Please see the letter below addressed to the Chair of the TBDWG as we see yet another study avoiding the late stage disabled Lyme patient population. Anyone wishing to contact the Lyme Disease Working Group can send an email to: tickbornedisease@hhs.gov --------- Original Message ---------- From: Carl Tuttle To: jaucott2@jhmi.edu, olx1@cdc.gov, tickbornedisease@hhs.gov, kbechto1@jhmi.edu, w.robinson@stanford.edu, members@tulane.edu, dmartin@tulane.edu Cc: mark.dayton@state.mn.us, daniel.tillson@mail.house.gov, kvf1@comcast.net, iturko@umd.edu, allen.l.richards.civ@mail.mil, richard.wolitski@hhs.gov, scott.cooper@cms.hhs.gov, khoney@stanford.edu, ddutko@hanszenlaporte.com, kalachakra108@aol.com, chris.smith@mail.house.gov, adam.durand@mail.house.gov, info@smith4nj.com, marisa.kovacs@mail.house.gov, ddiallo@sisterlove.org, tamir.elnabarawy@mail.house.gov, matt.hadro@mail.house.gov, collin.peterson@mail.house.gov, cbb0@cdc.gov, smithr@mmc.org, dennis.dixon1@nih.hhs.gov, estella.jones@fda.hhs.gov, mary.noonan@mail.house.gov, james.berger@hhs.gov, vanila.singh@hhs.gov, lise.nigrovic@childrens.harvard.edu, sdonta@comcast.net, wendyadams1@gmail.com, ptourad1@jhmi.edu, don.wright@hhs.gov Date: July 19, 2018 at 3:04 PM Subject: Robust B Cell Responses Predict Rapid Resolution of Lyme Disease Robust B Cell Responses Predict Rapid Resolution of Lyme Disease https://www.frontiersin.org/articles/10.3389/fimmu.2018.01634/full 18 July 2018 Lisa K. Blum, Julia Z. Adamska, Dale S. Martin, Alison W. Rebman, Serra E. Elliott, Richard R. L. Cao1, Monica E. Embers, John N. Aucott, Mark J. Soloski, William H. Robinson Inclusion Criteria and Clinical Classification Human subjects protocols were approved by the institutional review boards of Johns Hopkins University and Stanford University, and all subjects provided written informed consent in accordance with the Declaration of Helsinki. Bb-infected patients with an erythema migrans (EM) rash of at least 5 cm and either multiple skin lesions or at least one new-onset concurrent symptom were included in the study. Patients were recruited and enrolled at a suburban clinical practice in Maryland, and those with a previous history of Lyme disease, or preexisting confounding medical conditions associated with fatigue, pain, or neurocognitive symptoms were excluded. Following Infectious Diseases Society of America (IDSA) treatment guidelines, all patients were treated with 3 weeks of oral doxycycline (9). Dear Dr. Aucott, I would like to point out that once again the late stage disabled Lyme patient was excluded from this study and only patients with acute Lyme and early treatment were recruited. We need to know how Lyme disease disables its victim so we can treat these people and return them to productive members of society; the numbers are growing exponentially. The medical/scientific community is deliberately ignoring the fact that untreated Lyme of months, years or decades evolves into an entirely different disease unresponsive to the one-size-fits-all IDSA treatment guideline. It’s like ignoring the fact that untreated strep throat progresses to rheumatic fever which we all know causes irreversible heart damage. In reference to the following statement from your study: "Resolution of symptoms following antibiotic treatment was associated with robust plasmablast responses encodingBb-static antibodies, suggesting that plasmablast-derived anti-Bbantibodies could provide the basis for next-generation antibody-based therapeutics for Lyme disease." These "next-generation" therapeutics might be entirely useless (or even harmful) to the late stage disabled Lyme patient. Recruit the disabled Lyme patient and compare plasmablast responses in this class of patient before assuming results from this study can be applied to the entire patient population. We need to move away from the Wormser/IDSA bias study design and include the entire patient population if we are to make real progress here! This note was not meant to be disrespectful. Carl Tuttle Lyme Endemic Hudson, NH