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                              TBDWG March 3-4, 2020 - Meeting Summary - Day 2


    

    

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TBDWG March 3-4, 2020 - Meeting Summary - Day 2








  
  
    

  
      





*Note: For context and clarity, speaker credentials will be included upon first mention in each meeting’s summary. Subsequently, individuals will be referenced by their first names to equalize expertise across the many diverse disciplines represented in this document. All perspectives and expertise, including patient-lived experience, is valued equally. Speaking on a first-name basis helps the Tick-Borne Disease Working Group ensure that all voices are heard and valued based on merit and without the bias of titles, eminence, or prestige.*
Welcome and Roll Call
James (Jim) Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy (OIDP), Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (HHS); Designated Federal Officer (DFO) for the Tick-Borne Disease Working Group, called the meeting to order and conducted roll call (see Appendixes 1 and 2: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting started with a quorum.
Co-Chair Welcome, Recap of Day 1, Agenda for Day 2
Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking; Working Group Co-Chair, welcomed everyone to Day 2 of Meeting 12. She summarized what had taken place during Day 1 and explained that, because the Working Group was not able to complete their discussions because of time constraints, the agenda for Day 2 had been revised to ensure that all essential discussions related to the Report to Congress could take place. Specifically, meeting attendees would have a working lunch, and the Public Comment Subcommittee and Federal Inventory Subcommittee updates were postponed until the next Working Group public meeting.
Leigh Ann then transitioned the meeting to the Public Comment session.
Public Comments
Twelve members of the public provided comments.
*Enid Haller:*Enid stated that she is the founder and executive director of Lyme Center of Martha’s Vineyard and that she runs the Martha’s Vineyard Lyme Support Group. Enid suggested that, in addition to creating a subcommittee devoted to conflicts of interest in Lyme disease, the Working Group could initiate a subcommittee on Lyme disease and substance abuse. She mentioned having heard many stories of patients who self-medicate for Lyme disease symptoms using street drugs and pharmaceutical medications. She referenced Dr. Robert Bransfield’s work related to this subject. She recommended that the subcommittee target substance abuse centers to identify how many of their patients have Lyme Disease. Enid expressed her interest in being involved in this subcommittee.
*Lonnie Marcum:*Lonnie stated that she is a physical therapist and health and science writer for LymeDisease.org and a member of the Working Group’s Tick Biology, Ecology, and Control Subcommittee. She cited information found on CDC’s website that suggested that removing a tick under a certain threshold would mitigate or eliminate the risk of contracting the Lyme disease. She stated that this information was misleading. She specified that no studies have linked a minimum amount of attachment time to transmission of the disease to humans. However, she noted that one study showed transmission in less than six hours of attachment. She recommended revising the CDC website content to say that the chances of getting infected increase with attachment time and to encourage people to save the tick and send it in for testing if they come down with symptoms.
*Samuel Hiser:*Samuel stated that he is affiliated with the Lyme Center of Martha’s Vineyard. He explained that he had to go to Germany in order to get treatment and recover from Lyme disease. He expressed his concern that people affected by Lyme disease appear to be ignored. Samuel questioned the notion of a Lyme disease vaccine, citing the small proportion of people who would benefit from it. He identified a number of issues, systemic and other, that constitute a barrier to helping people affected by this disease. He suggested that the efforts and resources put into producing a Lyme disease vaccine are ill-advised because this vaccine would only immunize people against a small fraction of the pathogens that can infect people.
*Carl Tuttle:*Carl explained that he was speaking on behalf of 88,000 individuals who signed his Change.org petition calling for a Congressional investigation into the mishandling of Lyme disease. Carl suggested that the conventional wisdom that Lyme disease is “hard to catch and easy to treat” is based on data for acute cases that were diagnosed and treated right away. He stressed that patients with late-stage Lyme disease are ignored and that no studies are undertaken to find causes and discover treatments.
Carl also commented on the absence of information on congenital Lyme disease as well as on the aggressive treatment-resistant infections that affect patients with persistent symptoms. Carl commented that official efforts have been unable to treat and eradicate Lyme disease and chronic Lyme disease in particular. He pointed out how devastating these conditions are to those Lyme disease affects. He advocated for further large-scale efforts to be undertaken to fight the disease.
*Dorothy Leland:*Dorothy identified herself as the vice president of LymeDisease.org. She offered comments on the Working Group’s process integrity, stating that proxy votes should not be given to members who are not in attendance and that individuals with conflicts of interest should not be members.
Dorothy then questioned comments made earlier in the meeting about content on the CDC website. She stipulated that while some people who get diagnosed and treated do recover, 10-20% of patients remain ill after treatment. She calculated that, over 20 years, this would add up to three million individuals with persistent symptoms of the disease, not including those who are undiagnosed and untreated.
Dorothy expressed concern that the 2020 Working Group has only one patient representative, adding that the Working Group’s creation stems from efforts by advocates and patients with persistent Lyme disease. She urged members of the Working Group not to forget their core constituency.
*Mark Liberto:*Mark said that he is from Western Pennsylvania and that he was speaking on behalf of the Lyme disease and tick-borne disease patient community. He explained that he, his wife, and some of his friends had all been personally affected by Lyme disease. Mark explained how he started feeling the first symptoms, how the disease was not diagnosed for over a year, and how he suspects he may have originally contracted the disease before that. He remarked that, in spite of being misdiagnosed, he eventually felt better. He underscored that, before he got sick, he was an outgoing, contributing member of society.
Mark shared that he had recently experienced a full-blown relapse. He related that his wife started experiencing symptoms in the past year and that he wonders whether the disease may be sexually transmitted. He encouraged the Working Group to fund the efforts to investigate all possible avenues. He thanked the Working Group for giving him hope.
*Phyllis Mervine:*Phyllis stated that she is the president of LymeDisease.org. She urged Congress to instruct CDC to educate the medical community about the two standards of care for Lyme disease. Phyllis commented that for many years, CDC had presented only the Infectious Diseases Society of America (IDSA) diagnostic and treatment guidelines, even after the new International Lyme and Associated Diseases Society (ILADS) guidelines were published on the National Guideline Clearinghouse, and the IDSA guidelines were de-listed for being out of date. She explained that, by acknowledging the two standards of care, more patients could be diagnosed early. She also stated that CDC’s actions in this area resulted in applying a “one-size-fits-all approach” that does not take into account the complexity of the problem. She argued that ILADS does consider these complexities. Phyllis noted that, in a written public comment, she had made available the abstract of the ILADS guidelines.
*Melissa Potter:*Melissa stated that she was providing this testimonial on behalf of LymeDisease.org. She explained the significance of this organization and its reach within the community. Melissa commented that, while much is known about how to treat early Lyme disease, treatment failure rates remain unacceptably high. She remarked that there is scant information about treatment for late or persistent Lyme disease, in part because trials have been too small and have not observed real-world patient responses to clinical treatments.
Melissa underscored that patient registries excel at helping to improve quality of life and are cited as one way to advance knowledge on Lyme disease. She said that LymeDisease.org’s MyLymeData is an example of such a registry, with over 12,000 patients enrolled. She noted that the registry had gathered over 2 million data points on a range of criteria.
Melissa mentioned that the first peer-reviewed study analysis of the data had been published last year. She also described the collaboration currently underway with the National Disease Research Interchange and Bay Area Lyme Foundation. She cited the work presently done with academic researchers to explore big-data analytics using information from MyLymeData. She stressed that this endeavor represents an essential step in building a collaborative research engine designed to realize the promise of big data in Lyme disease.
*Dr. Elizabeth Maloney:*Elizabeth commented on the topic of independence and neutrality of CDC’s in-house treatment guidelines that were referenced by the Working Group during Day 1 of Meeting 12. She expressed concern that these guidelines were an unexamined and unquestioned synopsis of the IDSA guidelines. She pointed out the small number of references cited in the guidelines, noting that they have redundant authors. She noted that CDC had not made its own independent assessment.
Elizabeth also mentioned that, upon reviewing a comparative trial’s results, she had identified design and execution problems with the test, as well as an unsupported conclusion. She concluded that the standards supported by CDC were inadequate and, in some cases, ignored conflicting information. Elizabeth urged the Working Group to recommend that CDC’s curriculum development teams include a broader diversity of scientific viewpoints to avoid groupthink and bias.
*Mira Shapiro:*Mira identified her affiliation with LymeDisease.org and described herself as a chronic Lyme disease patient and biostatistician. She provided information about LymeDisease.org’s Institutional Review Board-approved research projects, and how the organization uses the data from its over 12,000 enrolled patients, all of whom, she noted, had consented to the use of their data.
Mira highlighted that too few clinical trials had been held, and the sample sizes were too small to allow subgroup analysis. Regarding current and prospective endeavors and strategies, she reported that LymeDisease.org:
Published the first peer-reviewed article that helped distinguish between subgroups of patients and their respective responses to treatment.
	Provided real-world data that may provide a path to more individualized care.
	Collaborates with research partners to conduct big-data research.
	Assists with clinical trial recruitment.
	Augments clinical trial research findings.
	Generates hypotheses for further studies.Mira concluded that LymeDisease.org views its patient registry as a vital part of a research engine that can accelerate the pace, and increase the depth, of Lyme disease research.
*Jennifer Platt:*Jennifer stated that she is from North Carolina and is a co-founder of Tick-Borne Conditions United. She thanked the Working Group and its subcommittees for their efforts and expressed gratitude for the references made to southern ticks and diseases during the previous day’s meeting. Jennifer suggested that the language in the recommendations be expanded to include all tick-borne conditions. She underlined that several conditions, such as Alpha-gal Syndrome and tick paralysis, were not medically defined as diseases and that their exclusion in recommendations may impede progress for patients with these conditions. For their 2020 report, she requested that the Working Group: a) include the word “condition” in relevant recommendations; or b) state clearly in the introduction that the word “disease” includes all conditions caused by a tick bite. She noted that she and many patients hope that the 2020 report will result in great progress in the research and treatment of tick-borne diseases.
*Jill Auerbach:*Jill mentioned that she had been a member of a 2018 subcommittee and that she is an advocate for the reduction of ticks and the pathogens they transmit. She indicated that reservoir animals are one of the main causes of the spread of such ticks. She expressed her belief that today’s technologies can help mitigate their spread and its effects. She cited a number of possible solutions and innovations, for example, gene editing and CRISPR. Jill commented that nootkatone kills ticks and mosquitoes, but is safe for humans. However, she added, this product has not been developed for lack of funding. She urged the Working Group to use its power to push for funding of new technologies that can help reduce tick populations and block the ability of ticks to transmit pathogens.
Discussion of the Proposed Recommendations from the Training, Education, Access to Care, and Reimbursement Subcommittee
Following the public comments, the Working Group continued their discussion of the following recommendations, put forth during Day 1 of the meeting by subcommittee Co-Chairs Pat Smith, President, Lyme Disease Association, and CAPT Scott J. Cooper (Coop), MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services (CMS).
Proposed Recommendation 1
Recommend the disclosure on all Federal and state government websites and educational materials and seminars for clinicians, the public, and public health departments that discuss Lyme disease or tick-borne diseases, including CDC, NIH, AHRQ, that the state of the science in Lyme disease, particularly for persistent Lyme disease, is limited, emerging, and unsettled; and increase public awareness that there are two divergent diagnostic and treatment approaches reflected in guidelines for Lyme disease and that shared medical decision-making may be appropriate in some circumstances.
Discussion of Recommendation 1
Pat began by asking if the Federal members of the Working Group would vote on behalf of their agencies or as individuals. Kaye Hayes, MPH, Alternate DFO for the Working Group, clarified that the Federal members represent their organizations, and they vote based on the best interest of their organization.
Pat asked if the Federal members of the Working Group had communicated with members of the informal working group on tick-borne diseases at the National Institutes of Health (NIH), and if issues discussed by the Tick-Borne Disease Working Group were also discussed by the NIH working group. Ben Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, CDC, responded that his group participated in the NIH working group meetings, which had occurred biannually in the past few years. The main purpose of the meetings, he clarified, was to improve coordination, minimize overlaps, and address gaps in the agencies’ initiatives, and that the recommendations made by the Tick-Borne Disease Working Group were not discussed at the NIH working group meetings.
Pat then asked CDR Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration (FDA), to clarify FDA’s position on guidance and guidelines. Todd responded that FDA publishes its own guidelines, not those of third parties. Other Federal members added that FDA’s guidelines are mostly related to products, which are different from treatment guidelines; in addition, FDA, as well as CMS, publish guidance on how to interpret regulations, which is also different from treatment guidelines.
Pat commented on NIH’s and CDC’s web content related to treatment for Lyme disease, and she urged the agency representatives to use the opportunity to help make a change (for example, by updating the content on the agencies’ websites). Dennis M. Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases (NIAID), NIH, and Ben expressed their understanding of Pat’s passion and their respect for patients with Lyme disease. They clarified that they do not represent their agencies’ website offices and do not have the authority to decide what goes on the website. They then discussed with Pat the types of information is on some of the CDC and NIH websites.
Sam Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases, urged the agencies to address persistent Lyme disease, and he suggested CDC and Medline revise their web content on antibiotic use. Kaye pointed out that the Working Group can collectively write a letter to the Secretary of Health about specific requests.
Ben asked if the report will be formally reviewed by the Federal agencies before it is submitted to Congress. Kaye and Jim clarified that the Working Group’s report to Congress does not go through agency clearance. The agencies have an opportunity to review the report for accuracy, but they cannot change the content.
Vote on Revised Recommendation 1
After revising the wording, 11 Working Group members voted yes to accept the following recommendation. Three members were absent.
Recommend that Federal government websites and educational materials and seminars for clinicians, the public, and public health departments, which discuss Lyme disease, provide information that the state of the science relating to persistent symptoms associated with Lyme disease, is limited, emerging, and unsettled; and increase public awareness that there are divergent views on diagnosis and treatment. Consider that shared medical decision-making may be appropriate in some circumstances.
Proposed Recommendation 2
Recommend that CDC provide input to the Council of State and Territorial Epidemiologists, CSTE, that the Lyme disease surveillance case definition should be revised such that it abandons the use of geographic parameters for Lyme disease; and that CDC, NIH, and other government agency websites, brochures, and educational materials abandon the use of geographic parameters for the diagnosis of Lyme disease and inform clinicians and the public that Lyme disease has been reported in all states. Recommend that funding be provided to the CDC to streamline the surveillance process and reduce the burden on clinicians and public health departments including by permitting direct laboratory reporting of positive cases from FDA approved and/or CLIA certified diagnostic labs to obtain a more accurate understanding of the geographic exposure and growth in the incidence of Lyme disease and other tick-borne diseases.
Discussion of Recommendation 2
The group discussed CDC’s case definition for Lyme disease and whether or not the use of geographic parameters is appropriate. Pat noted that some clinicians do not make a diagnosis if a patient is not in an area considered high-incidence, and she suggested that the geographic parameters should be removed from the case definition.
Ben noted that CDC would be willing to consider how to more clearly communicate about diagnosing and reporting Lyme disease in low-incidence states. He clarified that most cases in those states are travel-associated. He explained that the two-tier tests work together, and he indicated that geographic parameters are needed to reduce false-positive results. Using the coronavirus as an example, Ben pointed out that if geographic locations are not considered, symptoms alone would result in many false positives because no test is one-hundred-percent reliable. He suggested language for the recommendation that would meet with CDC approval.
Vote on Revised Recommendation 2
After revising the wording, 11 Working Group members voted yes to accept the following recommendation. One member voted no; one member abstained; and one member was absent.
Recommend that CDC work with Council of State and Territorial Epidemiologists, CSTE, to streamline the surveillance process and reduce the burden on clinicians and public health departments by permitting direct laboratory reporting of positive cases.
Proposed Recommendation 3
Fund and support a directive for CDC to develop (either directly or through an approved federal contract) a multi-leveled and nationwide curriculum on Lyme disease for clinicians-in-training as well as continuing medical education modules for practicing clinicians. The U.S. military must also be funded to participate in this CDC-directed nationwide training and education on Lyme disease and other tick-borne diseases.
The curriculum must focus on enhancing clinicians’ ability to 1) recognize the various clinical presentations of tick-borne diseases and 2) avoid misdiagnoses by highlighting the most frequent sources of diagnostic errors: inappropriately excluding Lyme disease because of geographic exclusions that inaccurately reflect the geographic scope of the disease; failing to recognize the full spectrum of Lyme disease-related symptoms; failing to identify *erythema migrans* rashes and/or other Lyme disease-related findings on physical exam; and failing to caution against over-reliance on inaccurate diagnostic tests. The curriculum development team must include representatives of all stakeholder groups, including meaningful patient representation as well as representation by clinical and/or patient members. Clinicians and research scientists with expertise in the field should be selected such that the team represents the full spectrum of scientific and clinical perspectives on Lyme and other tick-borne diseases.
Discussion of Recommendation 3
The group discussed how to revise the language to highlight the urgent need for more qualified practitioners; if CME alone can adequately address the issue; how CME programs should be funded; and who should develop the content. Coop and Pat noted there is a gap in current CME programs, and the recommendation is a positive start.
The group also discussed how the curriculum could be developed and how the Working Group can decide what to say in the recommendation without violating FACA rules. Several members pointed out that the Federal government may not have control over CME-related requirements at the state level. Pat emphasized that oversight is needed for curriculum development, especially for chronic Lyme disease.
Susanna N. Visser, DrPH, MS, alternate Working Group member for Ben Beard, shared that CDC is rebuilding its clinician education modules, and that CDC is open to collecting feedback through multiple channels, such as requests for information and listening sessions. She noted that CDC is very supportive of the Working Group making a recommendation to CDC regarding collecting feedback on new clinician education. CDC, she added, can also collect feedback from the stakeholder groups mentioned in the recommendation, as long as the suggestions are concrete and allowable by law.
Coop suggested discussing specifics of CME curriculum development in the chapter, not in the recommendation, and he agreed with other members that education-related recommendations for other tick-borne conditions need to be considered.
Sam suggested revising the language to ensure that the CDC curriculum will be presented to states. The group also discussed military representation in the recommendation.
Vote on Revised Recommendation 3
After revising the wording, 10 Working Group members voted yes to accept the following recommendation. Two members voted no; and two members were absent.
Fund and support a directive for CDC (or other appropriate HHS OPDIV or agency) to develop (either directly or through an approved Federal contract) a multi-leveled and nationwide curriculum on Lyme disease for clinicians-in-training as well as continuing medical education modules to increase the pool of qualified practicing clinicians. Provide funding to the U.S. military to participate in nationwide training and education on Lyme disease and other tick-borne diseases. This curriculum should be introduced and encouraged at the state level.
The final curriculum shall incorporate feedback from patients, clinicians, and research scientists with expertise/experience that represents diverse scientific and clinical experiences on the full spectrum of Lyme disease and other tick-borne diseases/conditions.
Brief Discussion of Proxy Voting
In response to Pat’s question, David explained the Eugene David Shapiro, MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine, had given David proxy for David to vote on behalf of Eugene. Jim clarified that his team had consulted the Office of the General Counsel of HHS regarding the issue, and the Office of the General Counsel had confirmed that proxy voting is a legal process under FACA rules.
Discussion of the Proposed Recommendations from the Pathogenesis and Physiology of Lyme Disease Subcommittee
Pathogenesis and Physiology of Lyme Disease Subcommittee Co-Chair Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases, presented the following proposed recommendations to the Working Group.
Proposed Recommendation 1
**Priority 1:** Determine the mechanisms underlying the persistence of *B. burgdorferi* in the host
**Potential Action 1.1:** Support targeted funding of research that aims to better understand the initial events and mechanisms involved in the entry of *B.* *burgdorferi* into the host.
	**Potential Action 1.2:** Support targeted funding of research that aims to better understand the mechanisms involved in the establishment of infection and its persistence in host tissues.
	**Potential Action 1.3:** Support targeted funding of research that aims to better understand the interactions between *B. burgdorferi* and host immune systems and development of more efficient tools to characterize host-pathogen interaction and facilitate approaches to genetically manipulate *B. burgdorferi.*
	**Potential Action 1.4:** Support targeted funding of research that aims to determine the potential roles of antibiotic tolerance and immunomodulation in the persistence of *B. burgdorferi* despite antibiotic treatment.
	**Potential Action 1.5:**Support targeted funding exploring the use of novel compounds or combinations of antibiotics in both preventing and resolving the persisting state.
	**Potential Action 1.6:**Support targeted clinical studies and the analysis of veterinary clinical data on Lyme disease in dogs, horses, and other species.
	**Potential Action 1.7:**Incentivize workforce development toward research addressing gaps in understanding of the pathogenesis and pathophysiology of Lyme disease, including studies of *Borrelia* persistence (for example, NIH F and K awards).Discussion of Recommendation 1
Working Group members suggested consolidating the potential actions into one recommendation and rephrasing it in plain language to ensure that it is well-received and understood by the intended audience. David commented that persistence and antibiotic resistance need to be proven before they can be studied. The group, therefore, decided to broaden the recommendation to encompass all types of research related to those topics.
Vote on Revised Recommendation 1
After revising the wording, 12 Working Group members voted yes to accept the following recommendation. Two members were absent.
Support targeted funding for research to understand the role of persistence in the pathophysiology of Lyme disease and its management.
Proposed Recommendation 2
**Priority 2:** Determine the role of persistence of *B. burgdorferi* or its components in the pathogenesis of Lyme arthritis and persistent Lyme disease.
**Potential Action 2.1:** Support targeted funding opportunities for research to better understand the role of bacterial antigens, including peptidoglycan, and the host immune response in the persistence of ongoing symptoms and signs of Lyme disease, including Lyme arthritis.
	**Potential Action 2.2:** Support targeted funding opportunities for research that determines whether different antibiotic regimens from those previously reported would be effective in resolving Lyme disease.
	**Potential Action 2.3:** Support targeted funding opportunities for research to determine whether the use of targeted immunomodulatory medications are effective in resolving Lyme arthritis and/or other residual Lyme disease symptoms that are not responsive to standardly recommended therapeutics.Discussion of Recommendation 2
Members discussed how to consolidate the content into one top-line recommendation. One member suggested using only potential action 2.1 in the recommendation, then combining 2.2 and 2.3 into a third recommendation. Sam stressed the importance of studying the effect of antibiotic regimens and/or immunomodulatory medications in humans with Lyme arthritis.
Decision to Eliminate Recommendation 2 and Re-vote on Revised Recommendation 1
Members decided to add “(e.g., antibiotic regimens and other therapeutics)” to the end of the revised recommendation 1 and eliminate recommendation 2. Twelve Working Group members voted yes to accept the following recommendation. Two members were absent.
Support the targeted funding of research to understand the role of persistence of bacteria and bacterial products in the pathogenesis and management of Lyme disease (e.g., antibiotic regimens and other therapeutics).
Proposed Recommendation 3
**Priority 3:** Determine the pathogenesis, pathophysiology, and effective treatment of Lyme carditis.
**Potential Action 3.1:** Support targeted funding opportunities for research to develop an animal model of Lyme carditis.
	**Potential Action 3.2:** Establish a clinical network to study patients with Lyme carditis and its treatment.Discussion of Recommendation 3
Dennis commented that starting with an animal model makes sense because there may not be enough human subjects to do a large trial. Sam agreed, but stated that the ultimate goal would be to address the human condition. His subcommittee, he added, had originally thought this could be done by establishing a clinical network or patient registry; however, upon discussion with the Working Group, he realized that this might be better accomplished through fundamental studies. Ben suggested being more specific in the recommendation about the current gaps in knowledge.
Vote on Revised Recommendation 3
After revising the wording, 13 Working Group members voted yes to accept the following recommendation. One vote was made by proxy; and one member was absent.
Support targeted funding opportunities for research to better inform the diagnosis, pathogenesis, and management of Lyme carditis.
Discussion of the Proposed Recommendations from the Clinical Aspects of Lyme Disease Subcommittee
Clinical Aspects of Lyme Disease Co-Chair Sam Donta presented the following proposed recommendations to the Working Group.
Proposed Recommendation 1
**Priority 1**: Conduct additional targeted controlled clinical treatment trials in patients with early and persistent Lyme disease, using different antibiotic regimens and longer durations of treatment than those used in previously conducted trials.
**Potential Action 1.1**: Establish a clinical treatment trials network to evaluate the potential of various antibiotic and non-antibiotic treatment regimens in patients with persistent Lyme disease.
A planning committee including involved stakeholders (clinicians and researchers representing a range of scientific and medical perspectives, patient advocates, and government funding agencies) should be established to discuss the essential components of future clinical trials, with a focus on studies that include antibiotic regimens differing from those used in previously conducted studies and of longer durations.
	Experts in clinical trial design and biostatistics should be included to ensure the integrity of patient inclusion criteria, study design, selection of outcome measures, and methods used to analyze the results of the trials.
	Patient inclusion criteria could include: a) patients previously treated (e.g., PTLDS); b) patients not previously treated with persisting symptoms; and c) patients with less stringent serologic evidence of exposure to *B. burgdorferi*. A particularly more homogeneous group of patients to be studied would be those with early Lyme disease, using longer courses of treatment, a combination of antibiotics, or both, to determine whether the results of these studies would lead to a lower incidence of subsequent persistent Lyme disease.**Potential Action 1.2:**Target research funding for the development of specific detection tests or biomarkers to determine whether persistent Lyme disease is due to continuing infection by *B. burgdorferi* and to monitor the results of treatment.
Discussion of Recommendation 1
Sam explained the background of this recommendation, emphasizing that Lyme disease has been identified as an infectious disease for over 40 years, and there have been very few trials. He brought up the issue of the lack of a marker, noting that perhaps it could be found in tissue, urine, or elsewhere, and that this issue should not stand in the way of conducting trials.
Dennis expressed his concern about establishing a clinical trials network, remarking that the time it would take for such a network to sequentially work through the different inquiries would far exceed the funding period for such studies. Both he and David recommended first conducting peer-reviewed studies to understand the pathogenesis before trying to determine how best to intervene. In response, Sam stressed that there is enough preliminary evidence to proceed with individual clinical trials, all of which would be subject to review. Dennis suggested rephrasing the recommendation to say “encourage clinical trials” so as not to dictate how those trials should be done.
Ben agreed that there is a critical need to address the issue of treatment of persistently ill patients. He cited the following quote from a New York Times article, entitled “Lyme Disease: Does It Really Linger?” by Elisabeth Rosenthal:
“Although some doctors prescribe long-term high-dose intravenous antibiotics, most do not. And many insurers refuse to pay for these long courses, ... citing that scientists who do not believe that extended therapy is necessary. Politicians at both the state and Federal levels, including the Labor and Human Resources Committee, are holding hearings in part to address patients’ complains that the practice is unfair. ‘I think the jury is still out on what chronic Lyme disease is and is not and that has resulted in quite a controversy.”
Ben added that the article was written on August 24, 1993, and expressed frustration that no progress has been made on this issue since that time. He stressed that taking the initiative now is most responsible and timely thing the Working Group can do. Pat also supported the idea of clinical trials, whether individual or network.
Vote on Revised Recommendation 1
After revising the wording, 12 Working Group members voted yes to accept the following recommendation. Two members were absent.
Encourage clinical trials on early and persistent Lyme disease.
Proposed Recommendation 2
**Priority 2:**Educate clinicians as to the limitations of currently available tests in the diagnosis and in the monitoring of treatment of patients with persistent Lyme disease
**Potential Action 2.1:**CDC should develop educational modules on limitations of available testing in the diagnosis and in the monitoring of treatment of persistent Lyme disease and of the limitations in the interpretations of the results of previously conducted controlled antibiotic treatment trials.
	**Potential Action 2.2:** Provide Federal and state support for the use of regional and local clinician forums to educate clinicians as to the limitations of available testing in the diagnosis and in the monitoring of treatment of persistent Lyme disease and of the limitations in the interpretations of the results of previously conducted controlled antibiotic treatment trials.Discussion of Recommendation 2
The Working Group agreed that this recommendation could be absorbed into the previous recommendation on clinician education from the Training, Education, Access to Care, and Reimbursement Subcommittee. Sam agreed to this as long as the limitations of diagnostic testing are covered in the earlier recommendation. Coop responded that those limitations are, in fact, covered.
Proposed Recommendation 3
**Priority 3:**Further evaluate potential maternal-fetal transmission of Lyme disease and of congenital Lyme disease.
**Potential Action 3.1:** Provide funding for a registry and more studies to determine the extent of maternal-fetal transmission of Lyme disease and of any congenital Lyme disease.
Discussion of Recommendation 3
Sam stated that while there is some evidence to suggest maternal-fetal transmission of Lyme disease, congenital Lyme disease is still in question. He noted that a registry could be used to help explore this issue.
The Working Group discussed combining the two statements into one that centers around “alternate routes of non-vector transmission.” They also discussed whether or not to include sexual transmission and transmission through blood transfusion in the recommendation. However, several members expressed concern about including those two issues. David remarked that the presence of *Borrelia* in the blood supply is transient, and the issue may be out of scope. Sam expressed his preference that this recommendation stay focused on maternal-fetal transmission and congenital Lyme disease, noting that sexual transmission could be covered in its own recommendation.
Vote on Revised Recommendation 3
After revising the wording, nine members voted yes to accept the following recommendation. Three members abstained; two members were absent.
Further evaluate potential maternal-fetal transmission of Lyme disease and of congenital Lyme disease.
Proposed Recommendation 4
**Priority 4:**Further evaluate purported human-to-human sexual transmission of Lyme disease.
**Potential Action 4.1:** Provide funding for research to support or refute the purported human-to-human sexual transmission of Lyme disease.
Discussion of Recommendation 4
Several members of the Working Group expressed concern about this recommendation, questioning if human-to-human sexual transmission is, in fact “purported,” and if this recommendation should be prioritized given the gravity of the many other issues being tackled in the report and the limited number of recommendations the Working Group can put forward.
Leigh Ann suggested eliminating recommendation 4 and broadening revised recommendation 3 in order to leave open the possibility of studying Lyme disease transmission through various means, as follows: “Further evaluate the non-tick bite transmission of Lyme disease, for example, maternal-fetal transmission.”
Members did not reach an agreement on how to handle this recommendation and decided to table the motion until later in the meeting.
Vote to Table the Motion to Change Revised Recommendation 3 and Eliminate Recommendation 4
All members present (11) voted to table the motion to change revised recommendation 3, as follows, and eliminate recommendation 4. Three members were absent.
**Tabled:** Further evaluate the non-tick bite transmission of Lyme disease, for example, maternal-fetal transmission.
Discussion of the Proposed Recommendations from the Tick Biology, Ecology, and Control Subcommittee
Tick Biology, Ecology, and Control Subcommittee Co-Chairs Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service; and Kevin R. Macaluso, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama, presented the following proposed recommendations to the Working Group.
Proposed Recommendation 1
Minimize the public health threat of Lyme disease and other tick-borne diseases through special emphasis on integrated tick management, disruption of tick biological processes that contribute to pathogen transmission, and support of public-private partnerships to develop and promote tick control strategies.
Discussion of Recommendation 1
Kevin asked to change the wording from “special emphasis on” to “special funding for.”
Vote on Revised Recommendation 1
After revising the wording, 13 Working Group members voted yes to accept the following recommendation. One member was absent.
Minimize the public health threat of Lyme disease and other tick-borne diseases through special funding for integrated tick management, disruption of tick biological processes that contribute to pathogen transmission, and support of public-private partnerships to develop and promote tick control strategies.
Proposed Recommendation 2
Support the CDC-directed national network for tick surveillance and control by promoting the development and implementation of best practices for tick surveillance, including human-biting tick surveillance, and streamlining coordination amongst relevant Federal, state, and local agencies. This support should coincide with the allocation of fiscal resources for local tick management programs and for education and training of all stakeholders, and be implemented by fiscal year 2021.
Discussion of Recommendation 2
Kevin clarified that this recommendation is intended to enhance and expand the national strategy for tick control currently being undertaken by CDC (as described by Ben on Day 1 of the meeting). Ben added that if additional funds were allocated to CDC for this initiative, they would be distributed to state and local health departments. He then explained how the allocation process works.
Ben questioned the inclusion of a timeline in the recommendation, stating that it may be beyond the bounds of what a Federal advisory committee can ask for. He added that CDC does not currently fund local tick management programs; therefore, that piece of the recommendation is outside the scope of CDC’s current activities.
Members discussed what CDC is currently able to do under the Strengthening Mosquito Abatement for Safety and Health (SMASH) Act and whether or not those activities could be leveraged to implement tick control. Ben commented that it may be possible; however, funding is not currently in place to do so.
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense, commented that the phrase “human-biting ticks” was included in the recommendation by the Alpha-Gal Subcommittee to ensure that ticks that have bitten people are collected and submitted for testing. Leigh Ann stressed that the phrasing was intentional and should remain as is.
Ben asked for clarification about best practices, noting that they do not currently exist for tick control. Therefore, he added, that part of the recommendation would be a significant undertaking. Kevin explained that multiple expert presenters emphasized to his subcommittee the need for best practices.
Vote on Revised Recommendation 2
After revising the wording, 14 Working Group members voted yes to accept the following recommendation. Two of the votes were made by proxy.
Provide funding to support the CDC-directed national network for tick surveillance and promoting the development and implementation of best practices for integrated tick management, capturing human tick bite events, and streamlining education, training, and coordination amongst relevant Federal, state, and local agencies.
Proposed Recommendation 3
Implement multi-agency, ecologically-based One Health efforts on tick-borne diseases that promote research and enhanced vector surveillance to identify and validate integrated tick management in keystone wildlife hosts, particularly white-tailed deer, and the sustainable management of their populations.
Discussion of Recommendation 3
Beto explained the One Health concept to the Working Group.
Vote on Recommendation 3
Thirteen Working Group members voted yes to accept the following recommendation, unchanged from the originally proposed version. Two members voted by proxy; one member was absent.
Implement multi-agency, ecologically-based One Health efforts on tick-borne diseases that promote research and enhanced vector surveillance to identify and validate integrated tick management in keystone wildlife hosts, particularly white-tailed deer, and the sustainable management of their populations.
Discussion of the Previously Tabled Motion
David reminded the group that the originally scheduled updates from the Federal Inventory Subcommittee and Public Comments Subcommittee had been canceled due to time constraints.
He then transitioned the meeting to a discussion of the following motion, which had been tabled during Sam’s presentation of the recommendations from the Clinical Aspects of Lyme Disease Subcommittee.
**Motion:** Replace revised recommendation 3 (“Further evaluate potential maternal-fetal transmission of Lyme disease and of congenital Lyme disease”) with the following language: “Further evaluation of non-tick bite transmission of Lyme disease, for example, maternal-fetal transmission.” Also, eliminate recommendation 4 (“Further evaluate purported human-to-human sexual transmission of Lyme disease.”).
Ben commented that the proposed language is broader and, thus, inclusive of all types of transmission. Sam responded that he would accept the change as long as maternal-fetal transmission is called out in the recommendation.
Vote on Revised Recommendation 3
After revising the wording, 13 Working Group members voted yes to accept the following recommendation. Two members voted by proxy; one member was absent.
Further evaluation of non-tick bite transmission of Lyme disease, for example, maternal-fetal transmission.
Discussion of the Outline for the 2020 Report to Congress and Alignment of Recommendations with Chapter Topics
Jennifer Gillissen, Contractor, Kauffman and Associates, Inc., presented the outline for the 2020 Report to Congress and opened it up to the Working Group for discussion. Members agreed to review it carefully, chapter by chapter, and consider each topic in light of the decisions that had been made during the meeting. They agreed that the outline may need to be revised to better reflect the final recommendations.
Topics discussed include the following:
Removal of the term “microbes” from Chapter 3
	Combining prevention with education
	Pairing of epidemiology with human surveillance
	Audience-appropriate terminology
	Coverage of treatment
	Separating education and access to care
	How access to care relates to Federal agency website content and geographic issues related to surveillance
	Separating clinical education from public education
	Lack of content on insurance coverageNext, the Working Group members worked together to align the finalized recommendations with the different chapter topics. Their discussion resulted in the following outline and alignment of corresponding recommendations.
**Executive Summary**
**Introduction to Tick-Borne Diseases: Where We Are Now**
**Chapter 1: Background**
**Chapter 2: Methods**
**Chapter 3: Tick Biology, Ecology, and Control**
**Recommendation:** Minimize the public health threat of Lyme disease and other tick-borne diseases through special funding for integrated tick management, disruption of tick biological processes that contribute to pathogen transmission, and support of public-private partnerships to develop and promote tick control strategies.
	**Recommendation:** Provide funding to support CDC-directed expanded tick surveillance and promoting the development and implementation of best practices for integrated tick management, capturing human tick bite events, and streamlining education, training, and coordination amongst relevant Federal, state, and local agencies.
	**Recommendation:** Implement multi-agency, ecologically-based One Health efforts on tick-borne diseases that promote research and enhanced vector surveillance to identify and validate integrated tick management in keystone wildlife hosts, particularly white-tailed deer, and the sustainable management of their populations.**Chapter 4:** **Clinical Manifestations, Diagnosis, and Diagnostics**
**Recommendation:** Establish and fund research for sensitive and specific diagnostic tests for acute rickettsial, ehrlichial, and anaplasmal diseases. Encourage development of these tests as in vitro diagnostics approved by FDA.
	**Recommendation:** Fund research aimed at characterizing the full clinical spectrum, clinical manifestations, and potential complications of human monocytic ehrlichiosis (HME) and human granulocytic anaplasmosis (HGA), including identification of risk factors for severe illness and the importance of specific co-morbidities, patient characteristics (age, gender, and race), immune impairment, and genetic host factors.
	**Recommendation:** Establish and fund research for sensitive and specific diagnostic tests for the broader range of tick-borne diseases, including tick-borne relapsing fever, Powassan virus, and other emerging tick-borne pathogens. Encourage development of these tests as in vitro diagnostics approved by FDA.
	**Recommendation:** Provide HHS with resources to partner with national Integrated Delivery Networks (IDNs) (e.g., Geisinger, Kaiser, etc.) to conduct a pilot feasibility study to leverage Electronic Medical Records (EMRs) using Best Practice Alerts at the patient point-of-care for Alpha-gal Syndrome in endemic areas (upholding patient confidentiality).
	**Recommendation:** Provide HHS with resources to partner with national Integrated Delivery Networks (IDNs) (e.g., Geisinger, Kaiser, etc.) to conduct a pilot feasibility study to leverage Electronic Medical Records (EMRs) using Best Practice Alerts at the patient point-of-care for rickettsia, ehrlichiosis, and anaplasmosis in endemic areas (upholding patient confidentiality).**Chapter 5: Causes, Pathogenesis, and Pathophysiology**
**Recommendation:**Provide HHS with resources necessary to fund basic science research and clinical research to investigate the pathology of the human immune response following tick bites (e.g., Alpha-gal Syndrome).
	**Recommendation:**Support the targeted funding of research to understand the role of persistence of bacteria and bacterial products in the pathogenesis and management of Lyme disease (e.g., antibiotic regimens and other therapeutics).
	**Recommendation:**Support targeted funding opportunities for research to better inform the diagnosis, pathogenesis, and management of Lyme carditis.**Chapter 6: Treatment**
**Recommendation:**Conduct laboratory, clinical, and field research to address gaps in our capacity to treat and prevent the broader range of tick-borne diseases, including particularly babesiosis, tick-borne relapsing fever, Powassan virus infection, and other low-incidence tick-borne diseases.
	**Recommendation:**Encourage clinical trials on early and persistent Lyme Disease.**Chapter 7: Clinician and Public Education, Patient Access to Care**
**Recommendation:**Fund efforts across the U.S. to expand/require medical education to inform emergency, primary care, and other healthcare providers and to raise clinician and public awareness of rickettsial (including Rocky Mountain spotted fever), ehrlichial, and anaplasmal diseases.
	**Recommendation:** Fund efforts across the U.S. to expand/require medical education to inform emergency, primary care, and other healthcare providers and to raise clinician and public awareness of babesiosis, tick-borne relapsing fever, emerging tick-borne viral infections, and other low-incidence tick-borne diseases.
	**Recommendation:** Generate broad awareness of Alpha-gal Syndrome through the following two mechanisms:
		Provide funding/support/resources necessary to create a National Tick-Borne Alpha-gal Syndrome Alert that is focused on awareness, prevention, and education regarding tick associated Alpha-gal Syndrome and that targets key stakeholder groups.
			Label foods/beverages, medications and medical products, cosmetics, etc. containing mammalian-derived components for the safety of consumers with Alpha-gal Syndrome.
	**Recommendation:** Recommend Federal government websites and educational materials and seminars for clinicians, the public, and public health departments, which discuss Lyme disease, provide information that the state of the science relating to persistent symptoms associated with Lyme disease, is limited, emerging, and unsettled; and increase public awareness that there are divergent views on diagnosis and treatment. Consider that shared medical decision-making may be appropriate in some circumstances.
	**Recommendation:** Fund and support a directive for CDC (or other appropriate HHS OPDIV or agency) to develop (either directly or through an approved federal contract) a multi-leveled and nationwide curriculum on Lyme disease for clinicians-in-training as well as continuing medical education modules to increase the pool of qualified and practicing clinicians. Provide funding for the U.S. military to participate in this nationwide training and education on Lyme disease and other tick-borne diseases and conditions. This curriculum should be introduced and encouraged at the State level. The final curriculum shall incorporate feedback from patients, clinicians, and research scientists with expertise/experience that represents diverse scientific and clinical experiences on the full spectrum of Lyme disease and other tick-borne diseases/conditions.**Chapter 8: Epidemiology and Surveillance**
**Recommendation:**Fund prospective acute febrile illness studies to understand burden of tick-borne diseases, including rickettsial, ehrlichial, and anaplasmal pathogens.
	**Recommendation:**Recommend that CDC work with Council of State and Territorial Epidemiologists, CSTE, to streamline the surveillance process and reduce the burden on clinicians and public health departments by permitting direct laboratory reporting of positive cases.
	**Recommendation:**Further evaluation of non-tick bite transmission of Lyme disease, for example maternal-fetal transmission.**Chapter 9: Looking Forward**
**Chapter 10: Conclusion**
**Appendices**
Vote on the 2020 Report to Congress Outline Including Recommendations
Ten Working Group members voted yes to approve the aforementioned outline including recommendations. One vote was made by proxy. Three members were absent.
Establishment of Writing Groups for the 2020 Report to Congress
Next, the Working Group members worked to divide themselves into writing groups assigned to each section of the report. The discussion resulted in the following assignments.
Executive Summary—Leigh Ann and David
Introduction to Tick-Borne Diseases: Where We Are Now—Leigh Ann and David
Chapter 1: Background— Leigh Ann and David with contractor support
Chapter 2: Methods— Leigh Ann and David with contractor support
Chapter 3: Tick Biology, Ecology, and Control—Beto and Kevin
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics—Sam and Todd
Chapter 5: Causes, Pathogenesis, and Pathophysiology—Scott and Angel
Chapter 6: Treatment—Dennis and Sam
Chapter 7: Clinician and Public Education, Patient Access to Care—Coop and Pat
Chapter 8: Epidemiology and Surveillance—Ben and Gene
Chapter 9: Looking Forward—Leigh Ann and David
Chapter 10: Conclusion—Leigh Ann and David
Jim commented that he would check with Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, HHS, to determine if he would be able to help with one of the chapters.
Pat asked if the Working Group would be able to include new information that may have come to light since the writing of the subcommittee reports. Kaye responded that the writing groups are not restricted to the content in the subcommittee reports; however, new content would be subject to the approval of the entire Working Group.
Review of Meeting 12 and Next Steps
Leigh Ann briefly reviewed what had been accomplished by the Working Group during Days 1 and 2 of Meeting 12. Specifically, she stated that all proposed potential actions had been reviewed, revised, voted upon, and incorporated into the newly revised report outline. She added that writing groups had been assigned to compile the 2020 Report to Congress. Leigh Ann concluded that the group’s highest priorities for the meeting had been met.
David thanked the Working Group members for their congeniality and willingness to work through challenging subjects in order to achieve consensus.
Leigh Ann briefly reviewed the timeline for upcoming public meetings, as well as writing, finalizing, and submitting the report. She added that the updated outline and recommendations would be sent to members immediately following the meeting.
Adjournment
The meeting was adjourned at 4:55 pm Eastern.
Appendix 1: Tick-Borne Disease Working Group Members
**In alphabetical order**
Co-Chair
*Leigh Ann Soltysiak*, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking (Present)
**Co-Chair**
*David Hughes Walker*, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases (Present)
*Charles Benjamin (Ben) Beard*, PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, HHS; Associate Editor, Emerging Infectious Diseases (Present) – *Susanna N. Visser*, DrPH, MS, Associate Director for Policy, Division of Vector-Borne Diseases, Centers for Disease Control, U.S. Department of Health and Human Services (Alternate present)
*CDR Rebecca Bunnell*, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services (Absent) – *CAPT Scott J. Cooper,* MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of health and Human Services (Alternate present)
*Scott Palmer Commins*, BS, MD, PhD, Associate Professor of Medicine & Pediatrics
	University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center (Absent; Designated proxy: Angel Davey)
*Angel M. Davey*, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense (Present)
*Dennis M. Dixon*, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Present) - *Samuel (Sam) S. Perdue,* PhD, Section Chief, Basic Sciences and Program Officer, Rickettsial and Related Diseases, Bacteriology and Mycology Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services (Alternate present)
*Sam T. Donta*, MD, Professor of Medicine (retired); Consultant, Infectious Diseases (Present by phone)
*CAPT Estella Jones*, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services (Absent) – *CDR Todd Myers*, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, U.S. Food and Drug Administration, U.S. Department of Health and Human Services (Alternate present)
*Kevin R. Macaluso*, PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama (Present)
*Adalberto (Beto) Pérez de León*, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service (Present; Designated proxy at the end of Day 2: Kevin Macaluso)
*Eugene David Shapiro,* MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine (Absent; Designated proxy: David Walker)
*Patricia V. Smith*, President, Lyme Disease Association, Inc. (Present)
*Leith Jason States**,* MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Absent) – Shahla Jilani, Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services (Alternate present)
Appendix 2: HHS Support Staff
**In alphabetical order**
*James (Jim) Berger*, MS, MT (ASCP), SBB, Designated Federal Officer, Tick-Borne Disease Working Group Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Jordan Broderick*, MA, Health Communication Specialist, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Kaye Hayes*, MPA, Alternate Designated Federal Officer, Tick-Borne Disease Working Group, Executive Director, Presidential Advisory Council on HIV/AIDS, Principal Deputy Director, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Chinedu Okeke*, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Allison Petkoff,*ORISE Policy Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
*Debbie Seem*, RN, MPH, Public Health Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Appendix 3: Subcommittee Co-Chairs
Alpha-Gal Subcommittee
*Scott Palmer Commins,*BS, MD, PhD, Associate Professor of Medicine & Pediatrics
	University of North Carolina; Member, UNC Food Allergy Initiative, Thurston Research Center
*Angel M. Davey,* PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense
*Leigh Ann Soltysiak,* MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking
Babesiosis and Tick-Borne Pathogens Subcommittee
*Charles Benjamin (Ben) Beard,* PhD, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Associate Editor, Emerging Infectious Diseases
*Eugene David Shapiro,* MD, Professor of Pediatrics, Epidemiology, and Investigative Medicine, Yale University School of Medicine; Vice Chair for Research, Department of Pediatrics; Co-Director of Education, Yale Center for Clinical Investigation; Deputy Director, Yale PhD Program in Investigative Medicine
Clinical Aspects of Lyme Disease Subcommittee
*CDR Rebecca Bunnell,* MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services
*Sam T. Donta,* MD, Professor of Medicine (retired); Infectious Disease Consultant, Falmouth Hospital
Ehrlichiosis and Anaplasmosis Subcommittee
*Dennis M. Dixon,* PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health and Human Services
*David Hughes Walker*, MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases
Pathogenesis and Physiology of Lyme Disease
*Sam T. Donta,* MD, Professor of Medicine (retired); Consultant, Infectious Diseases
*Leith Jason States*, MD, MPH, Acting Chief, Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services
Rickettsiosis Subcommittee
*CAPT Estella Jones,* DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services
*CDR Todd Myers,* PhD, Office of the Chief Scientist, Office of Counter Terrorism and Emerging Threats, Food and Drug Administration (Alternate Co-Chair)
*David Hughes Walker,* MD, Professor, Department of Pathology, the Carmage and Martha Walls Distinguished University Chair in Tropical Diseases; Executive Director, UTMB Center for Biodefense and Emerging Infectious Diseases
Tick Biology, Ecology, and Control
*Adalberto (Beto) Pérez de León,*MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service
*Kevin R. Macaluso,* PhD, MS, Locke Distinguished Chair, Chair of Microbiology and Immunology, College of Medicine, University of South Alabama
Training, Education, Access to Care, and Reimbursement
*Patricia V. Smith,* President, Lyme Disease Association, Inc.
*CDR Rebecca Bunnell*, MPAS, PA-C, Senior Advisor, Learning and Diffusion Group, Innovation Center, Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services
*CAPT Scott J. Cooper,* MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, Centers for Medicare and Medicaid Services, U.S. Department of health and Human Services (Alternate Co-Chair)

                    
  


Content created by Office of Infectious Disease and HIV/AIDS Policy (OIDP) Content last reviewed April 22, 2020Back to top
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