The United States (US) federal government recognizes May as Lyme disease Awareness Month. The Centers for Disease Control and Prevention (CDC) is the lead federal agency mandated to protect the health and welfare of the US population against the Lyme epidemic. The CDC’s Lyme policies and guidelines for diagnosis and treatment are followed by many nations across the world. In May 2016, the majority of state government health departments implemented annual public outreach activities for Lyme awareness. In almost every state, nongovernmental organizations implemented Lyme disease Awareness Month activities. In addition, many Lyme patient groups, scientists, healthcare professionals and other Lyme advocates met with their state officials and elected representatives to discuss concerns regarding the increasing medical, financial, and social costs of the Lyme epidemic. [i] Topics of concern included the lack of: - access to treatment options for Lyme, chronic Lyme and coinfections, and tickborne illnesses - insurance coverage for federally sanctioned patient centered treatment options - quality healthcare training regarding these illnesses and the need for: - improved diagnostics and fast-tracking their approval and access - enhanced management of the tick vector improved prevention technology - comprehensive strategies to provide public education to increasing numbers of school-age children suffering from tickborne illnesses and unable to maintain regular school attendance. The global Lyme community has also adopted May as Lyme disease Awareness Month and the results of this mobilization is gaining traction. In May 2016 the global Lyme movement made significant advances. Lyme activities were implemented in Canada, Luxembourg, Belgium, France, Austria, Netherlands, Italy, Spain, Switzerland, Norway, Sweden, Denmark, Finland, Iceland, Brazil, Germany, Greece, United Kingdom (UK), Ireland, Scotland, Croatia, Czechoslovakia, Poland, Romania, Russia, Hungary, Australia, New Zealand and South Africa. As in the US, Lyme patient groups, scientists, healthcare professionals and other Lyme advocates initiated most of these activities. For example, the August 9, 2013 Huffington Post article 'The Global Search for Education: In Search of Solutions – Ticks', by C. M. Rubin reported, “In Poland, doctors are allowed to treat patients the way they wish, and if you’re bitten, there are places where you can bring your ticks for analysis to see if they are infected…[and] in Germany, doctors can also treat patients as they think best, including plants, low frequency therapies, long term antibiotic treatments…” These patient-centered approaches do not reflect the CDC Lyme policies and guidance. In 2016, many Lyme organizations have cooperated globally to share such enlightened practices and counter the devastations of this pandemic. Media outlets, including national networks of television and print news, and many forms of social media reported and recorded an extraordinary level of activity regarding educational and political activities for Lyme, chronic Lyme and coinfections and tickborne illnesses. In addition to media attention, gains were made in political support for recognizing and providing affordable patient-centered options for chronic Lyme, coinfections and other tickborne illnesses. For example, the UK Lyme Disease (UKLD) Protest 2016 were held in Bath and London. “The events achieved unprecedented media attention with patients being interviewed around the country in newspapers, on TV and on local radio shows as well as at the events.” [ii] On 21st May 2016, Lyme Disease UK (LDUK) group members in the South West gave interviews to the UK’s eminent network British Broadcast (BBC). The Bath LDUK protest was also featured in The Midsomer Norton, Radstock & District Journal. A London protest was held in Parliament Square on 24th May 2016 and was very well attended - with Members of Parliament, Lyme patient champion Lady Mar and Veronica Hughes, CEO of Caudwell Lyme Disease all present to show support. Philanthropist billionaire and entrepreneur John Caudwell and LDUK member Lorraine Murray criticized UK’s National Health Service (NHS) for its failure to diagnose and treat sufferers of debilitating Lyme disease on ITV's Good Morning Britain. The NHS follows the CDC’s outdated and federally noncompliant Lyme diagnostics and treatment guidelines. Chronic Lyme patient testimonials, expert science and medical witnesses, and peer-reviewed and published scientific and medical studies supporting persistent Lyme infection, the high incidence of coinfections and complications from other tickborne illnesses are now officially on record in numerous governmental documents in many countries. These include the UK, Ireland, Australia, New Zealand, Canada, Luxembourg, Germany, the Netherlands, Belgium, France, Austria, Italy, Spain, Switzerland, Norway, Sweden, Denmark, Finland, Iceland, Brazil, Greece, Scotland, Croatia, Czechoslovakia, Poland, Australia, New Zealand, Senegal and Slovenia. [iii] Many of these countries now have nationally and internationally recognized government officials and elected representatives championing treatment options for chronic Lyme, coinfections and other tickborne illnesses. These champions include Canada’s Member of Provincial Parliament Toby Barrett and Elizabeth May, the National Green Party Leader; Australia’s Senator John Madigan, UK’s Lady Mar and Member of Parliament Julia Goldsworthy and Belgian’s Senator Nele Lijnen. The CDC also took a series of actions during the May 2016 Lyme disease Awareness Month. The Entomological Society of America, the Integrated Pest Management (IPM) Institute of North America, the North Central IPM Center and the CDC did co-host their annual ‘Integrated Tick Management Symposium: Solving America’s Tick-Borne Disease Problem’ on May 16 -17, 2016. However, the Symposium’s main focus was vector control and did not emphasize human Lyme disease. According to one local nonprofit Lyme organization – a white vehicle advertising Lyme Corps was seen on May 15, 2016 at the Guthrie Robert Packer Hospital in Sayre, Pennsylvania. According to the CDC, “Lyme Corps is ...dedicated to developing a talented, committed team of students and residents who provide Lyme disease education and outreach to both healthcare providers and the public…Lyme Corps is community-based… members facilitate Lyme disease education in …schools, and community events (farmers’ markets, trail runs, etc.).” [iv] Lyme Corps is not known for advance advertising to the general public nor engaging with local nonprofit Lyme organizations. Apparently, this Sayre Lyme Corps presence did not result in any known public education events or communication and coordination with local nonprofit Lyme organizations. Such groups have a wealth of talented and committed residents very actively undertaking Lyme public awareness activities in libraries, farmers’ markets, parks, etc. CDC leadership refused the May 2016 request to be interviewed by Emmy Nominated Investigative Reporter & Senior News Anchor Emily Lampa of ABC, a major news organization, on the topic of Lyme disease and the US Lyme epidemic. Unlike 2015 and previous years, the CDC did not even post a webpage announcement of the 2016 National Lyme disease Awareness Month. It can be accurately stated that the CDC provided no leadership for the May 2016 National Lyme disease Awareness Month. It should be noted that Lyme disease now ranks as the second most common infectious disease in the US. In mid-June 2016, there were two Lyme posts on US federal webpages: 1. The US General Services Administration, Office of Citizen Services and Innovative Technologies is responsible for ‘data.gov’. Data.gov announced “Lyme Innovation: Three Day Hackathon June 17 - June 19. Lyme Innovation aims to solve critical prevention, diagnostic, and treatment and rehabilitation challenges facing the Lyme disease field by bringing together diverse researchers and scientists at a series of hackathons in April and June 2016. This effort is led by the US Department of Veterans Affairs Center for Innovation (VACI), Dean Center for Tick Borne Illness at Spaulding Rehabilitation Network/Harvard Medical School Department of Physical Medicine and Rehabilitation, MIT Hacking Medicine, and the Open Medicine Institute with sponsorship from the Bay Area Lyme Foundation.” [v] This announcement celebrates a diverse and representative stakeholder event to advance Lyme science and treatments. There is no mention of CDC participation in this event. 2. In mid June 2016, the CDC Lyme website posted an advance publication of the Medscape Volume 22, Number 7—July 2016 'Continuing Medical Education (CME) Activity, Current Guidelines, Common Clinical Pitfalls, and Future Directions for Laboratory Diagnosis of Lyme Disease', United States. [vi] Four of the article’s five authors are CDC staff at the Division of Vector-Borne Diseases and have responsibility for the CDC Lyme policy, science and program. They are Christina Nelson, Claudia Molins, Paul Mead, and Martin Schriefer. The information provided in this CME activity appears to be limited to outdated information. As such, its directives are inappropriate and misleading. For example, it does not include mention of the CDC’s 2016 discovery of the Borrelia mayonii, closely related to B. burgdorferi and known to cause Lyme disease. [vii] The omission of this information indicates that trainees will not understand Lyme disease caused by Borrelia mayonii infection is not captured by the diagnostic testing promoted in this CME activity. The CME appears to exclude CDC findings published in the Journal of Medical Entomology article 'County-Scale Distribution of Ixodes scapularis and Ixodes pacificus (Acari: Ixodidae) in the Continental United States', authored by CDC staff Rebecca J. Eisen, Lars Eisen, Charles B. Beard in January 2016. Author Beard works in the Division of Vector-Borne Diseases staff and has direct responsibility for the CDC Lyme programs. [viii] Beard and his colleagues verified that ticks capable of spreading Lyme disease now live in almost half of US counties. Varieties of the blacklegged tick that may carry bacteria responsible for Lyme disease are now present in 45 percent of counties nationwide, compared with just 30 percent in 1998. In this case, the CME trainees will likely underestimate the endemic presence of Lyme in many areas of the country and possibly overlook an important piece of diagnostic data. The CME does not include information regarding certain at-risk patient groups and appears to omit the possibility of and complications from co-infections. For example, the CME does not appear to include important diagnostic information from the ‘Tick-Borne Disease Hazards to Outdoor Workers’ found on the CDC’s The National Institute for Occupational Safety and Health (NIOSH) website for Workplace Safety and Health Topics. [ix] [Updated 2012] Frequently Asked Questions: (1) Which workers are at risk of infection? ...Workers at risk of tick-borne diseases include, but are not limited to, those working in the following: Construction, Landscaping, Forestry, Brush clearing, Land surveying, Farming, Railroad work, Oil field work, Utility line work, Park or wildlife management, and other outdoor work ; (2) What diseases are transmitted by ticks in the US? Diseases caused by tick-borne pathogens in the US include: Lyme disease, Babesiosis, Ehrlichiosis, Rocky Mountain Spotted Fever, Southern Tick-Associated Rash Illness, Tick-Borne Relapsing Fever, Tularemia, Anaplasmosis, Colorado tick fever, Powassan encephalitis and Q fever; (3) Where are infected ticks found in the US? Common US Regions - Northeast, North Central, Pacific Coast, Midwest, Northwest, East, Southeast, Central, Atlantic Coast, Rocky Mountains and throughout the US. The lack of CDC attention to Lyme disease in May 2016 and the outdated misleading content of its June 2016 official CME Lyme publication stands in stark contrast to global Lyme activity and the corresponding advances in Lyme science and treatment options. An outcome of the May 2016 global Lyme movement is a growing consensus on one key finding: The greatest challenge to the global Lyme epidemic is adherence to the CDC Lyme science and policy. Across the globe, Lyme patients and the healthcare providers who treat them have experienced firsthand how the CDC’s commitment to one private medical society’s Lyme guidelines is resulting in increasing and unacceptable levels of undiagnosed illness, chronic and untreated illness, disability and death. Global communications have ensured that Lyme organizations and government officials in many countries know the following: CDC Lyme policies and programs are not based on the “best science” or even on good science. [x] The Agency for Healthcare Research and Quality (AHRQ) is the lead Federal agency charged with improving the safety and quality of America’s healthcare system. AHRQ develops the knowledge, tools and data needed to improve the health care system and help Americans, health care professionals and policymakers make informed health decisions. The National Guideline Clearinghouse (NGC) provides summaries regarding evidence-based clinical practice guidelines, including their development and implementation. AHRQ sponsors the NGC database and website for information on evidence-based clinical practice guidelines. The Institute of Medicine (IOM) set the Standards for Developing Trustworthy Clinical Practice Guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group system for grading the quality of evidence and strength of recommendations. [xi] The CDC states that the Infectious Diseases Society of America (IDSA) Lyme Guidelines represent the “best science” despite their failure to meet the criteria set by the AHRQ, NGC and GRADE standards for evidence-based medicine. CDC Lyme policy and programs, such as Lyme Corps, are based on the outdated and largely “opinion-based” IDSA Guidelines. Lyme organizations and government officials in many countries know the IDSA Lyme Guidelines were removed from the NGC website for noncompliance with its evidence-based criteria and that of the IOM. The Council of State and Territorial Epidemiologists (CSTE) is the organization responsible for providing CDC with disease surveillance guidance. In 2011, CSTE redefined the surveillance case definition for Lyme disease. [xii] They stated that the two-tiered test is to be used only for surveillance purposes and not for diagnosis. However, the CDC website - ‘Two-step Laboratory Testing Process’ [xiii] recommends following the outdated 1995 CSTE guidance.[xiv] All patients who use these Lyme surveillance testing face a 50 percent chance of inaccurate results. [xv] False negative test results often lead to delayed diagnosis and full systemic complications. These complications may include serious heart, nervous system and immune impairments, organ dysfunction, life-altering damage and death. Government officials in many countries have engaged with Lyme patients who have suffered devastating health, social and financial consequences from false-negative Lyme test results. Lyme organizations and government officials in many countries know the CDC concept of Lyme disease fails to take into account more than 700 peer-reviewed studies on the microbiology and immunology of the Lyme bacterial infection that show it to be an immune evasive, persistent infection that is capable of reactivation. Many have been informed by the scholarly work, 'Chronic Lyme - An Evidence-Based Review' by world renowned clinician and Lyme expert Steven Phillips, MD. In violation of the US government’s federal laws, the CDC has shown continuous preferential treatment for the IDSA, a private medical society. Lyme organizations and government officials in many countries know: - key CDC Directors responsible for Lyme disease are members of IDSA and there are no non-IDSA members among the Directors responsible for CDC’s Lyme policy and programs; - IDSA collaborates closely with big Pharma and members of IDSA hold key positions at medical journals, research institutions and institutions of higher learning; - IDSA has a long and documented history of conflicts of interest (COI) regarding Lyme - IDSA COIs include patents on Lyme test kits, accepting payments from vaccine manufacturers and acting as expert witnesses for health insurance companies to deny coverage for federally sanctioned patient-centered Lyme treatment options; [xvi] - CDC misinforms the public as to the complexity of Lyme disease and its potential for disability and death; - CDC ignores or discredits groundbreaking Lyme research accomplished by non-IDSA scientists; - CDC fails to advance patient-centered outcomes; and - CDC excludes federally and IOM sanctioned International Lyme and Associated Diseases Society (ILADS) individualized patient-centered Lyme treatment guidelines from its Lyme policy and all program material. [xvii] As of 2016, many nations still adopt CDC guidance for their public health strategies. However, the CDC’s apparent violations and promotion of outdated substandard and noncompliant Lyme guidelines are not the only area that should concern the leaders and populations of other nations. The CDC shares responsibility for the poor public health ratings found in the US population. According to the October 8, 2015 article 'US Health Care from a Global Perspective - Spending, Use of Services, Prices, and Health in 13 Countries' [xviii] by David Squires and Chloe Anderson, “Despite spending more on health care, Americans had poor health outcomes, including shorter life expectancy and greater prevalence of chronic conditions… This analysis draws upon data from the Organization for Economic Cooperation and Development (OECD) and…health outcomes across 13 high-income countries: Australia, Canada, Denmark, France, Germany, Japan, Netherlands, New Zealand, Norway, Sweden, Switzerland, the UK and the US. Health care spending in the US far exceeds that of other high-income countries…Even though the US is the only country without a publicly financed universal health system, it still spends more public dollars on healthcare than all but two of the other countries. On several measures of population health, Americans had worse outcomes than their international peers. The US had the lowest life expectancy at birth of the countries studied, at 78.8 years in 2013, compared with the OECD median of 81.2 years. Additionally, the US had the highest infant mortality rate among the countries studied, at 6.1 deaths per 1,000 live births in 2011; the rate in the OECD median country was 3.5 deaths. The prevalence of chronic diseases also appeared to be higher in the US. The 2014 Commonwealth Fund International Health Policy Survey found that 68 percent of US adults age 65 or older had at least two chronic conditions. In other countries, this figure ranged from 33 percent (UK) to 56 percent (Canada). A 2013 report from IOM reviewed the literature about the health disadvantages of Americans relative to residents of other high-income countries. It found the US performed poorly on several important determinants of health. The IOM found that poorer health in the US was not simply the result of economic, social, or racial and ethnic disadvantages—even well-off, nonsmoking, nonobese Americans appear in worse health than their counterparts abroad.” Japan has the best rating of these health measures, with life expectancy of 83.4 years, a 2.1 per 1,000 infant mortality rate, an elderly population that suffers from less significantly less chronic illness than the 13 other OECD countries and national obesity rate of 3.7. Given this data, it would be understandable if government health officials, elected representatives and populations in Australia, Canada, Denmark, France, Germany, Japan, Netherlands, New Zealand, Norway, Sweden, Switzerland and the UK rejected CDC guidance on many public health concerns. In addition, other nations’ leaders recognize that the CDC serves the US national interests before any other country. The health and wellbeing of populations in other countries is not of concern to the US government unless it threatens the US. It would be understandable if all nations rejected CDC guidance on many public health concerns. The global Lyme epidemic, information network and Lyme movement have generated an illuminating spotlight on CDC Lyme policy and the unsavory influence of the IDSA. CDC Lyme science and policy does not stand up to this independent global scrutiny. Other nations might be better served if they followed the public health practices of Japan and the Lyme diagnostics and treatment policies of Poland and Germany. [i] http://www.webwire.com/ViewPressRel.asp?aId=203322#.VzvINeL09rA.twitter [ii] http://lymediseaseuk.com/2016/05/26/uk-lyme-disease-protest-2016-2/ [iii] Not all of these national-level governmental chronic Lyme patient testimonials occurred in 2016, some have been on record prior to 2016. In some cases, the scientific and medical expert witness and publications were provided through research programs. [iv] http://www.cdc.gov/lyme/faq/index.html [v] https://www.data.gov/event/lymeinnovation-hackathon-2/ [vi] http://wwwnc.cdc.gov/eid/article/22/7/15-1694_article [vii] http://www.cdc.gov/media/releases/2016/p0208-lyme-disease.html [viii] http://jme.oxfordjournals.org/content/early/2016/01/15/jme.tjv237 [ix] http://www.cdc.gov/niosh/topics/tick-borne/ [x] These findings have been provided to and discussed with persons representing a number of the US Congressional and Senate committees, including Science Committee, Energy and Commerce Committee, House Energy and Commerce, House Science, Oversight Subcommittee. They have been presented in the Science and Technology Room in the Congressional Rayburn office building. [xi] IOM is now the Health and Medicine Divisions (HMD) [xii] https://wwwn.cdc.gov/nndss/conditions/lyme-disease/case-definition/2011/ [xiii] http://www.cdc.gov/lyme/diagnosistesting/labtest/twostep/index.html [xiv] http://www.cdc.gov/mmwr/preview/mmwrhtml/00038469.htm [xv] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2078675/ [xvi] For example, the 2008 Connecticut antitrust suit against IDSA describes the Ad Hoc International Lyme Disease Group. The Ad Hoc group was formed in 2005 and included government employees from CDC, NIH and IDSA. According to an overview of the suit written by science writer Kris Newby and Lorraine Johnson of LymeDisease.org: “The ad-hoc group convened during government-funded, closed-door meetings and had members who were researchers with significant commercial interests in Lyme disease tests and vaccines. It excluded the public and researchers whose views were not aligned with those of the IDSA. The group essentially set national Lyme disease policy and controlled the national research agenda in Lyme disease without public oversight or transparency. Subsequently, a large percentage of government grants were awarded to the [IDSA] group’s members.” Overview of LymeGate Findings, Prepared by Kris Newby and Lorraine Johnson. [xvii] The ILADS Lyme treatment guidelines are sanctioned by the US government, meet all AHRQ, NGC, Standards for Developing Trustworthy Clinical Practice Guidelines and GRADE standards, and are posted on the NGC [xviii] http://www.commonwealthfund.org/publications/issue-briefs/2015/oct/us-health-care-from-a-global-perspective