Please see the following letter to the Commissioner of the Food and Drug Administration. Consider writing an email of your own describing your experience with faulty Lyme testing and send it to Dr Ostroff with a copy to your state legislators. -Carl Tuttle ________________________________________ From: "Carl Tuttle" To: "Stephen Ostroff" Cc: "sally howard" , "Robert Califf" , "Luciana Borio" , "Walter Harris" , "Jeremy Sharp" , "Taha Kass-Hout" , "jeff shuren" , "Dick Blumenthal" , "Kemp Hannon" , bonacic@senate.state.ny.us, "Serino" , "Bud Fitch" , "Daniel Auger" , "Shaylyn Kelly" , "matt sheehey" Sent: Monday, September 28, 2015 8:49:59 AM Subject: FDA-regulated/approved Laboratory Tests U.S. Food and Drug Administration Protecting and Promoting Your Health "It’s a singular honor to be given the opportunity to represent the people of the FDA who every day dedicate their work to assure safe and effective medical products, foods, and cosmetics and to mitigate the health consequences of tobacco products," says Dr. Ostroff. Sept 28, 2015 U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Attn: Dr Stephen Ostroff, Acting Commissioner of Food and Drugs Dear Dr Ostroff, Per the U.S. Food and Drug Administration website there appears to be eleven pages of patient complaints regarding faulty/misleading Lyme disease antibody testing and subsequent misdiagnosis: MAUDE - Manufacturer and User Facility Device Experience http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/TextResults.cfm?dls=1&q=lyme&pf=&pn=10&sc= These tests are responsible for countless disabilities due to wrong or delayed diagnosis. Lyme disease can become a life altering experience when not treated immediately as many celebrities are now reporting. Celebrities reporting disability: https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/13301800 Per the email below addressed to the corresponding author of a tick study in Utah the current two-tier FDA-regulated testing algorithm has been identified as unreliable and misleading. I am hoping that you recognize this complaint as serious and respectfully request that you take the time to read the email and attachments to gain an understanding of the severity of this issue. It has become so dyer that the State of Virginia had to pass a law requiring physicians to notify patients that a negative Lyme test does not actually mean you do not have Lyme disease. Virginia House Bill 1933: https://www.lymedisease.org/virginia-gov-signs-lyme-bill-2/ A paper co-authored by Barbara Johnson, an expert with the CDC Lyme program, reveals that the current two-tier method is positive in only 31% of those with erythema migrans (the bull's-eye rash associated with Lyme disease) and in only 63% of those with acute neuroborreliosis or carditis due to burgdorferi Lyme disease. This means that out of 100 patients who have Lyme disease, we might misdiagnose 69 of them, leaving their infections untreated. Barbara Johnson paper: http://cid.oxfordjournals.org/content/50/1/20.full This travesty has been ongoing for three decades. It is time to stop turning a blind eye to this life altering infectious disease. Your immediate attention is requested. Sincerely, Carl Tuttle Hudson, NH Email to the Corresponding Author: ________________________________________ From: "Carl Tuttle" To: "scott bernhardt" , llarsen@standard.net Cc: "ryan davis" , "ricardo ramirez" , "laine anderson" , wkreisen@ucdavis.edu, "theodore andreadis" , rbarrera@cdc.gov, "journals publicity" Sent: Sunday, September 27, 2015 12:40:01 PM Subject: Study finds you probably can't get Lyme disease from Utah ticks Study finds you probably can't get Lyme disease from Utah ticks FRIDAY , SEPTEMBER 25, 2015 - 2:31 PM By: Leia Larsen, Reporter http://www.standard.net/Health/2015/09/24/You-probably-can-t-get-Lyme-disease-from-Utah-ticks.html Study involved in this story: “Journal of Medical Entomology” Distribution and Habitat of Ixodes pacificus (Acari: Ixodidae) and Prevalence of Borrelia burgdorferi in Utah Ryan S. Davis, Ricardo A. Ramirez, J. Laine Anderson, Scott A. Bernhardt http://jme.oxfordjournals.org/content/early/2015/08/17/jme.tjv124 Sept 27, 2015 Department of Biology Utah State University 5305 Old Main Hill Logan UT, 84322-5305 Attn: Scott Bernhardt, Corresponding Author Dear Scott, I would like to call attention to the following quotes found in Leia Larsen’s Standard Examiner’s article: “There hasn't been a documented case confirming that Lyme disease came from a Utah tick.” “we did not look at the entire state," Bernhardt said. “It’s not feasible. We went where the majority of human population is located.” “..all the recovered western black-legged ticks with the potential to carry Lyme disease came from the St. George area and southwest of Provo.” As of Sept 7, 2015 the following Change.org petition has generated 63 Signatures and heart wrenching comments from Lyme patients in the state of Utah. I have attached a copy of those comments for your review. (Removing the names of those who signed the petition) https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf (30,000 signatures growing worldwide) Signatures originating from locations in Utah: Lehi, Spanish Fork, Highland, Salt Lake City, Ephraim, Logan, Orem, Taylorsville, Murray, Cedar City, Payson, Brigham City, Sandy, Heber City, Eagle Mountain, Gunnison, West Jordan, Herriman, Bountiful, West Point, Ogden, West Valley City, Morgan, Hyde Park, Provo, American Fork, Layton, Moab, Roosevelt, Salina, Clearfield, Layton, Saratoga Springs, Pleasant Grove, Bryce Canyon, Lindon, Midvale A confirming case of Lyme disease requires that a patient meet the CDC’s strict criteria for positive test results; two out of three IgM and five out of ten IgG Western blot bands. Serology for Lyme disease is notoriously unreliable/misleading[1] causing great harm to patients across the country yet these tests are the only FDA approved method for diagnosing (And reporting) Lyme disease. In reference to Dr Volkman’s attached letter addressed to the CDC’s Dr. Thomas Frieden, the following study from China concluded that Western blot criteria for a positive diagnosis of Lyme disease were established with only one IgM band and one single IgG band. (Band 41) A Study of the Technique of Western Blot for Diagnosis of Lyme Disease caused by Borrelia afzelii in China* 2013 Mar;26(3):190-200. doi: 10.3967/0895-3988.2013.03.006. http://www.ncbi.nlm.nih.gov/pubmed/23425802 Per the U.S. Food and Drug Administration website there appears to be eleven pages of patient complaints regarding faulty/misleading Lyme disease antibody testing and subsequent misdiagnosis: MAUDE - Manufacturer and User Facility Device Experience http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/TextResults.cfm?dls=1&q=lyme&pf=&pn=10&sc= Dr Sin Lee of Milford Molecular Diagnostics developed DNA sequencing-based tests for Lyme disease which identified the causative agents in a sixteen year old patient’s blood wrongly diagnosed with psychiatric illness. His Western blot had only four IgG bands not the required five for positive results. A complaint was filed with the Massachusetts Medical Board: https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/9024981 What has been exposed here is evidence of a faulty diagnostic system (or one too stringent per Dr Volkman’s attached letter.) No one in our family met the CDC's criteria for positive results (see attached Western blot) so if we hadn't met Dr Sam Donta (Lyme disease specialist) none of us would have been treated for Lyme disease. This is not an isolated experience. One way to stop an epidemic is to redefine it by narrowing the disease's diagnostic criteria so tightly that it's hard for any chronically ill Lyme patient to fit the profile and obtain insurance reimbursement. This is exactly what has caused case numbers to be artificially low or appear to be “nonexistent.” Ignoring patient complaints equates to medical neglect as we are dealing with a life altering infection[2] when not treated immediately. The comments I have attached from Utah describe the difficulties obtaining a diagnosis and treatment due to the restrictive CDC case definition. I believe what we are dealing with here is the 21st Century plague horribly mismanaged as there are sick patients from 21 countries now signing the petition. Borrelia species are found throughout the world http://www.infectionecologyandepidemiology.net/index.php/iee/article/view/9545 and we missed a thirty plus year opportunity to find a medical solution as the immediate focus was vaccine development (epic failure[3]) ostracizing sick and disabled patients painting them as delusional while our blood supply is not screened for this pathogen. It is unfortunate that your study and subsequent article in the Standard Examiner only reinforces a false sense of security for an unsuspecting public while the medical community practices willful ignorance blindly following what has been wrongly established by the CDC. It is time to stop turning a blind eye to this thirty plus year deception to humanity. Respectfully submitted, Carl Tuttle Hudson, NH REFERENCES ________________________________________ [1] Understanding the EIA Test https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/11299975 [2] Long-Term Assessment of Health Related Quality of Life in Patients with Culture-Confirmed Early Lyme Disease https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/13301800 [3] Int J Risk Saf Med. 2011;23(2):89-96. doi: 10.3233/JRS-2011-0527. Neurological complications of vaccination with outer surface protein A (OspA). Marks DH1. http://www.ncbi.nlm.nih.gov/pubmed/21673416