Please see the following letters below regarding the CDC’s continual support for antiquated antibody tests for Lyme disease. ________________________________________ From: "Carl Tuttle" To: "alexander mcadam" Cc: cbrown@asmusa.org, jwallace@asmusa.org, "mms7" , "ard5" , esy7@cdc.gov, arz4@cdc.gov, "CDCExecSec" , "coh2" , "txf2" Sent: Monday, August 29, 2016 11:15:49 AM Subject: Lyme Borreliosis Serology: Performance with Several Commonly Used Laboratory Diagnostic Tests and a Large Resource Panel of Well-Characterized Patient Samples. Clin Microbiol. 2016 Aug 24. pii: JCM.00874-16. Lyme Borreliosis Serology: Performance with Several Commonly Used Laboratory Diagnostic Tests and a Large Resource Panel of Well-Characterized Patient Samples. Molins CR, Delorey MJ, Sexton C, Schriefer ME http://www.ncbi.nlm.nih.gov/pubmed/27558183 Excerpt: All tests were performed on sera from a recently available, well-defined archive of positive and negative control patients. Our study demonstrated differences in the results between individual first- and second-tier tests although the overall agreement of the different STTT algorithms used was strong. Aug 29, 2016 American Society for Microbiology 1752 N Street N.W. Washington DC 20036 Attn: Alexander J. McAdam, MD, Editor in Chief, Journal of Clinical Microbiology Dear Dr. McAdam, There are serious concerns regarding this study published in "Clinical Microbiology" by the CDC’s Division of Vector-Borne Diseases as performance of these antibody tests in the field conflict with the CDC’s results. False negatives seem to be a more serious problem than false positives. Lyme Serology: DNA Probes Reveal a Phalanx of False Negatives https://durayresearch.wordpress.com/our-work/other-topics/lyme-serology-dna-probes-reveal-a-phalanx-of-false-negatives/ The CDC surveillance/reporting criteria for positive serologic results require five out of ten IgG bands on the Western blot. In contrast, a single band criterion in China is sufficient to diagnose Lyme disease: (Please see the attached Dr David J. Volkman letter to Dr. Thomas Frieden, Director of the CDC regarding the five band IgG criteria for Lyme disease.) A Study of the Technique of Western Blot for Diagnosis of Lyme Disease caused by Borrelia afzelii in China http://www.ncbi.nlm.nih.gov/pubmed/23425802 In addition to the strict test criteria, bands 31 and 34 were removed from the Western blot to facilitate vaccine development. Bands 31 (Outer surface protein A) and 34 (Outer surface protein B) are highly specific to Borrelia so a positive result to either of these two bands confirms infection yet the two most important indicators of infection are no longer offered through standard commercial tests. The human Lyme vaccine was a failure while the two most significant Western blot bands have not been restored. Int J Risk Saf Med. 2011;23(2):89-96. doi: 10.3233/JRS-2011-0527. Neurological complications of vaccination with outer surface protein A (OspA). Marks DH1. http://www.ncbi.nlm.nih.gov/pubmed/21673416 Per the U.S. Food and Drug Administration website (MAUDE) there appears to be multiple pages of patient complaints regarding faulty/misleading Lyme disease antibody testing and subsequent misdiagnosis. In addition, 50% of patients identified with the recently discovered Borrelia mayonii (Mayo Clinic) did not test positive using the CDC’s two tier algorithm. Another pathogenic strain, Borrelia miyamotoi is not detected by current serology. Prof. Kerry Clark’s discovery of additional strains in the South are not detected: UNF Professor Discovers Two Lyme Disease Bacteria Previously Unknown to Infect Human Patients http://www.infectioncontroltoday.com/news/2014/05/unf-professor-discovers-two-lyme-disease-bacteria-previously-unknown-to-infect-human-patients.aspx Quote: “Current testing methods and interpretation criteria, designed to detect just one species (B. burgdorferi), may explain many of the complaints involving the unreliability of Lyme disease tests in the U.S.” Please see the following quote from Dr. Ben Beard Chief of the Bacterial Diseases Branch of CDC's Division of Vector-Borne Diseases in Fort Collins, Colorado: Interview From WGBH: http://wgbhnews.org/post/learn-more-about-lyme-war “Learn More About The Lyme War” Heather Goldstone: Why don’t we have better tests? Dr Ben Beard: “What we need to move toward is a whole new paradigm shift in Lyme disease testing looking for direct indicators of infection; proteins, the antigens of Borrelia or markers of human infection or DNA or PCR which is used and I was told recently by a colleague at the FDA that there’s no one single PCR assay that’s FDA cleared for any tick borne disease.” _________________________ Two questions for you Dr. McAdam: 1. With all the evidence pointing to seriously flawed Lyme disease testing, why does the CDC continue to promote antiquated antibody tests using 'textbook case' sera (Circular reasoning) to disingenuously claim current serology “accurate”? 2. What role has Journal Editors played in the ongoing CDC disinformation campaign? A response to this serious inquiry is requested. Respectfully Submitted, Carl Tuttle Hudson, NH Cc: Molins, Delorey, Sexton, Schriefer, Beard, Frieden 2nd letter to Editor-in Chief, Alexander J. McAdam, MD ________________________________________ From: "Carl Tuttle" To: "alexander mcadam" Cc: cbrown@asmusa.org, jwallace@asmusa.org Sent: Tuesday, August 30, 2016 1:06:50 PM Subject: Re: Lyme Borreliosis Serology: Performance with Several Commonly Used Laboratory Diagnostic Tests and a Large Resource Panel of Well-Characterized Patient Samples. Aug 30, 2016 American Society for Microbiology 1752 N Street N.W. Washington DC 20036 Attn: Alexander J. McAdam, MD, Editor in Chief, Journal of Clinical Microbiology Dear Dr. McAdam, As a follow-up to yesterday’s email I would like to refer to Dr. Ben Beard’s statement: Quote from Beard: “What we need to move toward is a whole new paradigm shift in Lyme disease testing looking for direct indicators of infection; proteins, the antigens of Borrelia or markers of human infection or DNA or PCR…” It was brought to my attention that the Editors of the Journal of Clinical Microbiology rejected a manuscript from Dr. Sin Lee who received blind coded serum samples from the CDC for the purpose of evaluating the accuracy of a new diagnostic test for Lyme disease; “Nested PCR and Sequencing.” (20 pre-treatment and 12 post-treatment sera from clinically suspect Lyme disease patients) CDC Reference: NCEZID-R137154-00 A Detection of Borreliae in Archived Sera from Patients with Clinically Suspect Lyme Disease http://www.mdpi.com/1422-0067/15/3/4284 Excerpts: “Of the 12 post-treatment serum samples, we found DNA evidence of a novel borrelia of uncertain significance in one, which was also positive for the 2-tier serology test.” “The #9 patient [Hudson Valley, NY] was diagnosed with “neurologic Lyme disease” and had been treated before the serum sample was drawn. Direct DNA sequencing of the nested PCR amplicon confirmed that the sequence of the amplicon is that of a novel borrelia in the relapsing fever group….” The novel partial 16S rRNA gene sequence was deposited in the GenBank labeled as CDC unnamed borrelia #KM052618 according to the document below presented at a meeting in Boston November 8, 2014. 16S rDNA Sequencing Diagnosis of Spirochetemia in Lyme and related Borrelioses http://www.dnalymetest.com/images/Nov._8_Handout.pdf ________________________________ I would like to point out that not only was a novel Borrelia discovered in this published study but there was a second pathogen (Borrelia miyamotoi) found in one serum sample which was 2-tier serology-negative and in two of the serum samples containing Borrelia burgdorferi, one sample was negative and one positive for 2-tier serology. How can the CDC use these serum samples from their serum repository to gauge the accuracy of newly developed Lyme disease test kits when they do not know what they contain? DNA sequencing from this study has identified serious flaws with current FDA approved testing (serology) for Lyme disease and there is talk on the street that this is the real reason why the CDC is avoiding not only this study and its authors but molecular diagnostics in general. Current FDA approved antibody tests cannot be used to gauge treatment failure or success perpetuating the dogma that persistent infection (Chronic Lyme) does not exist. Antibodies against the Lyme disease spirochete can take 4-6 weeks to develop causing not only a negative test result but a serious delay in treatment. The CDC has ended all communication with Dr. Lee, Director of Milford Molecular Diagnostics which offers DNA sequencing for reliable diagnosis of Lyme disease at the early stage of the disease when there is a high density of bacteria in the blood. Timely and appropriate treatment should be considered to be the standard practice. Early diagnosis and early treatment is the key for success in treating bacterial infections. It would appear that Dr. Ben Beard of the CDC has provided little more than lip service. Dr. Lee was successful in publishing his manuscript rejected by the Journal of Clinical Microbiology and I understand that the number of views tracked by Dove Press reached 5,100 in August: Lyme disease caused by Borrelia burgdorferi with two homeologous 16S rRNA genes: a case report https://www.dovepress.com/lyme-disease-caused-by-borrelia-burgdorferi-with-two-homeologous-16s-r-peer-reviewed-article-IMCRJ Sincerely, Carl Tuttle Hudson, NH Cc: The following law firms: Law Office of Robert J. Krakow, P.C. The Law Offices of Howard Swartz, P.C. Moore Leonhardt & Associates Leila Nadya Sadat, Special Advisor on Crimes Against Humanity Initiative