antibiotic treatment will be delayed. As in syphilis, spirochetes are more difficult to eradicate with antibiotics in late stages of the disease. Relying on antibody tests as the first-line laboratory diagnosis of Lyme disease may have generated a significant number of persistent Lyme infections or “chronic Lyme disease” patients with proven spirochetemia [2].
2. In its 2018 Report to Congress, the U.S. Department of Health and Human Services Tick-Borne Disease Working Group has openly stated: “Today, available diagnostic tests can be inaccurate and complex to interpret, especially during the earliest stage of infection when treatment is most effective” when it summarizes the current status on serology tests for the diagnosis of Lyme disease. In conclusion the report specifically recommends using metagenomic sequencing of DNA to identify tick-borne pathogens in clinical samples [3].
3. This statement contradicts the recent Viewpoints of the IDSA which states “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.” [4]
4. Lyme disease is a form of bacteremia, at least at the early stage of infection. Serological diagnosis of bacterial infectious diseases, for example in typhoid fever, requires a 4-fold increase in antibody titers in paired serum testing during convalescence provided there is a known common specific antigen shared by all strains of the causative agents. However, there is no known “core antigen” shared by all strains of borreliae which can cause “clinical Lyme disease”. Historically, infections by Borrelia miyamotoi in the United States might have been misidentified as infections by Borrelia burgdorferi, probably due to partial serologic cross reactions [5]. The extent of cross reactions between antibodies against borrelial antigens and those elicited by other antigens is not known. At least two CDC biorepository serum samples from “confirmed Lyme disease” patients were found to contain a borrelia other than Borrelia burgdorferi, one being a novel relapsing fever borrelia (GenBank Seq ID# KM052618) and one being Borrelia miyamotoi by partial 16S rRNA gene sequencing [6]. Dependence on using antibody tests, such as the Widal test, to diagnose bacterial infection has been proven to be unreliable [7].
5. Lyme disease was described in 1977 before Sanger sequencing and PCR were invented. If Lyme disease were to be reported today as an emerging infectious disease, it would have been diagnosed early at the spirochetemic stage of infection by nucleic acid sequencing as Ebola [8] and Zika [9] virus infections are. Clinging onto proven inaccurate antibody tests developed more than 30 years ago in writing the 2019 Lyme disease Guidelines is not right.
Lines 599- 602
In patients with one or more skin lesions suggestive of, but atypical for erythema migrans, we suggest antibody testing performed on an acute-phase serum sample (followed by a convalescent-phase serum sample if the initial result is negative) rather than currently available direct detection methods such as polymerase chain reaction (PCR) or culture performed on blood
Lines 1309-1311
In one study [137] B. burgdorferi spirochetes were moribund or dead in joint fluid even before antibiotic treatment, yet spirochetal DNA apparently persisted after live spirochetes were no longer present.
Comment: These two statements (copied and pasted above) were designed to discourage using DNAbased direct detection tests for the diagnosis of Lyme disease by cherry-picking one reference in which joint fluid samples of patients with Lyme arthritis were tested by PCR. Based on this one study, the Guidelines draft concluded “spirochetal DNA apparently persisted after live spirochetes were no longer present”, and dismissed the usefulness of DNA-based direct detection tests. The Guidelines draft ignored the fact that DNA-based direct detection tests are most useful in selecting patients with spirochetemia for treatment. If all Lyme disease patients were treated timely and properly at the initial spirochetemic stage of early infection, there would be no Lyme arthritis cases referred to the rheumatologists. The current Lyme disease crisis is the result of suppression of direct detection tests for the diagnosis of Lyme disease at the early stage of infection by the rheumatologists until arthritis occurs for pain management. Unlike extracellular DNA in joint fluids or in culture media, free spirochetal DNA in circulating blood of a patient will be rapidly degraded by various kinds of DNAses or excreted through the kidneys. When a signature segment of chromosomal DNA like the 16S rRNA gene is confirmed in a patient’s spun down platelet pellet by direct Sanger sequencing [2, 10], the diagnosis of active borreliosis is established beyond a reasonable doubt. The Guidelines should promote metagenomic DNA sequencing [3, 4] as a reliable tool for the diagnosis of “Lyme disease” as any bacteremias at the hospital laboratories located in endemic areas.
References
1. Steere AC, Strle F, Wormser GP, Hu LT, Branda JA, Hovius JW, Li X, Mead PS. Lyme borreliosis. Nat Rev Dis Primers. 2016;2:16090.
2. Lee SH, Vigliotti JS, Vigliotti VS, Jones W, Moorcroft TA, Lantsman K. DNA sequencing diagnosis of offseason spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections. Int J Mol Sci. 2014;15:11364-86.
3. U.S. Department of Health and Human Services Tick-Borne Disease Working Group. Report to Congress. 2018. https://www.hhs.gov/ash/advisory-committees/tickbornedisease/reports/index.html
4. Schutzer SE, Body BA, Boyle J, Branson BM, Dattwyler RJ, Fikrig E, Gerald NJ, Gomes-Solecki M, Kintrup M, Ledizet M, Levin AE, Lewinski M, Liotta LA, Marques A, Mead PS, Mongodin EF, Pillai S, Rao P, Robinson WH, Roth KM, Schriefer ME, Slezak T, Snyder JL, Steere AC, Witkowski J, Wong SJ, Branda JA. Direct Diagnostic Tests for Lyme Disease. Clin Infect Dis. 2019;68:1052-1057.
5. Krause PJ, Fish D, Narasimhan S, Barbour AG. Borrelia miyamotoi infection in nature and in humans. Clin Microbiol Infect. 2015;21:631-9.
6. Lee SH, Vigliotti JS, Vigliotti VS, Jones W, Shearer DM. Detection of borreliae in archived sera from patients with clinically suspect Lyme disease. Int J Mol Sci. 2014;15:4284-98.
7. CDC. Typhoid & Paratyphoid Fever; https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-relatedinfectious-diseases/typhoid-and-paratyphoid-fever
8. CDC. Ebola Virus Disease Case Definition for Reporting in EU. https://ecdc.europa.eu/en/all-topicszebola-and-marburg-feversthreats-and-outbreaksebola-outbreak-west-africa-2013-2016/ebola
9. CDC. Testing for Zika Virus Infections. https://www.cdc.gov/zika/laboratories/types-of-tests.html
10. Lee SH, Healy JE, Lambert JS. Single Core Genome Sequencing for Detection of both Borrelia burgdorferi Sensu Lato and Relapsing Fever Borrelia Species. Int J Environ Res Public Health. 2019;16. pii: E1779.
Submitted by Sin Hang Lee, MD
Email shlee01@snet.net
August 21, 2019
________________________________
Carl Tuttle
Lyme Endemic Hudson, NH
Cc: Cynthia L. Sears, MD, FIDSA, President of the IDSA