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 from the Working Group and Roll Call
James (Jim) Berger, MS, MT (ASCP), SBB, Senior Blood and Tissue Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, 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 at 9:00 am and conducted roll call (see Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff). The meeting started with a quorum.
Working Group co-chairs (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; Leigh Ann Soltysiak, MS, Owner, Principal, Silverleaf Consulting, LLC; Adjunct Professor, Stevens Institute of Technology, Entrepreneurship Thinking) welcomed all meeting attendants and recapped the Day-1 meeting.
Recap of Day-1 Meeting
David noted that the Working Group heard the following during the day-1 meeting.
- An encouraging message from ADM Brett Giroir, Assistant Secretary for Health, who highlighted the need for a One Health approach and urged the Working Group to provide evidence-based, actionable recommendations
- Updates on the strategic plans from Federal agencies
- The National Institutes of Health (NIH) has released its Strategic Plan for Tick-Borne Disease Research.
- The Centers for Disease Control and Prevention (CDC)-led Domestic Framework is currently under review.
- The Food and Drug Administration (FDA) encourages proactive interaction with the agency.
Leigh Ann noted that members of the public provided input and are continuing to provide comments online. The comments presented yesterday covered a wide range of topics, including ehrlichiosis, coinfections, challenges experienced by patients, Alpha-gal Syndrome (AGS), persistent Lyme disease, need for new research and innovation, issues associated with transplantation and CDC maps, other illnesses, as well as the involvement of advocacy groups.
At the Day-1 meeting, Leigh Ann added, five subcommittees presented their reports to the Working Group. The co-chairs of each subcommittee provided background information, explained methods used, and presented results, which included priority areas, issues, challenges and opportunities, and potential actions for the Working Group to consider.
Leigh Ann briefly reviewed the agenda for day-2 meeting and transitioned the meeting to the Public Comments Session.
Public Comments
Seven members of the public provided comments.
Melissa Potter: Melissa stated that she was speaking on behalf of LymeDisease.org. She highlighted several issues related to access to care, insurance coverage, and reimbursement for treatment of Lyme disease, including the following:
- Insufficient funding and research;
- Delayed diagnosis;
- Difficulty finding clinicians who follow the International Lyme and Associated Diseases Society (ILADS) guidelines;
- Lack of insurance coverage; and
- Limited treatment options, especially for patients who remain ill after treatment.
Melissa urged antitrust action and government intervention to help address the issues she outlined. She also asked that CDC and NIH acknowledge both the Infectious Diseases Society of America (IDSA) and ILADS standards of care on their websites and encourage meaningful representation of patients on all policies that affect them.
Andrea Roseman: Andrea stated that she is a supporter of Tick-Borne Conditions United and that her son was diagnosed with AGS at the age of eight, following a year of allergic reactions. She explained that, after the diagnosis, her son’s doctor did not provide additional information on the condition, so she resorted to doing her own research online. She added that her family ultimately found a doctor whom they trust.
Andrea highlighted the lack of educational materials and emphasized the importance of training clinicians. She also stressed the need for adequate food labeling and a better understanding of Alpha-gal allergy in general.
Kenneth Kozak: Kenneth provided a U.S. Army Veteran’s perspective on tick-borne diseases. He described his years-long experience trying to obtain accurate diagnoses through the Veterans Affairs (VA) healthcare system. He stated that he visited the emergency room in severe pain on multiple occasions, yet AGS was not considered in the differential diagnosis despite his insistence that it should be. He explained that he ultimately tested positive for AGS, Rocky Mountain spotted fever, and Lyme disease. He expressed frustration that the diagnoses took many years to obtain and that he had to go outside the VA healthcare system to get them. He added that he had been denied referrals to see clinicians in the private system, and that it often takes him 120 days to see a doctor. Kenneth urged the Tick-Borne Disease Working Group to work on behalf of Veterans to address these issues in the VA healthcare system.
Lonnie Marcum: Lonnie provided comment over the phone. She explained that she is a physical therapist, a health science writer for LymeDisease.org, and a member of one of the Tick-Borne Disease Working Group’s subcommittees. She commented on the CDC web content that recommends a single dose of doxycycline to prophylactically treat Lyme disease following a tick bite, stating that this practice does not represent effective antibiotic stewardship and does not ensure the best patient outcomes. She stated that there is a lack of evidence to support the use of a single dose of doxycycline, and she identified the limitations of the study referenced on the CDC website. Lonnie outlined the results of other studies, stating that they showed no benefit of antibiotic prophylaxis given after a tick bite. She urged the Tick-Borne Disease Working Group to recommend that CDC re-evaluate this information and revise the web content accordingly. She also referred the Working Group members to her written comments for more detail and references.
Jennifer Platt: Jennifer stated that she is with Tick-Borne Conditions United and Tick Warriors and her focus is on educating the public to prevent exposure to ticks, conducting research, and applying field techniques to control lone star ticks using EPA minimum-risk products recommended by CDC. She shared that an AGS patient survey is open on the Tick-Borne Conditions website and encouraged everyone to share it with patients who have AGS. Jennifer urged the Tick-Borne Disease Working Group to consider management of ticks and tick-borne disease from an ecosystem perspective, determine the extent of underdiagnosed conditions, and improve education for health care providers.
Kathleen Wallace: Kathleen provided comment over the phone. She shared that she lives in Upstate New York, was diagnosed with Lyme disease and multiple chemical sensitivity (MCS), and is a patient advocate. She explained that her illness has negatively affected her physical and emotional health and quality of life, leading to the loss of home, business, and family life. She described the triggers and symptoms of MCS and provided statistics on health outcomes and job loss associated with the illness. She noted that MCS is often experienced by tick-borne disease patients, Gulf War veterans, and survivors of 9/11. To address the issue of MCS and improve access to care and information, she emphasized the need for a medical code, research, education for physicians, and better air quality control.
Phyllis Mervine: Phyllis, over the phone, explained that she is the president of LymeDisease.org and a resident of Mendocino, California, a high-risk area for Lyme disease. However, she noted, the CDC incidence maps no longer include information about her county and only show that California is a low-incidence state. She provided statistics on incidence in her county that demonstrated comparability with high-risk states like Wisconsin and Vermont. She also cited a research project estimating that 37% of residents in her county have definite or probable Lyme disease.
Phyllis highlighted some of the complexities of diagnosing Lyme disease in California, including the use of tests that are tailored to antigens in the Northeast. She commented that her state has the most Borrelia species and at least 10 other tick-borne diseases. Yet, she noted, few tests screen for all of them. She emphasized the importance of early diagnosis and treatment to prevent chronic illness and recommended that CDC provide incidence maps that more accurately portray Lyme disease throughout the United States.
David and Leigh Ann thanked all of the public members for their comments and then transitioned the meeting to subcommittee presentations.
Subcommittee Presentations
Four subcommittees presented their work at the day-2 meeting. Co-chairs of the four subcommittees used a similar approach to present their work. They first provided a brief background, explained the methods used to produce the subcommittee report, and reviewed the subcommittee’s goals, all of which the subcommittees had reported to the Working Group at the last Working Group public meeting (Meeting #10 in September 2019). The co-chairs then presented the results of their work, including priorities areas, evidence and findings, challenges and opportunities, and potential actions for the Working Group to consider.
Babesiosis and Other Tick-Borne Pathogens Subcommittee
Charles Benjamin (Ben) Beard, PhD, Deputy Director, Division of Vector-Borne Diseases, CDC, HHS; Associate Editor, Emerging Infectious Diseases; Co-Chair of the Babesiosis and Other Tick-Borne Viruses Subcommittee, introduced himself and other members of the subcommittee (see Appendix 2 for membership of the subcommittee).
Background
Ben reported that in 2017, 59,349 cases of tick-borne disease were reported to CDC, of which 2,368 were babesiosis cases, 230 tularemia cases, and 33 Powassan virus infections. However, he noted, there are significant gaps in the understanding of the ecology and emergence of these pathogens. He noted that diseases caused by some of these pathogens are challenging to diagnose and treat, and he voiced concern over coinfections, which can affect symptoms and testing.
Ben explained that the subcommittee discussed eight types of diseases including: babesiosis, tick-borne relapsing fever (TBRF), Borrelia miyamotoi disease (BMD), Powassan virus disease, Colorado tick fever virus, Bourbon virus disease, Heartland virus disease, and tularemia.
Major Challenges and Issues
The subcommittee identified the following major challenges, issues, and needs.
- Better understanding of the disease ecology and natural history
- Improved surveillance for Babesia to capture species and travel history of patients
- Multiple pathogen interactions within vectors and hosts and subsequent impact on transmission
- Improved diagnostic assays, particularly for Borrelia miyamotoi
- Improved understanding of the range of illness associated with infection, from asymptomatic to severe manifestations
- Coinfections in patients and the impact on clinical symptoms, disease severity, and treatment response, particularly in the case of B. miyamotoi, Borrelia burgdorferi, and Babesia species
- Better understanding of the efficacies of currently recommended treatments and the need for new treatment options for Babesia infections
Priority Areas and Potential Actions
Ben noted that the subcommittee identified and discussed four priority areas and proposed potential actions for each of them.
Priority 1. Babesiosis
Potential Action 1.1: Explore the utility of newly developed blood screening technologies for validation for clinical diagnostic use.
Potential Action 1.2: Provide education to health care providers, including subspecialists and frontline providers (including but not limited to hospitalists, OB/GYN, and infectious disease doctors), in addition to family practice and internal medicine physicians, regarding the signs/symptoms/risks/laboratory evaluation/treatment challenges of babesiosis.
Potential Action 1.3: Conduct laboratory research and clinical trials to evaluate new treatment regimens for babesiosis. New treatment regimen investigation should include research on immunotherapies (for example, human monoclonal antibodies) or adjunctive therapies to control parasitemia while on drug treatment. New treatment regimens can be evaluated in animal models prior to clinical evaluation and human trials. Host factors are important therefore more research is needed to determine the best therapeutic regimen in conditions where chronic parasitemia may occur, in particular whether adjunctive therapy could be useful.
Potential Action 1.4: Conduct research on the ecology and distribution of B. duncani and other Babesia species (for example, MO-1) that might be pathogenic. To facilitate such research, development and validation of sensitive and specific serologic methods to detect exposure to Babesia duncani are needed.
Potential Action 1.5: Educate state health departments on the Council of State and Territorial Epidemiologist (CSTE) case definitions and the importance of reporting for these nationally notifiable diseases to the species level.
Priority 2. Tick-borne Relapsing Fever and Borrelia miyamotoi disease
Potential Action 2.1: Improve public education on prevention of tick bites. Improve education of health care providers regarding clinical manifestations, diagnosis, treatment, modes of transmission, surveillance reporting, and preventive measures for the unique exposure risks of TBRF and BMD.
Potential Action 2.2: Develop point-of-care testing, such as with a nucleic acid amplification test, to support the diagnosis of TBRF and BMD in their symptomatic stages.
Ben noted that the testing windows for TBRF and BMD are broader than for B. burgdorferi, and that this potential action holds a lot of promise.
Potential Action 2.3: Develop immunodiagnostic assays to discriminate between TBRF Borrelia species and B. miyamotoi.
Potential Action 2.4: Assess the effectiveness of alternatives to oral doxycycline and parenteral penicillin as treatments of TBRF and BMD, beginning first with in vitro testing and then animal models.
Potential Action 2.5: Initiate studies to assess sequela and other post-infection symptomology as a result of either TBRF or BMD.
Potential Action 2.6: Increase resources at the Federal and state levels for assessing the incidence of TBRF and BMD.
Potential Action 2.7: Encourage the Council of State and Territorial Epidemiologists to develop case criteria for inclusion of TBRF and BMD in the list of nationally reportable diseases.
Ben pointed out that TBRF is reportable in some states but reportability varies from state to state.
Potential Action 2.8: Investigate whether TBRF or B. miyamotoi spirochetes persist as cultivable or uncultivable forms in different tissues, including the brain, and under what conditions, after antibiotic therapy in suitable animal models.
Potential Action 2.9: Allocate funds to recruit and encourage professionals in the study of soft ticks, TBRF, and BMD.
Members of the subcommittee, Ben noted, pointed out that fewer and fewer labs have the expertise with soft ticks.
Priority 3. Tick-Borne Viruses
Potential Action 3.1: Allocate resources and establish uniform reporting criteria for Colorado Tick fever virus, Heartland virus, and Bourbon virus. Encourage conversations between CDC and CSTE to make all TBVs nationally notifiable.
Potential Action 3.2: Identify and promote simple, rapid, and straightforward viral diagnostics and incorporate them into existing, commercially available, tick-borne disease panels.
Ben explained that currently the tests are mostly conducted at CDC and in a few states.
Potential Action 3.3: Conduct serological surveys and clinical follow-up to determine the range of clinical presentations and outcomes following tick-born virus (TBV) infection.
Ben noted there are a lot of unknowns in the field.
Potential Action 3.4: Increase education to physicians and other health care providers on these uncommon diseases that have changing geographic distributions. If health care providers do not know about these diseases, they will never consider them in their diagnoses nor order tests for them.
Ben commented that education is a common theme, and members of the subcommittee had raised various concerns around education. He shared that CDC conducted a tick surveillance last year to: 1) find out where ticks are; 2) understand risk; and 3) use the information to educate clinicians. The goal was to address challenges and criticisms from the patients regarding underdiagnosis and misdiagnosis associated with CDC’s maps. Ben clarified that case definitions are determined by CSTE, not CDC.
Potential Action 3.5: Conduct research to better understand the relationship between virus perpetuation and human risk. Research efforts should include: long-term field studies of TBVs in relevant field locations as well as the use of existing collections of ticks and vertebrate specimens to determine the distribution of infection in space, in different tick species, and in putative vertebrate hosts.
Ben noted that the tick surveillance system launched by CDC could help achieve Potential Action 3.5.
Potential Action 3.6: Conduct laboratory experiments on virus-vector-vertebrate interactions to clarify molecular interactions that are critical to transmission and to identify weak points in transmission that could serve as targets for novel interventions.
Ben highlighted the need for basic research in this area.
Potential Action 3.7: Evaluate the potential role of the Asian longhorned tick, Haemaphysalis longicornis, in transmission of TBVs including laboratory and field studies to: evaluate host associations, particularly whether it will feed on humans; evaluate potential interactions between this tick species and important native tick vectors; for example, Ixodes scapularis and Amblyomma americanum; and determine the potential for significant changes in the risks for different tick-borne diseases.
Ben pointed out the need for better understanding of vectorial compacity and transmission between animals. He noted that a lot of work needs to be done.
Potential Action 3.8: Conduct experiments to determine the potential interactions between tick species where many different species coexist or are expected to coexist in the future. Expected increases or decreases in tick populations or species distributions have significant impacts on risk for different TBVs.
Potential Action 3.9: Assess the role of multi-pathogen interactions within vectors and vertebrates and their impacts on transmission. These studies should include: defining the tick microbiome giving attention to tick species, location, life-stage, time of year, and infection status for known pathogens. Efforts should also focus on experimental studies to define the extent that pathogenic and apathogenic microbiota impact virus replication and transmission.
Potential Action 3.9, Ben pointed out, is a crosscutting recommendation.
Potential Action 3.10: Develop molecular and entomological tools to analyze vector pathogen interactions, such as antibodies against tick cell markers, and improved reverse genetic systems for tick-borne virus studies in vivo.
Priority 4. Tularemia
Potential Action 4.1: Enhance education for healthcare providers to aid in appropriate diagnosis of potential tick-borne tularemia cases. This education would include epidemiology, natural history, signs and symptoms, preferred specimens and volumes for collection, and shipping requirements.
Potential Action 4.2: Improve prevention education targeting high-risk groups (for example, hunters, anglers, ranchers, and landscaping workers), especially in regions where transmission is known to occur.
Potential Action 4.3: Include tularemia testing in multiplex systems that are used for testing field collected ticks as a part of a national tick surveillance system to provide better information on pathogen occurrence and distribution.
Potential Action 4.4: Mitigate the administrative and legal effects of the Select Agent Rule to facilitate research on tularemia.
Summary
Ben concluded his presentation with the following crosscutting potential actions.
- Provide improved education to healthcare providers, including subspecialists and frontline providers, to facilitate disease identification/diagnosis. Provide improved public education on disease symptoms and tick bite prevention.
- Develop and utilize new diagnostic technologies (that is, blood screening, immunodiagnostic assays, and/or multiplex polymerase chain reaction [PCR]) for clinical, point-of-care testing.
- Identify additional treatment options for tick-borne illnesses (babesiosis in particular) and a better understanding of the efficacies of currently recommended treatments.
- Encourage the development of CSTE case definitions and increase the reporting of these diseases by making them nationally notifiable, if needed.
- Additional basic research funding to understand pathogen natural history and distribution, pathogen-vector interactions, the role of coinfections in disease, and the spectrum of each illness.
Discussion
After the presentation, Ben responded to questions and comments from members of the Working Group. The main discussion points are summarized below.
Pat Smith, president of Lyme Disease Association, asked about the tick testing program for national surveillance. Specifically, she wanted to know if ticks that are known to carry but not transmit a given infection to humans (for example, Ixodes spinipalpis and B. burgdorferi) would be tested for that infection. Ben replied that the ticks would be tested and the results reported using ArboNET, a system that allows states to input and transmit information to CDC. He added that CDC analyzes the data on an annual basis and provides occurrence maps. In addition, he described current efforts to implement surveillance data sharing between CDC and the U.S. Department of Agriculture (USDA).
The group discussed several possibilities for enhancing and expanding surveillance activities and supporting education and awareness. Todd Myers, PhD, HCLD (ABB), MB (ASCP), Office of Counterterrorism and Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, FDA, suggested incentivizing the veterinary community to have reportable diseases as a way to capture more data and enhance mapping. Ben referenced two organizations that currently report companion animal data to CDC. Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, USDA, emphasized that animal diseases can have a significant impact on human health, citing the Coronavirus outbreak in China. He suggested taking an ecosystem approach to better understand ticks and their associated pathogens, and engaging the interagency One Health group in activities recommended by the Tick-Borne Disease Working Group. Other members agreed the One Health approach is important to consider, with the understanding that the Tick-Borne Disease Working Group’s primary focus is human disease.
Sam T. Donta, MD, Professor of Medicine (retired); Consultant, Infectious Diseases, asked if it is possible, within the context of surveillance, to distinguish between acute babesiosis and coinfecting babesiosis. Ben responded that the CSTE case report forms would provide insight into that question.
Pat stated that the acaricide used on cattle at the U.S.-Mexican border to prevent infestation of cattle ticks is reportedly becoming less effective. Given the potential proliferation of those ticks, she asked if a Federal agency is currently assessing whether or not the ticks might be able to transmit Babesia to humans now or in the near future.
Ehrlichiosis and Anaplasmosis Subcommittee
Subcommittee Co-Chair David presented the subcommittee’s work. After explaining the subcommittee membership and methods used to produce the subcommittee report, David highlighted the key issues and priority areas, and presented potential actions.
Key Issues
- Ehrlichiosis and anaplasmosis comprise four different diseases caused by three Ehrlichia species including: human monocytotropic ehrlichiosis (HME) caused by Ehrlichia chaffeensis and transmitted by the lone star tick; E. ewingii infection transmitted by the lone star tick; E. muris eauclairensis, and human granulocytotropci anaplasmosis (HGA) transmitted by the blacklegged tick.
- The diseases have high fatality rates yet are not well known.
- The incidences of the diseases are on the rise (cases reported to CDC increased 4-fold and 8-fold from 2004 to 2016 for HME and HGA, respectively).
- Passive case reporting severely underestimated the true prevalence of the diseases.
- Clinical awareness is inadequate and knowledge gaps exist.
- The diseases are often misdiagnosed.
The subcommittee discussed the following four priority areas and proposed a total of 10 potential actions.
Priorities and Potential Actions
Priority 1. Gaps in the Epidemiology and Surveillance of Ehrlichiosis and Anaplasmosis
David explained that reported cases of ehrlichiosis and anaplasmosis markedly increased over the past 20-30 years. However, standardized tick surveillance and testing do not exist. Seroprevalence rates vary and may reach as high as 35% in some regions, suggesting underdiagnosis, underreporting, subclinical infections, and/or cross-reactive antibodies.
Potential Action 1.1. Determine the true number of human cases per year (incidence) and full clinical spectrum, clinical manifestations, and potential complications of human monocytic ehrlichiosis and human granulocytic anaplasmosis. Actions that accomplish this include:
- Enhance the system of case detection and reporting to capture the true incidence of infections and the specific agents that are causing the infections. Active surveillance is recommended for endemic regions.
- Support expanded participation among health departments in newly available electronic surveillance data submission through Message Mapping Guides, part of CDC’s National Notifiable Diseases Surveillance System Modernization Initiative.
- Establish a program to fund standardized tick surveillance and testing for pathogens using well-validated molecular methods that are capable of detecting pathogens to the genus and species level across all states in disease-endemic areas.
Priority 2. Gaps in Knowledge of the Clinical Features of Ehrlichiosis and Anaplasmosis
David noted that these diseases are associated with a range of non-specific, atypical features, and our knowledge of the frequency and features is fragmentary. Understanding these features, the risk factors for the severity of the infections, the true number of asymptomatic and sub-clinical cases, is needed to improve patient diagnosis and treatment.
Potential Action 2.1: Support clinical education for primary medical caregivers (family medicine, primary internal medicine, pediatrics, emergency medicine, and physician’s assistants) and public awareness of ehrlichiosis and anaplasmosis to reduce morbidity and mortality through prevention; early, accurate diagnosis; and appropriate treatment.
Potential Action 2.2: Establish studies to identify risk factors for severe illness including the presence or absence of specific comorbidities, patient characteristics (age, gender, and race), immune impairment/underlying medical condition, and genetic host factors.
Potential Action 2.3: Determine the impact of coinfection with other tick-borne pathogens, including emerging tick-borne viruses, in patients with ehrlichiosis or anaplasmosis, and how these coinfections are related to variations in clinical features and disease severity.
Priority 3: Gaps in Laboratory Diagnosis of Ehrlichiosis and Anaplasmosis
David highlighted the following gaps in ehrlichiosis testing.
- Blood smear detection of E. chaffeensis is extremely insensitive.
- Molecular methods are specific and sensitive, particularly before the detection of antibodies, but are not available in many locations.
- Serologic diagnosis that requires acute and convalescent sera detects a rising antibody titer in the second or third week after onset.
- There are no point-of-care or FDA-approved or cleared assays.
- Promising findings include detectable circulating ehrlichial proteins.
David pointed out that similar gaps exist in laboratory testing for anaplasmosis.
- Blood smear detection of Anaplasma phagocytophilum is 50% sensitive as an early point-of-care test.
- Serologic diagnosis is retrospective.
- Molecular tests are the methods of choice for early diagnosis.
- There are no FDA-approved or cleared nucleic acid amplification tests or point-of-care test for HGA.
Potential Action 3.1: Develop and evaluate diagnostic test(s), such as nucleic acid amplification tests (NAAT) or rapid immunoassays, that can be used in routine clinical laboratories, local clinical laboratories, and eventually as point-of-care tests that are sensitive and specific for the diagnosis of ehrlichioses and anaplasmosis during the early-acute disease state. Encourage development of these tests as in vitro diagnostics approved by the FDA.
Priority 4. Gaps in the Treatment of Ehrlichiosis and Anaplasmosis Treatment
David noted that doxycycline is the antibiotic of choice for both HME and HGA. However, the optimal duration of doxycycline therapy, the impact of patient demographics and clinical condition (for example, immunocompromised, children, or pregnant women) and coinfections on treatment outcome, and potential alternatives (for example, rifampin) to doxycycline need to be determined. No randomized controlled clinical trials for any antimicrobial agent have been conducted for ehrlichiosis or anaplasmosis.
Potential Action 4.1: Develop an organized and concerted public health approach to the prevention of ehrlichiosis and anaplasmosis that includes public and provider education and outreach.
Potential Action 4.2: Identify alternative antimicrobial treatments for
- Doxycycline contraindications and/or hesitancy to prescribe (for example, pregnant women, children under 8 years of age, and those with known allergies or coinfections);
- Broad spectrum coverage for potential bloodstream infections; and
- Acceptable alternatives during possible supply shortages of primary therapeutics.
Potential Action 4.3: Optimize duration of treatment to minimize the risk of adverse reactions to doxycycline and effects on healthy microbiomes, as well as address patients at risk for severe disease or complications (for example, HIV or immunomodulatory therapies).
Potential Action 4.4: Investigate adjunctive therapies, such as corticosteroids, etoposide, anakinra, or novel host-directed signaling pathways to address severe disease, including hemophagocytic lymphohistiocytosis (HLH).
Potential Action 4.5. Develop approaches for incorporating data mining and artificial intelligence into health care systems for real-time identification of characteristic signs, symptoms, exposures, and laboratory findings of ehrlichiosis and anaplasmosis at the point of patient presentation. Data analytics and systems should be able to access and analyze available clinical and laboratory information within the electronic medical record and provide guidance to clinicians for patient assessment, formulating a differential diagnosis, and recommending confirmatory laboratory testing, taking into account local disease prevalence and patient travel history.
David noted that in his view, Potential Action 4.5 is an overarching recommendation.
Discussion
Pat commented on the comparison between fatality rates of ehrlichiosis and those of Lyme disease, noting that while the Lyme disease fatality rates appear lower, they do not account for patients who die from chronic illness. She added that Lyme disease often does not appear on patients’ death certificates, making death rates especially difficult to track.
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense (DoD), asked if the subcommittee had considered ehrlichiosis in children, to which David replied that the report covers the use of doxycycline in young children.
Leigh Ann inquired about the approach that could be taken to track the true incidence of ehrlichiosis and anaplasmosis as well as coinfections. David responded that the subcommittee proposed the establishment of active surveillance to obtain more accurate information about diagnosis, clinical manifestations, and long-term sequelae.
In response to a question from Pat about transfusion cases and their implications, David explained that there have been cases where patients were infected in the hospital. He noted that patients who receive transfusions may have a suppressed immune system, which may cause them to have more severe manifestations of an infection. He referenced one case of fatal babesiosis that occurred through a transfusion.
Rickettsiosis Subcommittee
David, who is also a co-chair of the Rickettsiosis Subcommittee, presented the Rickettsiosis Subcommittee’s report.
David first reviewed background information, explained methods used to develop the subcommittee report, and introduced membership of the subcommittee. He then reported the four priority areas the subcommittee discussed. For each priority area, he noted, the subcommittee pointed out the critical issues (for example, threats, challenges, and gaps), identified opportunities, and proposed potential actions.
Priorities Areas, Issues, Challenges, and Opportunities
Priority 1: Clinical Management of Spotted Fever Rickettsial Infections
David noted there is a lack of clinical awareness of the infections and consideration of diagnosis. Many clinicians, he added, are unable to recognize the signs and symptoms of the infections and thus fail to initiate doxycycline.
He explained that currently there is no sensitive specific diagnostic test for early diagnosis, and clinically diagnosing these infections is difficult for various reasons, including the following.
- Early symptoms are nonspecific.
- Nausea, vomiting, and/or abdominal pain may suggest viral or bacterial enterocolitis or acute surgical abdomen.
- Neurologic manifestations may suggest other causes of meningoencephalitis.
- Pulmonary manifestations may suggest pneumonitis.
- Rash appears after several days of illness.
- History of tick bite is frequently absent.
David pointed out that delayed initiation of treatment is associated with adverse outcomes, including increased rates of hospitalization, intensive care unit admission, permanent sequelae, and mortality. However, the subcommittee, David noted, identified the following opportunities to improve the situation.
- Improve provider recognition and empiric treatment of Rocky Mountain spotted fever/spotted fever rickettsioses at early stages of the illness (for example, prior to the onset of a rash).
- Educate providers on updated recommendations for using doxycycline in children younger than eight years of age.
Priority 2: Education on Rickettsial Diseases
David noted that the failure to clinically recognize Rocky Mountain spotted fever as a possible diagnosis and misconceptions regarding the timing/appropriateness of doxycycline therapy can lead to severe illness and death. Current medical education regarding rickettsial infections (for medical students, residents, and practicing physicians) is inadequate.
David pointed out that severe manifestations, sequelae, and death can be avoided by the initiation of doxycycline treatment during the first few days of illness. However, erroneous assumption by many physicians regarding side effects of doxycycline have persisted, limiting its appropriate use.
David explained that some problems could potentially be addressed through medical education. For example, education could help improve awareness of the following.
- Early signs and symptoms are largely undifferentiated and may mimic other infectious syndromes.
- Rash, a characteristic for a rickettsiosis, is often absent during the early stages of the illness.
- Antibodies reactive to rickettsial antigens are not present during the early stages of the illness.
- Doxycycline is the treatment of choice for rickettsial diseases.
Priority 3: Surveillance and Epidemiology
David noted that the number of cases of spotted fever group rickettsioses reported to CDC per year has increased significantly in the last two decades. However, the national surveillance for spotted fever rickettsioses is based exclusively on passive reporting of cases, and the data are unlikely to accurately reflect the true prevalence of these diseases or identify the specific agent responsible for the actual illness.
David highlighted the following main challenges associated with surveillance.
- Current serological methods cannot determine the specific etiologic agent because of cross-reactive antigens of spotted fever group Rickettsia species.
- Molecular detection is challenging during the first few days of disease because only relatively small amounts of pathogen nucleic acid are found in circulation during the early stages of illness.
- Appropriate use of the immunofluorescence assay (IFA) requires tandem analysis of sera collected during the acute and convalescent phases of illness.
Priority 4: North American Tick Species Associated with the Transmission of Spotted Fever Rickettsial Agents to People
The subcommittee reported that currently six tick species in the U.S. are most commonly associated with, or suspected of transmitting, pathogenic and/or non-pathogenic spotted fever group rickettsial agents to people. Among the 11 identified spotted fever group Rickettsia agents carried by these six tick species, four spotted fever group Rickettsia species (R. rickettsii, R. parkeri, R. massiliae, and R. 364D) are proven human pathogens.
Ticks suspected of being able to transmit Rocky Mountain spotted fever to people commonly carry a variety of spotted fever group Rickettsia agents. Development of agent-specific diagnostic assays could help define the actual prevalence, prevent overdiagnosis and overtreatment, and identify serious rickettsial infections when they occur.
Potential Actions
The subcommittee proposed the following potential actions across the four priority areas.
Potential Action 1: Establish and fund a research program to develop sensitive and specific point-of-care tests that improve the availability of and access to species-specific assays for acute Rocky Mountain spotted fever and R. parkeri rickettsiosis; and establish serologic assays that distinguish between antibodies to R. rickettsii, R. parkeri, Rickettsia 364D, and R. amblyommatis.
Potential Action 2: Fund an educational outreach effort across the U.S. with mandatory rickettsial diseases continuing medical education to inform first-line responders (primary care physicians, advanced practice providers, pediatricians, urgent care providers, and emergency department providers) about the best diagnostic assays to use, best diagnostic samples to collect, and best strategies for treating patients (with a focus on doxycycline) diagnosed with or suspected of having Rocky Mountain spotted fever or another tick-borne rickettsiosis.
- Fund seasonal educational outreach efforts in endemic regions to raise public awareness about rickettsial diseases.
- Encourage accrediting bodies to ensure tick-borne diseases education in medical school curricula and graduate medical education and recommend that there be a greater presence of tick-borne disease material on licensing examinations and specialty board examinations.
Potential Action 3: Fund prospective programs on active clinical and environmental surveillance to understand the true geographic distributions and clinical incidence of rickettsial diseases including programs that survey for changing distributions of medically important tick species and rickettsial pathogens within these species.
Summary
David summarized his presentation with the following key points.
- Rocky Mountain spotted fever is the most severe tick-borne infectious disease.
- Emerging tick-borne spotted fever rickettsioses have been discovered.
- Funding is needed for
- Educational outreach efforts across the U.S.;
- Research program to develop sensitive and specific point-of-care tests; and
- Prospective programs on active clinical and environmental surveillance.
Discussion
After David’s presentation, the Working Group discussed the many challenges associated with studying and reporting rickettsial infections. Pat and David discussed the difficulties of determining which ticks carry which infections and in what percentage. David confirmed that the American dog tick (D. variabilis) is an important vector of Rocky Mountain spotted fever in the eastern United States; however, further study is needed to confirm if the lone star tick (A. americanum) can transmit the infection. He added that the other rickettsial infections are also important, yet they are commonly underreported.
Todd explained that because the individual rickettsial infections cannot be distinguished through serology, they are all grouped by CDC into the spotted fever group rickettsiosis, making it difficult to obtain surveillance data on each of them. Ben added that it is also challenging to interpret the data; for example, reported cases of spotted fever group rickettsioses are increasing while case fatalities are decreasing. He noted one major exception in the southwestern U.S. where Rocky Mountain spotted fever—transmitted in this case by brown dog ticks (R. sanguineous)—has a high fatality rate and represents a significant public health challenge. Ben also distinguished between surveillance and true burden of illness, which he noted, can never be fully understood using surveillance data.
David noted that the burden of illness associated with rickettsiosis is among the most underrecognized and that Rocky Mountain spotted fever is a deadly disease. He noted that passive surveillance data show a fatality rate of less than 0.5%, yet places like Mexicali, Mexico have much higher fatality rates (as high as 40%). He expressed concern about what this gap in knowledge and understanding might mean for the United States. Ben concurred and gave the example of the prevalence of brown dog ticks in Florida kennels, commenting that they do not currently transmit Rocky Mountain spotted fever, yet they have the potential to do so.
Sam and David discussed the cycling of Rocky Mountain spotted fever. David noted that reports of the illness have fluctuated since the 1920s. He reiterated that it is, however, very difficult to determine the incidence, given how often the illness is misdiagnosed and overlooked by clinicians.
Scott Palmer Commins, BS, MD, PhD, Associate Professor of Medicine and Pediatrics, University of North Carolina, wanted to know what people should do if they find out that a tick that has bitten them has tested positive for a rickettsial pathogen, and if there are reliable data on incidences of disease transmission from ticks attached to humans. David explained that those individuals with a tick that has tested positive may seek prophylactic treatment. He added that, while doxycycline is the most effective treatment for R. rickettsii, using antibiotics prophylactically merely prolongs the incubation period and does not prevent illness. David noted that he was not aware of any available data regarding how many ticks hosting rickettsial diseases will, in fact, transmit them.
Kevin highlighted the importance of characterizing the different Rickettsia genotypes, which, he added, can vary even within one species of the bacteria, with some being more virulent than others. He also stated that identifying “hot spots” for these agents is equally important.
Update on the Federal Inventory
Jim provided brief background information regarding the Federal inventory and introduced Dr. Chinedu Okeke, MD, MPH-TM, MPA, Senior Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, HHS, who had analyzed and reported the 2018 Federal inventory.
Jim explained that, according to 21st Century Cures Act, the Working Group is charged with: 1) reviewing all Federal activities within the U.S. Department of Health and Human Services related to all tick-borne diseases; 2) ensuring interagency coordination and minimizing overlap; and 3) identifying research priorities and gaps. To accomplish the task, an inventory request was sent to seven Federal agencies with responses due December 13, 2019. As of this meeting, the Working Group has received responses from all agencies, including NIH, CDC, FDA, Centers for Medicare and Medicaid Services (CMS), USDA, VA, and DoD.
Jim noted that Chinedu and Alison Petkoff, ORISE Policy Fellow, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, HHS, are organizing the data. After today’s meeting, he added, the Federal Inventory Subcommittee, formed at the last Working Group public meeting, will meet to discuss and decide how to use the information to inform the Working Group’s report to Congress.
Open Discussion for Working Group
Jim welcomed all meeting attendants again after a lunch break. He announced that CAPT Scott J. Cooper, MMSc, PA-C, Senior Technical Advisor and Lead Officer for Medicare Hospital Health and Safety Regulations, CMS, joined the meeting after the roll call in the morning; Leith Jason States, MD, MPH (FMF), Deputy Chief Medical Officer, Office of the Assistant Secretary for Health, HHS currently is not present; and Sam 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, NIH, is present on behalf of Dennis M. Dixon, PhD, Chief, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, NIH.
Leigh Ann then resumed the meeting. The Working Group conducted open discussion starting with addressing Pat’s earlier question on cattle fever ticks and the potential impact on animal and human health. The main discussion topics of the open discussion are summarized as follows.
Ticks, Animals, Humans, and the One Health Approach
The group discussed the impact of tick-borne diseases on humans as well as companion and livestock animals. In response to Pat’s question on Texas cattle fever transmitted by cattle ticks and the impact on humans, Beto explained the history of cattle tick eradication efforts and pointed out the complexity of the issues (for example, evolution of the species, environmental changes, land use, public demand for natural products, etc.). Animal trade between countries, he noted, also contributes to the complexity of the issues affecting the U.S.-Mexico border. To raise awareness and improve clinical education, he suggested reaching out to other professional societies and organizations, including those focusing on the health of farm and companion animal (for example, American Veterinary Medical Association and American College of Veterinary Pathologists). Beto clarified that the pathogens (Babesia and Anaplasma) carried by cattle ticks (Rhipicephalus [Boophilus] microplus and Rhipicephalus annulatus) affect animals but not humans. He noted that continued funding is needed to eradicate the ticks.
Disease Transmission, Studies, and Priorities
The Working Group members discussed the role of various ticks, such as the lone star tick and the Asian longhorned tick, in transmitting Heartland and Bourbon virus diseases and studies needed. Ben noted that laboratory studies of disease transmission using good animal models are limited, and that more studies (animal studies, natural history and ecological, as well as reservoir studies) are needed. In response to a question regarding the priority of these needed studies, Ben acknowledged that these are all priorities; however, prioritization can be challenging. Recommondations on these issues from the Working Group, he noted, might raise awareness and spur research interest.
Tick Eradication, Anti-Tick Vaccine, and Area-Wide Management
The group discussed tick eradication, anti-tick vaccines, and area-wide management for controlling the blacklegged tick (I. scapularis). Beto noted that a lot can be learned from the Cattle Fever Tick Eradication Program. He explained that his group has tested the effectiveness of the 4-poster technology using area-wide tick management programs, and an anti-cattle fever tick vaccine has been developed through a public-private partnership. He noted that insights and experiences gathered from the animal side can be adapted to the human side. He highlighted the advances in technology (for example, tick genome sequencing) and expressed his belief that vaccine development is feasible, though time-consuming. He noted that there are different strategies for vaccine development.
Kevin added that tick vaccines interrupt the life cycle and the feeding process of the ticks.
Beto noted that the U.S. is the only country in the world that employs area-wide tick management, and that the success of the strategy requires four critical elements: public support, regulation, funding, and infrastructure.
Education for Medical Professionals and the Public
The Working Group members generally agreed that education is needed for the public and healthcare providers. They discussed the effectiveness of various types of educational programs (for example, national and local continuing medical education [CME] conferences), educational approaches the Working Group should recommend, and the role of the government in educational efforts. Pat shared her experience in organizing conferences and providing CME programs. She pointed out the importance of having people with different views in the same room to conduct open discussion.
In response to Sam’s question on who should fund and support the educational programs for healthcare providers, David acknowledged it is a challenging question to answer. He emphasized the importance of education for caregivers and suggested the Working Group make recommendations to Congress.
Regarding public education, a couple of members pointed out the abundance and danger of false information online, and suggested figuring out a way to unify evidence-based messages. Pat commented that diverse viewpoints are needed when “the science is unsettled.”
AGS and Mechanism Studies
The group also discussed knowledge gaps associated with AGS (for example, lack of understanding of disease transmission mechanisms, an issue faced by all subcommittees). David suggested the AGS Subcommittee recommend funding studies on specific mechanisms, which, he noted, will enhance understanding. The three co-chairs of the AGS subcommittee explained the subcommittee’s potential actions. Scott shared that in 2019 NIH hosted a workshop on AGS and a publication that resulted from the workshop will help fill some gaps.
Treatment Guidelines
A couple of members indicated that information on CDC’s website (in particular, incidence maps and treatment guidelines) play an important role in public as well as healthcare providers’ understanding of and approaches taken to address tick-borne diseases. Given that public commenters have requested CDC update its web content, Sam wanted to know if CDC would make any changes. Ben acknowledged the complexity of the issue. He noted that CDC is an evidence-based organization and it is committed to making the best decisions in the most responsible manner. Currently CDC has limited information on treatment. Ben explained that decisions on what to say about challenging topics, and how best to say it, are not made by a single person; rather, they are based on long discussions and debates by dozens of experts.
Sam suggested adding non-controversial statements on CDC’s website, noting that there are opposing views regarding treatment strategies. Ben responded that he would take the suggestion back to CDC. CDC, Ben added, does acknowledge that every case is different, and that clinical diagnosis and judgement vary from person to person.
Diagnosis Criteria
David asked if there are diagnosis criteria for persistent Lyme disease. Betty Maloney, member of the Training, Education, Access to Care, and Reimbursement Subcommittee, responded that ILADS has established a definition for persistent Lyme disease but has not established validated diagnosis criteria.
NIH Activities
Sam expressed interest in learning more about the Trans-NIH Working Group on Chronic Fatigue Syndrome; specifically, he wanted to know if NIH would consider establishing another advisory subcommittee related to tick-borne diseases and if the Working Group can make recommendation specifically for NIH. Sam Perdue noted that NIH considers participating in the Tick-Borne Disease Working Group as one of its outreach opportunities. Kaye Hayes, MPA, Alternate DFO for the 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, HHS, clarified that the Trans-NIH Myalgic Encelphalomyelitis/Chronic Fatigue Syndrome Working Group was established in 1999 and sunsetted in September 2018.
Discussion of Next Steps and What Is Expected for the March Meeting
Timeline and Deliverables
In preparation for the Working Group’s next meeting, Leigh Ann reviewed the timeline and deliverables for the Working Group’s report to Congress.
- January 28-29, 2020: Subcommittees present reports to the Working Group
- January 30-March 3, 2020: Subcommittee co-chairs discuss priorities and decide top three potential actions for the Working Group to consider at the March public meeting
- March 3-4, 2020: Working Group in-person Meeting 12 to discuss potential actions from each subcommittee, finalize outline for report to Congress, form writing groups, and determine chairs for the writing groups
- March 5 – May, 2020: Working Group writes the report to Congress
- May 2020: Working Group Meeting 13 to discuss the draft report and recommendations
- June 2020: Working Group draft full report, including images and graphs
- July 15, 2020: Working Group Meeting 14 to review the content of report; review and approve images, graphics, and overall design of the final report
- July 15-18, 2020: Support staff make changes to the 1st draft of the report
- August 15, 2020: Working Group Meeting 15 to review the 2nd draft of the report
- August 15-18, 2020: Support staff incorporate changes to the 2nd draft of the report
- September 15, 2020: Working Group Meeting 16 to review and vote on the report to Congress
- September 16-October 20, 2020: Support staff finalize the final report (copyediting, 508 compliance, finalizing graphics, etc.)
- October 30-November 15, 2020: HHS agencies review and provide comments on the report
- November 15, 2020: Provide the 508-compliant version of the Working Group Report to Congress to HHS
- November 15, 2020: Submit the final 508-compliant version of the Working Group Report to Congress and HHS Secretary
What Is Expected for the March Meeting
Leigh Ann announced that the Working Group’s March meeting will be an in-person meeting. She explained that each subcommittee is expected to determine their top three potential actions prior to the meeting, then present them to the Working Group at the Meeting.
In response to Working Group members’ questions, Leigh Ann clarified that the top three potential actions from each subcommittee will be the subcommittee’s final recommendations. Leigh Ann and David noted that the subcommittees had successfully completed their work (that is, producing subcommittee reports), and that moving forward, the subcommittee co-chairs will work together as Working Group members on the report and the recommendations to Congress. They clarified that at the March meeting, the Working Group members will work together to review the report outline and the recommendations.
Next Steps and Action Items
- Co-chairs of each subcommittee will discuss and select their top three potential actions prior to the Working Group’s next meeting on March 3-4, 2020.
- Jennifer Gillissen, KAI, will resend the following documents to the Working Group members.
- Draft outline of the Working Group report to Congress
- Timeline and deliverables
- Date and venue of the next Working Group meeting
Next Meeting
Tick-Borne Disease Working Group in-person Meeting #12, March 3-4, 2020, Philadelphia, PA
Review of the Draft Outline of Report to Congress
Led by Leigh Ann and David, the Working Group reviewed and discussed the draft outline for the Working Group’s report to Congress. The main discussion points are summarized below.
From Potential Actions to Final Recommendations
Leigh Ann and David noted that after today’s meeting, the subcommittee co-chairs will be working on formal recommendations to Congress now that the subcommittees’ work has been completed.
In response to questions, Leigh Ann and David clarified that the subcommittee co-chairs can combine and consolidate their original potential actions if necessary.
Overlapping Recommendations
A few members pointed out that certain topics and recommendations (for example, education, research to understand infection and disease mechanisms, and surveillance) are crosscutting, and suggested that the subcommittee co-chairs perhaps need to coordinate across subcommittees. Leigh Ann and David confirmed that the subcommittee co-chairs can communicate across subcommittees regarding the potential actions they plan to present to the Working Group.
Subcommittee Reports, Potential Actions, and Recommendations
A few members commented that each subcommittee has done a tremendous amount of work and proposed a list of well-thought-out potential actions. They voiced concern that certain important actions might be lost if only three potential actions from each subcommittee can be incorporated into the final list of recommendations to Congress.
Leigh Ann noted that the subcommittee reports will not disappear. If Congress members are interested in a certain topic, she added, they can review the subcommittee reports.
Ben responded that formal recommendations included in the Working Group’s Report to Congress carry different weight from potential actions included in the subcommittee reports. He pointed out that some of the subcommittees’ potential actions may not be actionable by Congress. He noted that the Working Group needs actionable recommendations that can change policies. Another member agreed.
The group briefly discussed how the recommendations could be organized (for example, divided and included in different sections, or put together). Leigh Ann suggested discussing the topic at the March meeting.
Agency Review
Scott C. asked for clarification about the HHS agency review process, to which Jim explained that the agencies will have an opportunity to review the report and ensure accuracy; however, the agencies cannot change the recommendations.
Scott C. commented that for the 2018 Report to Congress, the agencies did not have adequate time to review the report and provide input, and he expressed his hope that there would be time for this type of review during the 2020 process. Ben agreed.
Congressional Briefing
David reported that there will be an opportunity to brief Congress about the written report and recommendations.
Jim explained that the Federal agencies have the option to do so to raise visibility. He suggested the Working Group discuss the topic at the March meeting.
Writing Process and Responsibilities
David noted that he and Leigh Ann will work on the Executive Summary, Background, Methods, Looking Forward/Conclusions sections of the report; and other members of the Working Group will form writing groups to write other chapters. He added that all members of the Working Group will provide input on all sections.
Regarding content, David clarified that the Working Group will develop content for the report to Congress based on the subcommittee reports.
Outline Revision
While some members of the Working Group commented that the current version of the outline appears to be logical for a report to Congress, other members wanted to make sure that the outline is not fixed and that they will have flexibility in the placement of recommendations within the different chapters.
Leigh Ann clarified the outline is still a draft, and that the Working Group still has time to revise it if needed.
Cross-Subcommittee Communication
The group discussed the need for the subcommittee co-chairs to communicate about their potential actions prior to the March meeting. Leigh Ann and David encouraged them to do so as the subcommittee co-chairs are now working on the formal recommendations as Working Group members.
Kaye explained that if the whole Working Group is going to meet, the meeting will be considered a Federal Advisory Committee Act (FACA) meeting and it must be open to the public.
Jim clarified that recommendations can only come from the Working Group members, not subcommittee members.
Closing Remarks
Leigh Ann provided a brief, high-level recap of the day-2 meeting.
- The public provided comments both in person and over the phone. Topics of the public comments included access to care, AGS, Rocky Mountain spotted fever, treatment-related issues, coinfections, MCS, and CDC maps.
- Subcommittees presented subcommittee reports.
- Jim provided an update on the Federal inventory.
- The Working Group members discussed a wide range of topics, including professional associations to reach, anti-tick vaccines, CME conferences, AGS, CDC data, NIH’s Working Group on chronic fatigue syndrome, as well as communication between subcommittee co-chairs before the March meeting.
- The Working Group also reviewed the draft outline for the report to Congress.
David commented that the Working Group had a productive meeting, and he thanked all members for their input.
Adjournment
Jim adjourned the meeting at 3:30 pm
Appendix 1: Tick-Borne Disease Working Group Members and HHS Support Staff
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
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
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
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) – CAP 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 (CMS), 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
Angel M. Davey, PhD, Program Manager, Tick-Borne Disease Research Program, Congressionally Directed Medical Research Programs, U.S. Department of Defense
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 - 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
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
Adalberto (Beto) Pérez de León, MS, PhD, Director, Knipling-Bushland U.S. Livestock Insects Research Laboratory, United States Department of Agriculture—Agricultural Research Service
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)
Patricia V. Smith, President, Lyme Disease Association, Inc.
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 (Present for the morning session)
HHS Support Staff
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
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
Alison 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, Health 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
Appendix 2: TBDWG Subcommittees
Babesiosis and Other Tick-Borne Pathogens Subcommittee
Co-Chair
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
Co-Chair
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
Bryon Backenson, MS, New York State Department of Health Bureau of Communicable Disease Control
Alan Barbour, MD, University of California Irvine School of Medicine and School of Biological Science
Greg Ebel, PhD, Department of Microbiology Immunology and Pathology, Colorado State University
Richard I. Horowitz, MD, Hudson Valley Healing Arts Center
Anne Kjemtrup, DVM, MPVM, PhD, California Department of Public Health Division of Communicable Disease Control
Anna Schotthoefer, PhD, Marshfield Clinic Research Institute, Integrated Research and Development Laboratory
Sam R. Telford III, MS, SD, Cummings School of Veterinary Medicine at Tufts University, Department of Infectious Disease and Global Health
Monica White, President/Co-Founder, Colorado Tick-Borne Disease Awareness Association
Ehrlichiosis and Anaplasmosis Subcommittee
Co-Chair
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
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
John Branda, MD, Clinical Microbiology and Pathology, Harvard University; Massachusetts General Hospital
Stephen Clark, Retired Associated Professor Emeritus, University of Connecticut School of Medicine
J. Stephen Dumler, MD, Professor and Chair, Joint Department of Pathology, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center, Joint Pathology Center
Harold Horowitz, MD, Professor, Department of Medicine (Infectious Diseases), Cornell University—Weill Medical College
Bobbi Pritt, MD, Professor, Vice Chair of Education, Department of Laboratory Medicine and Pathology; Director, Clinical Parasitology Laboratory; Co-Director, Vector-Borne Diseases Laboratory Services
Daniel Sexton, MD, Professor of Medicine (Infectious Diseases), Duke University School of Medicine
Gregory A. Storch, MD, Professor of Pediatrics (Infectious Diseases), Medicine, and Molecular Microbiology; Chief, Division of Pediatric Laboratory Medicine, Washington University
Rickettsiosis Subcommittee
Co-Chair
CAPT Estella Jones, DVM, Deputy Director, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services
Co-Chair
CDR Todd Myers, PhD, Office of the Chief Scientist, Office of Counter Terrorism and Emerging Threats, Food and Drug Administration (Alternate Co-Chair)
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
Lucas Blanton, MD, Associate Professor of Internal Medicine (Infectious Diseases), University of Texas Medical Branch at Galveston
Karen Bloch, MD, MPH, FIDSA, FACP, Associate Professor of Medicine (Infectious Diseases) and Health Policy, Vanderbilt University Medical Center
Vance Fowler, MD, Professor of Medicine, Duke University
Tony Galbo, Father of a child who died of Rocky Mountain spotted fever
David N. Gaines, PhD, State Public Health Entomologist, Virginia Department of Health
Christopher D. Paddock, MD, MPHTM, Rickettsial Zoonoses Branch, CDC
Hayley Yaglom, MS, MPH, One Health Genomics Epidemiologist, Translational Genomics Research Institute
