As a follow-up to the last petition update the CDC responded to the two questions I presented regarding a novel Borrelia species found in a CDC provided blind coded serum sample sent to Milford Molecular Diagnostics for the purpose of test development and evaluation. The CDC’s response does not make sense (and prompted more questions) as I could not find anything within the study claiming that Dr Sin Hang Lee reported “inconsistent results” regarding this novel Borrelia species from the Hudson Valley area of New York. A previous FOIA request revealed that Dr Gary Wormser of New York Medical College collected the original serum samples. The CDC awarded NY Medical College $129,956 for 78 early localized (EM) serum samples and $98,430 for 18 early disseminated serum samples. In one statement the CDC claims that it is not possible to trace back to the patient but then tells us he/she had 4 days of antibiotic treatment. (Patient #9 was previously treated for “neurologic Lyme disease”) This is the study which used CDC supplied serum samples: Detection of Borreliae in Archived Sera from Patients with Clinically Suspect Lyme Disease http://www.mdpi.com/1422-0067/15/3/4284 The email thread below contains the original two questions, the official CDC response and my new inquiry. NEW INQUIRY: ________________________________________ From: "Carl Tuttle" To: bzb8@cdc.gov Cc: "NCID" , ard5@cdc.gov, mms7@cdc.gov Sent: Sunday, March 6, 2016 9:40:32 PM Subject: Re: New Lyme-disease-causing bacteria species discovered (New Request) Mar 6, 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 presented two questions to your attention on Feb 16, 2016 regarding serum samples used for developing diagnostic tests and received a response from: NCID/VBI BZB Public Inquiries (see below). Although my two questions were answered, the response has prompted further examination of the CDC’s actions regarding the possibility of a novel neuro-invasive strain of Borrelia isolated in blind coded serum samples from your repository. Original question: Has the CDC investigated this “novel Borrelia” similar to the collaboration with the Mayo Clinic’s discovery of Borrelia mayonii? CDC Answer: No. Please note that the authors of this publication reported inconsistent results for this specimen and that their attempts to further characterize failed. The Mayo Clinic’s results were reproduced and culture-confirmed. Additional questions:(New) a) Since these authors stated in the article, “After the testing results were reported to the CDC, the blinded serum samples were decoded.”, did the CDC point out to the authors the inconsistent results for this specimen after receiving the authors’ report or after the publication of their article? b) Does the CDC now claim that the data presented in this publication are invalid and the article should be retracted for accuracy of science presented to the public? c) Does the CDC claim that failure to further characterization of a borrelial 16S rRNA gene DNA segment invalidates the DNA sequencing data that the authors reported in a peer-reviewed article and have deposited in GenBank ID# KM052618 as evidence for a novel borrelia? d) Does the CDC claim that all microorganisms, including human pathogens, in particular pathogenic spirochetes, must be culture-confirmed in artificial media for a molecular diagnosis to be established? e) Does the CDC claim all DNA sequencing-based diagnostic tests for borrelial infections must be reproduced on each human specimen to be valid, regardless of the density or the numbers of the microbes in the sample? f) How does the CDC interpret the DNA sequencing data reported to the CDC and published as Patient #9 in these authors’ article? Does the CDC consider these sequences are DNA contaminants from the air? Or the CDC considers these are representative of a strain of Borrelia burgdorferi sensu stricto causing neurologic Lyme in this case? ____________________________ 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. g) How can the CDC use these serum samples from their serum repository to gauge the accuracy of newly developed Lyme disease test kits when you don’t 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. Please follow-up and answer the seven new questions in this message. Sincerely, Carl Tuttle Hudson, NH Official CDC Response for the first two questions: ________________________________________ From: "NCID" To: runagain@comcast.net Sent: Friday, February 26, 2016 5:55:04 PM Subject: New Lyme-disease-causing bacteria species discovered (Second Request) Dear Mr. Tuttle, Thank you for your inquiry. We have provided responses to your questions below. Has the CDC investigated this “novel Borrelia” similar to the collaboration with the Mayo Clinic’s discovery of Borrelia mayonii? No. Please note that the authors of this publication reported inconsistent results for this specimen and that their attempts to further characterize failed. The Mayo Clinic’s results were reproduced and culture-confirmed. Patient #9 was previously treated for “neurologic Lyme disease” yet evidence of infection persists. Why hasn’t that infection cleared after antibiotic treatment? The serum sample that you refer to was received by CDC as part of an anonymized set of serum samples intended for widespread distribution for test development and evaluation. By both IRB review and patient consent, it is not possible to trace back to the patient. Patient #9 had received 4 days of antibiotic treatment at the time the sample was collected. Thank you, Centers for Disease Control and Prevention Division of Vector-Borne Diseases | Bacterial Diseases Branch Fort Collins, Colorado email: bzb_public@cdc.gov Original questions: ________________________________________ From: Carl Tuttle [mailto:runagain@comcast.net] Sent: Tuesday, February 23, 2016 9:10 AM To: Bell, Beth (CDC/OID/NCEZID) Cc: Molins, Claudia R. (CDC/OID/NCEZID); Schriefer, Martin (CDC/OID/NCEZID) Subject: Re: New Lyme-disease-causing bacteria species discovered (Second Request) Second Request Dr Bell…….Please answer the two questions submitted below on Feb 16, 2016. Thank you, -Carl Tuttle ________________________________________ From: "Carl Tuttle" To: bzb8@cdc.gov Cc: ard5@cdc.gov, mms7@cdc.gov Sent: Tuesday, February 16, 2016 3:27:52 PM Subject: 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