Please see the letter below regarding the preservation of antibody tests for Lyme disease. I was impressed that Dr. Wolitski called on HIV/AIDS activist Dazon Dixon Diallo to moderate public comment of the Working Group. We are all hoping that change comes out of this process but at the same time we cannot turn a blind eye to what has taken place over the past three decades as it appears that history is repeating itself with serologic testing for Lyme disease. Anyone wishing to contact the Lyme Disease Working Group can send an email to: tickbornedisease@hhs.gov Latest letter to the Working Group: --------- Original Message ---------- From: Carl Tuttle To: tickbornedisease@hhs.gov Cc: jgs@jacquessimon.com, cbb0@cdc.gov, gene@shraderlaw.com, lymeliter@aol.com, Allen.L.Richards.civ@mail.mil, Dennis.Dixon1@nih.hhs.gov, Richard.Wolitski@hhs.gov, info@honey2healing.org, rhiggins@rustyhardin.com, Scott.Cooper@cms.hhs.gov, Vanila.Singh@hhs.gov, James.Berger@hhs.gov, khoney@stanford.edu, ddutko@hanszenlaporte.com, lise.nigrovic@childrens.harvard.edu, wendyadams1@gmail.com, jaucott2@jhmi.edu, GSkall , sgreen@hardball-law.com, richard.henry@hhs.gov, LDA@LymeDiseaseAssociation.org, wlancelee@gmail.com, ddiallo@sisterlove.org, don.wright@hhs.gov Date: December 13, 2017 at 10:05 AM Subject: Re: Advances in Serodiagnostic Testing for Lyme Disease To the Administrator, Please include the following information and attachments into the record of the Working Group. I would like to call attention to a recent announcement regarding next generation serologic tests for Lyme disease: Advances in Serodiagnostic Testing for Lyme Disease Are at Hand https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/cix943/4706288?redirectedFrom=fulltext As we all know, the 1994 Dearborn Conference established a highly restrictive case definition and stripped out the two most important Western blot bands (Band 31 outer surface protein A and Band 34 outer surface protein B) to facilitate vaccine development. The disastrous results of that closed door conference has left thousands of Lyme patients untreated because those who don’t meet the strict case definition are often denied insurance coverage as identified in the racketeering lawsuit: Excerpt from the lawsuit: 49. Once these arbitrary guidelines were decided [Two-tier Serology], the Insurance Defendants could, and did, deny coverage for patients if they did not meet their new stringent Lyme testing protocols. Since most Lyme patients would not test positive under the new protocols, the Insurance Defendants could deny coverage for many people suffering from Lyme disease. ______________________ Once again we have a “closed door” conference for this new test hosted by Cold Spring Harbor Laboratory and two of the defendants of the racketeering lawsuit sat at the table; Raymond J. Dattwyler and Allen Steere. Source: https://www.sciencedaily.com/releases/2017/12/171207095001.htm I would like to point out that the Centers for Disease Control participated as well; Adriana Marques, Paul S Mead, Martin E Schriefer Anyone who feels that the CDC has not been involved in the mishandling of Lyme disease has been living under a rock because the seven defendants named in the racketeering lawsuit all have ties to the CDC. So we are to believe that what was established at Cold Spring Harbor Laboratory is in the best interest of the Lyme community? Doubtful! Who holds the patent of this new test and who stands to gain financially? What new restrictions will be found once this test is rolled out? There is still the issue of antibody production that may not develop for 4-6 weeks after the tick bite. Serology only serves to perpetuate the 30yr dogma as it cannot be used to gauge treatment failure or success. Direct detection methods have been purposely avoided by the CDC as they have the ability to detect persistent infection. In fact, the Sanger method of DNA sequencing was used to detect persistent Borrelia infection in a sixteen year-old boy that was falsely diagnosed with a psychiatric condition after his Western blot didn’t meet the strict case definition. His Western blot only had four out of the five IgG bands so he was sent to a psychiatric ward. When Dr. Sin Lee published his findings, all communication stopped with the CDC: DNA sequencing diagnosis of off-season spirochetemia with low bacterial density in Borrelia burgdorferi and Borrelia miyamotoi infections. https://www.ncbi.nlm.nih.gov/pubmed/24968274 Faulty/misleading antibody tests landed a sixteen year old male in a psychiatric ward when his lab results did not meet the CDC’s strict criteria for positive results. His Western blot had only four of the required five IgG bands. Subsequent DNA sequencing identified a spirochetemia in this patient’s blood so his psychiatric issues were a result of neurologic Lyme disease misdiagnosed by antiquated/misleading serology. This patient was previously treated with antibiotics. ________________ Milford Molecular Diagnostics has the ability to test our blood supply for Lyme disease and I have had discussions with Dr. Lee regarding this serious concern. Quote from Dr. Lee: “In order to perpetuate the dogma created before the era of DNA sequencing, government agencies and the mainstream healthcare industry, including those in the academic centers, have no interest in developing direct testing methods. Their modus operandi is to maintain the status quo of a dysfunctional system, while paying lip service to the need for more research on better testing.” Source: Should the Lyme Patients’ RICO lawsuit include Yale? https://on-lyme.org/en/sufferers/lyme-stories/item/277-should-the-lyme-patients-rico-lawsuit-include-yale Please see the following letter to the editor of Clinical Infectious Diseases --------- Original Message ---------- From: Carl Tuttle To: rschooley@ucsd.edu, alexa011@mc.duke.edu Cc: lliotta@gmu.edu Date: December 8, 2017 at 8:43 AM Subject: Advances in Serodiagnostic Testing for Lyme Disease Are at Hand Advances in Serodiagnostic Testing for Lyme Disease Are at Hand https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/cix943/4706288?redirectedFrom=fulltext Dec, 8 2017 Clinical Infectious Diseases Tufts University School of Medicine 200 Harrison Avenue, Posner Basement Boston, Massachusetts 02111 Attn: Robert T. Schooley, M.D. Editor-in-Chief Dear Dr. Schooley, Early detection and treatment of Lyme disease is of utmost importance but we know that antibodies are not produced for 4-6 weeks after a tick bite. The lack of early diagnostic tests for Lyme disease has caused untold pain and suffering worldwide as delayed diagnosis and treatment often leads to "chronic Lyme disease" or "Post Treatment Lyme Disease Syndrome". In May of 2012 the CDC announced the Development of a Novel Genus-specific Real-time PCR Assay for Detection and Differentiation of Bartonella Species and Genotypes http://www.ncbi.nlm.nih.gov/pubmed/22378904 DNA testing is being used for Bartonella and now Zika: CDC Lauds New DNA Test for Zika in Blood http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/58622?xid=nl_mpt_DHE_2016-06-18&eun=g750897d0r There is a double standard for Lyme disease in reference to DNA testing. Nested PCR and Sequencing for Lyme disease through Milford Molecular Diagnostics can detect early infection with as few as 25 bacteria per mL of blood. Source: http://www.dnalymetest.com/faq.html Antibody tests for Lyme disease cannot be used to gauge treatment failure or success which makes these outdated diagnostic tools ideal for perpetuating the dogma that Lyme disease cannot possibly become antibiotic resistant/tolerant as described in the attached letter addressed to Brenda Fitzgerald, MD Director of the Centers for Disease Control. (Please read this letter when you have a moment) Letter to the Director of the CDC: https://www.dropbox.com/s/xaul84dqmqgbre0/Brenda%20Fitzgerald%20MD%20Director%20CDC.docx?dl=0 There is a double standard regarding the testing for Lyme disease. “Frieden emphasized the distinction between this molecular test for Zika DNA versus serology tests. The latter can indicate any exposure to the virus over time, and also may not give a positive result in a person recently infected. In contrast, a positive molecular test result indicates a current, active infection.” http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/58622?xid=nl_mpt_DHE_2016-06-18&eun=g750897d0r It should be known that two of the authors of the article about to be published in Clinical Infectious Diseases have been named in a racketeering lawsuit; Raymond J. Dattwyler and Allen Steere. Insurers Accused of Conspiring to Deny Lyme Disease Coverage https://www.courthousenews.com/insurers-accused-conspiring-deny-lyme-disease-coverage/ Excerpt: “Twenty-eight people claim in a federal antitrust lawsuit that Lyme disease victims are being forced to pay hundreds of thousands of dollars for treatment because health insurers are denying coverage with bogus guidelines established by their paid consultants, who falsely say the disease can always be cured with a month of antibiotics.” The following statement regarding the IDSA Lyme treatment guidelines was taken from the attached court document: https://www.courthousenews.com/wp-content/uploads/2017/11/LymeDisease.pdf “169. The 2006 Guidelines do not have a legitimate purpose. The IDSA, the IDSA Panelists, and the Insurance Defendants use the Guidelines as a predatory device to injure doctors who do not follow the Guidelines. The 2006 IDSA Guidelines also prevent doctors from providing patients with proven treatment options because the IDSA Guidelines are extremely restrictive. The IDSA Guidelines also limit patients' ability to obtain health care and eliminate patients' choice of medical treatment in the Lyme treatment market.” The Insurance Defendants enlisted the help of doctors who were researching, not treating, Lyme disease. The Insurance Defendants paid these IDSA Panelists large fees and together they developed arbitrary guidelines for testing Lyme disease. 49. Once these arbitrary guidelines were decided [Two-tier Serology], the Insurance Defendants could, and did, deny coverage for patients if they did not meet their new stringent Lyme testing protocols. Since most Lyme patients would not test positive under the new protocols, the Insurance Defendants could deny coverage for many people suffering from Lyme disease. _________________________ It is time we recognize the shortcomings of antibody tests and scrap any attempts to promote this antiquated technology. Respectfully submitted, -Carl Tuttle Hudson, NH