March 12, 2016 Subject: Seeking Insight from a Member of both the Institute of Medicine of The National Academies and the Infectious Diseases Society of America For: Associate Director for Science Harold Jaffe. Jaffe is a member of the Institute of Medicine of The National Academies and the Infectious Diseases Society of America (IDSA). Dear Dr. Jaffe, I am writing you because I am confounded by a message I received today from the Office of the Chief of Staff, CDC. This correspondence is attached below. This Chief of Staff message raises additional questions that I had not included in my March 11, 2016 correspondence to you and your colleagues (Subject: CDC Lyme Corps program- Appearance of preferential treatment, Transparency concerns, Outdated low-quality scientific and medical content in training materials). I am writing you because you are uniquely placed and affiliated to shine some light on this CDC message for many reasons. You are a member of both the Institute of Medicine of The National Academies (IOM) and the Infectious Diseases Society of America (IDSA) and you have policy leadership and you understand the institutional dynamics of CDC. However, I would be much obliged should anyone copied in this correspondence provide answers to my questions. The Chief of Staff message states that “Promoting early and accurate diagnosis and treatment of Lyme disease remains one of the highest priorities of CDC’s Lyme disease program. CDC believes that IDSA currently represents the best available synthesis of the medical literature on the diagnosis and treatment of Lyme disease.” The Chief of Staff message also states that the “CDC is the HHS agency charged with tackling the biggest health problems causing death and disability to Americans.” According to the CDC, I understand that the Zika virus qualifies as one of the biggest health threats to Americans. Based on CDC information, I did a rapid comparison of Zika to Lyme and came to the conclusion Lyme disease would also qualify as one of biggest health problems. I have attached the Zika and Lyme Disease, Disability and Death in the USA Table below. Please bear with me as I detail some additional information that is very familiar to you. I do this so that you will know how I understand this situation. I understand that the “Institute of Medicine (IOM) is a division of the National Academies of Sciences, Engineering, and Medicine. The Academies are private, nonprofit institutions that provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions related to science, technology, and medicine.” (Excerpt from IOM website) I understand that in 2008, the U.S. Congress requested that the Secretary of the Department of Health and Human Services (DHHS) contract with the IOM to identify "the best methods used in developing clinical practice guidelines in order to ensure that organizations developing such guidelines have information on approaches that are objective, scientifically valid, and consistent." I understand the IOM recommended new standards for clinical practice guidelines (CPGs) to guide the process of developing trustworthy guidelines in March 2011. The revised inclusion criteria were posted to the National Guidelines Clearinghouse (NGC). I understand the “NGC mission is to provide physicians and other health professionals, health care providers, health plans, integrated delivery systems, purchasers, and others an accessible mechanism for obtaining objective, detailed information on clinical practice guidelines and to further their dissemination, implementation, and use.” [Excerpt taken from NCG website] I understand the revised inclusion criteria were posted to the NGC Web site in June 2013 and became effective in June 2014. Guidelines submitted after June 1, 2014 must meet the 2013 (revised) NGC's Inclusion Criteria and the IOM's updated definition of CPGs. As follows: "Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options." [Reference 1] I understand that the “Infectious Diseases Society of America (IDSA) represents physicians, scientists and other health care professionals who specialize in infectious diseases. IDSA’s purpose is to improve the health of individuals, communities, and society by promoting excellence in patient care, education, research, public health, and prevention relating to infectious diseases.” (Excerpt from IDSA website). I understand that on February 12, 2016, the IDSA Lyme Guidelines were removed from the NGC because they did not did not meet the NGC's revised Inclusion Criteria adopted from the IOM's updated definition of clinical practice guidelines. I do not understand how, under these circumstances, the CDC state can that “Promoting early and accurate diagnosis and treatment of Lyme disease remains one of the highest priorities of CDC’s Lyme disease program. CDC believes that IDSA currently represents the best available synthesis of the medical literature on the diagnosis and treatment of Lyme disease.” There is no correlation between this statement and the reasons for removing the IDSA Lyme Guidelines from the NGC. Is this CDC decision to promote IDSA Lyme guidelines based upon scientific and medical information regarding Lyme disease that is not available to anyone else? Is this CDC decision based upon some other unpublicized issue? What exactly are the reasons for the CDC’s promotion of the outdated substandard IDSA Lyme Guidelines? Please note that the absence of the IDSA guidelines has not resulted in the absence of Lyme guidelines that do meet these updated NGC's Inclusion Criteria; these are the International Lyme and Associated Diseases Society (ILADS) Lyme guidelines. ILADS Guidelines recognize that Lyme disease is a complex and serious illness of epidemic proportion and offers individualized patient-centered treatments. See link http://www.guideline.gov/content.aspx?id=49320&search=lyme+disease+and+ilads+guildlines One month after the IDSA guidelines were removed from the NGC, the CDC states “that IDSA currently represents the best available synthesis of the medical literature on the diagnosis and treatment of Lyme disease.” This communications also states “We are aware that IDSA is working on updates to its guidelines, but our agency is not involved in this effort.” I am in complete agreement that the CDC is not responsible for updating the IDSA guidelines. However, the CDC is entirely responsible for providing the best available synthesis of the medical literature on the diagnosis and treatment of Lyme disease. According to the IOM, NGC and HHS these “best available synthesis” are the ILADS Lyme Guidelines. Based on the understanding I have detailed to you - an understanding drawn directly from the CDC and HHS websites - the CDC statements above are insufficient and appear nonsensical. They do not indicate that "Lyme disease remains one of the highest priorities" to the CDC. Please inform me as to why, when there are available NGC and IOM sanctioned science-based patient-centered ILADS guidelines, the CDC promotes the substandard IDSA guidelines? If you are unable to provide this response, please provide me the names of persons and offices' contact information (emails and phone numbers) of those who have the authority and insight to provide a response to the above question. I look forward to your response. Please contact me should you have any questions or if I can be of further assistance. Thank you very much, Jenna [Reference 1] Institute of Medicine. Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E, editor(s). Clinical practice guidelines we can trust. Washington (DC): National Academies Press; 2011