Update 7A – Lyme Corps Assessment Brief, part 1 of 2 Greetings from Jenna, Today and tomorrow I will share my CDC Lyme Corps Assessment Brief. I have shared my Brief and recommendations for course correction, with many persons who I understand to have some measure of responsibility for the Lyme Corps program, such as the persons managing and implementing the program. CDC Director Thomas Friedan has been included in certain key correspondences since they began on January 14, 2016. To date, I have received two general responses that did not provide answers to my inquiries. This brief has five main findings. I will share Findings 1, 2 and 3 with you today. Your feedback in welcome! Introduction: This is an assessment brief of Lyme Corps, a program conceived and implemented by the Centers for Disease Control and Prevention (CDC) under the National Center for Emerging and Zoonotic Infectious Diseases’ (NCEZID) Division of Vector-Borne Diseases (DVBD). The assessment reviews the program for coherence between its design, stated objectives, intended results and related CDC strategic objectives. The review includes the identification of certain anomalies, unintended consequences and some considerations of economic impact. Background: The Lyme Corps program trains students pursuing health care degrees (MD, RN, MS, etc.) and public health degrees to provide Lyme disease education and outreach to the public and health care providers (HCPs). The Lyme Corps program “seeks new means of educating HCPs and the public about Lyme disease because: (1) recent surveys indicate that provider practices are often inconsistent with current guidelines and (2) inaccurate information about Lyme disease is disseminated broadly through internet forums, social media, and traditional media. ” [Ref 1] Once trained by Lyme Corps, participants’ primary responsibilities include: “(1) educating colleagues; (2) educating HCPs via clinic visits and material dissemination; and (3) increasing public knowledge in-person and online.”[Ref 1] Lyme Corps implementation initiated in 2013 and appears to be on-going. Finding One: Lyme Corps is ill-conceived. The Infectious Disease Society of America (IDSA) promotes the view that Lyme disease is easy to diagnose and simple to treat with a limited course of antibiotics. The International Lyme and Associated Diseases Society (ILADS) recognizes that Lyme disease is a complex and serious illness of epidemic proportion and offers individualized patient-centered treatment options. The ILADS Lyme guidelines are posted on the federal National Guidelines Clearinghouse (NCG) and conform to criteria based on the high evidentiary standards of the Institute of Medicine (IOM). It should be noted that on February 12, 2016 the IDSA Lyme treatment guidelines were removed from the NGC because they do not meet the high evidentiary standards set by the Institute of Medicine. However, DVBD surveys that indicated “provider practices are often inconsistent with current guidelines” are based on adherence to IDSA Lyme treatment guidelines and their exclusion of the sanctioned ILADS Lyme treatment guidelines. These flawed survey findings define all Lyme Corps activities and are foundational to the entire Lyme Corps program. Finding Two: Lyme Corps is disseminating misinformation about Lyme. Lyme Corps emphasizes a diagnostic reliance on sub-standard tests and a simplified symptoms list intended solely for surveillance purposes. The College of American Pathologists found that ELISA tests to not have adequate sensitivity to be used for screening purposes (Bakken 1997). 52% of patients with chronic Lyme disease are negative by ELISA but positive by Western blot (Donta 2002). Between 20-30% of patients with confirmed Lyme disease are seronegative (Aguero-Rosenfeld 1996, 1993; Donta 1997). The two-tiered test system misses roughly 54% of patients. (Stricker Minerva 2010) This substandard Lyme testing has prompted legislation, such as the Virginia Lyme Disease Testing Disclosure Act, which mandates that all physicians who suspect and test patients for Lyme disease must disclose that a negative test result does not necessarily mean that the patient does not have Lyme disease. Lyme Corps material makes little reference to significant knowledge gaps. For example, the increasing numbers of Borrelia that are linked to Lyme-like illnesses and how these are affecting diagnosis outcomes. These include Borrelia bissettii, Borrelia Americana, Borrelia andersonii, Borrelia lonestari, Borrelia miyamotoi, Borrelia turicatae, and Borrelia mayonii; all of which have been confirmed in the USA. [Ref 2, 3, 4, 5, 6] Lyme Corps training content uses and disseminates documents such as the TICKBORNE DISEASES OF THE UNITED STATES - A Reference Manual for Health Care Providers First Edition, 2013. The Lyme disease material in this publication mischaracterizes Lyme disease as a simple-to-diagnose-and-treat illness. [Ref 7] This publication cites seven references. Of the seven references, five were published a decade or more earlier, including a 33 year old publication and a 20 year old publication. One of the seven publications is a reference of the substandard IDSA Lyme treatment guidelines that have been removed from the NGC. And another reference is “a summary on Lyme disease.” Lyme Corps is promoting Lyme disease information largely derived from outdated expert opinion, rather than scientific evidence. A portion of the Lyme Corps training materials omit information regarding persisting Lyme symptoms and infection. Another portion of the training materials state there is no evidence of persistent Lyme infection and that the use of antibiotic treatment beyond the IDSA treatment protocol is unnecessary and dangerous. Altogether, there is wide-ranging misrepresentation of current science-based evidence that details the lingering complexity and dangers of Lyme. Lyme Corps portrays providers’ practices that conform to certain IOM and NCG sanctioned Lyme treatment guidelines as harmful - even fatal – for Lyme patients. The training materials do not present the ILADS patient-centered treatment protocols. Finding Three: Lyme Corps appears to be a stealth program; it does not conform to federal standards for transparency of non-classified activities. In January 2016, direct contact with the CDC provided little information about Lyme Corps. For example, unlike most CDC outreach programs, Lyme Corps has no reference link on the CDC website. Persistent calls to the CDC General Inquiries 800-CDC-INFO engaged an “information specialist” who did not access information about the program and did not provide a phone to reach the DVBD. Web research uncovered phone number (970) 221-6400 on a DVBD factsheet. However, general inquiry calls to DVBD yielded little to no information about Lyme Corps. Information regarding Lyme Corps funding, calendar and activity roll-out appear inaccessible. There are no public CDC links to the Lyme Corps programs implemented at John Hopkins University (2014), University of Vermont (2014), University of Maryland Baltimore (2015) or James Madison University and University of Virginia (2015). These Lyme Corps activities were discovered by broad web searches. General web search revealed anomalies such as a website that states “Nursery plant sale advertising flyer - Johns Hopkins” and then presents the Lyme Corps poster advertisement at Johns Hopkins University. [Ref 1] See link https://nphic.confex.com/cdc/nphic14/webprogram/Paper35413.html [Ref 2] http://www.ncbi.nlm.nih.gov/pubmed/26673735 [Ref 3] Lyme and/or Lyme-like Disease in Missouri, Edwin J. Masters and H. Denny Donnell. Mo Med. 1995 Jul; 92(7):346-53. [Ref 4] http://www.scientificamerican.com/article/new-cause-for-lyme-disease-complicates-already-murky-diagnosis1/?WT.mc_id=send-to-friend [Ref 5] Borrelia miyamotoi Disease in the Northeastern United States: A Case Series Philip J. Molloy, MD; Sam R. Telford III, ScD; Hanumara Ram Chowdri, MD; Timothy J. Lepore, MD; Joseph L. Gugliotta, MD; Karen E. Weeks, BS; Mary Ellen Hewins, BS; Heidi K. Goethert, ScD; and Victor P. Berardi See link - http://annals.org/article.aspx?articleid=2301402 [Ref 6] Eglin medical group first to find bacteria unseen in humans By Ilka Cole, Eglin Air Force Base Public Affairs / Published January 13, 2016 see link - http://www.af.mil/News/ArticleDisplay/tabid/223/Article/642832/eglin-medical-group-first-to-find-bacteria-unseen-in-humans.aspx [Ref 7] http://www.cdc.gov/lyme/resources/TickborneDiseases.pdf TO BE CONTINUED