Please see the letter below addressed to the two Designated Federal Officers overseeing the Tick-Borne Disease Working Group. Anyone wishing to contact the Lyme Disease Working Group can send an email to: tickbornedisease@hhs.gov --------- Original Message ---------- From: Carl Tuttle To: James.Berger@hhs.gov, Richard.Wolitski@hhs.gov Cc: jgs@jacquessimon.com, cbb0@cdc.gov, gene@shraderlaw.com, lymeliter@aol.com, tickbornedisease@hhs.gov, Allen.L.Richards.civ@mail.mil, Dennis.Dixon1@nih.hhs.gov, info@honey2healing.org, rhiggins@rustyhardin.com, Scott.Cooper@cms.hhs.gov, Vanila.Singh@hhs.gov, ddutko@hanszenlaporte.com, lise.nigrovic@childrens.harvard.edu, wendyadams1@gmail.com, richard.henry@hhs.gov, sgreen@hardball-law.com, GSkall , LDA@LymeDiseaseAssociation.org, wlancelee@gmail.com, jaucott2@jhmi.edu, khoney@stanford.edu Date: November 27, 2017 at 9:29 AM Subject: Re: Fwd: RE: Working Group Selection (Advisors for Blood Policy) Nov 27, 2017 Office of HIV/AIDS and Infectious Disease Policy (OHAIDP) U.S. Department of Health and Human Services 330 C St. SW, Rm L001 Washington, D.C. 20024 Attn: Dr. Richard Wolitski, Dr. James Berger, Advisors for Blood Policy Dear Dr.’s Wolitski and Berger, I understand that both of you are listed as an Advisor for Blood Policy: Advisory Committee on Blood and Tissue Safety and Availability https://www.hhs.gov/ohaidp/contact-us/index.html Please take a moment to read the following publication: Distribution and survival of Borrelia miyamotoi in human blood components. http://www.ncbi.nlm.nih.gov/pubmed/26689144 RESULTS: In vivo, all the SCID mice challenged with the components before storage and the RBCs stored for up to 42 days developed the infection. Wild-type mice also developed the infection when injected with prestorage samples from all components, while a lower number of mice were infected by RBCs stored for 42 days. In vitro, spirochetes grew in all samples but frozen plasma. Conclusions: This study demonstrated that B. miyamotoi can survive standard storage conditions of most human blood components, suggesting the possibility of transmission by blood transfusion. ____________________________ Lyme disease with its life-altering/life-threatening consequences as described (with references) in my email to CDC Director, Brenda Fitzgerald, MD belongs in the same health threat category as AIDS, Zika, cancer etc. but for unknown reasons misclassified as a low risk and non-urgent health issue. As you know, Babesia is another tick borne infection that has recently been isolated in the U.S. blood supply. If Babesia has found its way into the blood supply you can be sure Lyme is present as well because donated blood is not screened for Borrelia infection. When I questioned the Red Cross about this concern they told me that the Red Cross issues a questionnaire at the time of donation to screen out people who may have had a recent Lyme infection or those who are not feeling well. A questionnaire! Would a questionnaire keep AIDS from entering our blood supply? Of course not. That is why we screen donated blood for AIDS but because Lyme is classified as a simple “nuisance disease” there is no serious concern or screening yet stories of horrific disability and death continue to surface. The Department of Biomedical Sciences in New York conducted a study in 2016 and found that 27% of Lyme patients were positive for Babesia as well. A 2009 tick study here in the State of New Hampshire revealed that Lyme disease was 18 times more prevalent than Babesia. Why have we not conducted a study of our blood supply to determine the prevalence of Borrelia especially in the Lyme endemic regions? We have the ability to test whole blood using 16S rRNA sequence analysis which is promoted by the CDC: Molecular Approaches to Diagnosing and Managing Infectious Diseases: Practicality and Costs https://wwwnc.cdc.gov/eid/article/7/2/70-0312_article 16S rRNA Sequence Based Bacterial Identification February 22-24, 2017 or May 3-5, 2017 ● Atlanta, GA Sponsored by the National Laboratory Training Network in collaboration with the Bacterial Special Pathogens Branch, Centers for Disease Control and Prevention https://www.aphl.org/Materials/588-100_103-17_%2016S_rRNA_Flyer_FINAL.pdf Milford Molecular Diagnostics has had the ability to test for Borrelia using 16S rRNA sequencing for a number of years now and could be utilized for testing blood samples from our blood banks: http://www.dnalymetest.com/lymediseasednatesting.html As this plague continues to rage out of control it would be irrational to assume Lyme disease is not entering the blood supply. As Advisors for Blood Policy what do you intend to do about this serious concern? Please see the following letters regarding Lyme in the blood supply. There was no response from Dr. Moritz of the Red Cross. Respectfully submitted, Carl Tuttle Letters to the Department of Biomedical Sciences and Red Cross: ________________________________________ From: "Carl Tuttle" To: "azad gucwa" Cc: "erin moritz" , "susan stramer" , "comments" , "jdrazen" , "Maria Devlin" , "Jorge Rios" Sent: Tuesday, December 20, 2016 1:57:40 PM Subject: Seroprevalence of Babesia microti in Individuals with Lyme Disease (Published December 1, 2016) Seroprevalence of Babesia microti in Individuals with Lyme Disease http://online.liebertpub.com/doi/full/10.1089/vbz.2016.2020 Dec 1, 2016 Excerpt: In this study, we aimed to determine the seroprevalence of B. microti infection in individuals who tested positive for Lyme disease. Serum samples obtained from 130 subjects in New York were tested by immunofluorescence assay (IFA) for the presence of IgM and IgG antibodies against B. microti. Results: Overall, 26.9% of the serum samples tested were positive for IgM and IgG antibodies against B. microti, suggesting exposure to TBD. Dec 20, 2016 Department of Biomedical Sciences LIU Post 720 Northern Boulevard Brookville, NY 11548 Attn: Azad L. Gucwa Dear Prof Gucwa, I sent the following email to the Red Cross regarding a recent study published before your paper was available. My numbers are a bit off but the purpose was to emphasize that multiple pathogens are entering our blood supply. Unfortunately, Lyme is treated like a nuisance disease and it is not! Borrelia is a slow growing infection and when left untreated has the ability to disable its victim as described below. Sincerely, Carl Tuttle Hudson, NH Letter to the Red Cross: ________________________________________ From: "Carl Tuttle" To: "erin moritz" Cc: "susan stramer" , "comments" , "jdrazen" , "Maria Devlin" , "Jorge Rios" , "kevin mazuzan" Sent: Wednesday, December 14, 2016 2:04:28 PM Subject: NEJM: Screening for Babesia microti in the U.S. Blood Supply Screening for Babesia microti in the U.S. Blood Supply http://doi.org/10.1056/NEJMoa1600897 December 8, 2016 Excerpt: “Of 89,153 blood-donation samples tested, 335 (0.38%) were confirmed to be positive.” Dec 14, 2016 Scientific Affairs, American Red Cross, Gaithersburg, Maryland Attn: Erin D. Moritz, Ph.D Dear Dr. Moritz, Babesia microti is one of many infections transmitted by the bite of a tick. A 2009 tick study in the State of New Hampshire revealed that Lyme disease was 18 times more prevalent than Babesia. (High Lyme disease incidence sites) Correlation between Tick Density and Pathogen Endemicity, New Hampshire https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671416/ Table: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671416/table/T1/ Pathogen prevalence and coinfection in 2 regions of different tick density, New Hampshire Your study revealed 335 cases of Babesia in donated blood yet no one is screening for Borrelia; the causative agent of Lyme disease. It would be irrational to assume Lyme disease is not entering the blood supply and if you were to multiply the number of Babesia cases by a factor of 18 it is quite possible that there were 6,030 cases of Lyme disease right under your noses. This is a serious concern. Lyme disease is capable of producing sudden death with no warning signs; [i] [ii] [iii] heart damage requiring transplant,[iv] paralysis with seizures, [v] and persistent infection after antibiotic treatment [vi] [vii] [viii] [ix] [x] along with congenital transmission [xi] and ability to create wheelchair bound patients.[xii] The last time we recognized a disease with this potential to cause serious harm, (Zika) the CDC wanted 1.8 billion for research. [xiii] Here in the United States however, Lyme has been misclassified as a simple nuisance disease while the focus has been to discredit the sick and disabled [xiv] as opposed to finding a cure for this antibiotic resistant/tolerant superbug. Why are we not testing our blood supply for Lyme disease? A response to this inquiry is requested. Carl Tuttle Hudson, NH Cc: Jeffrey M. Drazen, M.D., Editor-in-Chief, NEJM References: ________________________________________ [i] Cardiac Tropism of Borrelia burgdorferi: An Autopsy Study of Sudden Cardiac Death Associated with Lyme Carditis. (March 2016) http://ajp.amjpathol.org/article/S0002-9440(16)00099-7/abstract Excerpt: “Fatal Lyme carditis caused by the spirochete Borrelia burgdorferi rarely is identified. Here, we describe the pathologic, immunohistochemical, and molecular findings of five case patients.” [ii] CDC Case Study #1: Three Sudden Cardiac Deaths Associated with Lyme Carditis: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6249a1.htm?s_cid=mm6249a1_w [iii] CDC Case Study #2: A case report of a 17-year old male with fatal Lyme carditis http://www.cardiovascularpathology.com/article/S1054-8807(15)00025-3/abstract?rss=yes [iv] Professor Neil Spector: Duke physician uses near-death experience to encourage patient self-advocacy http://www.dukechronicle.com/articles/2015/05/28/duke-physician-uses-near-death-experience-encourage-patient-self-advocacy#.VYlYnxtViko Dr Neil Spector from Duke University required a heart transplant after his Lyme disease went undiagnosed for four years. [v] Nashua Mom in the 'Lyme Light' on Katie Couric Show http://patch.com/new-hampshire/nashua/nashua-mom-talks-chronic-lyme-on-katie-couric-show Fifth-grade teacher Kelly Downing was paralyzed from the neck down and interviewed by Katie Couric. [vi] Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis. http://translational-medicine.biomedcentral.com/articles/10.1186/s12967-015-0701-z 41 of 100 patients under surveillance for persistent LB in an endemic area were positive for urinary OspA protein after antibiotic treatment. [vii] Culture evidence of Lyme disease in antibiotic treated patients living in the Southeast. http://danielcameronmd.com/culture-evidence-of-lyme-disease-in-antibiotic-treated-patients-living-in-the-southeast/ Rudenko and colleagues reported culture confirmation of chronic Lyme disease in 24 patients in North Carolina, Florida, and Georgia. All had undergone previous antibiotic treatment. [viii] 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. [ix] Granulomatous hepatitis associated with chronic Borrelia burgdorferi infection: a case report http://www.labome.org/research/Granulomatous-hepatitis-associated-with-chronic-Borrelia-burgdorferi-infection-a-case-report.html The patient had active, systemic Borrelia burgdorferi infection and consequent Lyme hepatitis, despite antibiotic therapy. [x] Scotty Shelton and Persistent Infection in Saginaw MN https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/11685820 “Scotty's brain (cerebral cortex) was positive for Borrelia burgdorferi and Borrelia myamotoi, his testicle is positive for Bb. We are now testing other tissues. Seven years of antibiotics and 3.5 years of natural treatments (along with antibiotics) and he was highly highly positive.” [xi] Congenital Transmission of Lyme/TBD https://www.dropbox.com/s/z10em0szgpm8bll/Congenital%20Transmission%20of%20Lyme%202015.doc?dl=0 [xii] Wheelchair-Bound Girl Calls Blessing By Pope Francis ‘Most Precious Moment Of My Life’http://newyork.cbslocal.com/2015/09/24/pope-francis-blesses-girl-in-wheelchair/ NEW YORK (CBSNewYork) — A 12-year-old girl who has been confined to a wheelchair since being diagnosed with Lyme disease said meeting Pope Francis as he arrived in New York Thursday was “the most precious moment of my life.” [xiii] $1.8 billion to fight Zika: CDC moves to highest alert level https://www.washingtonpost.com/news/post-politics/wp/2016/02/08/obama-to-ask-congress-for-1-8-billion-to-combat-zika-virus/ [xiv] Antiscience and ethical concerns associated with advocacy of Lyme disease. Auwaerter PG, Bakken JS, Dattwyler RJ, Dumler JS, Halperin JJ, McSweegan E, Nadelman RB, O'Connell S, Shapiro ED, Sood SK, Steere AC, Weinstein A, Wormser GP. http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70034-2/abstract