New species of Borrellia in the Hudson Valley, NY area? There may be a species of Borrellia yet to be discovered in the Hudson Valley, NY area as reported three years ago per the study identified in this update but unlike the recent Mayo Clinic discovery, the CDC has done nothing to investigate. The FOIA request which follows the letter below revealed that Dr Gary Wormser of New York Medical College provided the serum samples where this novel Borrelia was isolated. Not only was a novel Borrelia discovered but there was a second pathogen (Borrelia miyamotoi) found in one sample which was 2-tier serology-negative. In two of the samples containing Borrelia burgdorferi, one sample was negative and one positive for 2-tier serology making it obvious that current testing for Lyme disease has serious flaws. 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 don’t even know what they contain? DNA sequencing does not require that we wait for antibodies to appear to make the diagnosis and at a reasonable cost ($150) should be made available in walk-in clinics to provide early detection of Lyme disease. (DNA sequencing-proven molecular diagnosis) Currently, we need two serologic tests taken 6 weeks apart to compare while withholding preventive antibiotic treatment which is antiquated and extremely dangerous to the patient. Direct DNA sequencing has the potential to identify persistent infection (Chronic Lyme) which would threaten the existing thirty year dogma. Is this why the CDC is avoiding Milford Molecular Diagnostics? http://www.dnalymetest.com/ Letter to the CDC awaiting a response: ________________________________________ From: "Carl Tuttle" To: bzb8@cdc.gov Cc: mms7@cdc.gov, ard5@cdc.gov Sent: Tuesday, February 16, 2016 3:27:52 PM Subject: [MMI] New Lyme-disease-causing bacteria species discovered Feb 16, 2016 National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention 1600 Clifton Road Atlanta, GA 30329-4027 Attn: Beth P. Bell, MD, MPH, Director Dear Dr Bell, I would like to call attention to the following CDC study: New Lyme-disease-causing bacteria species discovered Borrelia mayonii closely related to B. burgdorferi http://www.cdc.gov/media/releases/2016/p0208-lyme-disease.html Excerpt: “Centers for Disease Control and Prevention, in collaboration with Mayo Clinic and health officials from Minnesota, Wisconsin, and North Dakota, report the discovery of a new species of bacteria (Borrelia mayonii) that causes Lyme disease in people.” In August of 2013 the CDC provided 32 blind coded serum samples to Milford Laboratory Services 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 Per the following published study results of the serum samples you sent to Milford Laboratory Services, it appears that a novel Borrelia was isolated in one of these samples. 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 ______________________ Questions for the CDC 1. Has the CDC investigated this “novel Borrelia” similar to the collaboration with the Mayo Clinic’s discovery of Borrelia mayonii? 2. Patient #9 was previously treated for “neurologic Lyme disease” yet evidence of infection persists. Why hasn’t that infection cleared after antibiotic treatment? Your prompt attention and response to these questions is greatly appreciated. Sincerely, Carl Tuttle Hudson, NH 3 Attachments: FOIA Request CDC Acknowledgement letter FOIA results: New York Medical College/Gary Wormser FOIA REQUEST (This request required the assistance of a legislator before information was released) ________________________________________ From: "Carl Tuttle" To: FOIARequests@cdc.gov Cc: "katherine norris" , "bruno viana" Sent: Saturday, April 4, 2015 11:58:08 AM Subject: FOIA Request 4-4-15 April 4, 2015 CDC/ATSDR FOIA Office, MS: D54 1600 Clifton Rd, N.E. Atlanta, GA 30333 Attn: Katherine Norris, CDC/ATSDR FOIA Officer Dear Katherine, Under the FOIA, I respectfully request that the Centers for Disease Control and Prevention, Fort Collins, CO release the names of the institutions/experts who supplied the standard samples under Material Transfer Agreements Reference Numbers NCEZID-R137154-00 and NCEZID-R147284-00 per the published study below. The CDC relies on these standard samples to evaluate other test kit developments. Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations and activities of the government therefore I request a waiver of any fee associated to this FOIA request. Published: 11 March 2014 Detection of Borreliae in Archived Sera from Patients with Clinically Suspect Lyme Disease http://www.mdpi.com/1422-0067/15/3/4284/htm Excerpt: Acknowledgments: The authors thank the Centers for Disease Control and Prevention, Fort Collins, CO for supplying two panels of blind-coded serum samples under Material Transfer Agreements Reference Numbers NCEZID-R137154-00 and NCEZID-R147284-00 in support of this study. Respectfully submitted, Carl Tuttle Hudson, NH 03051 Email: runagain@comcast.net