TBDWG December 12, 2017 - Meeting Summary
Meeting Two Proceedings
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 be heard and valued based on merit and without the bias of titles, eminence, or prestige.
Welcome, Roll Call, Meeting One Summary, Meeting Two Goals
John Aucott, Chair
Kristen Honey, Vice-Chair
The working group Chair, John Aucott, MD, Associate Professor, Division of Rheumatology, Johns Hopkins University School of Medicine; Director, Johns Hopkins Lyme Disease Clinical Research Center, convened the meeting by conducting a roll call of the Tick-Borne Disease Working Group members. All were present with the exception of Vanila Singh and Estella Jones, whose alternates (named on p. 6) stood in for them during portions of the meeting. With a quorum established, John began the meeting by summarizing the previous day’s meeting and identifying the major goal for Meeting Two, which was to continue listening actively and treating others with respect and civility as they share their views. Vice-Chair Kristen Honey, PhD, PMP, Senior Policy Analyst, Office of Management and Budget, Executive Office of the President; Senior Research Scholar, Stanford University; Member, Stanford University Lyme Disease Working Group, stated that all perspectives are valued and will be incorporated into the solutions going forward with an aim of better health through better partnerships.
Kristen then facilitated the following speaker presentations.
Health Care Providers - Key Stakeholder Perspective 1
Samuel Shor, International Lyme and Associated Diseases Society
Samuel (Sam) Shor, MD, FACP, identified three major barriers to the goals of preventing and detecting tick-borne diseases and improving outcomes for those suffering with tick-borne illnesses. All three barriers relate to language in the Infectious Diseases Society of America's clinical practice guidelines. According to Sam, dogmatic adherence to these guidelines inhibits appropriate patient care.
He stated that the first barrier is the two-tiered diagnostic testing, which the Infectious Diseases Society of America (IDSA) guidelines describe as “highly sensitive” for Lyme disease. Sam referenced two studies that conclude the sensitivity to be 50% on average. He also reported that the Virginia Governor’s Task Force on Lyme Disease concluded that no test existed at that time (2011) that could rule out Lyme disease.
The second barrier relates to the following statement in the IDSA guidelines: “There is no convincing biologic evidence for the existence of symptomatic chronic Borrelia burgdorferi infection among patients after receipt of recommended treatment regimens for Lyme disease.” Sam argued that this language perpetuates the belief in the medical community that chronic Lyme disease does not exist. He described chronic Lyme disease as a multisystem illness resulting from an ongoing infection by any pathogenic members of the B. burdorferi complex. He then referenced the following:
- Three studies showing evidence that Lyme disease persists after IDSA recommended protocols have been followed
- Seven studies demonstrating that “short-term antibiotics fail in 25-71% of patients with late stage disease”
- Seven studies documenting “chronic and late manifestations of untreated, active infection”
Sam added that several other factors also contribute to delayed diagnosis and misdiagnosis. These include the absence of the hallmark rash, patients having no recollection of being bitten, and patients presenting with symptoms that resemble other conditions and illnesses.
The third barrier stems from language in the IDSA guidelines that long-term antibiotic therapy is not recommended for treatment of patients who were diagnosed with Lyme disease based on studies that report no benefit from long-term antibiotics. Sam then referenced two National Institutes of Health (NIH)-sponsored trials and four others that “support the benefits of longer term treatment” with antibiotics.
He concluded by urging the working group to “maintain an open, balanced interpretation of the literature.” This in turn would help develop “more appropriate education to clinicians, the public and governmental agencies,” thus “supporting the goals to improve prevention, detection, and outcomes.”
Health Care Providers - Key Stakeholder Perspective 2
Elizabeth Maloney, President, Partnership for Tick-Borne Diseases Education
Participating by phone, Elizabeth Maloney, MD, stated that the purpose of her presentation was to identify knowledge gaps in the prevention, pathogenesis, diagnosis, and treatment of Lyme disease, and to make recommendations for achieving the greatest impact on the greatest number of people. In the longer term, Elizabeth recommended focusing on four areas of research:
- Focus on understanding pathogenesis and immune response. If clinicians can predict how species and strain variations develop in infected individuals, Elizabeth suggested "[they] might be better able to tailor antibiotic regimes based on the identified strain’s pathogenicity and antibiotic susceptibility.” Regarding host-pathogen interactions, clinicians might consider studying variations in clinical presentations to find out whether they stem from “differences between B. burgdorferi strains, differences between hosts, or a combination of these elements.” She reported that sufficient evidence exists that B. burgdorferi can persist following antibiotic therapy, and that some clinicians report that their patients have responded favorably to combination therapy. She identified disease latency, reactivation triggers, and B. burgdorferi survival mechanisms as other areas requiring further research.
- Develop reliable direct tests for B. burgdorferi. Given that “available serologic tests are unreliable…clinicians and researchers need clinically validated methodology that can directly identify B. burgdorferi.”
- Develop a safe, effective, durable vaccine.
- Sponsor trials reflecting community circumstances and patient concerns. The existing trial evidence is inadequate; moreover, it reports averages that cannot be applied effectively to patients with heterogeneous treatment responses. Given its complexity, Elizabeth continued, “Lyme disease does not lend itself to being studied with conventional, randomized controlled trials.” Instead, she recommended gathering information from “multi-centered observational studies in clinician reports.” She added that “conducting trials without a better understanding of pathogenesis and without tests that reliably determine infection status” is counterproductive. Additionally, multiply-infected patients, in particular, need to be represented in future research efforts, she said, since “evidence suggests the potential for pathogen synergy that may have clinical ramifications.”
In the shorter term, Elizabeth recommended implementing awareness and prevention campaigns, providing meaningful physician education with the goal of changing current practices to meet patient needs, and updating the websites at NIH and the Centers for Disease Control and Prevention (CDC) to include “evidence-based information and neutral analysis and presentation of current literature.”
Health Care Providers - Stakeholder Perspective 3
Paul Auwaerter, President, Infectious Diseases Society of America
As stated by Paul Auwaerter, MD, MBA, FIDSA, the goals of the IDSA are closely aligned with those of this working group, including surveillance, prevention, diagnostics, with the intent to provide the best care as evidence can inform in terms of treating Lyme disease.
Paul identified the following five recommendations to inform treatment of tick-borne infections:
- Strengthen surveillance. Given the geographic spread of Borrelia, a need exists for increased surveillance in high risk states, such as Pennsylvania, and neighboring states where cases of Lyme disease and other tick-borne coinfections will be increasing.
- Improve prevention. Although there are potential Lyme disease vaccine candidates, consider whether there is sufficient vaccine research and development, or if further incentives are needed. A new vaccine needs to cover multiple Borrelia species, provide multi-year protection, and have at least an 80 percent efficacy, with no serious adverse reactions. “The vaccine should be made standard for children and adults in states with endemic Lyme disease.” Paul added that prior CDC trials with acaricides showed them to be ineffective. Therefore, any future studies focused on controlling tick populations should be large enough to determine whether “such environmental interventions may benefit human health.”
- Advance diagnostics. Despite its inherent limitations (i.e., immune response dependency), Paul stated that “FDA-approved serologic tests remain the only well-validated diagnostic method, if erythema migrans is absent.” The CDC and others are currently developing direct diagnostic tests and biomarkers; and for future studies in this vane, Paul recommended researchers benchmark against the well-characterized Lyme disease patients in the existing NIH and CDC Serum Reference Repository. Current needs in Lyme disease diagnostics include reduced misinterpretation of test results and fewer false negatives and false positives, improved ability to detect early Lyme disease, development of tests that correlate with microbial cure, and education about using diagnostic Lyme disease tests.
- Ensure all patients receive effective and safe treatment. For patients who do not improve after initial antibiotic therapy, Paul stated that “well-performed, randomized control trials have not shown that giving antibiotics [for longer durations] have yielded…sufficient or durable benefit.” In those trials, the placebo response rate was around 30 percent, so there needs to be evidence that any new therapeutic interventions can improve upon that rate in order to be beneficial. He also noted that long-term antibiotic therapy has resulted in complications associated with antimicrobial resistance.
- Understand mechanisms of persistent symptoms following therapy for Lyme disease.
In conclusion Paul added, “Lyme disease can serve as a model for understanding why fatigue, pain, and sleep disturbance does not improve after antimicrobial treatment. Not unique to Lyme disease, it occurs after infectious mononucleosis [and] Q fever.… This mechanistic understanding can [then] inform both diagnostics and effective clinical therapies.”
Health Care Providers - Stakeholder Perspective 4
Oscar Alleyne, Senior Advisor, National Association of County and City Officials
Oscar Alleyne, DrPH, MPH, began by stating that his organization represents the county and city health departments who are on the front lines of public health. Their role is to provide essential public health services, track and report incidence of illnesses, and communicate with the public about the impact of such illnesses. They also serve as the bridge between the federal government and the community. He reported that upwards of a thousand tick-borne disease cases cross his desk each year; and he has personally witnessed the rapid transition from endemic to emerging threats of tick-borne illness in the Northeast and Midwest. Yet, despite their significant knowledge and experience with tick-borne diseases, county and city health departments struggle to share this information with the federal government and have it integrated into the federal response.
In an effort to bridge this gap, Oscar identified three areas of greatest need at the local and community level:
- The conversion of paper-based reporting to electronic health records to help county and city health departments quickly and efficiently identify, track, and respond to tick-borne illnesses (i.e., surveillance)
- The development of educational modules and tools to engage the public in preventing tick-borne diseases
- The overhaul of vector control data and processes
Oscar encouraged “true partnership and stakeholder engagement” in tackling the challenges of tick-borne diseases. He stressed that county and city governments represent untapped information and technical expertise. Strengthening their ability to report data and communicate their perspectives on prevention and intervention strategies can only contribute to the cause. He concluded by asking the working group how county and city governments can further engage in the process.
Public Health - Stakeholder Perspective 1
Catherine M. Brown, Council of State and Territorial Epidemiologists
Catherine M. Brown, DVM, MSc, MPH, described the Council of State and Territorial Epidemiologists (CSTE) as “an organization of epidemiologists at the state, territorial, local, and tribal levels…that advocates for public health at all levels.” In addition to informing and educating the public about health risks and interventions, a primary function of epidemiologists is performing surveillance. The data they have collected shows a national increase, not only in Lyme disease, but also in anaplasmosis, babesiosis, Powassan virus, and the spotted fever rickettsiosis disease. The increase is occurring even in new tick-borne diseases, including Bourbon virus, heartworm virus, Borrelia mayonii, and Borrelia miyamotoi. It is up to health care providers, public health practitioners, and reporting laboratories to provide surveillance data, which is often incomplete, particularly in areas where the disease incidence is highest. Yet, she said, this data is “critical for defining risk factors for diseases, developing preventive messages, and conducting research.” Therefore, to ensure effective surveillance and prevention of tick-borne illnesses, Catherine made the following recommendations:
- Improve diagnostics, especially for diseases where diagnosis is based on antibody detection rather than pathogen detection.
- Improve access to laboratory testing for emerging diseases such as Powassan.
- Support the development of public health infrastructure with less focus on disease-specific resources and more broad-based support, so that individual jurisdictions can direct resources toward the largest identified gaps.
- Prioritize the use of electronic health records and real-time disease reporting processes (e.g., electronic laboratory reporting and electronic case reporting) for improved surveillance.
- Conduct basic research into methods of effective tick control, in order to have tools that could be applied at a community level rather than relying on the current personal protection messages.
- Assist with outreach to achieve widespread behavioral changes around personal prevention. She emphasized data-driven prevention and educating healthcare providers about the changes in distribution of disease and emerging tick-borne threats, as well as educating the public about the importance of tick bite prevention.
Public Health - Stakeholder Perspective 2
Sara Vetter, Association of Public Health Laboratories
According to Sara Vetter, PhD, the Association of Public Health Laboratories advocates for “building and maintaining a comprehensive surveillance system for the detection of endemic and emerging tick-borne diseases, and investing in the development of new diagnostic approaches.” Her recommendation was based on the following challenges in the current system:
- Limited federal funding despite the expansion of ticks into new areas and the emergence of new tick-borne diseases
- Limited accessibility of diagnostic tools and guidance on the use of diagnostics for emerging tick-borne diseases such as Bourbon and Heartland viruses, Rickettsia philippi, and Borrelia miyamotoi
- Outdated diagnostic tools and guidance on more common pathogens such as Lyme disease
With this context in mind, Sara identified the following recommendations:
- Build the capacity to detect and respond to all tick-borne diseases of public health significance. This “comprehensive and adaptable” system should incorporate epidemiology, laboratory, and entomology resources; characterize regional differences in vector prevalence; and integrate regional differences in tick prevalence and associated pathogens.
- Encourage the development and use of new or improved diagnostic tools, including “multiplex assays” and integrate new laboratory diagnostic capabilities into surveillance programs as emerging pathogens are discovered. According to Sara, this includes “fostering an open dialog between diagnostic manufacturers, diagnostic laboratories, and FDA to enable clearance of assays that fill gaps in the marketplace.” It also includes increasing the appropriate use of recombinant proteins that improve the specificity for serologic assays.
- Encourage widespread access to high quality laboratory tools. Sara noted that “this includes enforcing existing mechanisms to ensure current diagnostic tools meet minimum quality standards; developing mechanisms to promote use of standardized reagents to ensure results, analysis, and interpretations are consistent across all laboratories; ensuring broad geographic access to quality diagnostic testing for all tick-borne diseases through the establishment of laboratory networks…; and establishing national training programs for tick-borne disease testing.”
- Develop updated or new testing guidelines for tick-borne diseases and implement mechanisms to allow for rapid updates when warranted.
- Improve guidelines for and education of clinicians on the appropriate use and interpretation of available diagnostic tools.
John then transitioned the meeting from provider and public health perspectives to the public perspective. Kristen then introduced the public commenters, each of whom had three minutes to describe their experiences and recommendations regarding tick-borne diseases.
The following individuals provided public comment to the Tick-Borne Disease Working Group members.
Tick-Borne Disease Patient
Founder and Director, Ad-Hoc Committee for Health Equity in ICD 11 Borreliosis Codes; Director, Global Network on Institutional Discrimination
Tick-Borne Disease Patient
Board Member, Dean Lyme Center; Tick-Borne Disease Patient and Advocate
Attorney in Defense of Doctors’ Licenses before Medical Boards; Tick-Borne Disease Patient
Tick-Borne Disease Patient
Tick-Borne Disease Patient
Infection Control Practitioner, University of Maryland Medical Center
Tick-Borne Disease Patient
Founder and Director, Lyme Society of New York; Tick-Borne Disease Patient and Advocate
Many public commenters described experiencing similar symptoms and health issues identified by those in the Meeting One session They also identified the following concerns based on the interactions they have had with patients, providers, and insurance companies:
- Commenters feel condescended to and written off, are told they do not have Lyme disease, have been diagnosed as having a psychiatric disorder instead, and have been misdiagnosed for years.
- Many report that Lyme practitioners endanger patients’ lives with their protocols.
- Many suffering from tick-borne illnesses have never tested positive using current diagnostic tests.
- Patients reported being depressed or suicidal from the chronic physical symptoms, which can be severe.
- Patients have limited or no access to providers willing to treat tick-borne diseases.
- Tick-borne disease sufferers have limited access to antibiotics despite the experience that long-term antibiotics were the only treatment available that helped bring them back to baseline health.
- Insurance companies have denied treatment coverage to tick-borne disease patients.
- Providers willing to treat tick-borne illnesses are often penalized by medical boards for prescribing long-term antibiotic treatment. Therefore, mainstream physicians will not provide treatment for fear of losing their license.
- Only holistic practitioners seem willing to support tick-borne disease patients.
- Commenters have been told by providers that chronic Lyme disease does not exist.
Public commenters made several recommendations compiled below in the order they were presented. (Redundancies have been excluded for the sake of concision.)
- Require insurance companies to cover treatment for Lyme disease and other tick-borne illnesses.
- Educate providers about diagnosing and treating chronic Lyme disease.
- Protect physicians who prescribe long-term antibiotics for the treatment of tick-borne illnesses.
- Promote open-minded collaboration among all stakeholders.
- Develop more effective and accurate diagnostic testing and investigate the use of metabolomics and nanoparticles.
- Partner with epidemiologists and the public health sector to identify where the pathogens occur.
Kristen and John concluded the public comment portion of the meeting by emphasizing the importance of each individual’s comments. All perspectives will be considered carefully and incorporated into the Tick-Borne Disease Working Group’s discussions. They then turned over the meeting to the Designated Federal Officer (DFO) who led the discussion on the working group’s governance.
Roles and Responsibilities of Working Group
Richard Wolitski, Designated Federal Officer
Richard (Rich) Wolitski, PhD, Director, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, began the discussion of roles and responsibilities of the working group by clarifying the role of special government employees. He said that they “will not be asked to conform their opinions to any existing policy or procedure”; rather, their role is to “provide their expert opinion…, challenge the issues that are raised in the discussion…, [and] make sure that the information that’s reviewed and discussed is complete.” What’s more, the group will agree on a systematic process for acknowledging differences of opinion. Rich W. encouraged those seeking further information about the role of special government employees to go to the Tick-Borne Disease Working Group website: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html.
Rich W. then described the various roles performed within the working group. The Chair is primarily responsible for the group’s activities, and the Vice-Chair serves as chair when the Chair is not available. Together they work as a team to set agendas; convene, conduct, and adjourn meetings; monitor and track subcommittee meetings; ensure efficiency and productivity; and approve minutes. They work with the DFO and alternate DFO to plan and track the work of the committee and ensure that the work is in alignment with the charter and all applicable regulations, including Federal Advisory Committee Act (FACA) regulations. With the assistance of a subcontractor (in this case, CommunicateHealth), the DFO and alternate DFO provide resources and support required by the group. This includes literature searches, meeting and writing support, and the collection and compilation of public comments.
Including the Chair and Vice-Chair, the working group has fourteen members (this does not include the DFO and alternate DFO). The role of each member is to provide independent subject matter advice and expertise; give input on the working group’s procedures and processes; identify all relevant literature; put forward motions for a vote; vote on issues presented to the group; review minutes; and review and approve the draft report to Congress. Except for the Chair and Vice-Chair, they will also participate in at least one subcommittee. All recommendations and decisions will be reviewed and approved by the full working group.
Review and Discussion of the Charter
Richard Wolitski, Designated Federal Officer
In continuation of the previous day’s discussion, Rich W. reiterated the working group’s charge according to the 21st Century Cures Act (see the full description on page 7). He described FACA and the Government Sunshine Act, which together represent the legal framework and transparency requirement for committees, including for the Tick-Borne Disease Working Group. He also clarified that the role of the working group is to assess what is currently being done, identify gaps, and make recommendations to Congress and the Secretary of Health and Human Services. However, the working group does not implement the recommendations it makes; for example, it does not conduct research or develop programs.
Rich W. stated that the working group adheres to strict laws regarding privacy and confidentiality. As long as consent is given, public comments will be part of the public record. When public commenters name third parties, the working group may contact those individuals named to ensure that they give their consent to be included in the public record.
Rich W. directed meeting participants to the Tick-Borne Disease Working Group website where the public can find regular status updates on the group’s activities: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html. The website also includes information about the foundation of the working group, its charter, its members and staff, meetings, reports, notices, and contact information (email@example.com). The following documents and files will be posted on the website after each working group meeting: videocast recording, transcript, minutes, and presentation slides. With the exception of the video recording, these files will also be posted after each subcommittee meeting. Rich W. stressed the importance that all content related to the working group be accessible and comprehensible to the general public.
He then turned over the meeting to the Chair and Vice-Chair, who opened the discussion of the working group’s vision, mission, and values.
Discussion of Proposed Vision and Mission Statements, and Working Group Values
John Aucott, Chair
Kristen Honey, Vice-Chair
Kristen began the discussion by defining a vision statement as “an aspirational description of what…this working group would like to achieve or accomplish in the mid- or long-term.” She then proposed the following vision statement as a starting point for discussion: “A nation free of tick-borne disease and where evidence-based, patient-centered outcomes return everyone to full wellness.”
John opened the discussion to the working group members, who made the following comments and recommendations:
Given the “lack of funding and difficulty of doing placebo-controlled, randomized clinical trials, Wendy Adams, MBA, Research Grant Director, Bay Area Lyme Foundation, suggested “referencing data without making it incumbent upon perfect data for everything.” Kristen proposed swapping “evidence-based” for “data-driven.” Karen Vanderhoof-Forschner, LLM, JD, MBA, Co-founder, Lyme Disease Foundation, suggested “scientifically supported.” After further discussion, the group decided on “data-driven” because scientific study can be flawed, whereas data is less disputable.
Rich W. suggested revising the original statement to say, “a nation free of tick-borne and related chronic diseases…[given that] Lyme is the great imitator.” The group then sought to clarify whether this statement includes both acute and chronic illness. To make the differentiation between tick-borne and non-tick-borne chronic diseases, Benjamin (Ben) Beard, PhD, Acting 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, suggested the term “associated” instead of “related.” The group also discussed whether to use “illness” versus “disorder” versus “disease,” and ultimately decided to keep the latter.
Karen expressed concern about “the cost to patients for finding medical care” and recommended including a reference to “low-cost evaluations.” Patricia Smith, President, Lyme Disease Association, agreed and suggested the term “economically viable…or feasible” for the patient. Kristen proposed “affordable care.” The group also discussed the terms “broadly available” and “broadly accessible.” They ultimately decided to use the terms “accessible” and “affordable” since accessible care is not necessarily affordable, but ideally it will be.
To make the vision statement feel more personal, Commander Scott Cooper, MMSc, PA-C, United States Public Health Service, 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, recommended changing “outcomes” to “care.”
Kristen suggested transposing “data-driven” and “patient-centered” in order to prioritize the patient.
Vanila Singh, MD, MACM, Chief Medical Officer, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, recommended using the term “compassionate,” but the group ultimately decided against it for the sake of concision.
Karen asked whether to include a statement about physicians having the ability to diagnose and treat patients without fear of punitive action. However, Rich W. indicated that this type of statement would be better placed in a mission statement. Kristen added that using the term “accessible” implies that “doctors in 50 states would have the freedom to prescribe as they see fit.”
Estella Jones, DVM, Director, Medical Countermeasure Regulatory Science and Senior Regulatory Veterinarian, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, U.S. Department of Health and Human Services, suggested replacing “return” with “restore” to which the group agreed. However, Ben argued that using the term “restore” excludes the notion of prevention. In response, Rich W. referenced the language used for HIV and hepatitis, both of which “focus on new infections and then talk about the health and well-being of people who have already contracted them.” He then suggested rewording the statement to “a nation free of tick-borne disease and associated chronic diseases where new infections are rare,” in order to incorporate the concept of prevention.
The discussion resulted in the following proposed vision statement: “A nation free of tick-borne disease and associated chronic diseases where new infections are rare and patients are restored to full wellness, with patient-centered, data-driven, accessible, and affordable care.”
Given time limitations, Patricia moved to table the discussion and finalize the statement over email. All members voted in favor.
- The Tick-Borne Disease Working Group agreed to finalize the vision statement over email.
Kristen also recommended tabling the discussion of the group’s mission in order to maintain the schedule. After the lunch break, John conducted roll call, identified a quorum, and reconvened the meeting, which he turned over to DFO Rich W. to discuss timeline and tasks.
Work Plan Development
Timeline and Tasks
Richard Wolitski, Designated Federal Officer
Rich W. presented the following draft timeline to the working group:
|First and second meeting||December 11 and 12|
|Call regarding subcommittee members||Not later than December 18|
|Minutes, transcript, and presenter slides posted online||December 22|
|Call for subcommittee nominations closes||January 1|
|Third meeting||January 17-26|
|Subcommittees start meeting
||After third meeting in February|
|Inventory request sent||February|
|Chair, Vice-Chair, and DFO support subcommittees and monitor progress||January-May|
|Draft subcommittees reports submitted to working group||Approximately May|
|Writing of working group report starts||May|
|Working group meeting (In person) –finalize recommendations||May—after RBDG meeting|
|Draft report with recommendations||June 15|
|Review and revision of report||July|
|Draft report released for public and agency comment||August 18|
|End of public comment and agency review||September 18|
|Review and summarize public comment||October 18|
|Document revision||November 18|
|Submit report||December 18|
Rich W. turned the meeting over to John to determine what subcommittees are needed and identify the principles for establishing subcommittee members.
John Aucott, Chair
John asked the working group members to review the 21st Century Cures Act, then provided a matrix of content areas and pathogens as a starting point for the group to determine the different types of subcommittees. He then opened up the discussion to the working group who made the following suggestions:
Patricia suggested subcommittees devoted to testing and diagnosis, pathogenesis, transmission, vectors, and tick-borne diseases other than Lyme disease. Karen agreed that disease burden is an important factor and suggested including wording about coinfections. She also suggested grouping transmission with pathogenesis, which prompted John to point out that pathogenesis drives treatment. He then proposed grouping the three together.
Ben divided diagnosis into two components: the practice of diagnosis by physicians, which involves an educational component; and the tests available for conducting diagnostics.
Lise Nigrovic, MD, MPH, Director, Population Health Sciences and Health Services Research Center of the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; Chair, Pediatric Emergency Medicine Collaborative Research Committee, American Academy of Pediatrics, recommended a subcommittee devoted to prevention—both tick- and vaccine-based—and surveillance. Although he believes it is important, Ben questioned whether surveillance should be a priority since it is practiced at the state rather than federal level, and any recommendations the group makes to Congress may not result in significant change. Patricia countered that the working group is charged with uncovering problems, which includes surveillance because it prevents patients from getting diagnosed and treated in many regions of the country. Wendy and Richard Horowitz, MD, Member, World Health Organization’s Ad Hoc Committee for Health Equity, supported the inclusion of surveillance, which Vanila clarified should comprise epidemiological services.
Patricia identified access to care as another major obstacle for tick-borne disease sufferers. Scott suggested grouping “access to care” with “support for patients,” which would include both provider and patient education and be in keeping with the 21st Century Cures Act.
John and Wendy both agreed that there should be a separate committee devoted exclusively to non-Lyme tick-borne diseases and their coinfections because they often get grouped with Lyme disease despite significant differences. However, Karen highlighted the importance of analyzing Lyme disease and the coinfections from the same tick. Wendy made the case that having a separate group devoted to non-Lyme tick-borne diseases would provide an opportunity to gain significant knowledge about those diseases, which would then serve as a “springboard for setting up the federal response to those illnesses.” To prevent the subcommittees from working in silos, Estella added that the non-Lyme subcommittee would be encouraged to exchange ideas with the other groups regarding different issues, and vice versa.
The group discussed at length the issue of vaccines. Karen clarified that the group should not engage in evaluating or promoting specific products. However, Dennis Dixon, PhD.
Chief, 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, along with Vanila and Ben, highlighted the importance of innovative research in vaccine development and agreed that the group should not be restricted from advocating for further research, if deemed appropriate. Ben and Karen suggested having a subcommittee devoted to vaccines and therapeutics, including immunotherapy.
Finally, the group identified cross-cutting themes that would be discussed in all of the subcommittees. These included education, research, and special populations—for example people of color whose rashes may appear black and blue rather than the red that physicians expect to see. (Karen had encountered this circumstance and reported it to the group as an example.)
The group’s discussion resulted in the following list of subcommittees:
- Disease vectors, surveillance and prevention (includes epidemiology of tick-borne diseases)
- Pathogenesis, transmission, and treatment
- Testing and diagnostics (includes laboratory-based diagnoses and clinical diagnoses)
- Access to care services and support to patients
- Vaccine and therapeutics
- Other tick-borne diseases and coinfections
Patricia moved to accept the list of subcommittees. All members voted in favor.
John then turned the group’s attention to the topic of subcommittee membership.
John Aucott, Chair
Kristen Honey, Vice-Chair
Before the discussion began, members requested clarification about the type of information the working group and its subcommittees would be investigating.
Scott asked whether the group will investigate only federal activities or whether it will also explore what is being done in other sectors of society. Rich W. explained that the 21st Century Cures Act charges the working group with examining what the federal government, particularly the Department of Health and Human Services (HHS), “is doing with taxpayer dollars and whether that money is being used well.” The working group is not charged with assessing the activities of non-federal entities and, for example, private drug manufacturers.
Patricia then inquired about the investigations of unofficial federal tick-borne disease working groups already in existence and how to access the information they have collected in order to prevent redundant efforts. Ben clarified that there are two unofficial federal working groups. One of them is devoted to pest management and published a white paper that offers a review of the prevention activities of ten different federal agencies (see below). The other informal group was initiated by CDC and NIH to begin coordinating HHS activities around tick-borne diseases and reduce duplication of efforts. The latter produced webinars that are also available online (see below).
Federal Initiative: Tick-Borne Disease Integrated Pest Management White Paper (2014); https://www.ars.usda.gov/ARSUserFiles/np104/TBD_IPM_WG_Final_White_Paper%2026%20February%202014.pdf
HHS Working Group on Lyme and Other Tickborne Diseases
Webinar: Trends in Tickborrne Diseases in the United States (June 9, 2016)
Webinar: Updates on Tickborne Disease Diagnostics (June 8, 2017)
The working group members agreed they would inventory these materials, and when relevant, they would invite subject matter experts from the unofficial groups to present at working group meetings.
John then directed the discussion to the process and principles of identifying subcommittee members. Their decisions are reflected below.
The 21st Century Cures Act requires that the subcommittees reflect inclusivity, diversity of opinions, and expertise. Each subcommittee will comprise eight to ten members, at least one of whom will be a patient or patient advocate. All working group members will participate in at least one subcommittee, except for the chair and vice-chair who will audit meetings, track activities, and focus on the big picture. To foster collaboration and prevent redundancy, the information presented by non-members in one subcommittee meeting will later be shared with all subcommittees.
While subcommittee members may vote on issues that are relevant to their work and their discussions, only the full working group can decide and vote on recommendations that will be made in the report to Congress. Each subcommittee will have two co-chairs—one of whom will be a working group member—to help manage discussions.
The selection process will be similar to the one used to identify the working group members. Individuals can nominate others or themselves, and selection will be merit-based and reflect the values of the working group. The group will also consider those who have already been nominated but not selected for the working group. In that case, they would not have to reapply but could provide supplemental information if they chose. Working group members will review the applications and discuss their recommendations with the Chair and Vice-Chair.
Kristen moved to vote on these principles for selecting and structuring subcommittees. All voted in favor.
Kristen proposed a motion to put out a call for nominations, opening December 18th and closing January 1st, 2018, through the HHS website, with the caveat that those who are already in the pool can resubmit their existing application or customize it to show their expertise in a specific area. Patricia seconded the motion and added that subcommittee nominees will be able to indicate which subcommittee they are most interested in joining. All voted in favor.
- Rich W. agreed to put out a call for subcommittee nominations, which would be gathered in early January for the working group to review.
Kristen turned over the meeting to Rich W. to discuss upcoming meetings.
Richard Wolitski, Designated Federal Officer
Before discussing upcoming meetings, Lise asked for more specific information about the nature of the work the subcommittees will be conducting. John clarified that they will be taking an inventory, obtaining reports from the various agencies about their work, reviewing literature and public comments, and bringing in experts to provide content, all with an eye toward identifying gaps and areas of need.
Rich W. directed the discussion to the third meeting, which will be virtual and scheduled to take place between January 17th and 26th, 2018. All working group and subcommittee members will be asked to attend. It will be at this time that they can discuss inventory and make requests to the agencies.
John motioned to adjourn the meeting. All were in favor.
- All working group members agreed to respond to the poll that will be used to schedule the third working group meeting.
- All working group members agreed to send in their requests for stakeholder perspectives to be include in the third public meeting.
- DFO Rich W. and the HHS team agreed to facilitate the previous step and manage the information.