As a follow-up to the “New species of Borrellia in the Hudson Valley, NY area” please see the following (2nd) letter from Dr Sin Lee demanding a retraction of the defamatory remarks by the CDC’s Director, Dr Beth Bell. My letter to Dr Bell follows Dr Lee’s letter below as I have offered to post any retraction from the CDC. Dr Lee’s letter to the CDC: _____________________ Dr Beth P Bell Director The National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Centers for Disease Control and Prevention (CDC) bzb8@cdc.gov cc: Carl Tuttle runagain@comcast.net May 1, 2016 Re: Demand a retraction of defamatory remarks Dear Dr Bell: In an open email correspondence dated March 13, 2016 https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/15826757, I requested that you point out the “inconsistent results” you allegedly found in a peer-reviewed publication in which the authors reported DNA sequencing-based evidence of a novel relapsing fever borrelia strain detected in a CDC-supplied archived serum sample originally collected from a patient who had been treated for neurologic Lyme disease [1]. Since you have not answered my email, I must assume that you cannot substantiate your base-less and disparaging allegation. As the lead author of the above referenced publication, I demand that you publish a retraction and openly apologize for having made such defamatory remarks to smear the reputation of the authors of the publication. As the Director of the CDC NCEZID, you approved a research project, the purpose of which was “to evaluate the accuracy of a new diagnostic test for Lyme disease, utilizing nested PCR and DNA sequencing” under CDC Material Transfer Agreements No. NCEZID-R137154-00 and No. NCEZID-R147284-00, listing me, Sin Hang Lee, MD as the Investigator. I submitted two reports dated September 4, 2013 and November 21, 2013, respectively to the NCEZID, stating in both reports the following conclusion: “Since Lyme disease-related borrelioses are now known to be caused by Borreliae other than Borrelia burgdorferi sensu stricto, PCR primers designed to amplify the 16S ribosomal RNA gene DNA of various members of the Borrelia burgdorferi sensu lato complex and Borreliae of the relapsing fever group are also used in this testing protocol. Molecular diagnosis of a Borrelia requires a 100% ID match of the nested PCR amplicon with the standard 16S ribosomal RNA gene DNA in the region selected for DNA sequence alignment analysis.” Using the same protocol for testing patient materials, another novel Lyme disease borrelia has been detected and reported in an article entitled “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 These published results indicate that there are as yet unrecognized borrelia strains causing “Lyme disease” in the United States. Based on information available in the public domain, Lyme and related borreliosis in the U.S. can be caused by Borrelia burgdorferi sensu stricto, B miyamotoi, B mayonii and at least two unnamed borrelia strains reported from my laboratory, one of which has a GenBank Seq ID KM052618. I understand you might try to discredit other innovative technologies which are in competition to the invention being patented by Theresa M. Russell and Barbara J.B. Johnson of the NCEZID under Pub. No. WO 2013110026 A1 entitled “Compositions and methods relating to Lyme disease”. However, as the director of the NCEZID, you also need to not ignore the scientific and technical advances made since the first description of Lyme disease in the mid-1970s before the DNA sequencing and PCR technologies were invented in the best interest of Lyme disease patients. Based on the conclusion of the project studies I reported to the CDC NCEZID in 2013, you knew or should have known that genus-specific PCR amplifications can detect all known strains, including Borrelia burgdorferi sensu stricto, B miyamotoi, and B mayonii and probably many unknown strains of pathogenic borreliae in human patients. I implore you to immediately implement a national proficiency test program to survey the competencies of all diagnostic laboratories offering Lyme disease testing in this country for their ability in detecting these microbes in simulated blind-coded samples, as routinely performed for all infectious agents by the College of American Pathologists, to stimulate innovative development of the diagnostic tools for reliable diagnosis of all Lyme-related borrelial infections at the early stage of the disease for timely appropriate treatment to prevent tissue damage and “chronic Lyme disease” whose existence we can no longer deny. I am looking forward to reading your response. Sincerely, Sin Hang Lee, MD Director Milford Molecular Diagnostics laboratory Shlee01@snet.net Reference [1] Lee SH, Vigliotti JS, Vigliotti VS, Jones W, Shearer DM. Detection of Borreliae in Archived Sera from Patients with Clinically Suspect Lyme Disease. Inter J Mol Sci. 2014; 15:4284-4298. Carl Tuttle’s follow-up letter to Dr Bell: _________________________________________ May 11, 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 am in receipt of Dr Sin Lee’s second letter addressed to you on May 1, 2016 and have posted his letter to the Change.org site. As a Lyme disease patient, I would like to know more of the research project which you approved and whose purpose was “to evaluate the accuracy of a new diagnostic test for Lyme disease, utilizing nested PCR and DNA sequencing”, as stated in Dr. Lee’s second letter to you. It is encouraging indeed to learn that the CDC actually had agreed to help initiate a PCR-based test for Lyme and related borreliosis for early diagnosis. I would be glad to publish in this forum any correspondence between the CDC and Dr. Lee on this matter because there seems to be a public health issue here; the public has a right to know. 1. I would gladly post a retraction of your remarks as Dr Lee demands; 2. You are welcome to point out the “inconsistent results” of Dr Lee’s publication. 3. Have an open debate to justify the CDC’s position to not consider Dr Lee’s proposal of instituting a national proficiency test program to survey the competencies of all diagnostic laboratories testing for Borrelia burgdorferi, B miyamotoi, B mayonii and other strains of pathogenic borreliae in human patients. Infections by B miyamotoi and B mayonii cannot be diagnosed by the current two-tiered serology tests so we can no longer maintain the status quo of a dysfunctional system by suppressing innovations. Sincerely, Carl Tuttle Hudson, NH